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{\*\generator Microsoft Word 10.0.6612;}{\info{\title The \'93New\'94 Politics of Abortion}{\author Jamie Lynn Bartholomew}{\operator Computing Services}{\creatim\yr2006\mo5\dy30\hr15\min18}{\revtim\yr2006\mo5\dy30\hr15\min18}
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This paper is submitted in satisfaction of the Food and Drug Law course requirement as well as the third year written paper requirement.}{\b0\fs22\insrsid4522186 
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\par }\pard\plain \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15415470 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid15415470 
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\fs22\insrsid15415470\charrsid14436599 . . . . . . . . . . . . . . . . . . .}{\fs22\insrsid14436599  . .}{\fs22\insrsid15415470\charrsid14436599  }{\fs22\insrsid4522186 .}{\fs22\insrsid15415470\charrsid14436599  }{\fs22\insrsid4522186  iv}{
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\par }{\fs22\insrsid4990389 Abstract . . . . . . . . . . . . . . . . . . . . . . . . . . .  v
\par 
\par }{\fs22\insrsid15415470\charrsid14436599 CHAPTER ONE: An}{\fs22\insrsid1915669  Introduction to the Off-Label U}{\fs22\insrsid15415470\charrsid14436599 se of }{\fs22\insrsid4522186 
\par }{\fs22\insrsid15415470\charrsid14436599 Acepromazine Maleate . . . }{\fs22\insrsid4522186 . . . . . . . . . . . . . .}{\fs22\insrsid3962652\charrsid14436599  }{\fs22\insrsid4522186 . . .}{\fs22\insrsid3962652\charrsid14436599  }{\fs22\insrsid4990389 .}{
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\par 
\par CHAPTER TWO: }{\fs22\insrsid14090637\charrsid14436599 The }{\fs22\insrsid15415470\charrsid14436599 F}{\fs22\insrsid1915669 ood and }{\fs22\insrsid15415470\charrsid14436599 D}{\fs22\insrsid1915669 rug }{\fs22\insrsid15415470\charrsid14436599 A}{
\fs22\insrsid1915669 dministration\rquote s}{\fs22\insrsid15415470\charrsid14436599  Regulation of Animal Drugs and }{\fs22\insrsid15480886 th}{\fs22\insrsid15607008 eir Off-Label Uses}{\fs22\insrsid15480886 . . .}{\fs22\insrsid15415470\charrsid14436599  
}{\fs22\insrsid1915669 . }{\fs22\insrsid15607008 . . . . . . . . . }{\fs22\insrsid14764965 1}{\fs22\insrsid4990389 7}{\fs22\insrsid15415470\charrsid14436599 
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\par }\pard \s20\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14238584 {\fs22\insrsid15415470\charrsid14436599 CHAPTER THREE: Use or Abuse: The }{\fs22\insrsid1915669 Off-Label U}{\fs22\insrsid3997818 se of }{
\fs22\insrsid4522186 
\par }{\fs22\insrsid3997818 Acepromazine Maleate}{\fs22\insrsid1915669  by Foxhunters  . . . }{\fs22\insrsid3997818  . .}{\fs22\insrsid15415470\charrsid14436599  . . . }{\fs22\insrsid4522186 . . . .}{\fs22\insrsid3997818  }{\fs22\insrsid1915669   49}{
\fs22\insrsid14238584 
\par }{\fs22\insrsid4522186\charrsid14436599 
\par }\pard\plain \s23\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15415470 \b\f2\fs44\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b0\fs22\insrsid15415470\charrsid14436599 CH}{\b0\fs22\insrsid15156867 
APTER FOUR: What, if Anything, }{\b0\fs22\insrsid6307569 s}{\b0\fs22\insrsid15156867 hould }{\b0\fs22\insrsid6307569 the Food and Drug Administration do}{\b0\fs22\insrsid15415470\charrsid14436599  }{\b0\fs22\insrsid7760612\charrsid14436599 about }{
\b0\fs22\insrsid15415470\charrsid14436599 the Off-Label use of Acepr}{\b0\fs22\insrsid7760612\charrsid14436599 omazine }{\b0\fs22\insrsid6307569 
\par }{\b0\fs22\insrsid7760612\charrsid14436599 Maleate}{\b0\fs22\insrsid6307569  . . . .}{\b0\fs22\insrsid7760612\charrsid14436599  . . . . . . .}{\b0\fs22\insrsid4522186  . . . . .}{\b0\fs22\insrsid6307569  . . . . . . . . . . .}{
\b0\fs22\insrsid15415470\charrsid14436599  }{\b0\fs22\insrsid4522186  }{\b0\fs22\insrsid15156867 6}{\b0\fs22\insrsid4990389 8}{\b0\fs22\insrsid15415470\charrsid6307569 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15415470 {\b0\insrsid15415470 
\par 
\par }\pard \s23\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6307569 {\b0\insrsid15415470 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15415470 {\b0\insrsid15415470 
\par 
\par 
\par 
\par 
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\par }{\insrsid15415470 
\par }{\fs24\insrsid14238584 
\par }\pard \s23\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14238584 {\fs24\insrsid14238584\charrsid14238584 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15415470 {\insrsid15415470 
\par }{\fs22\insrsid15415470 
\par }{\fs22\insrsid4655374 
\par }{\fs22\insrsid4990389 
\par 
\par }\pard \s23\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4990389 {\fs22\insrsid4655374\charrsid4655374 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4655374 {\b0\fs22\insrsid4655374 
\par }\pard \s23\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6307569 {\b0\fs22\insrsid6307569 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4990389 {\b0\fs22\insrsid15156867 i}{\b0\fs22\insrsid15415470\charrsid4655374 ii}{\b0\fs22\insrsid16277351\charrsid4655374 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15415470 {\fs40\insrsid15415470\charrsid14238584 ACKNOWLEDGEMENTS
\par }{\fs24\insrsid15415470\charrsid14238584 
\par }{\b0\fs24\insrsid15415470\charrsid14238584 
\par }\pard \s23\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15415470 {\b0\fs22\insrsid15415470\charrsid14436599 
I would like to first thank my advisor, Mr. Peter Barton Hutt, for his enthusiasm, guidance, expertise, and patience.  I am }{\b0\fs22\insrsid6627117 deeply grateful}{\b0\fs22\insrsid15415470\charrsid14436599  to
 him for his advice and support.  I would also like to thank my }{\b0\fs22\insrsid8390050 friends, }{\b0\fs22\insrsid15415470\charrsid14436599 family,}{\b0\fs22\insrsid8390050  }{\b0\fs22\insrsid15415470\charrsid14436599 
and especially my grandmother, who has made everything possible for me.
\par }{\insrsid15415470 
\par }{\insrsid14436599 
\par }{\insrsid15415470 
\par 
\par 
\par 
\par 
\par }\pard \s23\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4655374 {\insrsid4655374 
\par }\pard\plain \s20\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14238584 \f2\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\insrsid14238584 
\par }\pard \s20\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14238584 {\fs22\insrsid4655374 
\par 
\par 
\par }\pard \s20\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4990389 {\fs22\insrsid4990389 i}{\fs22\insrsid4655374 v}{\fs22\insrsid4990389 
\par }\pard\plain \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4990389 \b\f2\fs44\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs40\insrsid4990389\charrsid14238584 A}{\fs40\insrsid4990389 BSTRACT}{
\fs40\insrsid4990389\charrsid14238584 
\par }\pard\plain \s20\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4990389 \f2\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs22\insrsid4990389 
\par 
\par }\pard \s20\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1915669 {\fs22\insrsid13309113\charrsid1915669 In this paper, I }{\fs22\insrsid1732703\charrsid1915669 offer an evaluation of }{
\fs22\insrsid13309113\charrsid1915669 the off-label use of Acepromazine Maleate by foxhunters.  In Chapter One, I provide readers with}{\fs22\insrsid1732703\charrsid1915669  an}{\fs22\insrsid13309113\charrsid1915669 
 explanation of the most important elements of the topic, including what Acepromazine Maleate is, the nature of its off-label use, and how the Animal Medicinal Drug Use Clarification Act of 1994 affects the off-label use of the drug.  I also }{
\fs22\insrsid1915669 offer}{\fs22\insrsid13309113\charrsid1915669  readers a roadmap of the remainder of the paper, and I conclude }{\fs22\insrsid1732703\charrsid1915669 C}{\fs22\insrsid13309113\charrsid1915669 hapter }{
\fs22\insrsid1732703\charrsid1915669 One }{\fs22\insrsid13309113\charrsid1915669 with a literature review. }{\fs22\insrsid1732703\charrsid1915669  }{\fs22\insrsid13309113\charrsid1915669 In Chapter Two, I examine }{\fs22\insrsid1732703\charrsid1915669 how
}{\fs22\insrsid13309113\charrsid1915669  the Food and Drug Administration regulates animal drugs, as well as how it handles the off-label use of drugs}{\fs22\insrsid1732703\charrsid1915669 
 in animals.  In Chapter Three, I consider the off-label use of Acepromazine Maleate, analyzing}{\fs22\insrsid13309113\charrsid1915669  the physiological effects of the drug, its labeled uses, side effects, as well as}{
\fs22\insrsid1732703\charrsid1915669  its}{\fs22\insrsid13309113\charrsid1915669  off-label uses.}{\fs22\insrsid1732703\charrsid1915669   In doing so, I take into account the perspectives of both foxhunters and veterinarians.}{
\fs22\insrsid13309113\charrsid1915669  }{\fs22\insrsid1732703\charrsid1915669  In Chapter Four, I conclude the paper by offering an assessment of the off-label use of Acepromazine Maleate}{\fs22\insrsid1915669\charrsid1915669  by foxhunters}{
\fs22\insrsid1732703\charrsid1915669 .  I argue that although the drug is currently being used by foxhunters with }{\fs22\insrsid1915669 great}{\fs22\insrsid1732703\charrsid1915669  frequency, it is also being used by foxhunters with }{
\fs22\insrsid7944375 great}{\fs22\insrsid1732703\charrsid1915669  precaution, making it}{\fs22\insrsid7944375 , in the vast majority of cases,}{\fs22\insrsid1915669\charrsid1915669  both}{\fs22\insrsid1732703\charrsid1915669 
 safe and effective.  Veterinarians, however, need to do more on their end to comply with Food and Drug Administration regulations and }{\fs22\insrsid7944375 labeling }{\fs22\insrsid1732703\charrsid1915669 requirements, to ensure that this level of }{
\fs22\insrsid1915669\charrsid1915669 safety}{\fs22\insrsid1732703\charrsid1915669  does not drop.}{\fs22\insrsid4990389\charrsid1915669 
\par }\pard \s20\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4990389 {\fs22\insrsid4990389\charrsid1915669 
\par 
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\par }\pard \s20\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1915669 {\fs22\insrsid4990389\charrsid1915669 v}{\fs22\insrsid4990389\charrsid16277351 
\par }\pard \s20\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14238584 {\b\fs44\insrsid5205424 CHAPTER ONE
\par }\pard\plain \qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\fs24\insrsid5205424 
\par }{\f2\fs24\insrsid2888040 
\par }{\f2\fs24\insrsid13382162 
\par }\pard\plain \s1\qc \li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0 \f2\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs44\insrsid5205424 An Introduction to the }{\b\fs44\insrsid11471190 
Off-Label Use of Acepromazine Maleate}{\b\fs44\insrsid5205424 
\par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\fs24\insrsid5205424 
\par }{\f2\fs24\insrsid8350940 
\par }{\f2\fs24\ul\insrsid8350940\charrsid2440761 
\par }{\f2\fs22\ul\insrsid8350940\charrsid14436599 INTRODUCTION}{\f2\fs22\ul\insrsid8350940\charrsid460529 
\par }{\i\f2\fs22\insrsid4655374\charrsid14436599 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15355150 {\f2\fs22\insrsid8742295\charrsid14436599 \'93It takes the buck}{\cs17\f2\fs22\super\insrsid8742295\charrsid14436599 \chftn {\footnote 
\pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8742295 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  To \'93buck\'94 is for a horse to leap upward arching the back. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/buck" }{\f2\insrsid2450573\charrsid2450573 
{\*\datafield 
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\f2\insrsid2450573\charrsid2450573  (March 14, 2005).
\par }}}{\f2\fs22\insrsid8742295\charrsid14436599  out of them }{\f2\fs22\insrsid2450573\charrsid14436599 ...\'94}{\f2\fs22\insrsid8742295\charrsid14436599  one woman explained \'93I would not hunt}{\cs17\f2\fs22\super\insrsid8742295\charrsid14436599 \chftn 
{\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8742295 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  A \'93hunt\'94 entails mounted hunters follow hounds in pursuit of a 
\par }\pard \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11824650 {\f2\insrsid2450573\charrsid2450573 fox. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://www.thefreedictionary.com/foxhunt" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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5200000068007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f0066006f007800680075006e0074000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 
http://www.thefreedictionary.com/foxhunt}}}{\f2\insrsid2450573\charrsid2450573  (March 14, 2005).
\par }}}{\f2\fs22\insrsid8742295\charrsid14436599  this horse without at least one-and-a-half CCs}{\cs17\f2\fs22\super\insrsid8742295\charrsid14436599 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11824650 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 A CC is a metric unit of volume equal to one thousandth of a 
\par }\pard \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11824650 {\f2\insrsid2450573\charrsid2450573 liter. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://www.thefreedictionary.com/CC" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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70003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f00430043000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/CC}}}{
\f2\insrsid2450573\charrsid2450573  (March 14, 2005).
\par }}}{\f2\fs22\insrsid15598017\charrsid14436599 .\'94}{\cs17\f2\fs22\super\insrsid8390050 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8390050 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Anonymous Interview #33. Interview on file with author. Conducted on January 29, 2005 in Unionville, PA. }}
}{\f2\fs22\insrsid15598017\charrsid14436599   \'93Broken backs, cracked ribs, shattered patellae, and concussions are }{\f2\fs22\insrsid4936104\charrsid14436599 all too }{\f2\fs22\insrsid15598017\charrsid14436599 
common on the hunt field because of the crazy horses some people ride without taking the necessary precautions.  Just }{\f2\fs22\insrsid6292383\charrsid14436599 the other day, in fact, a woman}{\f2\fs22\insrsid15598017\charrsid14436599 \rquote 
s horse bucked her off and she landed on }{\f2\fs22\insrsid4936104\charrsid14436599 her head}{\f2\fs22\insrsid15820710\charrsid14436599 . }{\f2\fs22\insrsid8390050  }{\f2\fs22\insrsid15820710\charrsid14436599 S}{\f2\fs22\insrsid5050870 he was wearing a d}
{\f2\fs22\insrsid16193158\charrsid14436599 erby}{\cs17\f2\fs22\super\insrsid16193158\charrsid14436599 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11824650 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  A derby is a stiff felt hat with a rou
nd crown and a narrow, curved brim. Also known as the Bowler, this Derby hat popular for the past century and a half, has been worn by personalities ranging from Charlie Chaplin to Dion Sanders.}}}{\f2\fs22\insrsid16193158\charrsid14436599 , which }{
\f2\fs22\insrsid6292383\charrsid14436599 of course }{\f2\fs22\insrsid16193158\charrsid14436599 offer}{\f2\fs22\insrsid15820710\charrsid14436599 s l}{\f2\fs22\insrsid8390050 ittle to no head protection.  S}{\f2\fs22\insrsid15598017\charrsid14436599 he was 
}{\f2\fs22\insrsid16193158\charrsid14436599 knocked }{\f2\fs22\insrsid15598017\charrsid14436599 unconscious for seven minutes and had to be airlift}{\f2\fs22\insrsid15820710\charrsid14436599 ed to the nearest trauma center}{
\f2\fs22\insrsid4936104\charrsid14436599 ...}{\f2\fs22\insrsid15598017\charrsid14436599 \'94}{\cs17\f2\fs22\super\insrsid8390050 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12128273 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #12. Interview on file with author. Conducted on January 29, 2005 in Unionville, PA.
\par }}}{\f2\fs22\insrsid15598017\charrsid14436599   }{\f2\fs22\insrsid15820710\charrsid14436599 It is \'93just like a cocktail}{\f2\fs22\insrsid8742295\charrsid14436599 \'94 another interviewee offered \'93
it makes him relax.  Without it, he spends the entire day jigging}{\f2\fs22\insrsid12128273 ,}{\cs17\f2\fs22\super\insrsid8742295\charrsid14436599 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8742295 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  To \'93
jig\'94 is to move or bob up and down jerkily and rapidly. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/Jig" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\f2\insrsid2450573\charrsid2450573  (March 14, 2006).}}}{\f2\fs22\insrsid12128273  }{\f2\fs22\insrsid12128273\charrsid14436599 and quite frankly, ruins an otherwise lovely day of hunting.}{\f2\fs22\insrsid8742295\charrsid14436599 \'94}{
\cs17\f2\fs22\super\insrsid12128273 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12128273 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Anonymous Interview #14. Interview
 on file with author. Conducted on January 30, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid8742295\charrsid14436599   \'93}{\f2\fs22\insrsid13382162\charrsid14436599 It }{\f2\fs22\insrsid8742295\charrsid14436599 is}{
\f2\fs22\insrsid13382162\charrsid14436599  really}{\f2\fs22\insrsid8742295\charrsid14436599  a matter of safety ...\'94 a third }{\f2\fs22\insrsid6892570\charrsid14436599 interviewee}{\f2\fs22\insrsid8742295\charrsid14436599  commented, \'93}{
\f2\fs22\insrsid13313026\charrsid14436599 for you}{\f2\fs22\insrsid8742295\charrsid14436599 , your horse, the other riders}{\f2\fs22\insrsid7944375  on the hunt }{\f2\fs22\insrsid6109552\charrsid14436599 field}{\f2\fs22\insrsid8742295\charrsid14436599 
, their horses ... even the hounds}{\cs17\f2\fs22\super\insrsid8742295\charrsid14436599 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8742295 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8742295 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  A \'93hound\'94 or \'93foxhound\'94
 is a medium-sized glossy-coated hounds developed for hunting foxes. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/hound" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002700000068007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f0068006f0075006e0064000000e0c9ea79f9bace118c8200aa004ba90b4e000000
68007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f0068006f0075006e0064000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/hound
}}}{\f2\insrsid2450573\charrsid2450573  (March 14, 2005).}}}{\f2\fs22\insrsid13382162\charrsid14436599 !  }{\f2\fs22\insrsid8742295\charrsid14436599 I have watched a jittery horse kick a }{\f2\fs22\insrsid15598017\charrsid14436599 hound }{
\f2\fs22\insrsid12128273 directly in the }{\f2\fs22\insrsid7944375 head}{\f2\fs22\insrsid15598017\charrsid14436599  and }{\f2\fs22\insrsid7944375 knock it dead}{\f2\fs22\insrsid15598017\charrsid14436599 !\'94}{\cs17\f2\fs22\super\insrsid12128273 \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12128273 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #11. Interview on file with author. Conducted on February 1, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid15598017\charrsid14436599  }{\f2\fs22\insrsid15355150\charrsid14436599 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15355150 {\f2\fs22\insrsid15355150\charrsid14436599 
\par }{\f2\fs22\insrsid2440761\charrsid14436599 
\par }{\f2\fs22\ul\insrsid15355150\charrsid14436599 ACEPROMAZINE MALEATE}{\f2\fs22\ul\insrsid15355150 
\par }{\f2\fs22\insrsid15355150\charrsid14436599 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6109552 {\f2\fs22\insrsid8742295\charrsid14436599 What exactly is \'93it\'94?  What does \'93it\'94 do?  How does \'93it\'94
 work?  Why are so many foxhunters }{\f2\fs22\insrsid13382162\charrsid14436599 offering}{\f2\fs22\insrsid8742295\charrsid14436599  \'93it\'94}{\f2\fs22\insrsid13382162\charrsid14436599  such a ringing endorsement}{\f2\fs22\insrsid8742295\charrsid14436599 
?  \'93It\'94 is Acepromazine Maleate, commonly referred to in the foxhunting community as simply \'93Ace.\'94  }{\f2\fs22\insrsid2888040\charrsid14436599 Ace}{\f2\fs22\insrsid4936104\charrsid14436599 promazine Maleate}{
\f2\fs22\insrsid2888040\charrsid14436599  is available}{\f2\fs22\insrsid6109552\charrsid14436599  only}{\f2\fs22\insrsid2888040\charrsid14436599  by prescription from a veterinarian.}{\cs17\f2\fs22\super\insrsid4413482 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4413482 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 PromAce Injectable (Acepromazine Maleate Injection, USP) Label, Ford Dodge Animal Health, Fort Dodge Iowa 50501 USA, Rev. Apr. 2002.}}}{\f2\fs22\insrsid2888040\charrsid14436599  Fort Dodge Animal Health, the }{\f2\fs22\insrsid6109552\charrsid14436599 
manufacturer}{\f2\fs22\insrsid2888040\charrsid14436599  of PromAce Injectable, th}{\f2\fs22\insrsid13592819\charrsid14436599 e most commonly }{\f2\fs22\insrsid15820710\charrsid14436599 prescribed}{\f2\fs22\insrsid13592819\charrsid14436599  }{
\f2\fs22\insrsid2888040\charrsid14436599 form of Acepromazine Maleate, summarizes the drug\rquote }{\f2\fs22\insrsid7412644\charrsid14436599 s labeled uses on the}{\f2\fs22\insrsid6109552\charrsid14436599 
 insert accompanying the vial of Acepromazine Maleate:}{\f2\fs22\insrsid2888040\charrsid14436599  \'93}{\f2\fs22\insrsid6109552\charrsid14436599 
PromAce Injectable can be used as an aid in controlling fractious animals during examination, treatment, loading, and transportation}{\f2\fs22\insrsid2888040\charrsid14436599 .}{\f2\fs22\insrsid6109552\charrsid14436599 
  Particularly useful when used in conjunction with local anesthesia for firing, castration, neurectomy, removal of skin tumors, ocular surgery, and applying casts.\'94}{\cs17\f2\fs22\super\insrsid12128273 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12128273 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 PromAce Injectable (Acepromazine Maleate Injection, USP) Label, Ford Dodge Animal Health, Fort Dodge Iowa 50501 USA, Rev. Apr. 2002.}}}{\f2\fs22\insrsid2888040\charrsid14436599  }{\f2\fs22\insrsid6109552\charrsid14436599 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2440761 {\f2\fs22\insrsid6109552\charrsid14436599 Surprisingly }{\f2\fs22\insrsid16204001\charrsid14436599 - }{
\f2\fs22\insrsid6109552\charrsid14436599 or not so surprisingly}{\f2\fs22\insrsid2638932\charrsid14436599  upon }{\f2\fs22\insrsid13592819\charrsid14436599 close}{\f2\fs22\insrsid7944375 r}{\f2\fs22\insrsid13592819\charrsid14436599  examination}{
\f2\fs22\insrsid2638932\charrsid14436599  of the p}{\f2\fs22\insrsid16204001\charrsid14436599 hysiological effects of }{\f2\fs22\insrsid7944375 the drug }{\f2\fs22\insrsid16204001\charrsid14436599 -}{\f2\fs22\insrsid6109552\charrsid14436599 
 no mention is made of the drug\rquote s use for r}{\f2\fs22\insrsid13592819\charrsid14436599 iding}{\f2\fs22\insrsid6109552\charrsid14436599  purposes. }{\f2\fs22\insrsid4413482  Foxhunters, however, }{\f2\fs22\insrsid4413482\charrsid14436599 are }{
\f2\fs22\insrsid13982452 nonetheless }{\f2\fs22\insrsid4413482\charrsid14436599 administering the drug }{\f2\fs22\insrsid14960912 to their horses }{\f2\fs22\insrsid7944375 with great frequency, }{\f2\fs22\insrsid14960912 i}{
\f2\fs22\insrsid4413482\charrsid14436599 n a capacity not tested and/or approved by the Food and Drug Administration}{\f2\fs22\insrsid4413482 .}{\f2\fs22\insrsid4413482\charrsid14436599   }{\f2\fs22\insrsid4413482 Are they violating Federal law}{
\f2\fs22\insrsid13982452  and possibly subjecting themselves to civil and/or criminal sanctions }{\f2\fs22\insrsid4413482 in their efforts to }{\f2\fs22\insrsid13982452 keep }{\f2\fs22\insrsid7944375 their horses}{\f2\fs22\insrsid13982452  }{
\f2\fs22\insrsid7944375 calm}{\f2\fs22\insrsid13982452  while foxhunting}{\f2\fs22\insrsid7944375  them}{\f2\fs22\insrsid13982452 ?}{\f2\fs22\insrsid2440761 
\par }{\f2\fs22\insrsid13982452\charrsid14436599 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2440761 {\f2\fs22\ul\insrsid2440761\charrsid14436599 THE ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994}{\f2\fs22\ul\insrsid14764965\charrsid14764965 
\par }{\f2\fs22\insrsid14764965\charrsid14436599 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 {\f2\fs22\insrsid6109552\charrsid14436599 The Animal Medicinal Drug}{\f2\fs22\insrsid16204001\charrsid14436599 
 Use Clarification Act of 1994 }{\f2\fs22\insrsid6109552\charrsid14436599 amended the Federal Food, Drug, and Cosmetic Act to clarify the }{\f2\fs22\insrsid15820710\charrsid14436599 Federal Food, Drug, and Cosmetic }{
\f2\fs22\insrsid6109552\charrsid14436599 Act}{\f2\fs22\insrsid2638932\charrsid14436599  in regar}{\f2\fs22\insrsid16193158\charrsid14436599 ds to }{\f2\fs22\insrsid15820710\charrsid14436599 \'93}{\f2\fs22\insrsid16193158\charrsid14436599 other uses}{
\f2\fs22\insrsid15820710\charrsid14436599 \'94}{\f2\fs22\insrsid16193158\charrsid14436599  of animal drug}{\f2\fs22\insrsid15820710\charrsid14436599 s}{\f2\fs22\insrsid2638932\charrsid14436599 . }{\f2\fs22\insrsid13982452  }{
\f2\fs22\insrsid2638932\charrsid14436599 In particular, }{\f2\fs22\insrsid13592819\charrsid14436599 a drug can be used in an off-label capacity as long as the different use is prescribed by a }{\f2\fs22\insrsid16204001\charrsid14436599 veterinarian}{
\f2\fs22\insrsid13592819\charrsid14436599  }{\f2\fs22\insrsid15820710\charrsid14436599 who has}{\f2\fs22\insrsid13592819\charrsid14436599  an ongoing relationship with the horse}{\f2\fs22\insrsid15820710\charrsid14436599  and }{
\f2\fs22\insrsid16193158\charrsid14436599 owner, }{\f2\fs22\insrsid4936104\charrsid14436599 the use is not in or on animal feed}{\f2\fs22\insrsid16193158\charrsid14436599 ,}{\f2\fs22\insrsid4936104\charrsid14436599 
 and it complies with the regulations provided by the Secretary of Health and Human Services}{\f2\fs22\insrsid13592819\charrsid14436599 .}{\cs17\f2\fs22\super\insrsid15820710\charrsid14436599 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15820710 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  \'93The New Extra-Label Use Law: An Overview,\'94 by Jeannie Perron, Esq. Texas A&M \lquote 97}}}{\f2\fs22\insrsid13592819\charrsid14436599  }{
\f2\fs22\insrsid13982452  The f}{\f2\fs22\insrsid16193158\charrsid14436599 oxhunters who use Acepromazine }{\f2\fs22\insrsid13982452 Maleate }{\f2\fs22\insrsid16193158\charrsid14436599 for }{\f2\fs22\insrsid7944375 foxhunting}{
\f2\fs22\insrsid16193158\charrsid14436599  purposes are not violating federal law, }{\f2\fs22\insrsid15820710\charrsid14436599 therefore, }{\f2\fs22\insrsid16193158\charrsid14436599 assuming}{\f2\fs22\insrsid15820710\charrsid14436599  }{
\f2\fs22\insrsid7944375 that }{\f2\fs22\insrsid16193158\charrsid14436599 they comply with the }{\f2\fs22\insrsid6292383\charrsid14436599 Food and Drug Administration\rquote s above restrictions on off-label }{\f2\fs22\insrsid7944375 animal drug }{
\f2\fs22\insrsid6292383\charrsid14436599 usage}{\f2\fs22\insrsid16193158\charrsid14436599 .}{\f2\fs22\insrsid10244319 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15355150 {\f2\fs22\insrsid10244319\charrsid14436599 
\par }{\f2\fs22\insrsid2440761\charrsid14436599 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2440761 {\f2\fs22\ul\insrsid15355150\charrsid14436599 THE FOOD AND DRUG ADMINISTRATION\rquote S REGULATION OF ANIMAL }{\f2\fs22\ul\insrsid13700306\charrsid14436599 

\par 
\par }{\f2\fs22\ul\insrsid15355150\charrsid14436599 DRUGS AND}{\f2\fs22\ul\insrsid2440761\charrsid14436599  }{\f2\fs22\ul\insrsid13700306\charrsid14436599 ITS POSITION}{\f2\fs22\ul\insrsid2440761\charrsid14436599  ON OFF-LABEL DRUG USE}{
\f2\fs22\ul\insrsid2440761 
\par }{\f2\fs22\ul\insrsid4655374\charrsid14436599 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid460529 {\f2\fs22\insrsid6892570\charrsid14436599 The question then becomes whether }{\f2\fs22\insrsid10576609 the }{
\f2\fs22\insrsid8742295\charrsid14436599 F}{\f2\fs22\insrsid13382162\charrsid14436599 ood and }{\f2\fs22\insrsid8742295\charrsid14436599 D}{\f2\fs22\insrsid13382162\charrsid14436599 rug }{\f2\fs22\insrsid8742295\charrsid14436599 A}{
\f2\fs22\insrsid13382162\charrsid14436599 dministration }{\f2\fs22\insrsid10576609 adequately }{\f2\fs22\insrsid8742295\charrsid14436599 controls the }{\f2\fs22\insrsid6892570\charrsid14436599 regulation, }{\f2\fs22\insrsid8742295\charrsid14436599 
distribution and}{\f2\fs22\insrsid10576609 /or}{\f2\fs22\insrsid8742295\charrsid14436599  administration of animal drugs. }{\f2\fs22\insrsid6292383\charrsid14436599  }{\f2\fs22\insrsid8742295\charrsid14436599 In general, is the F}{
\f2\fs22\insrsid6892570\charrsid14436599 ood and }{\f2\fs22\insrsid8742295\charrsid14436599 D}{\f2\fs22\insrsid6892570\charrsid14436599 rug }{\f2\fs22\insrsid8742295\charrsid14436599 A}{\f2\fs22\insrsid6892570\charrsid14436599 dministration}{
\f2\fs22\insrsid8742295\charrsid14436599  }{\f2\fs22\insrsid10576609 doing enough to regulate}{\f2\fs22\insrsid6892570\charrsid14436599  }{\f2\fs22\insrsid7944375 the use of drugs in animals}{\f2\fs22\insrsid8742295\charrsid14436599 , or should it be}{
\f2\fs22\insrsid6892570\charrsid14436599  doing}{\f2\fs22\insrsid7944375  more?  O}{\f2\fs22\insrsid8742295\charrsid14436599 r less?  }{\f2\fs22\insrsid10576609 H}{\f2\fs22\insrsid6892570\charrsid14436599 ow does the Food and Drug Administration regulate 
}{\f2\fs22\insrsid10576609 the use of drugs in animals in an extra-label capacity}{\f2\fs22\insrsid6892570\charrsid14436599 ? }{\f2\fs22\insrsid10244319  }{\f2\fs22\insrsid6622946\charrsid14436599 Are t}{\f2\fs22\insrsid7944375 
he regulations on off-label use}{\f2\fs22\insrsid6622946\charrsid14436599  }{\f2\fs22\insrsid10576609 sufficient}{\f2\fs22\insrsid6622946\charrsid14436599 ?  }{\f2\fs22\insrsid10244319 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 {\f2\fs22\insrsid10244319 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15355150 {\f2\fs22\ul\insrsid15355150\charrsid14436599 A CLOSER LOOK AT ACEPROMAZINE MALEATE}{\f2\fs22\insrsid4655374\charrsid460529 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 {\f2\fs22\insrsid6622946\charrsid14436599 Narrowing the focus}{\f2\fs22\insrsid8742295\charrsid14436599 , }{
\f2\fs22\insrsid6622946\charrsid14436599 I will then consider the off-label use of animal drugs in}{\f2\fs22\insrsid8742295\charrsid14436599  the specific context of Acepromazine Maleate. }{\f2\fs22\insrsid6622946\charrsid14436599  }{
\f2\fs22\insrsid8742295\charrsid14436599 To do so, I }{\f2\fs22\insrsid6622946\charrsid14436599 will }{\f2\fs22\insrsid8742295\charrsid14436599 first look at }{\f2\fs22\insrsid10576609\charrsid14436599 how much Ace}{\f2\fs22\insrsid10576609 
promazine Maleate}{\f2\fs22\insrsid10576609\charrsid14436599  is actually being }{\f2\fs22\insrsid10576609 administered to horses}{\f2\fs22\insrsid10576609\charrsid14436599 .  Is the use of Ace}{\f2\fs22\insrsid10576609 promazine Maleate}{
\f2\fs22\insrsid10576609\charrsid14436599  for foxhunting purposes relatively rare, or is it commonplace?  Based on the (admittedly incomplete) information available, roughly 80% to 90% of foxhunters use Ace}{\f2\fs22\insrsid7944375 promazine Maleate }{
\f2\fs22\insrsid10576609\charrsid14436599 whenever they fox hunt, typically three times per week.}{\cs17\f2\fs22\super\insrsid10576609\charrsid14436599 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Information is based on anonymous interviews with subscribers to Mr. Stewart\rquote 
s Cheshire Foxhounds (Unionville, PA), the Radnor Hunt (Malvern, PA), and former members of the Brandywine Hunt (West Chester, PA), which dissolved in 2004.}}}{\f2\fs22\insrsid10576609   Around 10% to 2}{\f2\fs22\insrsid10576609\charrsid14436599 0% }{
\f2\fs22\insrsid10576609 of foxhunters give Acepromazine Maleate to their horses}{\f2\fs22\insrsid10576609\charrsid14436599  every time they ride, on average five to six times per week.}{\cs17\f2\fs22\super\insrsid10576609 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Information is based on anonymous intervi
ews with subscribers to Mr. Stewart\rquote s Cheshire Foxhounds (Unionville, PA), the Radnor Hunt (Malvern, PA), and former members of the Brandywine Hunt (West Chester, PA), which dissolved in 2004.}}}{\f2\fs22\insrsid10576609\charrsid14436599 
  Assuming that these }{\f2\fs22\insrsid7944375 figures}{\f2\fs22\insrsid10576609\charrsid14436599  are accurate, Acepromazine Maleate is, by any}{\f2\fs22\insrsid7944375  measure, being administered }{\f2\fs22\insrsid10576609\charrsid14436599 
by foxhunters with substantial frequency.}{\f2\fs22\insrsid10576609 
\par I will then consider w}{\f2\fs22\insrsid8742295\charrsid14436599 hat exactly Ace}{\f2\fs22\insrsid6622946\charrsid14436599 promazine Maleate}{\f2\fs22\insrsid7944375  is and how it affects the physiology of a }{\f2\fs22\insrsid8742295\charrsid14436599 
horse.  How is it currently prescribed? }{\f2\fs22\insrsid6622946\charrsid14436599  }{\f2\fs22\insrsid8742295\charrsid14436599 What are its approved uses? }{\f2\fs22\insrsid6622946\charrsid14436599  }{\f2\fs22\insrsid8742295\charrsid14436599 
How do the veterinarians prescribing Ace}{\f2\fs22\insrsid6307569 promazine Maleate}{\f2\fs22\insrsid8742295\charrsid14436599  feel about the nature and high rates of }{\f2\fs22\insrsid7944375 its use}{\f2\fs22\insrsid8742295\charrsid14436599 
?  Are foxhunters sufficiently capable of determining the }{\f2\fs22\insrsid7944375 appropriate }{\f2\fs22\insrsid8742295\charrsid14436599 amount of Ace}{\f2\fs22\insrsid6307569 promazine Maleate}{\f2\fs22\insrsid8742295\charrsid14436599  }{
\f2\fs22\insrsid7944375 to }{\f2\fs22\insrsid8742295\charrsid14436599 administer to their horses }{\f2\fs22\insrsid7944375 under veterinarian guidance?}{\f2\fs22\insrsid10244319 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15355150 {\f2\fs22\insrsid2440761\charrsid14436599 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid460529 {\f2\fs22\ul\insrsid15355150\charrsid14436599 CONCLUSION}{\f2\fs22\ul\insrsid2440761\charrsid14436599 S}{\f2\fs22\ul\insrsid460529 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid460529 {\f2\fs22\insrsid8742295\charrsid14436599 In this research paper, I will explore the}{\f2\fs22\insrsid11763129\charrsid14436599  above}{
\f2\fs22\insrsid8742295\charrsid14436599  questions and }{\f2\fs22\insrsid1445978\charrsid14436599 many others}{\f2\fs22\insrsid3483308\charrsid14436599 . }{\f2\fs22\insrsid10244319  }{\f2\fs22\insrsid1445978\charrsid14436599 
Ultimately, my goal is to offer an assessment of the off-label use of Acepromazine Maleate by foxhunters. }{\f2\fs22\insrsid10058490\charrsid14436599  Is the current use of Acepromazine Maleate in an off-label capacity }{
\f2\fs22\insrsid2576999\charrsid14436599 acceptable? }{\f2\fs22\insrsid12477280\charrsid14436599  }{\f2\fs22\insrsid2576999\charrsid14436599 Safe?}{\f2\fs22\insrsid12477280\charrsid14436599  }{\f2\fs22\insrsid2576999\charrsid14436599  }{
\f2\fs22\insrsid10058490\charrsid14436599 Or are further restrictions and regulations in order?}{\f2\fs22\insrsid2576999\charrsid14436599  }{\f2\fs22\insrsid10244319  }{\f2\fs22\insrsid2576999\charrsid14436599 I will conclude the}{
\f2\fs22\insrsid14814873\charrsid14436599  paper by }{\f2\fs22\insrsid7944375 offering an assessment of the off-label use of Acepromazine Maleate by foxhunters}{\f2\fs22\insrsid14814873\charrsid14436599 , always keeping in mind the impact }{
\f2\fs22\insrsid2576999\charrsid14436599 of any proposed }{\f2\fs22\insrsid7944375 changes}{\f2\fs22\insrsid2576999\charrsid14436599  }{\f2\fs22\insrsid10244319 on the }{\f2\fs22\insrsid14814873\charrsid14436599 Food and Drug Administration}{
\f2\fs22\insrsid10244319 ,}{\f2\fs22\insrsid6307569  the Center for Veterinary Medicine,}{\f2\fs22\insrsid10244319  }{\f2\fs22\insrsid14814873\charrsid14436599 veterinarians, foxhunters}{\f2\fs22\insrsid2576999\charrsid14436599 , a}{
\f2\fs22\insrsid7944375 nd of course, }{\f2\fs22\insrsid2576999\charrsid14436599 horses}{\f2\fs22\insrsid14814873\charrsid14436599 .}{\f2\fs22\ul\insrsid14814873\charrsid460529 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2576999 {\f2\fs22\insrsid1445978\charrsid14436599 As the situation stands, nothing at all has been written about the off-label use of }{
\f2\fs22\insrsid12477280\charrsid14436599 Acepromazine Maleate. }{\f2\fs22\insrsid10244319 Indeed, very little}{\f2\fs22\insrsid12477280\charrsid14436599  has been written about the off-label use of animal drugs in general. }{\f2\fs22\insrsid10244319 
 As one academic astutely commented}{\f2\fs22\insrsid12477280\charrsid14436599 , \'93}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12477280\charrsid14436599 the regulation of animal drugs at }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid7944375 the }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12477280\charrsid14436599 FDA always has taken a backseat to the larger regulation of human food, drugs, and medical devices.  Eve}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4990389 n with \lquote Center\rquote }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12477280\charrsid14436599 
 status, the Center for Veterinary Medicine (CVM) is not on par with the other four Centers: the Center for Food Safety and Applied Nutrition, the Center for
 Devices and Radiological Health, the Center for Drug Evaluation and Research, or the Center for Biologics Evaluation and Research.\'94}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid12477280\charrsid14436599 \chftn {\footnote \pard\plain 
\s28\ql \fi675\li45\ri45\sb45\sa45\widctlpar\aspalpha\aspnum\faauto\adjustright\rin45\lin45\itap0\pararsid348360 \cbpat8 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\fs20\insrsid2450573\charrsid2450573  Lambert, Eugene. \'93}{\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Animal Drugs: Future Stepchild or Pioneer?\'94 }{
\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. }{\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 (2000). }}}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12477280\charrsid14436599  }{\f2\fs22\insrsid12477280\charrsid14436599 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15607008 {\f2\fs22\insrsid1445978\charrsid14436599 Given the }{\f2\fs22\insrsid16667383\charrsid14436599 relatively }{
\f2\fs22\insrsid1445978\charrsid14436599 high frequency }{\f2\fs22\insrsid12477280\charrsid14436599 in which }{\f2\fs22\insrsid1445978\charrsid14436599 foxhunters are using }{\f2\fs22\insrsid12477280\charrsid14436599 Acepromazine Maleate in an}{
\f2\fs22\insrsid1445978\charrsid14436599  off-label capacity}{\f2\fs22\insrsid12477280\charrsid14436599 ,}{\f2\fs22\insrsid7944375  }{\f2\fs22\insrsid12477280\charrsid14436599 often }{\f2\fs22\insrsid15607008 with }{
\f2\fs22\insrsid10058490\charrsid14436599 extremely }{\f2\fs22\insrsid16667383\charrsid14436599 vague }{\f2\fs22\insrsid10058490\charrsid14436599 guidance from }{\f2\fs22\insrsid16667383\charrsid14436599 the prescribing veterinarian}{
\f2\fs22\insrsid15607008 , }{\f2\fs22\insrsid12477280\charrsid14436599 this}{\f2\fs22\insrsid10058490\charrsid14436599  issue }{\f2\fs22\insrsid10244319 deserves }{\f2\fs22\insrsid16667383\charrsid14436599 attention. }{
\f2\fs22\insrsid8350940\charrsid14436599  }{\f2\fs22\insrsid10244319 Even if one agrees with }{\f2\fs22\insrsid16667383\charrsid14436599 the}{\f2\fs22\insrsid4944022  Food and Drug Administration\rquote s}{\f2\fs22\insrsid16667383\charrsid14436599 
 general prioritizati}{\f2\fs22\insrsid4944022 on of }{\f2\fs22\insrsid16667383\charrsid14436599 human health over animal health, human health is on the line here has well. }{\f2\fs22\insrsid4944022  }{\f2\fs22\insrsid16667383\charrsid14436599 
If horses are }{\f2\fs22\insrsid8350940\charrsid14436599 being drugged to the point that they cannot perform what is being asked of them}{\f2\fs22\insrsid7944375  on the hunt field}{\f2\fs22\insrsid8350940\charrsid14436599 , both horses and human}{
\f2\fs22\insrsid7944375  health}{\f2\fs22\insrsid8350940\charrsid14436599  }{\f2\fs22\insrsid4944022 are in danger}{\f2\fs22\insrsid8350940\charrsid14436599 . }{\f2\fs22\insrsid4944022  }{\f2\fs22\insrsid15607008 
\par My research indicates is that although Acepromazine Maleate}{\f2\fs22\insrsid15607008\charrsid15607008  is currently being used by foxhunter
s with great frequency, it is also being used by foxhunters with great precaution, making it, in the vast majority of cases, both safe and effective.  Veterinarians, however, need to do more on their end to comply with Food and Drug Administration regulat
ions and labeling requirements, to ensure that this level of safety does not drop.}{\f2\fs22\insrsid15607008\charrsid14436599 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3483308 {\f2\fs22\ul\insrsid8350940\charrsid14436599 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4655374 {\f2\fs22\ul\insrsid3483308\charrsid14436599 LITERATURE REVIEW}{\f2\fs22\ul\insrsid4655374 
\par }{\f2\fs22\ul\insrsid4655374\charrsid14436599 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 {\f2\fs22\insrsid7944375 I will begin this}{\f2\fs22\insrsid8944519\charrsid14436599  paper by exploring }{
\f2\fs22\insrsid8538348\charrsid14436599 the Food and Drug Administration\rquote s regulation }{\f2\fs22\insrsid13770757\charrsid14436599 of }{\f2\fs22\insrsid4216408 animal }{\f2\fs22\insrsid8538348\charrsid14436599 drugs,}{
\f2\fs22\insrsid13770757\charrsid14436599  }{\f2\fs22\insrsid8538348\charrsid14436599 both in general and in}{\f2\fs22\insrsid13770757\charrsid14436599  }{\f2\fs22\insrsid4216408 an off-label capacity}{\f2\fs22\insrsid8538348\charrsid14436599 .  }{
\f2\fs22\insrsid13700306\charrsid14436599 E}{\f2\fs22\insrsid13770757\charrsid14436599 xisting literature thoroughly details the current regulation of animal drugs.  }{\f2\fs22\insrsid13700306\charrsid14436599 The Food and Drug Administration}{
\f2\fs22\insrsid4216408 \rquote s website}{\f2\fs22\insrsid13700306\charrsid14436599 , in fact, provides quite extensive details on the approval process for animal drugs.  }{\f2\fs22\insrsid10576609 
\par I}{\f2\fs22\insrsid348360 n analyzing the off-label use of animal drugs, I}{\f2\fs22\insrsid10576609  will}{\f2\fs22\insrsid4216408  also}{\f2\fs22\insrsid10576609  }{\f2\fs22\insrsid3812984\charrsid14436599 make }{\f2\fs22\insrsid10576609 heavy }{
\f2\fs22\insrsid3812984\charrsid14436599 use of the }{\f2\fs22\insrsid7485955\charrsid14436599 legislative history}{\cs17\f2\fs22\super\insrsid3038972\charrsid14436599 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3038972 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3038972 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  94 CIS PL 103396; 103 CIS Legis. Hist. P.L. 396.
\par }}}{\f2\fs22\insrsid13770757\charrsid14436599  behind }{\f2\fs22\insrsid7485955\charrsid14436599 the Animal Medicinal Drug Use Clarification Act of 1994, }{\f2\fs22\insrsid12210080\charrsid14436599 whose pu}{\f2\fs22\insrsid4216408 rpose i}{
\f2\fs22\insrsid10576609 s: "t}{\f2\fs22\insrsid12210080\charrsid14436599 o amend the Federal Food, Drug, and Cosmetic Act to clarify the application of the Act with respect to alternate uses of n
ew animal drugs and new drugs intended for human use, and for other purposes."}{\cs17\f2\fs22\super\insrsid3038972\charrsid14436599 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3038972 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 140 Congressional Record, 103rd Congress, 2nd Session \endash  December 1994. CIS-NO: 94-PL103-396.
\par }}}{\f2\fs22\insrsid3038972\charrsid14436599   What are the reasons behind the }{\f2\fs22\insrsid4944022 passage of the }{\f2\fs22\insrsid3038972\charrsid14436599 Animal Medicinal Drug }{\f2\fs22\insrsid4216408 Use }{
\f2\fs22\insrsid3038972\charrsid14436599 Clarification Act}{\f2\fs22\insrsid3557918\charrsid14436599  of 1994}{\f2\fs22\insrsid4944022 ?  }{\f2\fs22\insrsid348360 These justifications will enable me to later assess whether t}{\f2\fs22\insrsid4944022 he }{
\f2\fs22\insrsid3038972\charrsid14436599 uses }{\f2\fs22\insrsid1724033\charrsid14436599 I have encountered in the realm of }{\f2\fs22\insrsid6307569 foxhunting}{\f2\fs22\insrsid348360  are }{\f2\fs22\insrsid3038972\charrsid14436599 in }{
\f2\fs22\insrsid1724033\charrsid14436599 line with what was intended by C}{\f2\fs22\insrsid3038972\charrsid14436599 ongress in passing the Act}{\f2\fs22\insrsid4216408 .}{\f2\fs22\insrsid1724033\charrsid14436599   Prior to 1994, the off-lab}{
\f2\fs22\insrsid348360 el use of prescription drugs }{\f2\fs22\insrsid1724033\charrsid14436599 was }{\f2\fs22\insrsid348360 a criminal act}{\f2\fs22\insrsid1724033\charrsid14436599  \endash  should it still be? }{\f2\fs22\insrsid1724033 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid348360 {\f2\fs22\insrsid348360\charrsid14436599 Few }{\f2\fs22\insrsid348360 other sources, unfortunately, }{\f2\fs22\insrsid4216408 examine}{
\f2\fs22\insrsid348360\charrsid14436599  the }{\f2\fs22\insrsid4216408 off-label use of drugs in animals.  }{\f2\fs22\insrsid10576609 I will }{\f2\fs22\insrsid4216408 therefore draw on several }{\f2\fs22\insrsid10576609\charrsid14436599 articles }{
\f2\fs22\insrsid4216408 exploring }{\f2\fs22\insrsid10576609\charrsid14436599 the extra-label use }{\f2\fs22\insrsid4216408 of drugs in humans, as many of the same issues arise.  }{\f2\fs22\insrsid10576609\charrsid14436599 The }{
\i\f2\fs22\insrsid10576609\charrsid14436599 Food and Drug Law Journal}{\f2\fs22\insrsid10576609\charrsid14436599  offers a }{\f2\fs22\insrsid4216408 plethora }{\f2\fs22\insrsid10576609\charrsid14436599 of }{\f2\fs22\insrsid4216408 
information in this regard}{\f2\fs22\insrsid10576609\charrsid14436599 , and }{\i\f2\fs22\insrsid10576609\charrsid14436599 Food and Drug Law: Cases and Materials}{\f2\fs22\insrsid10576609\charrsid14436599  }{\f2\fs22\insrsid4216408 
provides a good overview of off-label drug use}{\f2\fs22\insrsid10576609\charrsid14436599 .}{\f2\fs22\cf1\insrsid10576609\charrsid348360 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13064368 {\f2\fs22\insrsid10576609 I}{\f2\fs22\insrsid348360  will then explore the}{\f2\fs22\insrsid10576609\charrsid14436599  }{
\f2\fs22\insrsid10576609 capacities}{\f2\fs22\insrsid10576609\charrsid14436599  }{\f2\fs22\insrsid348360 in which }{\f2\fs22\insrsid10576609\charrsid14436599 and exactly ho}{\f2\fs22\insrsid6307569 w much Acepromazine Maleate }{\f2\fs22\insrsid4216408 
is being used by }{\f2\fs22\insrsid6307569 fox}{\f2\fs22\insrsid10576609\charrsid14436599 hunters in an off-label capacity.  To obtain this information, I }{\f2\fs22\insrsid4216408 conducted}{\f2\fs22\insrsid10576609\charrsid14436599  in
terviews with subscribers of three hunts in Pennsylvania: Mr. Stewart\rquote s Cheshire Hounds, the Radnor Hunt, and former members of the Brandywine Hunt, which dissolved in 2004.  This data presents an admit}{\f2\fs22\insrsid4216408 
tedly incomplete picture of fox}{\f2\fs22\insrsid10576609\charrsid14436599 hunters }{\f2\fs22\insrsid4216408 as a whole}{\f2\fs22\insrsid10576609\charrsid14436599  and the extent to which they use Acepromazine Maleate in an off-label capacity}{
\f2\fs22\insrsid4216408 , but d}{\f2\fs22\insrsid10576609\charrsid14436599 ue to the relatively small num}{\f2\fs22\insrsid4216408 ber of foxhunts in the United States }{\f2\fs22\insrsid10576609\charrsid14436599 
as well as the general unwillingness of hunt leadership to provide me with access to membership databases and/or mailing lists, }{\f2\fs22\insrsid4216408 interviews were hard to obtain.  As a result, }{\f2\fs22\insrsid13064368 the}{
\f2\fs22\insrsid10576609\charrsid14436599  inter}{\f2\fs22\insrsid13064368 views were exclusively with fox}{\f2\fs22\insrsid10576609\charrsid14436599 hunters I know}{\f2\fs22\insrsid10576609  personally}{\f2\fs22\insrsid13064368 
 (fortunately, as a foxhunter myself, I know quite a few)}{\f2\fs22\insrsid10576609\charrsid14436599 .  }{\f2\fs22\insrsid10576609 For various reasons, foxhunts are quite protective of their subscribers\rquote  privacy, and they often}{
\f2\fs22\insrsid10576609\charrsid14436599  restrict the use of their email lists to \'93matters relating to the hunt, to local equestrian events, and land preservation matters,\'94 as one hunt spokesman }{\f2\fs22\insrsid13064368 noted}{
\f2\fs22\insrsid10576609\charrsid14436599  in an email in which he declined to distribute my questionnaire to hunt members.}{\cs17\f2\fs22\super\insrsid10576609\charrsid14436599 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Email from an anonymous Board Member of Cheshire Conservancy, dated February 10, 2006.
\par }}}{\f2\fs22\insrsid13064368   
\par Many individuals also refused my request to interview them. }{\f2\fs22\insrsid10576609 A}{\f2\fs22\insrsid10576609\charrsid14436599  Board Member of Cheshire Conservancy, the governing body of Mr. Stewart\rquote 
s Cheshire Foxhounds, briefly summarized some of the reasons behind people\rquote s hesitation: \'93Is there a p
ossibility your paper would result in a negative reaction about or criticism of the use of ace [Acepromazine Maleate] as we use it or that it will call for greater regulation of its use?  Also, the "antis" will jump on any aspect of hunting that they beli
eve they can use to end hunting, so even a questionnaire that\~relates to "drugging horses" (which is how they would characterize it) could be exploited by them if they got their hands on it...\'94}{\cs17\f2\fs22\super\insrsid10576609\charrsid14436599 
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10576609 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  }{\i\f2\insrsid2450573\charrsid2450573 Id.}}}{\f2\fs22\insrsid10576609\charrsid14436599   }{\f2\fs22\insrsid13064368 
\par Despite the limitations noted above}{\f2\fs22\insrsid10576609\charrsid14436599 , }{\f2\fs22\insrsid10576609 these}{\f2\fs22\insrsid10576609\charrsid14436599  interviews }{\f2\fs22\insrsid13064368 nonetheless }{\f2\fs22\insrsid10576609 
provide me with some }{\f2\fs22\insrsid10576609\charrsid14436599 sense of the nature and frequency of the off-label use of Acepromazine Maleate by foxhunters.  No data has even been collected on t}{\f2\fs22\insrsid10576609 his subject matter in the past}{
\f2\fs22\insrsid10576609\charrsid14436599 , so although incomplete, the data is indeed the first of its kind. 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15607008 {\f2\fs22\insrsid13064368 After assessing the frequency and nature of Acepromazine Maleate use, I}{
\f2\fs22\insrsid1724033\charrsid14436599  then }{\f2\fs22\insrsid13064368 examine the drug itself more closely. }{\f2\fs22\insrsid1724033\charrsid14436599  }{\f2\fs22\insrsid13064368 The}{\f2\fs22\insrsid1724033\charrsid14436599  manufacturer}{
\f2\fs22\insrsid13064368  of Acepromazine Maleate}{\f2\fs22\insrsid1724033\charrsid14436599  provides some basic information on the drug, as do various veterinary databases and discussion groups.  }{\f2\fs22\insrsid13064368\charrsid14436599 
What exactly does the drug do?  How does it }{\f2\fs22\insrsid13064368\charrsid15607008 
affect the physiology of the horse?  Is it safe for foxhunters to use the drug to sedate their horses before riding and/or foxhunting them?  Are foxhunters overusing the drug?  Are foxhunters capable of sel
ecting and/or administering the appropriate dosage of the drug (per guidance from the veterinarian)?  }{\f2\fs22\insrsid2450573\charrsid15607008 The a}{\f2\fs22\insrsid2450573 nswers to these questions offer}{\f2\fs22\insrsid2450573\charrsid15607008 
 useful insight into how the drug is used in an off-label capacity and the general safety doing so.}{\f2\fs22\insrsid8538348\charrsid15607008 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14090637 {\f2\fs22\insrsid1724033\charrsid15607008 Because these resources, although helpful, are somewhat incomplete, I }{
\f2\fs22\insrsid6307569\charrsid15607008 also }{\f2\fs22\insrsid13064368\charrsid15607008 draw on }{\f2\fs22\insrsid15607008\charrsid15607008 the }{\f2\fs22\insrsid13064368\charrsid15607008 interviews I conducted with}{
\f2\fs22\insrsid1966824\charrsid15607008  veterinarians }{\f2\fs22\insrsid8742295\charrsid15607008 at New Bolton Center, the site of the University of Pennsylvania\rquote s School of Veterinary Medicine's teaching hospital for large animals.}{
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\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\f2\fs20\insrsid2450573\charrsid2450573 
 In 1964 the large-animal clinic opened at New Bolton Center, a farm in Chester County that the University acquired in 1952.  The Widener Hospital at New Bolton Center has more than 70 buildings and 141 stalls for patients.  Each ye
ar the George D. Widener Hospital for Large Animals sees more than 6,000 patient visits, and the Field Service sees more than 19,000 animals.  Penn boasts one of the largest equine surgical faculties in the world.  Many members of Penn's surgical faculty 
are known internationally in their fields.  Because of these credentials, New Bolton Center enjoys a large and varied caseload.  Because of its location, it treats valuable horses that engage in all kinds of athletic activities. }
{\field\flddirty{\*\fldinst {\f2\fs20\insrsid2450573\charrsid2450573  HYPERLINK "http://www.vet.upenn.edu/nbc/" }{\f2\fs20\insrsid2450573\charrsid2450573 {\*\datafield 
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\par }}}{\f2\fs22\insrsid13064368\charrsid15607008   What is their perspective}{\f2\fs22\insrsid8742295\charrsid15607008  on the off-label use of Acepromazine Maleate? }{\f2\fs22\insrsid8538348\charrsid15607008  }{\f2\fs22\insrsid15081790\charrsid15607008 

\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15607008 {\f2\fs22\insrsid15607008\charrsid15607008 I }{\f2\fs22\insrsid883288\charrsid15607008 conclude the paper by}{
\f2\fs22\insrsid6307569\charrsid15607008  ret}{\f2\fs22\insrsid15607008\charrsid15607008 urning to the original questions}{\f2\fs22\insrsid6307569\charrsid15607008 
 posed at the beginning of the paper.  Is the current practice of using Acepromazine Maleate }{\f2\fs22\insrsid15607008\charrsid15607008 in an }{\f2\fs22\insrsid6307569\charrsid15607008 off-label}{\f2\fs22\insrsid15607008\charrsid15607008  capacity}{
\f2\fs22\insrsid6307569\charrsid15607008  safe?  W}{\f2\fs22\insrsid14090637\charrsid15607008 hat more}{\f2\fs22\insrsid13700306\charrsid15607008 , if anything,}{\f2\fs22\insrsid14090637\charrsid15607008 
 should the Food and Drug Administration be doing to }{\f2\fs22\insrsid15607008\charrsid15607008 step in and }{\f2\fs22\insrsid14090637\charrsid15607008 regulate? }{\f2\fs22\insrsid13700306\charrsid15607008  }{\f2\fs22\insrsid14090637\charrsid15607008 
How can the Food and Drug Administration curtail abuse while permitting}{\f2\fs22\insrsid13700306\charrsid15607008  legitimate off-label use of the drug?  Most }{\f2\fs22\insrsid15607008 of the information for this portion of the paper I extract}{
\f2\fs22\insrsid13700306\charrsid15607008  from the foxhunters and veterinarians I interviewed, as well as my own thoughts and impressions}{\f2\fs22\insrsid15607008 .}{\f2\fs22\insrsid15607008\charrsid15607008 
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\par 
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\par }\pard \s20\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid348360 {\b\fs44\insrsid348360 
\par }{\b\fs44\insrsid5050870 
\par 
\par 
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\par 
\par 
\par 
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\par }\pard \s20\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15607008 {\b\fs44\insrsid7760612 CHAPTER TWO
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\par 
\par 
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\b\fs44\insrsid3962652  Regulation of Animal Drugs and their Off-Label Uses}{\b\fs44\insrsid7760612  
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\par 
\par 
\par }{\f2\fs22\ul\insrsid7760612\charrsid2450573 INTRODUCTION}{\f2\fs22\ul\insrsid460529\charrsid2450573 
\par 
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\f2\fs22\lang9\langfe1033\langnp9\insrsid7760726\charrsid2450573 FDA}{\f2\fs22\lang9\langfe1033\langnp9\insrsid7760726\charrsid2450573 
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S REGULATION OF ANIMAL DRUG}{\f2\fs22\ul\insrsid460529\charrsid2450573 S}{\f2\fs22\lang9\langfe1033\langnp9\insrsid460529\charrsid2450573  }{\f2\fs22\lang9\langfe1033\langnp9\insrsid16344176\charrsid2450573 
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metic Act, a new animal drug may not be \'93sold in interstate commerce\'94 unless it is the subject of a New Animal Drug Application (NADA)}{\f2\fs22\insrsid1388730\charrsid2450573 .}{
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\f2\fs22\insrsid13511175\charrsid2450573 the}{\f2\fs22\insrsid16591479\charrsid2450573  Foo}{\f2\fs22\insrsid13511175\charrsid2450573 d and Drug Administration determine whether an animal drug is}{\f2\fs22\insrsid1388730\charrsid2450573  \'93safe\'94}{
\f2\fs22\insrsid16591479\charrsid2450573  and}{\f2\fs22\insrsid12416965\charrsid2450573 /or}{\f2\fs22\insrsid16591479\charrsid2450573  \'93effective\'94}{\f2\fs22\insrsid1388730\charrsid2450573 ?}{\f2\fs22\insrsid9245939\charrsid2450573  }{
\f2\fs22\insrsid16591479\charrsid2450573  A}{\f2\fs22\insrsid9245939\charrsid2450573 n animal drug }{\f2\fs22\insrsid16591479\charrsid2450573 is considered \'93safe}{\f2\fs22\insrsid9245939\charrsid2450573 \'94 }{\f2\fs22\insrsid16591479\charrsid2450573 
if }{\f2\fs22\insrsid13511175\charrsid2450573 \'93}{\f2\fs22\insrsid9245939\charrsid2450573 a}{\f2\fs22\insrsid1388730\charrsid2450573 dequate tests by all methods reasonably applicable }{\f2\fs22\insrsid9245939\charrsid2450573 must }{
\f2\fs22\insrsid1388730\charrsid2450573 show that the drug is safe for use under the conditions prescribed, recommended, or suggested in the proposed labeling}{\f2\fs22\insrsid1388730\charrsid2450573 .}{\f2\fs22\insrsid13511175\charrsid2450573 \'94}{
\cs17\f2\fs22\super\insrsid4540022\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4540022 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573  United States Food an Drug Administration, C
enter for Veterinary Medicine, Office of New Animal Drug Evaluation.}{\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid1388730\charrsid2450573  }{\f2\fs22\insrsid9245939\charrsid2450573  \'93Safe\'94}{\f2\fs22\insrsid1388730\charrsid2450573  may be bro}{\f2\fs22\insrsid9245939\charrsid2450573 ken down into four categories: h}{
\f2\fs22\insrsid1388730\charrsid2450573 uman food safety, }{\f2\fs22\insrsid9245939\charrsid2450573 target animal safety, environmental safety}{\f2\fs22\insrsid1388730\charrsid2450573 , and user safety. }{\f2\fs22\insrsid12416965\charrsid2450573  }{
\f2\fs22\insrsid1388730\charrsid2450573 In regards to human food safety, t}{\f2\fs22\insrsid6375584\charrsid2450573 he Food and Drug A}{\f2\fs22\insrsid1388730\charrsid2450573 dministration is primarily concerned with }{
\f2\fs22\insrsid9245939\charrsid2450573 whether the }{\f2\fs22\insrsid1388730\charrsid2450573 drug has left any residue}{\f2\fs22\insrsid1388730\charrsid2450573  }{\f2\fs22\insrsid9245939\charrsid2450573 in }{\f2\fs22\insrsid1388730\charrsid2450573 
the meat, milk, and eggs of}{\f2\fs22\insrsid9245939\charrsid2450573  the}{\f2\fs22\insrsid1388730\charrsid2450573  anima}{\f2\fs22\insrsid9245939\charrsid2450573 l}{\f2\fs22\insrsid9723058\charrsid2450573 ,}{\f2\fs22\insrsid9245939\charrsid2450573 
 which may harm human health }{\f2\fs22\insrsid1388730\charrsid2450573 either direct}{\f2\fs22\insrsid9245939\charrsid2450573 ly}{\f2\fs22\insrsid1388730\charrsid2450573  (acute toxic response or chronic exposure toxicity) or indirect}{
\f2\fs22\insrsid9245939\charrsid2450573 ly}{\f2\fs22\insrsid1388730\charrsid2450573  (antimicrobial resistance)}{\f2\fs22\insrsid9245939\charrsid2450573 .}{\cs17\f2\fs22\super\insrsid4540022\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4540022 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573  United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{
\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid4540022\charrsid2450573  }{\f2\fs22\insrsid1388730\charrsid2450573  }{\f2\fs22\insrsid9723058\charrsid2450573 To make such an assessment, the Food and Drug Administration}{\f2\fs22\insrsid13511175\charrsid2450573 
 frequently employs (1) mutagenicity studies, (2) two 90-day feeding st
udies, (3) reproductive studies, (4) teratology studies, (5) other special studies as needed, (6) Salmonella shedding studies, (7) resistance studies, (8) studies of total metabolism in target animals as well as compar}{
\f2\fs22\insrsid9723058\charrsid2450573 ative metabolism in rodents, and/or}{\f2\fs22\insrsid13511175\charrsid2450573  (9) Tissue residue depletion studies.}{\cs17\f2\fs22\super\insrsid13511175\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13511175 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573  United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{
\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid13511175\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid349970 \cbpat17 {\f2\fs22\insrsid9723058\charrsid2450573 To assess }{\f2\fs22\insrsid1388730\charrsid2450573 
target animal safety, the F}{\f2\fs22\insrsid9245939\charrsid2450573 ood and Drug Administration monitors t}{\f2\fs22\insrsid1388730\charrsid2450573 he cumulative eff}{\f2\fs22\insrsid9245939\charrsid2450573 ect of the drug on animals to ensure }{
\f2\fs22\insrsid1388730\charrsid2450573 that the drug does not advers}{\f2\fs22\insrsid9245939\charrsid2450573 ely affect the treated animal\rquote s health.}{\cs17\f2\fs22\super\insrsid4540022\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4540022 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573  United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{
\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid1388730\charrsid2450573  }{\f2\fs22\insrsid4540022\charrsid2450573  }{\f2\fs22\insrsid349970\charrsid2450573 To do so, it conduc
ts (1) tolerance studies, (2) reproductive safety studies, (3) animal class safety studies (e.g., young, geriatric), and}{\f2\fs22\insrsid9723058\charrsid2450573 /or}{\f2\fs22\insrsid349970\charrsid2450573  (4) special case studies (specific breeds).

\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9723058 \cbpat17 {\f2\fs22\insrsid9723058\charrsid2450573 To create }{\f2\fs22\insrsid9245939\charrsid2450573 
environmental safety, the Food and Drug Administration aims to ensure that the u}{\f2\fs22\insrsid1388730\charrsid2450573 se, manufacture and disposal}{\f2\fs22\insrsid9245939\charrsid2450573  of the drug}{\f2\fs22\insrsid9723058\charrsid2450573  do}{
\f2\fs22\insrsid1388730\charrsid2450573  not pose a significant environmen}{\f2\fs22\insrsid9245939\charrsid2450573 tal impact as per }{\f2\fs22\insrsid9723058\charrsid2450573 the }{\f2\fs22\insrsid9245939\charrsid2450573 N}{
\f2\fs22\insrsid9723058\charrsid2450573 ational Environmental }{\f2\fs22\insrsid9245939\charrsid2450573 P}{\f2\fs22\insrsid9723058\charrsid2450573 olicy }{\f2\fs22\insrsid9245939\charrsid2450573 A}{\f2\fs22\insrsid9723058\charrsid2450573 ct}{
\cs17\f2\fs22\super\insrsid6375584\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6375584 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573   The National Environmental Policy Act (NEPA) requires federal agencies to integrate environmental values into their decision
 making processes by considering the environmental impacts of their proposed actions and reasonable alternatives to those actions. To meet this requirement, federal agencies prepare a detailed statement known as an Environmental Impact Statement (EIS). EP
A reviews and comments on EISs prepared by other federal agencies, maintains a national filing system for all EISs, and assures that its own actions comply with NEPA. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://www.epa.gov/compliance/nepa/index.html" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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ce118c8200aa004ba90b5c00000068007400740070003a002f002f007700770077002e006500700061002e0067006f0076002f0063006f006d0070006c00690061006e00630065002f006e006500700061002f0069006e006400650078002e00680074006d006c000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.epa.gov/compliance/nepa/index.html}}}{\f2\insrsid2450573\charrsid2450573 . April 24, 2006.
\par }}}{\f2\fs22\insrsid349970\charrsid2450573  and }{\f2\fs22\insrsid9245939\charrsid2450573 C}{\f2\fs22\insrsid9723058\charrsid2450573 lean }{\f2\fs22\insrsid9245939\charrsid2450573 W}{\f2\fs22\insrsid9723058\charrsid2450573 ater }{
\f2\fs22\insrsid9245939\charrsid2450573 A}{\f2\fs22\insrsid9723058\charrsid2450573 ct}{\cs17\f2\fs22\super\insrsid6375584\charrsid2450573 \chftn {\footnote \pard\plain 
\s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6375584 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\fs20\insrsid2450573\charrsid2450573 
 Growing public awareness and concern for controlling water pollution led to enactment of the Federal Water Pollution Control Act Amendments of 1972. As amended in 1977, this law became commonly known as the Clean Wate
r Act. The Act established the basic structure for regulating discharges of pollutants into the waters of the United States. It gave EPA the authority to implement pollution control programs such as setting wastewater standards for industry. The Clean Wat
e
r Act also continued requirements to set water quality standards for all contaminants in surface waters. The Act made it unlawful for any person to discharge any pollutant from a point source into navigable waters, unless a permit was obtained under its p
r
ovisions. It also funded the construction of sewage treatment plants under the construction grants program and recognized the need for planning to address the critical problems posed by non-point source pollution. Subsequent enactments modified some of th
e earlier Clean Water Act provisions. }{\field\flddirty{\*\fldinst {\f2\fs20\insrsid2450573\charrsid2450573  HYPERLINK "http://www.epa.gov/r5water/cwa.htm" }{\f2\fs20\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002300000068007400740070003a002f002f007700770077002e006500700061002e0067006f0076002f0072003500770061007400650072002f006300770061002e00680074006d000000e0c9ea79f9bace118c8200aa004ba90b460000006800740074007000
3a002f002f007700770077002e006500700061002e0067006f0076002f0072003500770061007400650072002f006300770061002e00680074006d000000}}}{\fldrslt {\cs27\f2\fs20\ul\cf2\insrsid2450573\charrsid2450573 http://www.epa.gov/r5water/cwa.htm}}}{
\f2\fs20\insrsid2450573\charrsid2450573 . April 24, 2006.
\par }}}{\f2\fs22\insrsid1388730\charrsid2450573 .}{\cs17\f2\fs22\super\insrsid4540022\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4540022 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{
\f2\insrsid2450573\charrsid2450573  United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid9245939\charrsid2450573  }{\f2\fs22\insrsid349970\charrsid2450573  }{\f2\fs22\insrsid9245939\charrsid2450573 In fact, }{\f2\fs22\insrsid1388730\charrsid2450573 N}{\f2\fs22\insrsid9245939\charrsid2450573 ew }{
\f2\fs22\insrsid1388730\charrsid2450573 A}{\f2\fs22\insrsid9245939\charrsid2450573 nimal }{\f2\fs22\insrsid1388730\charrsid2450573 D}{\f2\fs22\insrsid9245939\charrsid2450573 rug }{\f2\fs22\insrsid1388730\charrsid2450573 A}{
\f2\fs22\insrsid9245939\charrsid2450573 pplication}{\f2\fs22\insrsid9723058\charrsid2450573  a}{\f2\fs22\insrsid1388730\charrsid2450573 pproval }{\f2\fs22\insrsid9723058\charrsid2450573 must}{\f2\fs22\insrsid12416965\charrsid2450573  }{
\f2\fs22\insrsid349970\charrsid2450573 include}{\f2\fs22\insrsid1388730\charrsid2450573  either a Categorical Exclusion or an Environmental Assessment accompanied by}{\f2\fs22\insrsid7755304\charrsid2450573  a }{\f2\fs22\insrsid7755304\charrsid2450573 
Finding of }{\f2\fs22\insrsid12416965\charrsid2450573 \'93}{\f2\fs22\insrsid7755304\charrsid2450573 No Significant Impact}{\cs17\f2\fs22\super\insrsid7755304\charrsid2450573  }{\f2\fs22\insrsid12416965\charrsid2450573 ?}{
\cs17\f2\fs22\super\insrsid6375584\charrsid2450573 \chftn {\footnote \pard\plain \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\widctlpar
\tx916\tx1832\tx2748\tx3664\tx4580\tx5496\tx6412\tx7328\tx8244\tx9160\tx10076\tx10992\tx11908\tx12824\tx13740\tx14656\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6375584 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\fs20\insrsid2450573\charrsid2450573 \tab }{\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\f2\fs20\insrsid2450573\charrsid2450573  \'93Finding of No Significant Impact.\'94
 The purpose of this Notice is to make available to the public the Finding of No Significant Impact pursuant to an Environmental }{\f2\fs20\cf1\insrsid2450573\charrsid2450573 Assessment. www.epa.gov
\par }}}{\f2\fs22\insrsid1388730\charrsid2450573  or }{\f2\fs22\insrsid7755304\charrsid2450573 an }{\f2\fs22\insrsid12416965\charrsid2450573 \'93}{\f2\fs22\insrsid1388730\charrsid2450573 E}{\f2\fs22\insrsid7755304\charrsid2450573 nvironmental }{
\f2\fs22\insrsid1388730\charrsid2450573 I}{\f2\fs22\insrsid7755304\charrsid2450573 mpact }{\f2\fs22\insrsid1388730\charrsid2450573 S}{\f2\fs22\insrsid7755304\charrsid2450573 tatement}{\f2\fs22\insrsid12416965\charrsid2450573 \'94}{
\cs17\f2\fs22\super\insrsid6375584\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6375584 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  \'93Environmental Impact Statement.\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.epa.gov" }{
\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 www.epa.gov}}}{\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid9245939\charrsid2450573 .}{\cs17\f2\fs22\super\insrsid4540022\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4540022 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{
\f2\insrsid2450573\charrsid2450573  United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid9245939\charrsid2450573   }{\f2\fs22\insrsid349970\charrsid2450573 To assess the environmental impact of the drug, }{\f2\fs22\insrsid7755304\charrsid2450573 researchers}{\f2\fs22\insrsid349970\charrsid2450573  often use}{
\f2\fs22\insrsid12416965\charrsid2450573  (1) environmental introduction }{\f2\fs22\insrsid349970\charrsid2450573 and fate studies, (2) environmental effects studies, and (3) environmental assessment.}{\cs17\f2\fs22\super\insrsid349970\charrsid2450573 
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid349970 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573 
 United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid349970\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16591479 \cbpat17 {\f2\fs22\insrsid9245939\charrsid2450573 
Finally, in regards to user safety, the Food and Drug Administration }{\f2\fs22\insrsid9723058\charrsid2450573 aims to assess}{\f2\fs22\insrsid9245939\charrsid2450573  the dangers }{\f2\fs22\insrsid1388730\charrsid2450573 associated with manufacturing }{
\f2\fs22\insrsid9245939\charrsid2450573 the drug, either direct}{\f2\fs22\insrsid1388730\charrsid2450573  }{\f2\fs22\insrsid9245939\charrsid2450573 (}{\f2\fs22\insrsid1388730\charrsid2450573 occupational exposure at }{
\f2\fs22\insrsid9245939\charrsid2450573 the }{\f2\fs22\insrsid1388730\charrsid2450573 site}{\f2\fs22\insrsid9245939\charrsid2450573 ) or indirect}{\f2\fs22\insrsid1388730\charrsid2450573  }{\f2\fs22\insrsid9245939\charrsid2450573 (}{
\f2\fs22\insrsid1388730\charrsid2450573 manufacturing emissions}{\f2\fs22\insrsid9245939\charrsid2450573 ) as well as the h}{\f2\fs22\insrsid1388730\charrsid2450573 azards associated with}{\f2\fs22\insrsid9245939\charrsid2450573  administering the drug}{
\f2\fs22\insrsid1388730\charrsid2450573  to animals}{\f2\fs22\insrsid9245939\charrsid2450573  and }{\f2\fs22\insrsid9723058\charrsid2450573 the }{\f2\fs22\insrsid9245939\charrsid2450573 h}{\f2\fs22\insrsid1388730\charrsid2450573 azards associated with }{
\f2\fs22\insrsid9245939\charrsid2450573 the }{\f2\fs22\insrsid1388730\charrsid2450573 use of air, water and solid wastes contaminated via use and disposal of the drug}{\f2\fs22\insrsid9245939\charrsid2450573 .}{
\cs17\f2\fs22\super\insrsid4540022\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4540022 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573 
 United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{\f2\insrsid2450573\charrsid2450573  
\par }\pard \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f2\insrsid2450573\charrsid2450573  }}}{\f2\fs22\insrsid16591479\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16344176 \cbpat17 {\f2\fs22\insrsid16591479\charrsid2450573 An animal drug is considered \'93effective\'94 
based on substantial evidence consisting of one or more adequate and well-controlled investigations, such as: (1) a study in a target species, (2) a study in laboratory animals, (3) any field investigation, (4) a bioequivalence study,}{
\f2\fs22\insrsid9723058\charrsid2450573  and}{\f2\fs22\insrsid16591479\charrsid2450573  (5) an }{\i\f2\fs22\insrsid16591479\charrsid2450573 in vitro }{\f2\fs22\insrsid16591479\charrsid2450573 study.}{\cs17\f2\fs22\super\insrsid4540022\charrsid2450573 
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4540022 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573  United States Food an Dru
g Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{\f2\insrsid2450573\charrsid2450573  
\par }}}{\f2\fs22\insrsid16591479\charrsid2450573  }{\f2\fs22\insrsid4540022\charrsid2450573  }{\f2\fs22\insrsid16591479\charrsid2450573 
These investigations must be performed by experts qualified by scientific training and experience to evaluate the effectiveness of the drug involved, on the basis of which \'93it could fairly and reasonably be concluded by such experts that the drug w
ill have the effect it purports or is represented to have under the conditions of use prescribed, recommended or suggested in the labeling or proposed labeling thereof.\'94}{\cs17\f2\fs22\super\insrsid16591479\charrsid2450573 \chftn {\footnote 
\pard\plain \ql \fi720\li0\ri0\widctlpar\faauto\rin0\lin0\itap0\pararsid10638521 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
  Vaughn, Steven D., D.V.M. \'93Overview of the Animal Drug Approval Process\'94}{\f2\insrsid2450573\charrsid2450573  United States Food an Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation.}{
\f2\insrsid2450573\charrsid2450573 
\par }}}{\f2\fs22\insrsid460529\charrsid2450573 
\par }{\f2\fs22\insrsid16344176\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3557918 \cbpat17 {\f2\fs22\ul\insrsid14494985\charrsid2450573 THE MARGINALIZATION OF THE CENTER FOR VETERINARY MEDICINE 
}{\f2\fs22\ul\insrsid460529\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3557918 \cbpat17 {\f2\fs22\insrsid10638521\charrsid2450573 Despite the seemingly ext
ensive procedures described above, some critics argue that o}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 rganizationally, the regulation of animal drugs{\*\bkmkstart SR\'3b77}{\*\bkmkend SR\'3b77}
 at the Food and Drug Administration \'93has always taken a backseat to the larger regulation of human food, drugs, and medical devices.\'94}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 \chftn {\footnote \pard\plain 
\s28\ql \fi675\li45\ri45\sb45\sa45\widctlpar\aspalpha\aspnum\faauto\adjustright\rin45\lin45\itap0\pararsid10638521 \cbpat8 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\fs20\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. Food and Drug Law Institute (}{
\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573   Even with "Center" status, some say that the Center for Veterinary Medicine (CVM) is \'93not on par\'94
 with the other four Centers: the Center for Food Safety and Applied Nutrition, the Center for Devices and Radiological Health, the Center for Drug Evaluation and Research, or the Center for Biologics Evaluation and Research.}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 \chftn {\footnote \pard\plain \s28\ql \fi675\li45\ri45\sb45\sa45\widctlpar\aspalpha\aspnum\faauto\adjustright\rin45\lin45\itap0\pararsid10638521 \cbpat8 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\f2\fs20\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93Animal Drugs: Future Stepchild or Pioneer?\'94 }{
\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. Food and Drug Law Institute (}{\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).
\par }}}{\cs29\f2\fs22\ul\insrsid10638521\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16339889 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 The Food and Drug 
}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8789557\charrsid2450573 Administration}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid9723058\charrsid2450573 , or more specifically, }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3557918\charrsid2450573 the Center for Veterinary Medicine}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid9723058\charrsid2450573 ,}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3557918\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 has }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6124312\charrsid2450573 particularly }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 marginalized}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6124312\charrsid2450573  companion}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6124312\charrsid2450573 animal}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid460529\charrsid2450573 \chftn 
{\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid460529 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  A pet or companion animal is an animal that is kept by humans for companionship and enjoyment, rather than for economic reasons. }{\f2\cf1\insrsid2450573\charrsid2450573 
"Companion animal" or "pet" means any dog or cat, and shall also mean any other domesticated animal nor
mally maintained in or near the household of the owner or person who cares for such other domesticated animal. "Pet" or "companion animal" shall not include a "farm animal."}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6124312\charrsid2450573  }
{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 drugs}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8789557\charrsid2450573 , which }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 
for many years}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8789557\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 remained }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573 stagnant}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  and limited}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573  al
most exclusively}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  to drugs for which there was no real human market, }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573 such as}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  wormers.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid540858 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug 
L.J. 33. Food and Drug Law Institute (}{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573   }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8789557\charrsid2450573 As }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 owners }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8789557\charrsid2450573 have }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3557918\charrsid2450573 grown}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8789557\charrsid2450573  more}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573 concerned}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573 
with extending the life }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 and }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573 maximizing the }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 comfort of their }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8789557\charrsid2450573 pets}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 
, however, many of the issues that humans face in regards to aging have become issues}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573  for companion animals as well.}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid540858 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93
Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. Food and Drug Law Institute (}{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).}}}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573   P}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573 et owners have shown }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 increasing}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573  interest in the development }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 of drugs that have been proven }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573 \'93}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 effective and safe in the target companion animal species.}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573 \'94}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2713024 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93
Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. Food and Drug Law Institute (}{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).}}}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12782229\charrsid2450573 Specifically, }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 nonsteroidal }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 anti}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 
-inflammatory drugs}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12782229\charrsid2450573  have taken off}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 , and}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  other "aging population" drugs are likely to follow.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid540858 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93
Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. Food and Drug Law Institute (}{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).}{
\f2\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 
Because consumers }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12782229\charrsid2450573 are now }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 demand}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12782229\charrsid2450573 ing}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  the same safety and eff}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573 ectiveness}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  of drugs for their companion animal}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573 s as }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 already }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 
exist for humans}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573 , the Food and Drug }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 A}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573 dministration}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  will not be able to avoid devoting significant resources to }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 the arena of animal }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573 drugs}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12782229\charrsid2450573  for much longer}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573 .}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid540858 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. Food and Drug Law Institute (}{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid398535\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid71418\charrsid2450573 The Food and Drug Administration will }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 probably}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573  have to address}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573  "alternative care}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid11630688\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard\plain \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11630688 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 
\chftn }{\f2\fs20\insrsid2450573\charrsid2450573 
 Chiropractic, high-dose vitamins and herbal therapies such as St. John's Wort and Ginkgo are among the myriad of "alternative treatments" currently enticing and perplexing patients and physicians alike.  Approxim
ately $13 billion a year are spent in the United States on these therapies, which some patients opt to use over conventional medicines. Alternative therapies, as they have become known, can range from innocuous family remedies to unproven but potentially 
p
romising remedies to harmful and ineffective treatments.  Many physicians take issue with the term "alternative," feeling it gives a degree of legitimacy to therapies that may or may not be effective.  For example, in conventional medicine, alternative us
u
ally refers to options within generally accepted medical practices, such as medical vs. surgical therapy for coronary artery disease.  One common definition of alternative medicine refers to therapies not widely taught in medical schools, not generally us
ed in hospitals and not typically reimbursed by medical insurance companies.  More than 50 medical schools in the United States now offer courses in alternative medicine.
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 "}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573  for companion animals}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14494985\charrsid2450573  as well}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573 , including}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 
 not only medical but also dietary supplement }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12648730\charrsid2450573 issues.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid540858 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Lambert, Eugene I. \'93Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug L.J. 33. Food and Drug Law Institute (}{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 2000).}{\f2\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12648730\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 Others }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14494985\charrsid2450573 questions will }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 also }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14494985\charrsid2450573 
likely }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 arise: d}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573 oes}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10638521\charrsid2450573 
 the}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573  }{\f2\fs22\insrsid2713024\charrsid2450573 Dietary Supplement Health and Education Act of 1994}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid540858\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid540858 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 The Dietary Supplement Health and Education Act of 1994 (DSHEA) acknowledges that millions of consumers believe dietary supplements may help to augment daily diets and provide health benefits. Congress's intent i
n enacting the DSHEA was to meet the concerns of consumers and manufacturers to help ensure that safe and appropriately labeled products remain available to those who want to use them. In the findings associated with the DSHEA, Congress stated that there 
m
ay be a positive relationship between sound dietary practice and good health, and that, although further scientific research is needed, there may be a connection between dietary supplement use, reduced health-care expenses, and disease prevention.  The pr
o
visions of DSHEA define dietary supplements and dietary ingredients; establish a new framework for assuring safety; outline guidelines for literature displayed where supplements are sold; provide for use of claims and nutritional support statements; requi
r
e ingredient and nutrition labeling; and grant FDA the authority to establish good manufacturing practice (GMP) regulations.  The law also requires formation of an executive level Commission on Dietary Supplement Labels and an Office of Dietary Supplement
s within the National Institutes of Health.
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2713024\charrsid2450573  apply, for example, or should it?}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid16339889\charrsid2450573 
\par }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid460529 \cbpat17 {\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14494985\charrsid2450573 
ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid16734645\charrsid2450573 
\par }{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14486002\charrsid2450573 1. INTRODUCTION}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid460529\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8673987 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 
The Animal Medicinal Drug Use Cl}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 arification Act of 1994 modified}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573  veterinarians\rquote 
 ability to prescribe both approved human and animal drugs in an off-label capa}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 city.  In doing so, it broadened}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573  the variety of drugs available to treat companion animals}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573  and addressed}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3563146\charrsid2450573  a concern with the Center for }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 
Veterinary Medicine stated above, namely that not enough drugs are on the market to treat the various ailments suffered by animals}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 .  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 T}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 he }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10057048\charrsid2450573 
Animal Medicinal Drug Use Clarification Act of 1994 }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 states that if a New Animal Drug Application }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12803223\charrsid2450573 
(NADA) }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 is approved and in effect with respect to a particular use or intended use of a new animal drug, the drug \'93shall not be deemed unsafe\'94 and \'93shall be ex}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 empt from the requirements ..}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 
. with respect to a different use or intended use of the drug, other than a use in or on animal feed,\'94 if such use or intended use: (i) is by or on the lawful written or oral order of a licensed veterinarian within the context of a veterinar}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 ian-client-patient relationship}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573  and}{
\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 (ii) is in compliance with regulations promulgated by the Secretary that e}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14486002\charrsid2450573 stablish the conditions for such}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573  different use or intended use.\'94}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid5580109\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5580109 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\field\fldedit{\*\fldinst {\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 
 HYPERLINK "http://web2.westlaw.com/find/default.wl?DB=1000819&DocName=USPL103%2D396&FindType=L&AP=&mt=LawSchoolPractitioner&fn=_top&sv=Split&vr=2.0&rs=WLW6.03" \\t "_top" }}{\fldrslt {
\cs27\f2\ul\cf2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Pub. L. No. 103-396}}}{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 , 108 Stat. 4153 (codified at }{\field\fldedit{\*\fldinst {
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573  HYPERLINK "http://web2.westlaw.com/find/default.wl?DB=1000546&DocName=21USCAS360B&FindType=L&AP=&mt=LawSchoolPractitioner&fn=_top&sv=Split&vr=2.0&rs=WLW6.03" \\t "_top" }}{\fldrslt {
\cs27\f2\ul\cf2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 21 U.S.C. \'a7 360b(a) (1994)}}}{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 ).
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 
\par 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 \cbpat17 {\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8673987\charrsid2450573 
2. OFF-LABEL DRUG USE DEFINED}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 
Technically, "off-label" prescribing occurs when a physician prescribes a drug either \'93for a use, or in a manner\'94 not indicated on its FDA-approved label.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 \chftn 
{\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug Law Journal 33, Food and Drug Law Institute, 2000.}{
\f2\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573  {\*\bkmkstart FN\'3bB6}{\*\bkmkend FN\'3bB6} }{\cs37\f2\fs22\insrsid15746520\charrsid2450573 
Terms such as "unlabeled use" or "unapproved use of approved drugs" are synonymous with "off-label."}{\cs17\f2\fs22\super\insrsid15746520\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  \'93}{
\cs37\f2\insrsid2450573\charrsid2450573 For an overview of the medical and legal issues of off-label drug use, see David A. Kessler, Regulating the Prescribing of Human Drugs for Nonapproved Uses Under
 the Food, Drug, and Cosmetic Act, 15 HARV.J. ON LEGIS. 693 (1978); Sidney A. Shapiro, Limiting Physician Freedom to Prescribe a Drug for Any Purpose: The Need for FDA Regulation, 73 NW.U.L.REV. 801 (1978).\'94 In }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 William L. Christopher\rquote s \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}{\f2\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 
Variations from the "package insert," or manufacturer\rquote s label for the product, can take many forms.  Prescribing an approved drug to treat a disease 
that is not indicated on its label as a method of treatment, for example, but is closely related to an indicated disease,}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 {\*\bkmkstart FN\'3bB7}{\*\bkmkend FN\'3bB7}
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  \'93}{\cs37\f2\insrsid2450573\charrsid2450573 UNITED STATES GOV. ACCT. OFF., OFF-LABEL DRUGS: REIMBURSEMENT POLICIES CONSTRAIN PHYSICIANS IN THEIR CHOICE OF CANCER THERAPIES, GAO/PEMD-91- 
14 at 11 (1991) (off-label use of breast cancer drug to treat colon cancer)\'94 in }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 William L. Christopher\rquote s \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94
 48 Food & Drug Law Journal 247, }{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 
 treating diseases that are both unrelated and not indicated (although treating }{\cs37\f2\fs22\insrsid15746520\charrsid2450573 diseases unrelated to approved uses may constitute dangerous experimentation}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  \'93}{\cs37\f2\insrsid2450573\charrsid2450573 
The drug DES was once the subject of widespread, informal experimentation despite limited FDA approval; one physician prescribed the drug as a "growth retardant" for adolescents. See DIANA B. DUTTON, WORSE THAN THE DISEASE 46 (1988)\'94 in }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 William L. Christopher\rquote s \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs37\f2\fs22\insrsid15746520\charrsid2450573 ), }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 {\*\bkmkstart FN\'3bB8}
{\*\bkmkend FN\'3bB8}and treating the disease indicated in the labeling but varying from the regimen, dosage, or patient population {\*\bkmkstart FN\'3bB9}{\*\bkmkend FN\'3bB9}indicated may all also constitute off-label use.}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15746520 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14486002 \cbpat17 {\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid16734645\charrsid2450573 
\par }{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15746520\charrsid2450573 3}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14486002\charrsid2450573 . SMOOTH SAILING FROM BILL TO LAW
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10057048 \cbpat17 {\f2\fs22\insrsid2834540\charrsid2450573 S}{\f2\fs22\insrsid2758910\charrsid2450573 
enator Howell He}{\f2\fs22\insrsid1987091\charrsid2450573 f}{\f2\fs22\insrsid2758910\charrsid2450573 l}{\f2\fs22\insrsid1987091\charrsid2450573 in}{\f2\fs22\insrsid15755149\charrsid2450573  }{\f2\fs22\insrsid1987091\charrsid2450573 of Alabama }{
\f2\fs22\insrsid15755149\charrsid2450573 introduced}{\f2\fs22\insrsid1987091\charrsid2450573  the Animal Medicinal Drug Use Clarification Act of 1994 (}{\f2\fs22\insrsid12803223\charrsid2450573 before its passage}{\f2\fs22\insrsid1987091\charrsid2450573 
, }{\f2\fs22\insrsid2834540\charrsid2450573 \'93a}{\f2\fs22\insrsid291615\charrsid2450573 
 bill to amend the Federal Food, Drug, and Cosmetic Act to clarify the application of the Act with respect to alternate uses of new animal drugs and new drugs intended for hu}{\f2\fs22\insrsid12803223\charrsid2450573 man use, and for other purposes\'94)}{
\f2\fs22\insrsid291615\charrsid2450573  }{\f2\fs22\insrsid1987091\charrsid2450573 to the United States Senate }{\f2\fs22\insrsid291615\charrsid2450573 on }{\f2\fs22\insrsid16410344\charrsid2450573 February 4, 1993.}{
\cs17\f2\fs22\super\insrsid15755149\charrsid2450573 \chftn {\footnote \pard\plain \s3\ql \fi720\li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin0\itap0\pararsid11300589 
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 ALTERNATE USES OF NEW ANIMAL DRUGS, STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS (Senate - February 04, 1993)  }{\field\flddirty{\*\fldinst {\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2 
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\par }}}{\f2\fs22\insrsid16410344\charrsid2450573  }{\f2\fs22\insrsid15152170\charrsid2450573  }{\f2\fs22\insrsid16410344\charrsid2450573 The measure was read twice and referred to the}{\f2\fs22\insrsid2834540\charrsid2450573  Senate}{
\f2\fs22\insrsid16410344\charrsid2450573  Committee of Labor and Human Resources.}{\cs17\f2\fs22\super\insrsid10903777\charrsid2450573 \chftn {\footnote \pard\plain 
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\f2\fs22\insrsid16410344\charrsid2450573   On October 4, 1993, the Committee on Labor and Human Resources discharged the bill by Unanimous Consent, and on the same day, the measure was laid before the Senate}{\f2\fs22\insrsid7150343\charrsid2450573 .}{
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\f2\insrsid2450573\charrsid2450573 Floor Actions/Congressional Record Page References 
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\f2\fs22\insrsid15152170\charrsid2450573  Senator Ford,}{\f2\fs22\insrsid16594374\charrsid2450573  for}{\f2\fs22\insrsid2758910\charrsid2450573  Senator He}{\f2\fs22\insrsid16594374\charrsid2450573 f}{\f2\fs22\insrsid2758910\charrsid2450573 l}{
\f2\fs22\insrsid16594374\charrsid2450573 in, proposed an }{\f2\fs22\insrsid15152170\charrsid2450573 amendment, Amendment SP 2612, which}{\f2\fs22\insrsid2834540\charrsid2450573  the Senate}{\f2\fs22\insrsid15152170\charrsid2450573 
 agreed to by Voice Vote.}{\cs17\f2\fs22\super\insrsid13773197\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
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\f2\insrsid2450573\charrsid2450573 Floor Actions/Congressional Record Page References 
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\f2\fs22\insrsid2834540\charrsid2450573  }{\f2\fs22\insrsid1987091\charrsid2450573 This}{\f2\fs22\insrsid2834540\charrsid2450573  }{\f2\fs22\insrsid15152170\charrsid2450573 Amendment }{\f2\fs22\insrsid12803223\charrsid2450573 primarily }{
\f2\fs22\insrsid13716054\charrsid2450573 altered }{\f2\fs22\insrsid15152170\charrsid2450573 the title }{\f2\fs22\insrsid16594374\charrsid2450573 of the bill }{\f2\fs22\insrsid13716054\charrsid2450573 and added some exceptions to}{
\f2\fs22\insrsid1987091\charrsid2450573  permit more extensive}{\f2\fs22\insrsid13716054\charrsid2450573  off-label }{\f2\fs22\insrsid1987091\charrsid2450573 drug }{\f2\fs22\insrsid13716054\charrsid2450573 use}{\f2\fs22\insrsid1987091\charrsid2450573 
 in some }{\f2\fs22\insrsid8673987\charrsid2450573 situations}{\f2\fs22\insrsid13716054\charrsid2450573 .}{\cs17\f2\fs22\super\insrsid13773197\charrsid2450573 \chftn {\footnote \pard\plain 
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\f2\insrsid2450573\charrsid2450573 Floor Actions/Congressional Record Page References 
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\f2\fs22\insrsid16594374\charrsid2450573 On October 5, 1994, the Message on Senate action was sent to the House, and on October 7, 1994}{\f2\fs22\insrsid9702978\charrsid2450573 ,}{\f2\fs22\insrsid10057048\charrsid2450573  the bill}{
\f2\fs22\insrsid16594374\charrsid2450573  was Passed without objection and cleared for the White House.}{\cs17\f2\fs22\super\insrsid13773197\charrsid2450573 \chftn {\footnote \pard\plain 
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\f2\fs22\insrsid2834540\charrsid2450573  }{\f2\fs22\insrsid16594374\charrsid2450573 On October 17, 1994}{\f2\fs22\insrsid2834540\charrsid2450573 , the bill }{\f2\fs22\insrsid16594374\charrsid2450573 
was presented to the President, who signed it on October 22, 1994.}{\cs17\f2\fs22\super\insrsid13773197\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
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\f2\insrsid2450573\charrsid2450573 Floor Actions/Congressional Record Page References 
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\f2\fs22\insrsid1987091\charrsid2450573  }{\f2\fs22\insrsid16594374\charrsid2450573 On the same day, the Animal Medicinal Drug Use Clarification Act of 1994 became public law.}{\cs17\f2\fs22\super\insrsid13773197\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13773197 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 ALL ACTIONS, }{
\f2\insrsid2450573\charrsid2450573 Floor Actions/Congressional Record Page References 
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\par }{\f2\fs22\ul\insrsid15746520\charrsid2450573 4}{\f2\fs22\ul\insrsid14486002\charrsid2450573 . }{\f2\fs22\ul\insrsid3430254\charrsid2450573 THE NEED FOR OFF-LABEL DRUG USE IN ANIMALS}{\f2\fs22\ul\insrsid14486002\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10320498 {\f2\fs22\insrsid1987091\charrsid2450573 As }{\f2\fs22\insrsid12803223\charrsid2450573 one can observe }{
\f2\fs22\insrsid1987091\charrsid2450573 above, t}{\f2\fs22\insrsid2834540\charrsid2450573 he Animal Medicinal Drug Use Clarification Act of 1994 created little }{\f2\fs22\insrsid1987091\charrsid2450573 controversy}{\f2\fs22\insrsid8673987\charrsid2450573 
, }{\f2\fs22\insrsid10320498\charrsid2450573 disagreement}{\f2\fs22\insrsid10057048\charrsid2450573 , or protest}{\f2\fs22\insrsid10320498\charrsid2450573  in either the United States House of Representatives or the United States Senat}{
\f2\fs22\insrsid15755149\charrsid2450573 e}{\f2\fs22\insrsid2834540\charrsid2450573 . }{\f2\fs22\insrsid10320498\charrsid2450573  }{\f2\fs22\insrsid2834540\charrsid2450573 What we}{\f2\fs22\insrsid5920240\charrsid2450573 re the arguments put forth }{
\f2\fs22\insrsid8673987\charrsid2450573 by the bill\rquote s sponsors }{\f2\fs22\insrsid2834540\charrsid2450573 to enable }{\f2\fs22\insrsid8673987\charrsid2450573 it}{\f2\fs22\insrsid2834540\charrsid2450573  to }{\f2\fs22\insrsid1987091\charrsid2450573 
sail}{\f2\fs22\insrsid2834540\charrsid2450573  so smoothly}{\f2\fs22\insrsid1987091\charrsid2450573  through }{\f2\fs22\insrsid10320498\charrsid2450573 Congr}{\f2\fs22\insrsid154908\charrsid2450573 ess?
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4549587 {\f2\fs22\insrsid2758910\charrsid2450573 As Senator Hefl}{\f2\fs22\insrsid154908\charrsid2450573 
in, the sponsor of the bill, described it: \'93Extra-label drug use is an important issue for farmers and ranchers, veterinarians, pet owners, and consumers.}{\f2\fs22\insrsid4549587\charrsid2450573  }{\f2\fs22\insrsid154908\charrsid2450573  For man
y years, [the Food and Drug Administration] has recognized that the current Food, Drug and Cosmetic Act places veterinarians in an untenable position. }{\f2\fs22\insrsid4549587\charrsid2450573  }{\f2\fs22\insrsid154908\charrsid2450573 
On the one hand, the Veterinarian's Oath p}{\f2\fs22\insrsid4549587\charrsid2450573 ledges the veterinarian to use }{\f2\fs22\insrsid154908\charrsid2450573 scientific knowledge and skills
 for the benefit of society through the protection of animal health, the relief of animal suffering, the conservation of livestock resources, the promotion of public health, and the ad}{\f2\fs22\insrsid4549587\charrsid2450573 
vancement of medical knowledge.}{\f2\fs22\insrsid154908\charrsid2450573  }{\f2\fs22\insrsid4549587\charrsid2450573  }{\f2\fs22\insrsid154908\charrsid2450573 On the other hand, the use of many effe
ctive drugs is illegal because they are not specifically labeled for the use intended by the veterinary medical practitioners.}{\f2\fs22\insrsid4549587\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid4549587\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4549587 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\f2\insrsid2450573\charrsid2450573 THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS (Senate - October 04, 1994)  }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:2:./temp/~r1039lNPvy:e0" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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}}{\f2\insrsid2450573\charrsid2450573 : 
\par }}}{\f2\fs22\insrsid2834540\charrsid2450573  }{\f2\fs22\insrsid154908\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9140008 {\f2\fs22\insrsid5920240\charrsid2450573 
Representative Waxman of California, in his statement to the United States House of Representatives, describes the situation prior to the passage of the Animal Medicinal Drug Use Clarification Act of 1994}{\f2\fs22\insrsid10057048\charrsid2450573  }{
\f2\fs22\insrsid8673987\charrsid2450573 in similar terms}{\f2\fs22\insrsid5920240\charrsid2450573 : \'93
a problem that has plagued veterinarians for many years: namely, the divergence between the law and veterinary practice with respect to the prescribing of animal drugs.\'94}{\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\f2\insrsid2450573\charrsid2450573 ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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002f0046003f0072003100300033003a0033003a002e002f00740065006d0070002f007e0072003100300033004b006300580031006a004c003a006500340037000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 
http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 : }}}{\f2\fs22\insrsid5920240\charrsid2450573   \'93It is common medical practice for animal doctors to use drugs th}{
\f2\fs22\insrsid8673987\charrsid2450573 at have been approved by the [Food and Drug Administration]}{\f2\fs22\insrsid5920240\charrsid2450573  for unapproved uses\'94 Waxman states.}{\cs17\f2\fs22\super\insrsid10057048\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid883288 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 
ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47" }{
\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 : }}}{\f2\fs22\insrsid5920240\charrsid2450573   He provides a}{\f2\fs22\insrsid8673987\charrsid2450573 n example for clarification: }{
\f2\fs22\insrsid2450573\charrsid2450573 \'93A}{\f2\fs22\insrsid5920240\charrsid2450573  drug that has been approved for sh
eep is often used in cows.  Since there may be no drug approved for cows for a particular disease, the veterinarian has little choice but to break the law.\'94}{\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote \pard\plain 
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\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 
ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47" }{
\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 :
\par }}}{\f2\fs22\insrsid5920240\charrsid2450573   In fact, as a matter of \'93enforcement discretion\'94 (a.k.a. not prosecuting veterinarians even though they are technically breaking the law), the Food and Drug Administration implicitly }{
\i\f2\fs22\insrsid5920240\charrsid2450573 permits}{\f2\fs22\insrsid5920240\charrsid2450573  animal doctors to prescribe drugs for unapproved uses.}{\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote \pard\plain 
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\f2\insrsid2450573\charrsid2450573 ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 : }}}{\f2\fs22\insrsid5920240\charrsid2450573   }{\f2\fs22\insrsid9140008\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 {\f2\fs22\insrsid5920240\charrsid2450573 Waxman notes that in recent years, veterinarians have grown \'93
increasingly concerned\'94 with the fact that on a regular basis, they are breaking the law.}{\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote \pard\plain 
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ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47" }{
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  In his statement to the United States House of Representatives, therefore, Waxman urges the House to take in account the \'93realities of medical practice\'94 and make this type of off-label usage legal.}{
\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 
ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47" }{
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 :}}}{\f2\fs22\insrsid5920240\charrsid2450573   
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10057048 {\f2\fs22\insrsid5920240\charrsid2450573 He offers}{\f2\fs22\insrsid8673987\charrsid2450573  a}{
\f2\fs22\insrsid5920240\charrsid2450573  caveat worth}{\f2\fs22\insrsid10057048\charrsid2450573 y noting}{\f2\fs22\insrsid5920240\charrsid2450573 :  \'93
The Food and Drug Administration must know what animal drugs are being used in food-producing animals for unapproved uses, so that it can determine the tools that it needs to monitor drug residue in animals.\'94}{
\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
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ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47" }{
\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 :
\par }}}{\f2\fs22\insrsid5920240\charrsid2450573   In this a way, the Food and Drug Administration can strike a balance between the needs of veterinarians in treating sick animals and the needs of the Food and Drug Administration in monitoring the food supply.
}{\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst 
{\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 :}}}{\f2\fs22\insrsid5920240\charrsid2450573   In summary, \'93veterinarians should be allowed to prescribe d
rugs for unapproved uses, while giving the Food and Drug Administration the power to regulate the drug uses and to create requirements to protect human health where needed.\'94}{\cs17\f2\fs22\super\insrsid5920240\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 
ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47" }{
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103KcX1jL:e47}}}{\f2\insrsid2450573\charrsid2450573 :}}}{\f2\fs22\insrsid16339889\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3430254 {\f2\fs22\insrsid7150917\charrsid2450573 What creates the }{\f2\fs22\insrsid12849970\charrsid2450573 
need for}{\f2\fs22\insrsid7150917\charrsid2450573  veterinarians to prescribe drugs in an }{\f2\fs22\insrsid12849970\charrsid2450573 off-label }{\f2\fs22\insrsid7150917\charrsid2450573 capacity}{\f2\fs22\insrsid10057048\charrsid2450573  in the first place
}{\f2\fs22\insrsid7150917\charrsid2450573 ?  }{\f2\fs22\insrsid9140008\charrsid2450573 A}{\f2\fs22\insrsid16339889\charrsid2450573  }{\f2\fs22\insrsid154908\charrsid2450573 modification of the law}{\f2\fs22\insrsid9140008\charrsid2450573 
, according to Senator Heflin,}{\f2\fs22\insrsid2758910\charrsid2450573  is}{\f2\fs22\insrsid154908\charrsid2450573  necessary rectify \'93a serious problem facing America's veterinarians and the animals they treat. . .\'94}{
\cs17\f2\fs22\super\insrsid154908\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid154908 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard\plain \s3\ql \fi720\li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin0\itap0\pararsid154908 \fs24\lang1033\langfe1033\loch\af2\hich\af2\dbch\af34\cgrid\langnp1033\langfenp1033 {
\cs17\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  ALTERNATE USES OF NEW ANIMAL DRUGS, STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS (Senate - Febr\hich\af2\dbch\af34\loch\f2 
uary 04, 1993)  }{\field\flddirty{\*\fldinst {\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103QRnTQL:e586177" }{\fs20\insrsid2450573\charrsid2450573 {\*\datafield 
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\hich\af2\dbch\af34\loch\f2 http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103QRnTQL:e586177}}}{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2 :
\par }}}{\f2\fs22\insrsid154908\charrsid2450573   \'93If the FDA were to strictly enforce the Federal Food, Drug, and Cosmetic Act as it is written today\'94 Heflin comments in his introduction of the bill, \'93
the act would prevent the relief of pain and the prevention of suffering in a host of animal species from cattle to pet birds, for which there are no FDA approved drugs for these purposes.\'94}{\cs17\f2\fs22\super\insrsid154908\charrsid2450573 \chftn 
{\footnote \pard\plain \s3\ql \fi720\li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin0\itap0\pararsid154908 \fs24\lang1033\langfe1033\loch\af2\hich\af2\dbch\af34\cgrid\langnp1033\langfenp1033 {
\cs17\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  ALTERNATE USES OF NEW ANIMAL DRUGS, STATEMENTS ON INTRODUCED BILLS AND JOIN\hich\af2\dbch\af34\loch\f2 
T RESOLUTIONS (Senate - February 04, 1993)  }{\field\flddirty{\*\fldinst {\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103QRnTQL:e586177" }{
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\hich\af2\dbch\af34\loch\f2 http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103QRnTQL:e586177}}}{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2 :
\par }}}{\f2\fs22\insrsid154908\charrsid2450573   }{\f2\fs22\insrsid10057048\charrsid2450573 Basically, t}{\f2\fs22\insrsid2758910\charrsid2450573 here is a huge shortage of}{\f2\fs22\insrsid10757843\charrsid2450573 
 drugs available to treat animals. A new animal dr}{\f2\fs22\insrsid2758910\charrsid2450573 ug application review process must be completed, as required by the law, }{\f2\fs22\insrsid9140008\charrsid2450573 within six}{
\f2\fs22\insrsid10757843\charrsid2450573  months. }{\f2\fs22\insrsid2758910\charrsid2450573 T}{\f2\fs22\insrsid10757843\charrsid2450573 he reality}{\f2\fs22\insrsid2758910\charrsid2450573 , however,}{\f2\fs22\insrsid10757843\charrsid2450573 
 is that the review process at }{\f2\fs22\insrsid2758910\charrsid2450573 the }{\f2\fs22\insrsid10757843\charrsid2450573 F}{\f2\fs22\insrsid2758910\charrsid2450573 ood and }{\f2\fs22\insrsid10757843\charrsid2450573 D}{
\f2\fs22\insrsid2758910\charrsid2450573 rug }{\f2\fs22\insrsid10757843\charrsid2450573 A}{\f2\fs22\insrsid2758910\charrsid2450573 dministration}{\f2\fs22\insrsid10757843\charrsid2450573  now }{\f2\fs22\insrsid2758910\charrsid2450573 
takes, on average, four}{\f2\fs22\insrsid10757843\charrsid2450573  years.}{\cs17\f2\fs22\super\insrsid10757843\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid883288 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\f2\insrsid2450573\charrsid2450573 ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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}}{\f2\insrsid2450573\charrsid2450573 : }}}{\f2\fs22\insrsid10757843\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid154908 {\f2\fs22\insrsid10057048\charrsid2450573 Furthermore, }{\f2\fs22\insrsid1987091\charrsid2450573 
Senator Heflin }{\f2\fs22\insrsid10057048\charrsid2450573 describes how}{\f2\fs22\insrsid1987091\charrsid2450573  }{\f2\fs22\insrsid10037805\charrsid2450573 the Food and Drug Administration has approved only a }{\f2\fs22\insrsid10057048\charrsid2450573 
very }{\f2\fs22\insrsid10037805\charrsid2450573 small number }{\f2\fs22\insrsid16410344\charrsid2450573 animal drugs}{\f2\fs22\insrsid10037805\charrsid2450573 , and only}{\f2\fs22\insrsid16410344\charrsid2450573  for the m}{
\f2\fs22\insrsid7150917\charrsid2450573 ost common of domestic species. }{\f2\fs22\insrsid10037805\charrsid2450573  }{\f2\fs22\insrsid16410344\charrsid2450573 Few, if any, ne
w animal drugs are approved for species of animals which are used extensively in most of the Nation's research facilities}{\f2\fs22\insrsid10037805\charrsid2450573 ,}{\f2\fs22\insrsid16410344\charrsid2450573  such as }{
\f2\fs22\insrsid10037805\charrsid2450573 \'93}{\f2\fs22\insrsid16410344\charrsid2450573 mice, rats, hamsters, gerbils, guinea pigs, and rabbits.}{\f2\fs22\insrsid10037805\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid16191546\charrsid2450573 \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard\plain \s3\ql \fi720\li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin0\itap0\pararsid13376058 \fs24\lang1033\langfe1033\loch\af2\hich\af2\dbch\af34\cgrid\langnp1033\langfenp1033 {
\cs17\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  ALTERNATE USES OF NEW ANIMAL DRUGS, STATEMENTS ON\hich\af2\dbch\af34\loch\f2 
 INTRODUCED BILLS AND JOINT RESOLUTIONS (Senate - February 04, 1993)  }{\field\flddirty{\*\fldinst {\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  HYPERLINK "http://thomas.loc.gov/cgibin/query/F?r103:1:./temp/~r103QRnTQL:e586177" }{
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http://thomas.loc.gov/cgibin/query/F?r103:1:./temp/~r103QRnTQL:e586177}}}{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2 :
\par }}}{\f2\fs22\insrsid14486002\charrsid2450573   }{\f2\fs22\insrsid5920240\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5920240 {\f2\fs22\insrsid10057048\charrsid2450573 Given the shortage of Food and Drug Administration-approved dru
gs therefore, p}{\f2\fs22\insrsid16345288\charrsid2450573 roper}{\f2\fs22\insrsid14486002\charrsid2450573  veterinary }{\f2\fs22\insrsid16345288\charrsid2450573 care}{\f2\fs22\insrsid5920240\charrsid2450573  }{\f2\fs22\insrsid10057048\charrsid2450573 
effectively }{\f2\fs22\insrsid16345288\charrsid2450573 requires }{\f2\fs22\insrsid10057048\charrsid2450573 extra-label drug use. }{\f2\fs22\insrsid8673987\charrsid2450573  }{\f2\fs22\insrsid10057048\charrsid2450573 T}{
\f2\fs22\insrsid154908\charrsid2450573 he Food and Drug Administration has }{\f2\fs22\insrsid16339889\charrsid2450573 simply }{\f2\fs22\insrsid154908\charrsid2450573 not approved enough}{\f2\fs22\insrsid14486002\charrsid2450573 
 therapies to treat the conditions that veterinarians routinely }{\f2\fs22\insrsid16345288\charrsid2450573 come across}{\f2\fs22\insrsid14486002\charrsid2450573  in practice. }{\f2\fs22\insrsid154908\charrsid2450573  }{
\f2\fs22\insrsid10057048\charrsid2450573 Exa}{\f2\fs22\insrsid8673987\charrsid2450573 mples of necessary off-label use}{\f2\fs22\insrsid10057048\charrsid2450573 s in}{\f2\fs22\insrsid14486002\charrsid2450573  companion animals include }{
\f2\fs22\insrsid154908\charrsid2450573 \'93}{\f2\fs22\insrsid14486002\charrsid2450573 
insulin to treat diabetes, cardiac and chemotherapeutic drugs that bear a human drug label; anesthetic, analgesic and sedative agents for food animals; and effective antibiotics for food and companion animals to name just a few.}{
\f2\fs22\insrsid154908\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid154908\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13376058 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 STATEMENTS ON INTRODUCE
D BILLS AND JOINT RESOLUTIONS (Senate - February 04, 1993) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103sVc74R:e586177" }{\f2\insrsid2450573\charrsid2450573 
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\par }}}{\f2\fs22\insrsid14486002\charrsid2450573  
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16191546 {\f2\fs22\insrsid11090483\charrsid2450573 R}{\f2\fs22\insrsid13376058\charrsid2450573 
epresentative Moorhead confirms}{\f2\fs22\insrsid16339889\charrsid2450573  the}{\f2\fs22\insrsid10057048\charrsid2450573  need for the }{\f2\fs22\insrsid13571374\charrsid2450573 passage of the }{\f2\fs22\insrsid10057048\charrsid2450573 
Animal Medicinal Drug Use Clarification Act of 1994}{\f2\fs22\insrsid16339889\charrsid2450573  }{\f2\fs22\insrsid13571374\charrsid2450573 in his statement to the United States House of Representatives}{\f2\fs22\insrsid11090483\charrsid2450573 : }{
\f2\fs22\insrsid16191546\charrsid2450573 
\par }\pard \s28\ql \li1440\ri1526\sb100\sa100\sbauto1\saauto1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1526\lin1440\itap0\pararsid16339889 {\f2\fs22\insrsid16191546\charrsid2450573 T}{\f2\fs22\insrsid11090483\charrsid2450573 
he primary purpose of this legislation is to permit 
veterinarians to prescribe approved animal or human drugs to species of animals for which the drugs are not currently approved.  The legislation is necessary because there are an insufficient number of drugs approved for all the various disease problems i
n
 all the animal species. Generally, an animal drug is approved on a species-by-species basis. For example, if a drug is approved for use in cows, the company must also go through the approval process to get that same drug approved for use in sheep. This p
rocess can be prohibitively expensive and, therefore, many animal drugs are not approved for use in multiple animals, especial}{\f2\fs22\insrsid16191546\charrsid2450573 ly for so-called minor species.}{\cs17\f2\fs22\super\insrsid16191546\charrsid2450573 
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16191546 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 ANIMAL MEDICINAL DRUG USE CLARIFICATION ACT OF 1994 (House of Representatives - October 06, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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http://thomas.loc.gov/cgi-bin/query/F?r103:3:./temp/~r103RV7XqP:e609}}}{\f2\insrsid2450573\charrsid2450573 : 
\par }}}{\f2\fs22\insrsid16339889\charrsid2450573 
\par }\pard \s28\ql \li0\ri1526\sb100\sa100\sbauto1\saauto1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin1526\lin0\itap0\pararsid16339889 {\f2\fs22\insrsid16339889\charrsid2450573 
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\f2\fs22\insrsid2758910\charrsid2450573 , it is }{\f2\fs22\insrsid13376058\charrsid2450573 just }{\f2\fs22\insrsid16339889\charrsid2450573 not cost-effective for a }{\f2\fs22\insrsid2758910\charrsid2450573 pharmaceutical com
pany to seek an approved label for all }{\f2\fs22\insrsid13571374\charrsid2450573 of the }{\f2\fs22\insrsid2758910\charrsid2450573 species for which a drug is }{\f2\fs22\insrsid13571374\charrsid2450573 both }{\f2\fs22\insrsid2758910\charrsid2450573 
beneficial and safe.  }{\f2\fs22\insrsid16345288\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6772057 {\f2\fs22\insrsid9140008\charrsid2450573 The Animal Medicinal Drug Use Clarification Act of 1994}{
\f2\fs22\insrsid13571374\charrsid2450573 , however, provi}{\f2\fs22\insrsid3430254\charrsid2450573 des a solution to this problem, }{\f2\fs22\insrsid13571374\charrsid2450573 \'93enabl[ing] }{\f2\fs22\insrsid16345288\charrsid2450573 veterinarians to }{
\f2\fs22\insrsid2758910\charrsid2450573 prevent pain}{\f2\fs22\insrsid9140008\charrsid2450573 , suffering, and death in }{\f2\fs22\insrsid16345288\charrsid2450573 animals}{\f2\fs22\insrsid13571374\charrsid2450573 .\'94}{
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\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS (Senate - October 04, 1994) }{\field\flddirty{\*\fldinst {
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\f2\fs22\insrsid16345288\charrsid2450573 n dogs prior to its use in humans}{\f2\fs22\insrsid2758910\charrsid2450573 , }{\f2\fs22\insrsid16345288\charrsid2450573 can be an effective treatment for dogs with }{\f2\fs22\insrsid2758910\charrsid2450573 
diabetes, even though the }{\f2\fs22\insrsid16345288\charrsid2450573 drug}{\f2\fs22\insrsid2758910\charrsid2450573  has never }{\f2\fs22\insrsid16345288\charrsid2450573 been formally approved for }{\f2\fs22\insrsid2758910\charrsid2450573 use}{
\f2\fs22\insrsid16345288\charrsid2450573  in dogs}{\f2\fs22\insrsid2758910\charrsid2450573 .}{\cs17\f2\fs22\super\insrsid16339889\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
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\par }}}{\f2\fs22\insrsid2758910\charrsid2450573  }{\f2\fs22\insrsid16345288\charrsid2450573  Other medications, including }{\f2\fs22\insrsid2758910\charrsid2450573 anesthetics}{\f2\fs22\insrsid16345288\charrsid2450573  and analgesics}{
\f2\fs22\insrsid2758910\charrsid2450573 , may not be approved in cattle or goats, but are}{\f2\fs22\insrsid16345288\charrsid2450573  nonetheless}{\f2\fs22\insrsid2758910\charrsid2450573  invaluable in }{\f2\fs22\insrsid16345288\charrsid2450573 
relieving pain in animals }{\f2\fs22\insrsid2758910\charrsid2450573 and making surg}{\f2\fs22\insrsid16345288\charrsid2450573 ery}{\f2\fs22\insrsid2758910\charrsid2450573  }{\f2\fs22\insrsid16345288\charrsid2450573 more}{
\f2\fs22\insrsid2758910\charrsid2450573  bearable.}{\cs17\f2\fs22\super\insrsid16339889\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16339889 
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}}{\f2\insrsid2450573\charrsid2450573 : }}}{\f2\fs22\insrsid2758910\charrsid2450573  }{\f2\fs22\insrsid16345288\charrsid2450573  \'93}{\f2\fs22\insrsid2758910\charrsid2450573 Can you imagine that in the United Kingdom it is illegal to dehor}{
\f2\fs22\insrsid3430254\charrsid2450573 n a goat without an anesthetic - }{\f2\fs22\insrsid2758910\charrsid2450573 and that in the United States it is currently illegal to use one?}{\f2\fs22\insrsid16345288\charrsid2450573 \'94 Senator Heflin asks.}{
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THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS (Senate - October 04, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:2:./temp/~r103btaZup:e0" }{
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}}{\f2\insrsid2450573\charrsid2450573 : }}}{\f2\fs22\insrsid2758910\charrsid2450573  }{\f2\fs22\insrsid16339889\charrsid2450573  }{\f2\fs22\insrsid2758910\charrsid2450573 By authorizing}{\f2\fs22\insrsid16345288\charrsid2450573 
 judicious extra-label use, Animal Medicinal Drug Use Clarification Act of 1994}{\f2\fs22\insrsid2758910\charrsid2450573  }{\f2\fs22\insrsid16345288\charrsid2450573 rectifies the}{\f2\fs22\insrsid2758910\charrsid2450573  situation.}{
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\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS (Senate - October 04, 1994) }{\field\flddirty{\*\fldinst {
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\par }}}{\f2\fs22\insrsid16339889\charrsid2450573 
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\par }{\f2\fs22\ul\insrsid3430254\charrsid2450573 5}{\f2\fs22\ul\insrsid16339889\charrsid2450573 . THE CONSEQUENCES OF NOT LEGALIZING THE }{\f2\fs22\ul\insrsid16345288\charrsid2450573 OFF-LABEL }{\f2\fs22\ul\insrsid16339889\charrsid2450573 U}{
\f2\fs22\ul\insrsid16345288\charrsid2450573 SE }{\f2\fs22\ul\insrsid16339889\charrsid2450573 OF DRUGS 
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eterinarians use drugs in an extra-label manner to save animal lives, prevent suffering, and to protect human health.}{\f2\fs22\insrsid16345288\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid5586700\charrsid2450573 \chftn {\footnote \pard\plain 
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\f2\insrsid2450573\charrsid2450573 THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AMENDMENTS (Senate - October 04, 1994) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?
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}}{\f2\insrsid2450573\charrsid2450573 : 
\par }}}{\f2\fs22\insrsid16410344\charrsid2450573  }{\f2\fs22\insrsid16345288\charrsid2450573  }{\f2\fs22\insrsid5586700\charrsid2450573 What are the beneficial effects of making off-label drug use in animals legal}{\f2\fs22\insrsid9969871\charrsid2450573 
, or conversely, the drawbacks of keeping such extra-label usage illegal}{\f2\fs22\insrsid5586700\charrsid2450573 ? }{\f2\fs22\insrsid5516596\charrsid2450573  }{\f2\fs22\insrsid5586700\charrsid2450573 Permitting veterinarians to treat }{
\f2\fs22\insrsid16410344\charrsid2450573 sick food-producing animals }{\f2\fs22\insrsid5586700\charrsid2450573 with drugs in an off-label capacity would }{\f2\fs22\insrsid3430254\charrsid2450573 likely }{\f2\fs22\insrsid5586700\charrsid2450573 
result in increased }{\f2\fs22\insrsid16410344\charrsid2450573 food }{\f2\fs22\insrsid5586700\charrsid2450573 safety, because sick animals would not be shipped to market as frequently}{\f2\fs22\insrsid16410344\charrsid2450573 .}{
\f2\fs22\insrsid5586700\charrsid2450573   Under the current state of the law, i}{\f2\fs22\insrsid16410344\charrsid2450573 f legal therapies are }{\f2\fs22\insrsid5586700\charrsid2450573 un}{\f2\fs22\insrsid16410344\charrsid2450573 available to ve}{
\f2\fs22\insrsid5586700\charrsid2450573 terinarians, producers \'93may }{\f2\fs22\insrsid16410344\charrsid2450573 ship sick animals to market, rather than watch them suffer and }{\f2\fs22\insrsid5586700\charrsid2450573 perhaps }{
\f2\fs22\insrsid16410344\charrsid2450573 die, or take a chance that they may infect the remainder of the herd.}{\f2\fs22\insrsid5586700\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid13376058\charrsid2450573 \chftn {\footnote \pard\plain 
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\f2\insrsid2450573\charrsid2450573 STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS (Senate - February 04, 1993) }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r10
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\par }{\f2\fs22\insrsid5586700\charrsid2450573 P}{\f2\fs22\insrsid2758910\charrsid2450573 ublic health}{\f2\fs22\insrsid9969871\charrsid2450573  may also be at stake}{\f2\fs22\insrsid3430254\charrsid2450573 
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\f2\fs22\insrsid5586700\charrsid2450573 hlamydiosis,}{\f2\fs22\insrsid9969871\charrsid2450573  for example,}{\f2\fs22\insrsid5586700\charrsid2450573  }{\f2\fs22\insrsid2758910\charrsid2450573 a disease which is}{\f2\fs22\insrsid5586700\charrsid2450573 
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\par }{\f2\fs22\ul\insrsid13762814\charrsid2450573 6}{\f2\fs22\ul\insrsid7031962\charrsid2450573 . THE ULTIMATE TAKEAWAY}{\f2\fs22\ul\insrsid9969871\charrsid2450573 
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\f2\fs22\insrsid7031962\charrsid2450573 \'93}{\f2\fs22\insrsid16410344\charrsid2450573 clear and easily enforceable statute.}{\f2\fs22\insrsid9969871\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid14436599\charrsid2450573 \chftn {\footnote \pard\plain 
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http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103xOZI9Q:e586177}}}{\f2\insrsid2450573\charrsid2450573 :}}}{\f2\fs22\insrsid9969871\charrsid2450573  }{\f2\fs22\insrsid16410344\charrsid2450573  }{\f2\fs22\insrsid4522186\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9467115 {\f2\fs22\insrsid14436599\charrsid2450573 F}{\f2\fs22\insrsid9969871\charrsid2450573 urthermore, }{
\f2\fs22\insrsid14436599\charrsid2450573 it}{\f2\fs22\insrsid9969871\charrsid2450573  codifies current Food and Drug Administration}{\f2\fs22\insrsid16410344\charrsid2450573 
 policy and authorizes extra-label drug use by veterinarians only, under carefully controlled supervision}{\f2\fs22\insrsid14436599\charrsid2450573 .}{\cs17\f2\fs22\super\insrsid14436599\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14436599 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14436599 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 
STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS (Senate - February 04, 1993)}{\f2\insrsid2450573\charrsid2450573  }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103xOZI9Q:e586177}}}{\f2\insrsid2450573\charrsid2450573 :}}}{\f2\fs22\insrsid14436599\charrsid2450573   It }{\f2\fs22\insrsid3430254\charrsid2450573 does not, therefore, }{
\f2\fs22\insrsid16410344\charrsid2450573 result in increased }{\f2\fs22\insrsid14436599\charrsid2450573 harmful drug residues in food products and it }{\f2\fs22\insrsid3430254\charrsid2450573 does not}{\f2\fs22\insrsid16410344\charrsid2450573 
 increase or alter overall patterns of drug usage by veterinari}{\f2\fs22\insrsid14436599\charrsid2450573 a}{\f2\fs22\insrsid16410344\charrsid2450573 ns.}{\f2\fs22\insrsid14436599\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid14436599\charrsid2450573 
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\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\insrsid2450573\charrsid2450573 STATEMENTS ON INTRODUCED BILLS AND JOINT RESOLUTIONS (Senate - February 04, 1993)}{\f2\insrsid2450573\charrsid2450573  }
{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103xOZI9Q:e586177" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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http://thomas.loc.gov/cgi-bin/query/F?r103:1:./temp/~r103xOZI9Q:e586177}}}{\f2\insrsid2450573\charrsid2450573 :}}}{\f2\fs22\insrsid16410344\charrsid2450573  }{\f2\fs22\insrsid4342212\charrsid2450573 
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid883288 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs29\f2\fs22\insrsid14960912\charrsid2450573 
\par }\pard\plain \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2568132 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 T}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 HE OFF-LABEL USE OF DRUGS: A CLOSER LOOK}{
\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid16734645\charrsid2450573 
\par }{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3563146\charrsid2450573 1. INTRODUCTION}{\cs29\f2\fs22\insrsid3563146\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5516596 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
What are the possible }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3563146\charrsid2450573 upsides }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3430254\charrsid2450573 and }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 downsides of permitting the off-label use of drugs}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid539960\charrsid2450573 , both in}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3430254\charrsid2450573  humans}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid539960\charrsid2450573  and in animals}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
?  In the section above, }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 
the United States Senators and Representatives supporting the bill described many of the upsides of off-label drug use in animals.  Because there was no opposition to the bill, however, none of the downsides of off-label drug use }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 are}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573  brought to light.  The question remains, therefore, whether }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 the off-label use of prescription drugs, subject to some reasonable constraints, is a }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 
really good thing.  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 In this section}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid539960\charrsid2450573 , I will examine the }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 qu}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid539960\charrsid2450573 e}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 stion}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573  more closely. 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid539960 \cbpat17 {\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid16734645\charrsid2450573 
\par }{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3563146\charrsid2450573 2}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid539960\charrsid2450573 . THE ART OF MEDICINE
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2568132 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 \'93
The practice of medicine is often described not as a science, but as an art . . . consistent with this simile, physicians attack some attempts to regulate medicine with the vigor of an artist resisting censorship.\'94}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2568132 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard\plain \s28\ql \fi675\li45\ri45\sb45\sa45\widctlpar\aspalpha\aspnum\faauto\adjustright\rin45\lin45\itap0\pararsid3563146 \cbpat8 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\fs20\insrsid2450573\charrsid2450573  \'93}{\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Legislation generally has overridden the physician lobby against drug regulation only in times of medical disaster. See, e.g., }
{\field\fldedit{\*\fldinst {\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573  HYPERLINK "http://web2.westlaw.com/find/default.wl?DB=1190&SerialNum=0101438793&FindType=Y&ReferencePositio
nType=S&ReferencePosition=1015&AP=&mt=LawSchoolPractitioner&fn=_top&sv=Split&vr=2.0&rs=WLW6.03" \\t "_top" }}{\fldrslt {\cs27\f2\fs20\ul\cf2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 
Nancy M.P. King & Gail Henderson, Treatments of Last Resort: Informed Consent and the Diffusion of New Technology, 42 MERCER L.REV. 1007, 1015-19 (1991)}}}{\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 .\'94
 in William L. Christopher\rquote s \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993). 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid9467115\charrsid2450573   }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3430254\charrsid2450573 The medical community largely believes}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  that \'93overregulation chills innovation and reduces medicine to \lquote cookbook\rquote  therapy.\'94}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 \chftn {\footnote \pard\plain \s28\ql \fi675\li45\ri45\sb45\sa45\widctlpar\aspalpha\aspnum\faauto\adjustright\rin45\lin45\itap0\pararsid9467115 \cbpat8 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\f2\fs20\insrsid2450573\charrsid2450573  \'93}{\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 
See, e.g., Mary McCabe & Michael A. Friedman, Impact of Third-Party Reimbursement on C
ancer Clinical Investigation: A Consensus Statement Coordinated by the National Cancer Institute, 81 J.NAT'L CANCER INST. 1585, 1585-86 (1989) (The American Medical Association and the National Cancer Institute, among others, arguing that efficacy should 
primarily determine appropriate drug therapy; other criteria "may prevent patients from receiving the best available therapy").\'94 in William L. Christopher\rquote s \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94
 48 Food & Drug Law Journal 247, }{\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).\line }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  {\*\bkmkstart FN\'3bB2}
{\*\bkmkend FN\'3bB2} }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid9467115\charrsid2450573 An}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 
 editor of the Journal of the American Medical Society recently expressed the suspicion with which physicians view the
 Food and Drug Administration, saying: "I would rather have the [Food and Drug Administration] withdraw a drug from the market for adverse effects [than}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid2450573 
 regulate prescribing practices}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 ]}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid2450573 .}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 Otherwise, the F}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 ood and }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 D}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 rug }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 A}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 dministration}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 
 would be involved in actually regulating the in-office practice of medicine by the individual physician.}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573  And, frankly, I don't trust the government to do that."}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 \chftn {\footnote \pard\plain 
\s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11032931 \cbpat17 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\fs20\insrsid2450573\charrsid2450573  \'93Henig, }{\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 
Robin Marantz, FDA Assails "Off-Label" Uses of Cosmetic Drugs; Painful Medical Problems Continue for Years, Patients Allege, WASH. POST, June 18, 1991, at Z7.\'94 In William L. Christopher\rquote s \'93Off-Label Drug Prescriptio
n: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}{\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573  
\par }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 Certain types of regulation, however, are clearly necessary }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 to }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 ensure }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid2450573 the }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 safety}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  and effective}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid2450573 ness}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
 health care.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 \chftn {\footnote \pard\plain \s28\ql \fi675\li45\ri45\sb45\sa45\widctlpar\aspalpha\aspnum\faauto\adjustright\rin45\lin45\itap0\pararsid11032931 \cbpat8 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\f2\fs20\insrsid2450573\charrsid2450573  Christopher, }{\cs29\f2\fs20\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 
William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}{
\cs29\f2\fs20\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid216003\charrsid2450573   In balancing}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  competing interests, }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 the Food and Drug Administration}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
 must distinguish between necessary regulations, which ensure patient safety, and unnecessary interference, which }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 curbs}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  the expansion of medical knowledge and }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 may limit}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  treatment to outdated}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573  procedures}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 .  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 The regulation of drugs }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 becomes even more }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4342212\charrsid2450573 difficult}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  when the patients themselves }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 condemn the}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  regulator}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 s}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
 as bureaucratic roadblock}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 s}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  to necessary treatment{\*\bkmkstart FN\'3bB4}{\*\bkmkend FN\'3bB4}.}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid11032931\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11032931 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Christopher, William L. }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 \'93
Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5516596 \cbpat17 {\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5050870\charrsid2450573 
\par }{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3563146\charrsid2450573 3}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid539960\charrsid2450573 . OFF-LABEL PRESCRIBING}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2568132 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 Finding the }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 appropriate level of}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  regulation is a problem }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid216003\charrsid2450573 that was }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 brought to }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 
the Food and Drug Administration\rquote s attention }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 by the practice of off-label prescribing.}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14240735 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 Once the Food and Drug Administration approves a drug, {\*\bkmkstart FN\'3bB5}{\*\bkmkend FN\'3bB5}
physicians }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 can }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 prescribe the drug }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 to }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid2450573 (human) }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid5516596\charrsid2450573 patients }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 \'93}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 as they see fit}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 
\'94}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 .}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14240735 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Lambert, Eugene I. \'93
Animal Drugs: Future Stepchild or Pioneer?\'94 }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 55 Food & Drug Law Journal 33, Food and Drug Law Institute, 2000.
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14240735\charrsid2450573  
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3874558 \cbpat17 {\cs37\f2\fs22\insrsid1990509\charrsid2450573 As we have seen in the
 section prior to this one, the Food and Drug Administration }{\cs37\f2\fs22\insrsid14816858\charrsid2450573 is more conservative in its}{\cs37\f2\fs22\insrsid1990509\charrsid2450573  }{\cs37\f2\fs22\insrsid14816858\charrsid2450573 regulation of the }{
\cs37\f2\fs22\insrsid1990509\charrsid2450573 off-label use of drugs}{\cs37\f2\fs22\insrsid14816858\charrsid2450573  }{\cs37\f2\fs22\insrsid14105273\charrsid2450573 in}{\cs37\f2\fs22\insrsid14816858\charrsid2450573  animals}{
\cs37\f2\fs22\insrsid1990509\charrsid2450573 . }{\cs37\f2\fs22\insrsid14816858\charrsid2450573  }{\cs37\f2\fs22\insrsid1990509\charrsid2450573 Although the Animal Medicinal Drug Use Clarification Act of 1994 gave veterinarians }{
\cs37\f2\fs22\insrsid14816858\charrsid2450573 more leeway in their ability to prescribe drugs to animals in an}{\cs37\f2\fs22\insrsid1990509\charrsid2450573  off-label }{\cs37\f2\fs22\insrsid14816858\charrsid2450573 
capacity, veterinarians, unlike doctors,}{\cs37\f2\fs22\insrsid1990509\charrsid2450573  are not free to prescribe drugs to animals \'93as they see fit.\'94 }{\cs37\f2\fs22\insrsid14816858\charrsid2450573 
 The benefits and drawbacks of off-label prescribing}{\cs37\f2\fs22\insrsid14105273\charrsid2450573 , however,}{\cs37\f2\fs22\insrsid1990509\charrsid2450573  are largely the }{\cs37\f2\fs22\insrsid3874558\charrsid2450573 similar}{
\cs37\f2\fs22\insrsid14105273\charrsid2450573 . }{\cs37\f2\fs22\insrsid3874558\charrsid2450573  }{\cs37\f2\fs22\insrsid14105273\charrsid2450573 Thus, as there is little existing literature examining the off-label use of }{
\cs37\f2\fs22\insrsid1990509\charrsid2450573 drugs}{\cs37\f2\fs22\insrsid14105273\charrsid2450573  in animals}{\cs37\f2\fs22\insrsid1990509\charrsid2450573 , I will mainly }{\cs37\f2\fs22\insrsid3874558\charrsid2450573 discuss}{
\cs37\f2\fs22\insrsid14816858\charrsid2450573  }{\cs37\f2\fs22\insrsid14105273\charrsid2450573 articles and examples assessing }{\cs37\f2\fs22\insrsid14816858\charrsid2450573 the }{\cs37\f2\fs22\insrsid1990509\charrsid2450573 off-label use of drugs}{
\cs37\f2\fs22\insrsid14816858\charrsid2450573  in humans}{\cs37\f2\fs22\insrsid3874558\charrsid2450573 .}{\cs37\f2\fs22\insrsid14105273\charrsid2450573  }{\cs37\f2\fs22\insrsid16734645\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3874558 \cbpat17 {\cs29\f2\fs22\insrsid3874558\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14105273 \cbpat17 {\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3563146\charrsid2450573 4}{
\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14105273\charrsid2450573 . THE FREQUENCY OF OFF-LABEL PRESCRIBING}{\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14105273\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12520743 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12520743\charrsid2450573 In a }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 study }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12520743\charrsid2450573 conducted by the United}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  States Government Accounting Office (GAO)}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 , the Office }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 found off-label prescribing more the rule than the exception in }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 the context of }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 cancer therapy.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid12520743\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12520743 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  \'93}{\cs37\f2\insrsid2450573\charrsid2450573 
GAO REPORT, supra note 7, at 3. The GAO Report was summa
rized and editorialized recently in the Journal of the American Medical Association. See Thomas Laetz & George Silverman, Reimbursement Policies Constrain the Practice of Oncology, 266 JAMA 2996 (1991); Charles G. Moertel, Off-Label Drug Use for Cancer Th
erapy and National Health Care Priorities, 266 JAMA 3031 (1991).\'94}{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573  William L. Christopher\rquote s \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94
 48 Food & Drug Law Journal 247, }{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 {\*\bkmkstart FN\'3bB10}{\*\bkmkend FN\'3bB10} O}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
ne-third of all prescriptions in cancer chemotherapy were off-label.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 {\*\bkmkstart FN\'3bB11}{\*\bkmkend FN\'3bB11}\chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14762109 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs37\f2\insrsid2450573\charrsid2450573 
The study covered 2018 patients {\*\bkmkstart SDU_23}{\*\bkmkend SDU_23}suffering from 15 forms of cancer, who were prescribed a total of 5239 administrations of 46 anticancer drugs. Id. at 18-19.}{\f2\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  Furthermore, off-label use was}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573  not limited to certain patients}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14762109 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs37\f2\insrsid2450573\charrsid2450573 Fifty-six percent of the patients received at least one off-label drug. Id. at 21.}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 , a few popular drugs}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14762109 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs37\f2\insrsid2450573\charrsid2450573 
Forty-four of the 46 approved anticancer drugs were prescribed off-label at least once. Id. at 20. Off-label use of three drugs, ifosfamide, interferon, and mitoxantrone, constituted 85% of their total prescriptions. Id. at 22.}}}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 , or some specific forms of cancer}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14762109 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs37\f2\insrsid2450573\charrsid2450573 
All of the fifteen cancers were treated with at least one off-label drug; in the case of society's most prevalent cancer, lung cancer, nearly all the studied patients received at least one off-label drug. Id. at 25.}}}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 , rather the practice was found to be prevalent in}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 every realm.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid14762109\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14762109 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2568132\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14105273 \cbpat17 {\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3563146\charrsid2450573 5}{
\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14105273\charrsid2450573 . THE POTENTIAL DANGERS OF OFF-LABEL PRESCRIBING}{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6045223 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6045223\charrsid2450573 
In treating cancer, off-label chemotherapy }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 is beneficial to patients }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 \'93}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 in most }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6045223\charrsid2450573 circumstances}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 ,}
{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 \'94}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  {\*\bkmkstart FN\'3bB15}{\*\bkmkend FN\'3bB15}and }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6045223\charrsid2450573 data indicates}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  that off-label use frequently leads to }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6045223\charrsid2450573 unforeseen}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  drug discovery.}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3239196 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}{\f2\insrsid2450573\charrsid2450573 
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 {\*\bkmkstart FN\'3bB16}{\*\bkmkend FN\'3bB16} }{\cs37\f2\fs22\insrsid6045223\charrsid2450573 
The benefits of off-label drug use, either to the patient or to society, }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 may be less certain}{\cs37\f2\fs22\insrsid6045223\charrsid2450573  when one factors cost into the analysis.}{
\cs17\f2\fs22\super\insrsid3239196\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3239196 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94
 48 Food & Drug Law Journal 247, }{\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs37\f2\fs22\insrsid6045223\charrsid2450573   }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 Probably n}{
\cs37\f2\fs22\insrsid6045223\charrsid2450573 ot surprisingly, }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 the use of }{\cs37\f2\fs22\insrsid6045223\charrsid2450573 off-label }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 therapies}{
\cs37\f2\fs22\insrsid6045223\charrsid2450573  is higher in cases of incurable}{\cs37\f2\fs22\insrsid3874558\charrsid2450573  }{\cs37\f2\fs22\insrsid6045223\charrsid2450573 cancer }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 
in the advanced stages, as well as }{\cs37\f2\fs22\insrsid6045223\charrsid2450573 when standard chemotherapy }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 proves ineffective}{\cs37\f2\fs22\insrsid6045223\charrsid2450573 .}{
\cs17\f2\fs22\super\insrsid6045223\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 

\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3239196 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  GAO }{\cs37\f2\insrsid2450573\charrsid2450573 
REPORT, at 27.}}}{\cs37\f2\fs22\insrsid3239196\charrsid2450573  }{\cs15\f2\fs22\insrsid6045223\charrsid2450573  }{\cs37\f2\fs22\insrsid6045223\charrsid2450573 This}{\cs37\f2\fs22\insrsid3239196\charrsid2450573  desperate search}{
\cs37\f2\fs22\insrsid6045223\charrsid2450573  for a cure }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 is expensive, though.}{\cs37\f2\fs22\insrsid6045223\charrsid2450573  }{\cs37\f2\fs22\insrsid3239196\charrsid2450573  }{
\cs37\f2\fs22\insrsid6045223\charrsid2450573 One physician at the Mayo Clinic reports reviewing an insurance claim for nearly $750,000 for off-label {\*\bkmkstart SDU_24}{\*\bkmkend SDU_24}drugs given to a single, dying patient.}{
\cs17\f2\fs22\super\insrsid3239196\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 

\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3239196 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs37\f2\insrsid2450573\charrsid2450573 
Charles G. Moertel, Off-Label Drug Use for Cancer Therapy and National Health Care Priorities, 266 JAMA 3031 (1991) at 3031.}}}{\cs15\f2\fs22\insrsid6045223\charrsid2450573   }{\cs37\f2\fs22\insrsid6045223\charrsid2450573 
Such "treatments of last resort" raise ethical questions about }{\cs37\f2\fs22\insrsid3239196\charrsid2450573 \'93}{\cs37\f2\fs22\insrsid6045223\charrsid2450573 costs and benefits to the individual and society, patient autonomy, and the decision}{
\cs37\f2\fs22\insrsid3239196\charrsid2450573 -}{\cs37\f2\fs22\insrsid6045223\charrsid2450573 making process on the appropriateness of the therapy.}{\cs37\f2\fs22\insrsid3239196\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid3239196\charrsid2450573 
\chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3239196 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid6045223\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1927765 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 Costs aside, r}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 egulators and physicians must }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 also acknowledge}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  that he}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 alth risks from off-label use are alive and real}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 . }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 {\*\bkmkstart FN\'3bB17}{\*\bkmkend FN\'3bB17} The}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  antibiotic chloramphenicol,}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573  for example,}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  was widely prescribed off-label during the 1970s despite }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 its association}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  with fatal aplastic anemia.}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573 {\*\bkmkstart FN\'3bB18}{\*\bkmkend FN\'3bB18}\chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3239196 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs37\f2\insrsid2450573\charrsid2450573 
The manufacturer's label warns that "Chloramphenicol must not be used when less potentially dan
gerous agents will be effective.... It must not be used in the treatment of trivial infections...." PHYSICIANS' DESK REFERENCE 1588 (1990). Essentially the same warning was in place in 1965 when Helen Muldar died from aplastic anemia following chloramphen
icol therapy for an ear infection. See }{\field\fldedit{\*\fldinst {\cs37\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://web2.westlaw.com/find/default.wl?DB=595&SerialNum=1970126326&FindType=Y&AP=&mt=LawSchoolPractitioner&fn=_top&sv=Split&sn=3BCAFE1BA531498B90C5DB477013ED39&vr=2.0&rs=WLW6.04" \\t "_top" }}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 Muldar v.}}}{\cs37\f2\insrsid2450573\charrsid2450573  {\*\bkmkstart SDU_25}{\*\bkmkend SDU_25}}{\field\fldedit{\*\fldinst {\cs37\f2\insrsid2450573\charrsid2450573  H
YPERLINK "http://web2.westlaw.com/find/default.wl?DB=595&SerialNum=1970126326&FindType=Y&AP=&mt=LawSchoolPractitioner&fn=_top&sv=Split&sn=3BCAFE1BA531498B90C5DB477013ED39&vr=2.0&rs=WLW6.04" \\t "_top" }}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 Parke, Davis & Co., 288 Minn. 332, 181 N.W.2d 882 (1970)}}}{\cs37\f2\insrsid2450573\charrsid2450573 .}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3239196\charrsid2450573   }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 Similarly, physicians often prescribed }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1927765\charrsid2450573 \'93}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 DES}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1927765\charrsid2450573 \'94}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  off-label.}{
\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid1927765\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1927765 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).
\par }}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1927765\charrsid2450573 {\*\bkmkstart FN\'3bB19}{\*\bkmkend FN\'3bB19} \'93}{
\f2\fs22\cf18\insrsid1927765\charrsid2450573 DES\'94 is a synthetic estrogen that was heavily pres}{\f2\fs22\cf18\insrsid3874558\charrsid2450573 cribed between 1940 and 1970; k}{\f2\fs22\cf18\insrsid1927765\charrsid2450573 nown as diethylstilbestrol, DES
 was used to prevent miscarriages. }{\f2\fs22\cf18\insrsid3874558\charrsid2450573  A}{\f2\fs22\cf18\insrsid1927765\charrsid2450573 n estimated ten million children that were exposed to the DES during pregnancy and are }{
\f2\fs22\cf18\insrsid3874558\charrsid2450573 now }{\f2\fs22\cf18\insrsid1927765\charrsid2450573 suffering side effects because of it.  Some DES problems that have occurred include physical, psychological, and reproductive sy
stem abnormalities and disorders.  DES exposure has }{\f2\fs22\cf18\insrsid3874558\charrsid2450573 been found to affect even third-generation children from DES-}{\f2\fs22\cf18\insrsid1927765\charrsid2450573 exposed women.}{
\cs17\f2\fs22\cf18\super\insrsid1927765\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1927765 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573   \'93Defective Drugs\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.adrugrecall.com/des/des.html" }{
\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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000068007400740070003a002f002f007700770077002e006100640072007500670072006500630061006c006c002e0063006f006d002f006400650073002f006400650073002e00680074006d006c000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.adrugr
ecall.com/des/des.html}}}{\f2\insrsid2450573\charrsid2450573  }}}{\f2\fs22\cf18\insrsid1927765\charrsid2450573  }{\cs29\f2\fs22\cf18\insrsid1927765\charrsid2450573 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1927765 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid7692372\charrsid2450573 E}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 ven if not }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid7692372\charrsid2450573 physically}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 
 dangerous, in many cases an off-label }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid2450573 use}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid2450573 of}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  a drug may not be }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3753355\charrsid2450573 
desirable either politically or }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 ethically}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid9376920\charrsid2450573 {\*\bkmkstart FN\'3bB20}{\*\bkmkend FN\'3bB20}.  }{
\cs37\f2\fs22\insrsid3753355\charrsid2450573 The controversial progesterone antagonist RU-486, for example, is a potential treatment for breast and uterine tumors, Cushing's syndrome, glaucoma, and other medical problems.}{
\cs17\f2\fs22\super\insrsid9376920\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 

\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9376920 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs37\f2\insrsid2450573\charrsid2450573 
Rudy M. Baum, RU-486: Abortion Controversy in U.S. Clouds Future of Promising Drug, CHEMICAL & ENGINEERING NEWS, Mar. 11, 1991, at 7, 12-13.}}}{\cs37\f2\fs22\insrsid3753355\charrsid2450573 
  Anti-abortionists in this country oppose importation of the drug for }{\cs37\f2\fs22\insrsid3874558\charrsid2450573 a }{\cs37\f2\fs22\insrsid3753355\charrsid2450573 study, however, fearin}{\cs37\f2\fs22\insrsid3874558\charrsid2450573 
g that Food and Drug Administration}{\cs37\f2\fs22\insrsid3753355\charrsid2450573  approval for any use would lead to widespread off-{\*\bkmkstart SDU_26}{\*\bkmkend SDU_26}label use.}{\cs37\f2\fs22\insrsid9376920\charrsid2450573   }{
\cs37\f2\fs22\insrsid3874558\charrsid2450573 
\par }{\cs37\f2\fs22\insrsid9376920\charrsid2450573 Thomas Murray provides another example}{\cs37\f2\fs22\insrsid3874558\charrsid2450573 :}{\cs37\f2\fs22\insrsid9376920\charrsid2450573  \'93
years ago, at an FDA hearing, I speculated that once hGH [human growth hormone] was approved, pe
ople would want to use it for all sorts of non-therapeutic purposes.  One member of the FDA committee told me that several parents had already asked her if they could get the drug for their kids, who weren't hGH-deficient.  All, she recalled, were physici
ans. }{\cs37\f2\fs22\insrsid2450573\charrsid2450573 Why...}{\cs37\f2\fs22\insrsid9376920\charrsid2450573 ? Quite simply, because it's advantageous to be tall....\'94}{\cs17\f2\fs22\super\insrsid9376920\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9376920 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{\cs37\f2\insrsid2450573\charrsid2450573 
Thomas Murray, The Growing Danger from Gene-Spliced Hormones, in ETHICAL ISSUES IN MODERN MEDICINE 409, 410 (John D. Arras & Nancy K. Rhoden eds., 3d ed. 1989).
\par }}}{\cs37\f2\fs22\insrsid3753355\charrsid2450573 
\par }{\cs37\f2\fs22\insrsid16734645\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9376920 \cbpat17 {\cs37\f2\fs22\ul\insrsid3563146\charrsid2450573 6}{\cs37\f2\fs22\ul\insrsid9376920\charrsid2450573 
. NO CLEAR ANSWERS
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1126692 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 The term \'93
off-label use\'94 includes a wide range of treatments, from}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  "clearly experi}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 
mental use to standard therapy a}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 nd even to state of the art treatment."}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid9376920\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10572781 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\cs37\f2\insrsid2450573\charrsid2450573  UNITED STATES GOV. ACCT. OFF., OFF-LABEL DRUGS: REIMBURSEMENT POLICIES CONSTRAIN PHYSICIANS IN THEIR CHOICE OF CANCER THERAPIES, GAO/PEMD-91- 14 at 11 (1991) }}}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid9376920\charrsid2450573 {\*\bkmkstart FN\'3bB22}{\*\bkmkend FN\'3bB22} }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 The multiple meanings of \'93}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 off-label use}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 ,\'94 however,}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 make a
}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 ny }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 effor}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 t}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 s}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  to define the practice as either }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 useful}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  or }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 
harmful, to determine}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  i}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 f regulation is necessary}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 , or to decide if }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 the Food and Drug Administration, the courts, or the marketplace should }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 regulat}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 e, }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid8158594\charrsid2450573 somewhat }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 futile}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573 .}{\cs17\f2\fs22\cf1\super\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573 \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5664795 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  }{
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Christopher, William L. \'93Off-Label Drug Prescription: Filling the Regulatory Vacuum,\'94 48 Food & Drug Law Journal 247, }{
\f2\chshdng0\chcfpat0\chcbpat8\insrsid2450573\charrsid2450573 Food and Drug Law Institute (1993).}}}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid1990509\charrsid2450573  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10572781\charrsid2450573  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14764965\charrsid2450573 
\par }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4990389 
\par }\pard \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1126692 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4990389 
\par 
\par 
\par 
\par 
\par 
\par 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3874558 \cbpat17 {\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid4990389 
\par }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3874558\charrsid3345984 
\par }\pard\plain \s6\qc \li0\ri0\sl480\slmult1\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel5\adjustright\rin0\lin0\itap0\pararsid5523418 \b\f2\fs44\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid5205424 CHAPTER THREE}{
\fs24\insrsid16734645\charrsid16734645 
\par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16734645 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid16734645\charrsid16734645 
\par }\pard\plain \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\f2\fs44\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid14764965 Use or Abuse}{\insrsid5205424 : The }{\insrsid3997818 
Off-Label Use of Acepromazine Maleate}{\insrsid5205424 
\par }\pard\plain \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14764965 \cbpat17 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs29\f2\cf1\chshdng0\chcfpat0\chcbpat8\insrsid16734645 
\par }{\cs29\f2\fs22\ul\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15480886\charrsid2450573 INTRODUCTION
\par }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15480886\charrsid2450573 \tab In this chapter I will }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2495404\charrsid2450573 consider a}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10558826\charrsid2450573  specific}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2495404\charrsid2450573  example of }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10558826\charrsid2450573 
the }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2495404\charrsid2450573 off-label use }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10558826\charrsid2450573 of drugs in animals, namely, the extra-label use of }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15480886\charrsid2450573 Acepromazine Maleate}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid2495404\charrsid2450573  for foxhunting purposes. }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10558826\charrsid2450573  I will begin by expl}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3505145\charrsid2450573 oring the question of how often}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid14381739\charrsid2450573  and in what capacities the}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid10558826\charrsid2450573  drug is used in an off-label manner.  Next}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3298802\charrsid2450573 , I will look at}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3505145\charrsid2450573  the physiology of the drug \endash  how exactly does it affect a horse?  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12873898\charrsid2450573 What are the drug\rquote s side effects?  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3505145\charrsid2450573 What are its labeled uses?  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12873898\charrsid2450573 What are its off-label uses?  }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3505145\charrsid2450573 
Is the way in which foxhunters are using Acepromazine Maleate in an off-label manner }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3298802\charrsid2450573 safe?  Effective?  }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12873898\charrsid2450573 How do veterinarians feel about the current off-label uses of the drug?  Under}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3298802\charrsid2450573  veterinarian }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12873898\charrsid2450573 supervision}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3298802\charrsid2450573 , are horse owners capable of determining the appropriate }{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid12873898\charrsid2450573 quantities}{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3298802\charrsid2450573  of the drug to administer their horses?}{
\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid3997818\charrsid2450573   In this chapter, I will explore these questions and more in order to flesh out a specific example of just how the off-label use of
 drugs in animals operates in practice, as well as the positives and negatives of the status quo. }{\cs29\f2\fs22\cf1\chshdng0\chcfpat0\chcbpat8\insrsid15480886\charrsid2450573 
\par }\pard \s28\ql \li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14764965 {\cs29\f2\fs22\ul\insrsid10714228\charrsid2450573 
\par }{\cs29\f2\fs22\ul\insrsid14764965\charrsid2450573 THE FREQUENCY }{\cs29\f2\fs22\ul\insrsid12873898\charrsid2450573 AND NATURE }{\cs29\f2\fs22\ul\insrsid14764965\charrsid2450573 OF OFF-LABEL ACEPROMAZINE MALEATE USE
\par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10714228 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\fs22\insrsid14764965\charrsid2450573 
Although not a violation of Federal law, should the }{\f2\fs22\insrsid12203648\charrsid2450573 off-label }{\f2\fs22\insrsid14764965\charrsid2450573 use of Acepromazine Maleate be a cause for concern?  }{\f2\fs22\insrsid12203648\charrsid2450573 
To answer this question}{\f2\fs22\insrsid14764965\charrsid2450573 , one must consider just how much Ace}{\f2\fs22\insrsid3997818\charrsid2450573 promazine Maleate}{\f2\fs22\insrsid14764965\charrsid2450573  is }{\f2\fs22\insrsid3997818\charrsid2450573 
actually }{\f2\fs22\insrsid12476877\charrsid2450573 being administered to horses.  First, i}{\f2\fs22\insrsid14764965\charrsid2450573 s the use of Acepromazine Maleate for foxhunting purposes relatively rare, or is it commonplace?  Based o
n the (admittedly incomplete) information available, roughly 80% to 90% of foxhunters use Ace}{\f2\fs22\insrsid12476877\charrsid2450573 promazine Maleate whenever they fox}{\f2\fs22\insrsid14764965\charrsid2450573 hunt, typically three times per week.}{
\cs17\f2\fs22\super\insrsid14764965\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14764965 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Information is based on fifty anonymous interviews with subscribers to Mr. Stewart\rquote s Cheshire Foxhounds (Unionvil
le, PA), the Radnor Hunt (Malvern, PA), and former members of the Brandywine Hunt (West Chester, PA), which dissolved in 2004.}}}{\f2\fs22\insrsid14764965\charrsid2450573 
  Around 10% to 20% of foxhunters give Acepromazine Maleate to their horses every time they ride, on average five to six times per week.}{\cs17\f2\fs22\super\insrsid14764965\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14764965 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14764965 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Information is based on anonymous fifty interviews with subscribers to Mr. Stewart\rquote s Cheshire Foxhounds (Unionville, PA), the Radnor Hunt (Malvern, PA), and former members of the Brandywine Hunt (West Chester, PA), which dissolved in 2004.
\par }}}{\f2\fs22\insrsid14764965\charrsid2450573   Assuming that these statistics are accurate, Acepromazine Maleate is, by any measure, being administered to horses by foxhunters with substantial frequency.}{\f2\fs22\insrsid12873898\charrsid2450573 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14764965 {\f2\fs22\insrsid12873898\charrsid2450573 
\par }{\f2\fs22\insrsid1915669\charrsid2450573 
\par 
\par 
\par 
\par 
\par 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12873898 {\f2\fs22\ul\insrsid14764965\charrsid2450573 ACEPROMAZINE MALEATE}{\f2\fs22\ul\insrsid14381739\charrsid2450573 : }{
\f2\fs22\ul\insrsid8923144\charrsid2450573 AN OVERVIEW OF }{\f2\fs22\ul\insrsid14381739\charrsid2450573 THE DRUG}{\f2\fs22\ul\insrsid12873898\charrsid2450573 
\par 
\par 
\par }{\f2\fs22\ul\insrsid4280145\charrsid2450573 1. }{\f2\fs22\ul\insrsid8923144\charrsid2450573 BASIC INFORMATION}{\f2\fs22\ul\insrsid4280145\charrsid2450573  
\par }{\f2\fs22\ul\insrsid10714228\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid15152529 {\f2\fs22\insrsid15152529\charrsid2450573 Acepromazine M}{\f2\fs22\insrsid8923144\charrsid2450573 aleate}{\f2\fs22\insrsid10820691\charrsid2450573 
 is a very effective }{\f2\fs22\insrsid15152529\charrsid2450573 tranquilizer that depresses the central nervous system, causing sedation, relaxation, and a reduction in involuntary movements.  It}{\f2\fs22\insrsid8923144\charrsid2450573 
 is a phenothiazine}{\cs17\f2\fs22\super\insrsid5586650\charrsid2450573 \chftn {\footnote \pard\plain \s28\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12935979 \cbpat17 
\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\f2\fs20\insrsid2450573\charrsid2450573  }{\f2\fs20\lang9\langfe1033\langnp9\insrsid2450573\charrsid2450573 Phenothiazine}{
\f2\fs20\lang9\langfe1033\langnp9\insrsid2450573\charrsid2450573  is a pesticide and industrial chemical used in pharmaceutical manufacturing.  It was introduced by DuPont as an insecticide i
n 1935. It is now most commonly used as an intermediate chemical in the manufacture of various psychiatric drugs. The word "phenothiazines" is used to describe the largest of the five main classes of antipsychotic drugs. Although these drugs are generally
 effective, there are often serious side effects including tardive dyskinesia and sedation (especially in the early stages of treatment). }{\f2\fs20\insrsid2450573\charrsid2450573 Wikipedia Contributors, }{\i\f2\fs20\insrsid2450573\charrsid2450573 
Wikopedia, the Free Encyclopedia,}{\f2\fs20\lang9\langfe1033\langnp9\insrsid2450573\charrsid2450573  Page Version ID: 50195723 }{\field\flddirty{\*\fldinst {\f2\fs20\lang9\langfe1033\langnp9\insrsid2450573\charrsid2450573 
 HYPERLINK "http://en.wikipedia.org/wiki/Phenothiazine" }{\f2\fs20\lang9\langfe1033\langnp9\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002b00000068007400740070003a002f002f0065006e002e00770069006b006900700065006400690061002e006f00720067002f00770069006b0069002f005000680065006e006f0074006800690061007a0069006e0065000000e0c9ea79f9bace118c8200aa
004ba90b5600000068007400740070003a002f002f0065006e002e00770069006b006900700065006400690061002e006f00720067002f00770069006b0069002f005000680065006e006f0074006800690061007a0069006e0065000000}}}{\fldrslt {
\cs27\f2\fs20\ul\cf2\lang9\langfe1033\langnp9\insrsid2450573\charrsid2450573 http://en.wikipedia.org/wiki/Phenothiazine}}}{\f2\fs20\lang9\langfe1033\langnp9\insrsid2450573\charrsid2450573  (April 22, 2006).
\par }}}{\f2\fs22\insrsid10820691\charrsid2450573  derivative, used by veterinarians}{\f2\fs22\insrsid8923144\charrsid2450573  as a neuroleptic}{\cs17\f2\fs22\super\insrsid12935979\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12935979 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Tranquilizer used to treat psychotic conditions when a calming effect is desired. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/neuroleptic" }{\f2\insrsid2450573\charrsid2450573 
{\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002d00000068007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f006e006500750072006f006c00650070007400690063000000e0c9ea79f9bace11
8c8200aa004ba90b5a00000068007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f006e006500750072006f006c00650070007400690063000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/neuroleptic}}}{\f2\insrsid2450573\charrsid2450573  (April 22, 2005).
\par }}}{\f2\fs22\insrsid8923144\charrsid2450573  agent}{\f2\fs22\insrsid10820691\charrsid2450573 , primarily in}{\f2\fs22\insrsid8923144\charrsid2450573  dogs, cats and horses.}{\cs17\f2\fs22\super\insrsid4280145\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4280145 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Dr. Barbara Forney, VMD. \'93Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).
\par }}}{\f2\fs22\insrsid8923144\charrsid2450573  }{\f2\fs22\insrsid4280145\charrsid2450573  }{\f2\fs22\insrsid8923144\charrsid2450573 Phenothiazines decrease dopamine levels and depress some portions of the reticular activating system.}{
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\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid8923144\charrsid2450573  }{\f2\fs22\insrsid4280145\charrsid2450573  }{
\f2\fs22\insrsid8923144\charrsid2450573 Acepromazine }{\f2\fs22\insrsid10820691\charrsid2450573 Maleate }{\f2\fs22\insrsid8923144\charrsid2450573 is metabolized by the liver and excreted in the urine.}{\cs17\f2\fs22\super\insrsid4280145\charrsid2450573 
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4280145 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13711216 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573   Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid4280145\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid4280145 {\f2\fs22\insrsid8923144\charrsid2450573 I}{\f2\fs22\insrsid13711216\charrsid2450573 n addition to tranquilization, A}{\f2\fs22\insrsid8923144\charrsid2450573 
cepromazine }{\f2\fs22\insrsid10820691\charrsid2450573 Maleate }{\f2\fs22\insrsid8923144\charrsid2450573 has multiple other important systemic effects including anti-cholinergic}{\cs17\f2\fs22\super\insrsid13711216\charrsid2450573 \chftn {\footnote 
\pard\plain \ql \fi720\li0\ri0\sb225\sa225\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13711216 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  Inhibiting or blocking the action of acetylcholine at a receptor site. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/cholinergic" }{
\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/cholinergic}}}{\f2\insrsid2450573\charrsid2450573  (April 22, 2005). }}}{\f2\fs22\insrsid8923144\charrsid2450573 , anti-emetic}{
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\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  A drug that prevents or alleviates nausea and vomiting. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/antiemetic}}}{\f2\insrsid2450573\charrsid2450573  (April 22, 2005). }}}{\f2\fs22\insrsid8923144\charrsid2450573 , antispasmodic}{
\cs17\f2\fs22\super\insrsid13711216\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 

\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13711216 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  A drug used to relie
ve or prevent spasms (especially of the smooth muscles). }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/antispasmodic" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/antispasmodic}}}{\f2\insrsid2450573\charrsid2450573  (April 22, 2005).}}}{\f2\fs22\insrsid8923144\charrsid2450573 , antihistaminic, and alpha-adrenergic}{
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\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10820691 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Of, relating to, or being an alpha-receptor. }
{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/alpha-receptor" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/alpha-receptor}}}{\f2\insrsid2450573\charrsid2450573  (April 22, 2005).
\par }}}{\f2\fs22\insrsid8923144\charrsid2450573  blocking properties. }{\f2\fs22\insrsid10820691\charrsid2450573  }{\f2\fs22\insrsid8923144\charrsid2450573 Acepromazine causes hypotension due to decreased vasomotor}{
\cs17\f2\fs22\super\insrsid13711216\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13711216 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Relating to the nerves and muscles that cause the blood vessels to constrict or dilate. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
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http://www.thefreedictionary.com/vasomotor}}}{\f2\insrsid2450573\charrsid2450573  (April 22, 2005). }}}{\f2\fs22\insrsid8923144\charrsid2450573  tone. It may change heart and respiratory rate, and thermoregulatory ability}{
\f2\fs22\insrsid10820691\charrsid2450573 ,}{\f2\fs22\insrsid8923144\charrsid2450573  allowing for either hypo- or hyperthermia.}{\cs17\f2\fs22\super\insrsid13711216\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8985330 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).
\par }}}{\f2\fs22\insrsid4280145\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid13711216 {\f2\fs22\insrsid8923144\charrsid2450573 Acepromazine }{\f2\fs22\insrsid15152529\charrsid2450573 Maleate }{\f2\fs22\insrsid8923144\charrsid2450573 
may be given intramuscularly, intravenously or orally. }{\f2\fs22\insrsid8985330\charrsid2450573  }{\f2\fs22\insrsid8923144\charrsid2450573 It provides no analgesia and the tranquilizing effect of the drug can be overcome unexpectedly}{
\f2\fs22\insrsid8985330\charrsid2450573 ,}{\f2\fs22\insrsid8923144\charrsid2450573  particularly by sensory stimulation.}{\cs17\f2\fs22\super\insrsid8985330\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid8985330 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Dr. Barbara Forney, VMD. \'93Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).
\par }}}{\f2\fs22\insrsid8923144\charrsid2450573  }{\f2\fs22\insrsid13711216\charrsid2450573  }{\f2\fs22\insrsid8923144\charrsid2450573 Acepromazine }{\f2\fs22\insrsid15152529\charrsid2450573 Maleate }{\f2\fs22\insrsid8923144\charrsid2450573 
is usually less effective if given after the animal is excited. }{\f2\fs22\insrsid10820691\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid10714228 {\f2\fs22\insrsid10820691\charrsid2450573 Noteworthy is the fact that t}{\f2\fs22\insrsid8923144\charrsid2450573 here is a great deal of individual }{
\f2\fs22\insrsid13711216\charrsid2450573 variability in the response to A}{\f2\fs22\insrsid8923144\charrsid2450573 cepromazine }{\f2\fs22\insrsid10820691\charrsid2450573 Maleate.  D}{\f2\fs22\insrsid8923144\charrsid2450573 
espite being a very commonly used medication}{\f2\fs22\insrsid13711216\charrsid2450573 ,}{\f2\fs22\insrsid8923144\charrsid2450573  there are important species and even br}{\f2\fs22\insrsid13711216\charrsid2450573 eed differences in response to A}{
\f2\fs22\insrsid8923144\charrsid2450573 cepromazine }{\f2\fs22\insrsid15152529\charrsid2450573 Maleate }{\f2\fs22\insrsid8923144\charrsid2450573 that need to be ta}{\f2\fs22\insrsid13711216\charrsid2450573 ken into consideration.}{
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\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573   Dr. Barbara Forney, VMD. \'93Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).
\par }}}{\f2\fs22\insrsid10820691\charrsid2450573  }{\f2\fs22\insrsid3231205\charrsid2450573  }{\f2\fs22\insrsid10820691\charrsid2450573 Draft horses, for example, are particularly sensitive to Acepromazine Maleate\rquote s effects. }{
\f2\fs22\insrsid12477300\charrsid2450573  }{\f2\fs22\insrsid10820691\charrsid2450573 Pony breeds, however, do not appear to differ from horses in their response to Acepromazine Maleate.}{\cs17\f2\fs22\super\insrsid10820691\charrsid2450573 \chftn 
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\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{
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\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid10714228\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid16734645 {\f2\fs22\insrsid16734645\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid10714228 {\f2\fs22\ul\insrsid16277351\charrsid2450573 2. SIDE EFFECTS OF ACEPROMAZINE MALEATE}{\f2\fs22\ul\insrsid10714228\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid10714228 {\f2\fs22\insrsid16277351\charrsid2450573 Common side effects of Acepromazine Maleate include hypotension, decreased respiratory rate and bradycardia}{
\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Slowness of the heart rate, usually fewer than 60 beats per minute in an adult human. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://www.thefreedictionary.com/bradycardia" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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8c8200aa004ba90b5a00000068007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f00620072006100640079006300610072006400690061000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/bradycardia}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid16277351\charrsid2450573 
.  Sudden collapse, decreased or absent pulse and breathing, pale gums, and unconsciousness may occur in some animals.}{\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000e0c9ea79f9bace118c82
00aa004ba90b5800000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).
\par }}}{\f2\fs22\insrsid16277351\charrsid2450573   Acepromazine Maleate will cause a dose dependent decrease in hematocrit}{\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 The percentage by volume of packed red blood cells in a given sample of blood after centrifugation. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/hematocrit" }{
\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f00680065006d00610074006f0063007200690074000000e0c9ea79f9bace118c82
00aa004ba90b5800000068007400740070003a002f002f007700770077002e007400680065006600720065006500640069006300740069006f006e006100720079002e0063006f006d002f00680065006d00610074006f0063007200690074000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.thefreedictionary.com/hematocrit}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005). }}}{\f2\fs22\insrsid16277351\charrsid2450573  in both dogs and
 horses.  This effect occurs within thirty minutes of administration and may last for twelve hours or more.}{\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000e0c9ea79f9bace118c82
00aa004ba90b5800000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid16277351\charrsid2450573   The hematocrit in horses may decrease by as much as 50%.}{
\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000e0c9ea79f9bace118c82
00aa004ba90b5800000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid16277351\charrsid2450573 
  Penile paralysis is a rare but recognized adverse side effect of Acepromazine Maleate use in the horse.}{\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002c00000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000e0c9ea79f9bace118c82
00aa004ba90b5800000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid16277351\charrsid2450573   Thus, the drug should be avoided in breeding stallions.  }{
\f2\fs22\insrsid4523769\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid4523769 {\f2\fs22\insrsid16277351\charrsid2450573 
Acepromazine Maleate overdose will cause excessive sedation, slow respiratory and heart rate, pale gums, unsteady gait, poor coordination, and inability to stand.}{\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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00aa004ba90b5800000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid16277351\charrsid2450573   It may also ca
use sudden collapse, unconsciousness, seizures and }{\f2\fs22\insrsid13837005\charrsid2450573 even }{\f2\fs22\insrsid16277351\charrsid2450573 death.}{\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid725738 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Barbara Forney, VMD. \'93
Acepromazine Maleate For Veterinary Use\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medi-vet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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00aa004ba90b5800000068007400740070003a002f002f007700770077002e006d006500640069002d007600650074002e0063006f006d002f00640065007400610069006c002e0061007300700078007e00490044007e0032003100350032000000}}}{\fldrslt {
\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.medi-vet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 24, 2005).}}}{\f2\fs22\insrsid16277351\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid3934107 {\f2\fs22\ul\insrsid13837005\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid15152529 {\f2\fs22\ul\insrsid725738\charrsid2450573 3}{\f2\fs22\ul\insrsid16277351\charrsid2450573 . }{\f2\fs22\ul\insrsid10820691\charrsid2450573 ACEPROMAZINE MALEATE DOSAGE}{
\f2\fs22\ul\insrsid9911347\charrsid2450573 S}{\f2\fs22\ul\insrsid10714228\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10820691 {\f2\fs22\insrsid15152529\charrsid2450573 Intravenous and intramuscular administration is recommended at a dosage of 2-4 mg}{
\f2\fs22\insrsid10820691\charrsid2450573  per }{\f2\fs22\insrsid10769255\charrsid2450573 100 pounds}{\f2\fs22\insrsid15152529\charrsid2450573  of body weight.}{\cs17\f2\fs22\super\insrsid2887819\charrsid2450573 \chftn {\footnote \pard\plain 
\s2\ql \fi720\li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0\pararsid6635400 \fs24\lang1033\langfe1033\loch\af2\hich\af2\dbch\af34\cgrid\langnp1033\langfenp1033 {\fs20\insrsid2450573\charrsid2450573 
\hich\af2\dbch\af34\loch\f2  
\par }{\cs17\fs20\super\insrsid2450573\charrsid2450573 \chftn }{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2 Charlotte M. Newell, DVM. {\*\bkmkstart top}\hich\f2 \'93\loch\f2 Vet Rap A-E{\*\bkmkstart ace}{\*\bkmkend top}: ACE{\*\bkmkend ace
}\hich\f2  [Acepromazine Maleate]\'94\loch\f2  }{\field\flddirty{\*\fldinst {\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  HYPERLINK "http://www.horse-country.com/vet/newel\hich\af2\dbch\af34\loch\f2 l.html#ace" }{
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}{\fldrslt {\cs27\fs20\ul\cf2\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2 http://www.horse-country.com/vet/newell.html#ace}}}{\fs20\insrsid2450573\charrsid2450573 \hich\af2\dbch\af34\loch\f2  }}}{\f2\fs22\insrsid10769255\charrsid2450573  }{
\f2\fs22\insrsid15152529\charrsid2450573  This dose }{\f2\fs22\insrsid10769255\charrsid2450573 generally }{\f2\fs22\insrsid15152529\charrsid2450573 result}{\f2\fs22\insrsid10769255\charrsid2450573 s}{\f2\fs22\insrsid15152529\charrsid2450573 
 in marked sedation, suitable for carrying out minor surgical procedures with the use of a local anesthetic.}{\cs17\f2\fs22\super\insrsid6635400\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard\plain \s1\ql \fi720\li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid6635400 \f2\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\fs20\super\insrsid2450573\charrsid2450573 \chftn }{
\fs20\insrsid2450573\charrsid2450573  Horseproducts.stablemate.com Author. \'93Acepromazine Maleate\'94 }{\field\flddirty{\*\fldinst {\fs20\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }{
\fs20\insrsid2450573\charrsid2450573 {\*\datafield 
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2e00680074006d000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f0068006f00720073006500700072006f00640075006300740073002e0073007400610062006c0065006d006100640065002e0063006f006d002f005f00410072007400690063006c00650073002f006100630065
002e00680074006d000000}}}{\fldrslt {\cs27\fs20\ul\cf2\insrsid2450573\charrsid2450573 http://horseproducts.stablemade.com/_Articles/ace.htm}}}{\fs20\insrsid2450573\charrsid2450573  (December 15, 2005).}}}{\f2\fs22\insrsid15152529\charrsid2450573 
 When tranquilizing horses for minor procedures, such as clipping, braiding, or for shipping, doses of 0.5-1 mg}{\f2\fs22\insrsid10769255\charrsid2450573  per 100 pounds}{\f2\fs22\insrsid15152529\charrsid2450573  of body weight will usually prove ade
quate and leave the horse with enough muscular coordination so that tailing is not a serious problem.}{\cs17\f2\fs22\super\insrsid6635400\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard\plain \s1\ql \fi720\li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel0\adjustright\rin0\lin0\itap0\pararsid6635400 \f2\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\fs20\super\insrsid2450573\charrsid2450573 \chftn }{
\fs20\insrsid2450573\charrsid2450573  Horseproducts.stablemate.com Author. \'93Acepromazine Maleate\'94 }{\field\flddirty{\*\fldinst {\fs20\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }{
\fs20\insrsid2450573\charrsid2450573 {\*\datafield 
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2e00680074006d000000e0c9ea79f9bace118c8200aa004ba90b6c00000068007400740070003a002f002f0068006f00720073006500700072006f00640075006300740073002e0073007400610062006c0065006d006100640065002e0063006f006d002f005f00410072007400690063006c00650073002f006100630065
002e00680074006d000000}}}{\fldrslt {\cs27\fs20\ul\cf2\insrsid2450573\charrsid2450573 http://horseproducts.stablemade.com/_Articles/ace.htm}}}{\fs20\insrsid2450573\charrsid2450573  (December 15, 2005).
\par }}}{\f2\fs22\insrsid15152529\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4523769 {\f2\fs22\insrsid6635400\charrsid2450573 When given intravenously, full effect is reac}{\f2\fs22\insrsid16277351\charrsid2450573 
hed in approximately fifteen}{\f2\fs22\insrsid6635400\charrsid2450573  minutes.}{\cs17\f2\fs22\super\insrsid7879127\charrsid2450573 \chftn {\footnote \pard\plain 
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 Horseproducts.stablemate.com Author. \'93Acepromazine Maleate\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\f2\fs22\insrsid7879127\charrsid2450573  }{\f2\fs22\insrsid6635400\charrsid2450573 With}{\f2\fs22\insrsid7879127\charrsid2450573  intramuscular use, a full thirty to forty-five}{\f2\fs22\insrsid6635400\charrsid2450573  minutes should b
e allowed (occasionally longer).}{\cs17\f2\fs22\super\insrsid7879127\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
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Acepromazine Maleate\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\f2\fs22\insrsid7879127\charrsid2450573  }{\f2\fs22\insrsid6635400\charrsid2450573 For best effect, horses should be left undisturbed following administration of the drug.}{\cs17\f2\fs22\super\insrsid7879127\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid7879127 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Horseproducts.stablemate.com Author. \'93
Acepromazine Maleate\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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\f2\fs22\insrsid5009228\charrsid2450573  Peak activity lasts from one to four }{\f2\fs22\insrsid6635400\charrsid2450573 hours after administration.}{\cs17\f2\fs22\super\insrsid5009228\charrsid2450573 \chftn {\footnote \pard\plain 
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\par }}}{\f2\fs22\insrsid6635400\charrsid2450573  }{\f2\fs22\insrsid5009228\charrsid2450573  }{\f2\fs22\insrsid6635400\charrsid2450573 This }{\f2\fs22\insrsid12477300\charrsid2450573 may be}{\f2\fs22\insrsid6635400\charrsid2450573 
 prolonged in sensitive animals.}{\cs17\f2\fs22\super\insrsid5009228\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5009228 
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\f2\fs22\insrsid5009228\charrsid2450573  }{\f2\fs22\insrsid6635400\charrsid2450573 Residual mild tranquiliza}{\f2\fs22\insrsid5009228\charrsid2450573 tion is commonly observed for twelve}{\f2\fs22\insrsid6635400\charrsid2450573 
 hours or even longer after administration.}{\cs17\f2\fs22\super\insrsid5009228\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5009228 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Horseproducts.stablemate.com Author. \'93
Acepromazine Maleate\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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002e00680074006d000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://horseproducts.stablemade.com/_Articles/ace.htm}}}{\f2\insrsid2450573\charrsid2450573  (December 15, 2005).
\par }}}{\f2\fs22\insrsid4523769\charrsid2450573 
\par A warning}{\f2\fs22\insrsid9911347\charrsid2450573  in regards to the dosage of Acepromazine Maleate }{\f2\fs22\insrsid6635400\charrsid2450573 is }{\f2\fs22\insrsid5009228\charrsid2450573 worth noting}{\f2\fs22\insrsid6635400\charrsid2450573 :}{
\f2\fs22\insrsid10769255\charrsid2450573  }{\f2\fs22\insrsid6635400\charrsid2450573 \'93}{\f2\fs22\insrsid15152529\charrsid2450573 THE DOSAGE OF ACEPROMAZINE MALEATE MUST BE INDIVIDUALIZED. WHILE SOME HORSES TOLERATE A FU
LL DOSE WELL OTHERS WILL BECOME MARKEDLY ATAXIC}{\cs17\f2\fs22\super\insrsid5009228\charrsid2450573 \chftn {\footnote \pard\plain \ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5009228 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Loss of the ability to coordinate muscular movement. }{\field\flddirty{\*\fldinst {
\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.thefreedictionary.com/ataxic" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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http://www.thefreedictionary.com/ataxic}}}{\f2\insrsid2450573\charrsid2450573  (December 16, 2005).
\par }}}{\f2\fs22\insrsid15152529\charrsid2450573  AT LOWER DOSES.}{\f2\fs22\insrsid6635400\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid6635400\charrsid2450573 \chftn {\footnote \pard\plain 
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 Horseproducts.stablemate.com Author. \'93Acepromazine Maleate\'94 }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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002e00680074006d000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://horseproducts.stablemade.com/_Articles/ace.htm}}}{\f2\insrsid2450573\charrsid2450573  (December 15, 2005).
\par }}}{\f2\fs22\insrsid9911347\charrsid2450573   }{\f2\fs22\insrsid15152529\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid725738 {\f2\fs22\insrsid725738\charrsid2450573 
\par }{\f2\fs22\ul\insrsid725738\charrsid2450573 4. }{\f2\fs22\ul\insrsid14822226\charrsid2450573 THE }{\f2\fs22\ul\insrsid725738\charrsid2450573 LABEL}{\f2\fs22\ul\insrsid14822226\charrsid2450573 ED }{\f2\fs22\ul\insrsid725738\charrsid2450573 
USES OF ACEPROMAZINE MALEATE
\par }{\f2\fs22\insrsid725738\charrsid2450573 \tab Like all prescription drugs, f}{\f2\fs22\cf1\insrsid725738\charrsid2450573 ederal law restricts Acepromazine Maleate to use by or on the order of a licensed veterinarian.}{
\f2\fs22\insrsid725738\charrsid2450573   Acepromazine Maleate }{\f2\fs22\cf1\insrsid725738\charrsid2450573 is labeled for use as }{\f2\fs22\cf1\insrsid10714228\charrsid2450573 \'93}{\f2\fs22\cf1\insrsid725738\charrsid2450573 
an aid in controlling intractable animals during examination, treatment, x-ray and minor surgical procedures.}{\f2\fs22\cf1\insrsid10714228\charrsid2450573 \'94}{\cs17\f2\fs22\cf1\super\insrsid725738\charrsid2450573 \chftn {\footnote \pard\plain 
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 Medi-vet.com Author. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573  HYPERLINK "http://www.medivet.com/detail.aspx~ID~2152" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
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http://www.medivet.com/detail.aspx~ID~2152}}}{\f2\insrsid2450573\charrsid2450573  (April 21, 2006).}}}{\f2\fs22\cf1\insrsid725738\charrsid2450573 
\par }{\f2\fs22\cf1\insrsid14822226\charrsid2450573 
\par }{\f2\fs22\ul\cf1\insrsid14822226\charrsid2450573 5. THE }{\f2\fs22\ul\cf1\insrsid16734645\charrsid2450573 OFF-}{\f2\fs22\ul\cf1\insrsid14822226\charrsid2450573 LABEL USE OF ACEPROMAZINE MALEATE}{\f2\fs22\ul\cf1\insrsid94870\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid8272948 {\f2\fs22\cf1\insrsid10819705\charrsid2450573 \tab In an off-label capacity, }{\f2\fs22\cf1\insrsid725738\charrsid2450573 Acepromazine Maleate serves a}{
\f2\fs22\cf1\insrsid14824683\charrsid2450573  }{\f2\fs22\cf1\insrsid725738\charrsid2450573 different function.  }{\f2\fs22\cf1\insrsid10819705\charrsid2450573 For years, }{\f2\fs22\cf1\insrsid1988180\charrsid2450573 riders }{
\f2\fs22\cf1\insrsid10819705\charrsid2450573 have }{\f2\fs22\cf1\insrsid725738\charrsid2450573 use}{\f2\fs22\cf1\insrsid10819705\charrsid2450573 d}{\f2\fs22\cf1\insrsid725738\charrsid2450573  Acepromazine Maleate to }{
\f2\fs22\cf1\insrsid1988180\charrsid2450573 keep their horses }{\f2\fs22\cf1\insrsid725738\charrsid2450573 calm while }{\f2\fs22\cf1\insrsid1988180\charrsid2450573 foxhunting}{\f2\fs22\cf1\insrsid725738\charrsid2450573  them. }{
\f2\fs22\cf1\insrsid14824683\charrsid2450573  }{\f2\fs22\cf1\insrsid1988180\charrsid2450573 Until the passage of the Animal Medicinal Drug Use Clarification Act of 1994, which made off-label use of the drug legal, foxhunters were }{
\f2\fs22\cf1\insrsid10714228\charrsid2450573 largely}{\f2\fs22\cf1\insrsid202585\charrsid2450573  secretive about their use of Acepromazine Maleate}{\f2\fs22\cf1\insrsid1988180\charrsid2450573 .  }{\f2\fs22\cf1\insrsid10714228\charrsid2450573 \'93}{
\f2\fs22\cf1\insrsid1988180\charrsid2450573 A dangling penis}{\cs17\f2\fs22\cf1\super\insrsid94870\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard\plain \s38\ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3231205 \f36\fs20\cf1\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 
\chftn }{\f2\insrsid2450573\charrsid2450573  }{\f2\cf1\insrsid2450573\charrsid2450573 In adult male horses, }{\f2\insrsid2450573\charrsid2450573 A}{\f2\cf1\insrsid2450573\charrsid2450573 cepromazine }{\f2\insrsid2450573\charrsid2450573 Maleate }{
\f2\cf1\insrsid2450573\charrsid2450573 normally causes relaxation of the retractor penis muscle. This results in the penis being relaxed and dropped out other sheath. }{\f2\insrsid2450573\charrsid2450573  V}{\f2\cf1\insrsid2450573\charrsid2450573 
ery occasional cases have been reported where an irreversible paralysis of the retractor penis muscle has occurred, alth
ough this is more common with at least one other phenothiazine tranquilizer. This risk should be considered before giving acepromazine to an intact male horse. When used, minimum dosage recommendations should be followed.}{
\f2\insrsid2450573\charrsid2450573  }{\field\fldedit{\*\fldinst {\f2\cf1\insrsid2450573\charrsid2450573  HYPERLINK "http://horseproducts.stablemade.com/_Articles/ace.htm" }}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 
http://horseproducts.stablemade.com/_Articles/ace.htm}}}{\f2\insrsid2450573\charrsid2450573  (April 29, 2006).}}}{\f2\fs22\cf1\insrsid1988180\charrsid2450573  here and there was the on}{\f2\fs22\cf1\insrsid202585\charrsid2450573 
ly sign that the drug was being used}{\f2\fs22\cf1\insrsid10714228\charrsid2450573 \'94}{\f2\fs22\cf1\insrsid1185124\charrsid2450573  one foxhunter }{\f2\fs22\cf1\insrsid12477300\charrsid2450573 comments.}{
\cs17\f2\fs22\cf1\super\insrsid10714228\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10714228 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #28. Interview on file with author. Conducted on February 4, 2005 in Unionville, PA.}}}{\f2\fs22\cf1\insrsid1988180\charrsid2450573  }{\f2\fs22\cf1\insrsid14815229\charrsid2450573  }{\f2\fs22\cf1\insrsid14822226\charrsid2450573 \'93
Twenty years ago, people were as hush hush abo}{\f2\fs22\cf1\insrsid12477300\charrsid2450573 ut Ace}{\f2\fs22\cf1\insrsid1185124\charrsid2450573  as you could imagine\'94 another interviewee confirms}{\f2\fs22\cf1\insrsid14822226\charrsid2450573 .}{
\cs17\f2\fs22\cf1\super\insrsid14822226\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3231205 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Anonymous Interview #24. Interview on
 file with author. Conducted on February 3, 2005 in Unionville, PA.}}}{\f2\fs22\cf1\insrsid5596771\charrsid2450573   Most got the drug from their veterinarians but were }{\f2\fs22\cf1\insrsid12477300\charrsid2450573 told not to discuss their use}{
\f2\fs22\cf1\insrsid5596771\charrsid2450573  of the drug with others, as it was technically illegal. }{\f2\fs22\cf1\insrsid14822226\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid14822226 {\f2\fs22\cf1\insrsid1988180\charrsid2450573 Since that time, how}{\f2\fs22\cf1\insrsid10714228\charrsid2450573 ever, }{\f2\fs22\cf1\insrsid12477300\charrsid2450573 
the widespread }{\f2\fs22\cf1\insrsid10714228\charrsid2450573 use of the }{\f2\fs22\cf1\insrsid202585\charrsid2450573 drug has been brought out into the open to a much greater extent.  Foxhunters today are much }{
\f2\fs22\cf1\insrsid1988180\charrsid2450573 more }{\f2\fs22\cf1\insrsid1185124\charrsid2450573 frank}{\f2\fs22\cf1\insrsid202585\charrsid2450573  about their use of }{\f2\fs22\cf1\insrsid12477300\charrsid2450573 Acepromazine Maleate}{
\f2\fs22\cf1\insrsid202585\charrsid2450573 , at least with each other. }{\f2\fs22\cf1\insrsid10714228\charrsid2450573  }{\f2\fs22\cf1\insrsid1185124\charrsid2450573 As one foxhunter describes, \'93a}{\f2\fs22\cf1\insrsid10714228\charrsid2450573 
lmost a day doesn\rquote t pass now where you don\rquote t hear one rider or another chuckling about the fact that they should have given their horse an extra CC of Ace.\'94}{\cs17\f2\fs22\cf1\super\insrsid10714228\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10714228 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #8. Interview on file with author. Conducted on February 6, 2005 in Unionville, PA.}}}{\f2\fs22\cf1\insrsid14822226\charrsid2450573  }{\f2\fs22\cf1\insrsid202585\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid14822226 {\f2\fs22\ul\cf1\insrsid3231205\charrsid2450573 
\par }{\f2\fs22\ul\cf1\insrsid14822226\charrsid2450573 6}{\f2\fs22\ul\cf1\insrsid3231205\charrsid2450573 . WHY THE NEED FOR OFF-LABEL USE OF ACEPROMAZINE MALEATE}{\f2\fs22\ul\cf1\insrsid14822226\charrsid2450573 ?}{
\f2\fs22\ul\cf1\insrsid3231205\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid14822226 {\f2\fs22\cf1\insrsid14824683\charrsid2450573 Why should foxhunters need }{\f2\fs22\cf1\insrsid14822226\charrsid2450573 Acepromazine Maleate}{
\f2\fs22\cf1\insrsid14824683\charrsid2450573  to keep their horses calm? }{\f2\fs22\cf1\insrsid10714228\charrsid2450573  Shouldn\rquote t training alone be sufficient?  }{\f2\fs22\cf1\insrsid14824683\charrsid2450573 Generally, horses }{
\f2\fs22\cf1\insrsid10714228\charrsid2450573 that }{\f2\fs22\cf1\insrsid14824683\charrsid2450573 are athletic enough to be able to jump over five foot fences and gallop through field after field for hours on end (what is }{
\f2\fs22\cf1\insrsid10714228\charrsid2450573 often }{\f2\fs22\cf1\insrsid14824683\charrsid2450573 entailed in the sport of foxhunting) }{\f2\fs22\cf1\insrsid10714228\charrsid2450573 are very athletic and }{\f2\fs22\cf1\insrsid8916737\charrsid2450573 
have huge amounts of energy}{\f2\fs22\cf1\insrsid14822226\charrsid2450573 . }{\f2\fs22\cf1\insrsid12477300\charrsid2450573  }{\f2\fs22\cf1\insrsid14824683\charrsid2450573 Unfortunately, many }{\f2\fs22\cf1\insrsid8916737\charrsid2450573 of these horses }{
\f2\fs22\cf1\insrsid14824683\charrsid2450573 are too energetic for their }{\f2\fs22\cf1\insrsid14822226\charrsid2450573 riders to be able to control them,}{\f2\fs22\cf1\insrsid14824683\charrsid2450573  and }{\f2\fs22\cf1\insrsid14822226\charrsid2450573 
they }{\f2\fs22\cf1\insrsid14824683\charrsid2450573 misbehave}{\f2\fs22\cf1\insrsid10714228\charrsid2450573  in various ways}{\f2\fs22\cf1\insrsid8916737\charrsid2450573 .  T}{\f2\fs22\cf1\insrsid14824683\charrsid2450573 heir }{
\f2\fs22\cf1\insrsid14822226\charrsid2450573 antics, including }{\f2\fs22\cf1\insrsid14824683\charrsid2450573 bucking and rearing u}{\f2\fs22\cf1\insrsid10714228\charrsid2450573 p}{\f2\fs22\cf1\insrsid14822226\charrsid2450573 ,}{
\f2\fs22\cf1\insrsid10714228\charrsid2450573  often sends their riders }{\f2\fs22\cf1\insrsid14824683\charrsid2450573 flying off}{\f2\fs22\cf1\insrsid10714228\charrsid2450573  their backs}{\f2\fs22\cf1\insrsid14824683\charrsid2450573 . }{
\f2\fs22\cf1\insrsid12477300\charrsid2450573  }{\f2\fs22\cf1\insrsid3231205\charrsid2450573 Indeed, \'93at least a person or two fall}{\f2\fs22\cf1\insrsid12477300\charrsid2450573 s}{\f2\fs22\cf1\insrsid3231205\charrsid2450573  off during every foxhunt
, most often resulting in a trip to the emergency room in the back of an ambulance, if not a trip to the }{\f2\fs22\cf1\insrsid12477300\charrsid2450573 nearest}{\f2\fs22\cf1\insrsid3231205\charrsid2450573  trauma center in the back of a helicopter.\'94}{
\cs17\f2\fs22\cf1\super\insrsid3231205\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 

\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3231205 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #10. Interview on file with author. Conducted on February 6, 2005 in Unionville, PA.
\par }}}{\f2\fs22\cf1\insrsid14824683\charrsid2450573  }{\f2\fs22\cf1\insrsid3231205\charrsid2450573  
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid14822226 {\f2\fs22\cf1\insrsid8916737\charrsid2450573 To avoid this potentially dangerous situation, foxhunters give their horses Acepromazine Maleate to }{
\f2\fs22\cf1\insrsid10714228\charrsid2450573 \'93take the buck\'94 out of}{\f2\fs22\cf1\insrsid8916737\charrsid2450573  them}{\f2\fs22\cf1\insrsid14822226\charrsid2450573 .}{\cs17\f2\fs22\cf1\super\insrsid10714228\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10714228 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  Anonymous Interview #33. Interview on file with author. Conducted on January 29, 2005 in Unionville, PA.}}}{\f2\fs22\cf1\insrsid8916737\charrsid2450573  }{\f2\fs22\cf1\insrsid10714228\charrsid2450573  }{
\f2\fs22\cf1\insrsid3231205\charrsid2450573 Foxhunters do not }{\f2\fs22\cf1\insrsid12477300\charrsid2450573 administer enough}{\f2\fs22\cf1\insrsid8916737\charrsid2450573  }{\f2\fs22\cf1\insrsid3231205\charrsid2450573 of the drug}{
\f2\fs22\cf1\insrsid12477300\charrsid2450573  to their horses to }{\f2\fs22\cf1\insrsid8916737\charrsid2450573 fully }{\f2\fs22\cf1\insrsid10714228\charrsid2450573 sedate}{\f2\fs22\cf1\insrsid14822226\charrsid2450573 , as }{
\f2\fs22\cf1\insrsid3231205\charrsid2450573 they}{\f2\fs22\cf1\insrsid14822226\charrsid2450573  still want to run and jump them. }{\f2\fs22\cf1\insrsid12477300\charrsid2450573  }{\f2\fs22\cf1\insrsid14822226\charrsid2450573 Rather, the}{
\f2\fs22\cf1\insrsid3231205\charrsid2450573 y}{\f2\fs22\cf1\insrsid12477300\charrsid2450573  aim to}{\f2\fs22\cf1\insrsid14822226\charrsid2450573  give their horses j}{\f2\fs22\cf1\insrsid8916737\charrsid2450573 ust enough to keep them from misbehaving.  
}{\f2\fs22\cf1\insrsid725738\charrsid2450573 
\par }{\f2\fs22\cf1\insrsid16734645\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid16734645 {\f2\fs22\ul\cf1\insrsid16734645\charrsid2450573 7. FOXHUNTERS\rquote  ASSESSMENT OF THE DRUG}{\f2\fs22\cf1\insrsid16734645\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3231205 {\f2\fs22\insrsid16734645\charrsid2450573 How do}{\f2\fs22\insrsid16277351\charrsid2450573  foxhunters }{
\f2\fs22\insrsid16734645\charrsid2450573 feel about}{\f2\fs22\insrsid16277351\charrsid2450573  Acepromazine Maleate? }{\f2\fs22\insrsid10766740\charrsid2450573  The vast majority seem to}{\f2\fs22\insrsid14822226\charrsid2450573  think}{
\f2\fs22\insrsid10766740\charrsid2450573  that Acepromazine }{\f2\fs22\insrsid1185124\charrsid2450573 Maleate }{\f2\fs22\insrsid10766740\charrsid2450573 is fantastic: }{\f2\fs22\insrsid6380449\charrsid2450573 \'93
I would not be foxhunting today if it were not for Ace!  My horse is wonderful on his own, but put him with }{\f2\fs22\insrsid12477300\charrsid2450573 a group of a}{\f2\fs22\insrsid10766740\charrsid2450573  hundred}{
\f2\fs22\insrsid6380449\charrsid2450573  other horses and hounds, and he goes crazy}{\f2\fs22\insrsid10766740\charrsid2450573  ... Ace is the only thing that keeps his head on straight!}{\f2\fs22\insrsid6380449\charrsid2450573 \'94}{
\cs17\f2\fs22\super\insrsid10766740\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 

\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid10766740 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #31. Interview on file with author. Conducted on February 4, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid10766740\charrsid2450573   The numbers actuall}{\f2\fs22\insrsid12477300\charrsid2450573 y speak for themselves, though: w}{
\f2\fs22\insrsid10766740\charrsid2450573 ith }{\f2\fs22\insrsid12477300\charrsid2450573 roughly 80% - 9}{\f2\fs22\insrsid3231205\charrsid2450573 0% of foxhunters using Acepromazine Maleate }{\f2\fs22\insrsid12477300\charrsid2450573 every time they fox}{
\f2\fs22\insrsid3231205\charrsid2450573 hunt, typically three times per week, the drug must be doing something right.}{\cs17\f2\fs22\super\insrsid3231205\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3231205 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Informatio
n is based on anonymous fifty interviews with subscribers to Mr. Stewart\rquote s Cheshire Foxhounds (Unionville, PA), the Radnor Hunt (Malvern, PA), and former members of the Brandywine Hunt (West Chester, PA), which dissolved in 2004.
\par }}}{\f2\fs22\insrsid3231205\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6781076 {\f2\fs22\insrsid3231205\charrsid2450573 A couple of}{\f2\fs22\insrsid16277351\charrsid2450573  interviewee}{
\f2\fs22\insrsid3231205\charrsid2450573 s, however, are more skeptical of the drug. }{\f2\fs22\insrsid12477300\charrsid2450573  }{\f2\fs22\insrsid3231205\charrsid2450573 One interviewee}{\f2\fs22\insrsid16277351\charrsid2450573  noted the following: }{
\f2\fs22\insrsid12208646\charrsid2450573 \'93I am all too aware of the rampant use of Acepromazine Maleate by my contemporaries.  I have never used the drug myself.  Think about it . . . you are giving a horse something that significantly slows down its }
{\f2\fs22\insrsid6781076\charrsid2450573 brain}{\f2\fs22\insrsid12208646\charrsid2450573  processing}{\f2\fs22\insrsid6781076\charrsid2450573  capacity}{\f2\fs22\insrsid12208646\charrsid2450573 . }{\f2\fs22\insrsid12477300\charrsid2450573  }{
\f2\fs22\insrsid12208646\charrsid2450573 Then}{\f2\fs22\insrsid6781076\charrsid2450573 ,}{\f2\fs22\insrsid12208646\charrsid2450573  you }{\f2\fs22\insrsid6781076\charrsid2450573 are }{\f2\fs22\insrsid12208646\charrsid2450573 ask}{
\f2\fs22\insrsid6781076\charrsid2450573 ing}{\f2\fs22\insrsid12208646\charrsid2450573  it to perform at its peak, running over, under, through, and around obstacles that most horses could never touch.}{\f2\fs22\insrsid6781076\charrsid2450573 
 Is this really fair?\'94}{\cs17\f2\fs22\super\insrsid6781076\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6781076 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Anonymous Interview #1. Interview on file with author. Conducted on February 2, 2005 in Unionville, PA.}}}{
\f2\fs22\insrsid12208646\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15432658 {\f2\fs22\insrsid6781076\charrsid2450573 Another interviewee analogizes Acepromazine Maleate to alcohol: \'93
Imagine getting drunk. Now you try to jump over a three-rail fence!\'94}{\cs17\f2\fs22\super\insrsid6781076\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid6781076 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #11. Interview on file with author. Conducted on February 2, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid6781076\charrsid2450573   Yet another discusses some}{\f2\fs22\insrsid12477300\charrsid2450573  of the adverse effects of the drug
}{\f2\fs22\insrsid6781076\charrsid2450573 : }{\f2\fs22\insrsid16277351\charrsid2450573 \'93}{\f2\fs22\insrsid12477300\charrsid2450573 I have had couple of dozen}{\f2\fs22\insrsid11477906\charrsid2450573  experiences using this product in training}{
\f2\fs22\insrsid12477300\charrsid2450573 ,}{\f2\fs22\insrsid11477906\charrsid2450573  when riding}{\f2\fs22\insrsid12477300\charrsid2450573 ,}{\f2\fs22\insrsid11477906\charrsid2450573  or training for other trainers}{
\f2\fs22\insrsid12477300\charrsid2450573 ,}{\f2\fs22\insrsid11477906\charrsid2450573  in my youn}{\f2\fs22\insrsid8916737\charrsid2450573 ger days (small doses, usually only one}{\f2\fs22\insrsid16277351\charrsid2450573  CC}{
\f2\fs22\insrsid11477906\charrsid2450573 ). }{\f2\fs22\insrsid16277351\charrsid2450573  }{\f2\fs22\insrsid11477906\charrsid2450573 My experiences }{\f2\fs22\insrsid3231205\charrsid2450573 pr}{\f2\fs22\insrsid12477300\charrsid2450573 
oduced following observations: i}{\f2\fs22\insrsid14843262\charrsid2450573 n racehorses I have noticed "heavier" breathing and excessive perspiration}{\f2\fs22\insrsid16277351\charrsid2450573 ,}{\f2\fs22\insrsid14843262\charrsid2450573 
 while the product had no effect in reducing the horse\rquote s nervousness}{\f2\fs22\insrsid16277351\charrsid2450573  for which the product was used}{\f2\fs22\insrsid14843262\charrsid2450573 .}{\f2\fs22\insrsid16277351\charrsid2450573  }{
\f2\fs22\insrsid14843262\charrsid2450573  The horses also seemed to tire quicker when on this drug.}{\f2\fs22\insrsid16277351\charrsid2450573  }{\f2\fs22\insrsid8916737\charrsid2450573  }{\f2\fs22\insrsid14843262\charrsid2450573 
When riding and training, this drug noticeably dulled the horse\rquote s responses and the animal was in less cooperative mood.}{\f2\fs22\insrsid8916737\charrsid2450573   }{\f2\fs22\insrsid16277351\charrsid2450573 
It was also obvious that the learning speed was noticeably reduced; as the horses were very often barely aware of what was going on, and their attention/interest to the work was greatly reduced as well.}{\f2\fs22\insrsid3231205\charrsid2450573 \'94}{
\cs17\f2\fs22\super\insrsid15432658\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15432658 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Anonymous Interview #47. Interview on file with author. Conducted on February 2, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid3231205\charrsid2450573  }{
\f2\fs22\insrsid15432658\charrsid2450573  }{\f2\fs22\insrsid3231205\charrsid2450573 This interviewee concludes by noting: \'93}{\f2\fs22\insrsid16277351\charrsid2450573 There are alternate \lquote calmers\rquote }{\f2\fs22\insrsid6781076\charrsid2450573 
 (tranquilizers)}{\f2\fs22\insrsid16277351\charrsid2450573  that can be used in training without }{\f2\fs22\insrsid6781076\charrsid2450573 in any way abusing}{\f2\fs22\insrsid16277351\charrsid2450573  the animal.\'94}{
\cs17\f2\fs22\super\insrsid16277351\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid16277351 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\f2\insrsid2450573\charrsid2450573 
\par }{\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Anonymous Interview #47. Interview on file with author. Conducted on February 2, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid16277351\charrsid2450573  }{
\f2\fs22\insrsid94870\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15432658 {\f2\fs22\insrsid15432658\charrsid2450573 \tab The overwhelming majority of foxhunters fully endorse the off-lab}{
\f2\fs22\insrsid14358535\charrsid2450573 el use of Acepromazine Maleate}{\f2\fs22\insrsid5571839\charrsid2450573 , however,}{\f2\fs22\insrsid14358535\charrsid2450573  }{\f2\fs22\insrsid15432658\charrsid2450573 
and have little to no reserve in using it on a regular basis.  Several interviewees note, however, the potential dangers of using the drug if its effects have not been }{\f2\fs22\insrsid14358535\charrsid2450573 thoroughly }{
\f2\fs22\insrsid15432658\charrsid2450573 tested on}{\f2\fs22\insrsid14358535\charrsid2450573  the horse before }{\f2\fs22\insrsid5571839\charrsid2450573 taking it }{\f2\fs22\insrsid14358535\charrsid2450573 foxhunting.  \'93As Acepromazine Maleate}{
\f2\fs22\insrsid15432658\charrsid2450573  affect}{\f2\fs22\insrsid14358535\charrsid2450573 s }{\f2\fs22\insrsid15432658\charrsid2450573 different horses differently, }{\f2\fs22\insrsid14358535\charrsid2450573 
and you can never tell just how sensitive a horse will be to the drug, you must test test test it before using it on the hunt}{\f2\fs22\insrsid16734645\charrsid2450573  }{\f2\fs22\insrsid14358535\charrsid2450573 field! }{
\f2\fs22\insrsid13437027\charrsid2450573  Follow this rule of thumb, }{\f2\fs22\insrsid14358535\charrsid2450573 and you\rquote re golden!\'94  }{\f2\fs22\insrsid13437027\charrsid2450573 As another interviewee put it: \'93}{
\f2\fs22\insrsid14358535\charrsid2450573 E}{\f2\fs22\insrsid13437027\charrsid2450573 ach horse requires a specific}{\f2\fs22\insrsid15432658\charrsid2450573  dosage}{\f2\fs22\insrsid14358535\charrsid2450573  of Acepromazine}{
\f2\fs22\insrsid13437027\charrsid2450573  Maleate. I}{\f2\fs22\insrsid15432658\charrsid2450573 t can take }{\f2\fs22\insrsid14358535\charrsid2450573 several trial and errors to know for sure exactly what that dosage is}{
\f2\fs22\insrsid13437027\charrsid2450573  }{\f2\fs22\insrsid14358535\charrsid2450573 .}{\f2\fs22\insrsid13437027\charrsid2450573 ..}{\f2\fs22\insrsid14358535\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid13437027\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13437027 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #43. Interview on file with author. Conducted on February 5, 2005 in Unionville, PA.
\par }}}{\f2\fs22\insrsid15432658\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14358535 {\f2\fs22\insrsid14358535\charrsid2450573 M}{\f2\fs22\insrsid15432658\charrsid2450573 ost foxhunters have spen}{
\f2\fs22\insrsid1185124\charrsid2450573 t years and years around horses}{\f2\fs22\insrsid14358535\charrsid2450573  }{\f2\fs22\insrsid13437027\charrsid2450573 and }{\f2\fs22\insrsid1185124\charrsid2450573 are certain}{
\f2\fs22\insrsid13437027\charrsid2450573  that they, as well as their fellow foxhunters, are }{\f2\fs22\insrsid5571839\charrsid2450573 fully }{\f2\fs22\insrsid11883889\charrsid2450573 able to}{\f2\fs22\insrsid15432658\charrsid2450573  determin}{
\f2\fs22\insrsid11883889\charrsid2450573 e}{\f2\fs22\insrsid15432658\charrsid2450573  the appropriate }{\f2\fs22\insrsid13437027\charrsid2450573 dosage}{\f2\fs22\insrsid15432658\charrsid2450573  of Ace}{\f2\fs22\insrsid11883889\charrsid2450573 
promazine Maleate}{\f2\fs22\insrsid15432658\charrsid2450573  for each horse}{\f2\fs22\insrsid13437027\charrsid2450573  they ride: \'93We\rquote re horse people. }{\f2\fs22\insrsid5571839\charrsid2450573  }{\f2\fs22\insrsid13437027\charrsid2450573 
We know horses and we know how to take care of them.\'94}{\cs17\f2\fs22\super\insrsid13437027\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13437027 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Anonymous Interview #47. Interview on file with author. Conducted on February 2, 2005 in Unionville, PA.}}}
{\f2\fs22\insrsid13437027\charrsid2450573   Another interviewee notes: \'93We are aware enough of the dangers of using Acepromazine Maleate recklessly NOT to use the drug recklessly.\'94  }{\f2\fs22\insrsid5571839\charrsid2450573 \'93}{
\f2\fs22\insrsid13437027\charrsid2450573 Many of the horses we ride cost upwards of $50,000}{\f2\fs22\insrsid5571839\charrsid2450573 \'94}{\f2\fs22\insrsid4733474\charrsid2450573  a}{\f2\fs22\insrsid5571839\charrsid2450573  }{
\f2\fs22\insrsid4733474\charrsid2450573 third }{\f2\fs22\insrsid5571839\charrsid2450573 interviewee commented}{\f2\fs22\insrsid13058096\charrsid2450573  ... }{\f2\fs22\insrsid13437027\charrsid2450573 our p}{\f2\fs22\insrsid4733474\charrsid2450573 
ocketbooks alone keep us }{\f2\fs22\insrsid13437027\charrsid2450573 precautious!\'94}{\cs17\f2\fs22\super\insrsid13437027\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13437027 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Anonymous Interview #36. Interview on file with author. Conducted on February 2, 2005 in Unionville, PA.
\par }}}{\f2\fs22\insrsid13437027\charrsid2450573   }{\f2\fs22\insrsid5571839\charrsid2450573 Statistically, this }{\f2\fs22\insrsid4733474\charrsid2450573 statement }{\f2\fs22\insrsid5571839\charrsid2450573 
could be true.  Out of the fifty foxhunters interviewed, not}{\f2\fs22\insrsid4733474\charrsid2450573  a single one reported an}{\f2\fs22\insrsid5571839\charrsid2450573  accident with their horse }{\f2\fs22\insrsid4733474\charrsid2450573 
in any way related to their use of}{\f2\fs22\insrsid5571839\charrsid2450573  Ace}{\f2\fs22\insrsid4733474\charrsid2450573 promazine Maleate.}{\cs17\f2\fs22\super\insrsid4733474\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4733474 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Information is based on anonymous fifty interviews with subscribers to Mr. Stewart\rquote s Cheshire Foxhounds (Unionville, PA), the Radnor Hunt (Malvern, PA), and former members of the Brandywine Hunt (West Chester, PA), which dissolved in 2004.}}}{
\f2\fs22\insrsid15432658\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15432658 {\f2\fs22\insrsid13058096\charrsid2450573 \tab }{\f2\fs22\insrsid5596771\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid94870 {\f2\fs22\ul\insrsid13762814\charrsid2450573 8}{\f2\fs22\ul\insrsid15432658\charrsid2450573 . }{\f2\fs22\ul\insrsid94870\charrsid2450573 A VETERINARIAN\rquote S PERSPECTIVE

\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid13058096 {\f2\fs22\insrsid13058096\charrsid2450573 \tab How do veterinarians feel about the off-label use of Acepromazine Maleate? }{\f2\fs22\insrsid2322019\charrsid2450573  }{
\f2\fs22\insrsid11883889\charrsid2450573 T}{\f2\fs22\insrsid4016371\charrsid2450573 hey must be }{\f2\fs22\insrsid1185124\charrsid2450573 pretty confident}{\f2\fs22\insrsid4016371\charrsid2450573  in its safety}{\f2\fs22\insrsid13058096\charrsid2450573 
, or they wouldn\rquote t be prescribing it }{\f2\fs22\insrsid11883889\charrsid2450573 as}{\f2\fs22\insrsid10771670\charrsid2450573  }{\f2\fs22\insrsid5596771\charrsid2450573 frequently}{\f2\fs22\insrsid11883889\charrsid2450573  as they do}{
\f2\fs22\insrsid16734645\charrsid2450573 .  In }{\f2\fs22\insrsid11883889\charrsid2450573 some }{\f2\fs22\insrsid16734645\charrsid2450573 interviews with }{\f2\fs22\insrsid13058096\charrsid2450573 veterinarians at University of Pennsylvania\rquote 
s New Bolton Center, }{\f2\fs22\insrsid2322019\charrsid2450573 I explore}{\f2\fs22\insrsid13058096\charrsid2450573  the question in further depth. 
\par }{\f2\fs22\insrsid1185124\charrsid2450573 \tab Dr. Ray Sweeney, VMD,}{\f2\fs22\insrsid4016371\charrsid2450573  my first interviewee,}{\f2\fs22\insrsid1185124\charrsid2450573  is an Assistant Professor of Medicine at University of Pennsylvania\rquote 
s New Bolton Center, the School of Veterinary Medicine\rquote s Large Animal Teaching Hospital.}{\cs17\f2\fs22\super\insrsid14622703\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11150460 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  In 1964 the large-animal clinic opened at New Bol
ton Center, a farm in Chester County that the University acquired in 1952.  The Widener Hospital at New Bolton Center has more than 70 buildings and 141 stalls for patients.  Each year the George D. Widener Hospital for Large Animals sees more than 6,000 
p
atient visits, and the Field Service sees more than 19,000 animals.  Penn boasts one of the largest equine surgical faculties in the world.  Many members of Penn's surgical faculty are known internationally in their fields.  Because of these credentials, 
New Bolton Center enjoys a large and varied caseload.  Because of its location, it treats valuable horses that engage in all kinds of athletic activities. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://www.vet.upenn.edu/nbc/" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000001e00000068007400740070003a002f002f007700770077002e007600650074002e007500700065006e006e002e006500640075002f006e00620063002f000000e0c9ea79f9bace118c8200aa004ba90b3c00000068007400740070003a002f002f0077007700
77002e007600650074002e007500700065006e006e002e006500640075002f006e00620063002f000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.vet.upenn.edu/nbc/}}}{\f2\insrsid2450573\charrsid2450573  (March 14, 2005)
\par }}}{\f2\fs22\insrsid1185124\charrsid2450573   When asked how the Animal Medicinal Drug Use Clarification Ac}{\f2\fs22\insrsid4016371\charrsid2450573 t of 1994 affected veterinarian}{\f2\fs22\insrsid1185124\charrsid2450573  prescribing practices, }{
\f2\fs22\insrsid4016371\charrsid2450573 Dr. Sweeney responded}{\f2\fs22\insrsid1185124\charrsid2450573 : }{\f2\fs22\insrsid12680433\charrsid2450573 
\par }\pard \ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0\pararsid12680433 {\f2\fs22\insrsid12680433\charrsid2450573 
\par }\pard \ql \li1440\ri1440\widctlpar\faauto\rin1440\lin1440\itap0\pararsid12680433 {\f2\fs22\insrsid10233123\charrsid2450573 I}{\f2\fs22\insrsid1185124\charrsid2450573 t}{\f2\fs22\insrsid4016371\charrsid2450573 
 affected veterinarians primarily in the areas}{\f2\fs22\insrsid1185124\charrsid2450573  of cattle and food-producing animals.  It did not affect actual prescribing, but rather it legalized what we were doing. }{\f2\fs22\insrsid12680433\charrsid2450573  }
{\f2\fs22\insrsid1185124\charrsid2450573 Before, it was illegal to use prescription drugs off-label. This law was not enforced}{\f2\fs22\insrsid10119674\charrsid2450573  }{\f2\fs22\insrsid1185124\charrsid2450573 by the Food and Drug }{
\f2\fs22\insrsid12680433\charrsid2450573 Administration\rquote s}{\f2\fs22\insrsid1185124\charrsid2450573  Center of Veterinary }{\f2\fs22\insrsid10119674\charrsid2450573 Medicine}{\f2\fs22\insrsid12680433\charrsid2450573 .  They }{
\f2\fs22\insrsid10119674\charrsid2450573 did not}{\f2\fs22\insrsid12680433\charrsid2450573  step in unless }{\f2\fs22\insrsid10119674\charrsid2450573 the }{\f2\fs22\insrsid12680433\charrsid2450573 extra-label use led to adultered food p
roducts.  Veterinarians lobbied to legalize what was already }{\f2\fs22\insrsid10119674\charrsid2450573 taking place}{\f2\fs22\insrsid12680433\charrsid2450573  in practice, and finally, }{\f2\fs22\insrsid10119674\charrsid2450573 in 1994, }{
\f2\fs22\insrsid12680433\charrsid2450573 the bill was passed and the necessary provisions were codified.}{\cs17\f2\fs22\super\insrsid12680433\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12680433 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. R
ay Sweeney, VMD. Interview on File with Author. Conducted on February 2, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid2322019\charrsid2450573 
\par }\pard \ql \li1440\ri1440\widctlpar\faauto\rin1440\lin1440\itap0\pararsid12680433 {\f2\fs22\insrsid16663731\charrsid2450573 
\par }\pard \ql \li0\ri0\widctlpar\faauto\rin0\lin0\itap0\pararsid94870 {\f2\fs22\insrsid13058096\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid10233123 {\f2\fs22\insrsid16663731\charrsid2450573 My second veterinarian interviewee, Dr. Mark Donaldson, a former Assistant Profe
ssor of Medicine at University of Pennsylvania\rquote s New Bolton Center and current solo practitioner, was far less knowledgeable about the Animal Medicinal Drug }{\f2\fs22\insrsid13501581\charrsid2450573 Use Clarification Act of 1994.  In fact w}{
\f2\fs22\insrsid16663731\charrsid2450573 hen asked about the Act, Dr. Donaldson admitted to }{\f2\fs22\insrsid14746761\charrsid2450573 having no knowledge of it at all.}{\cs17\f2\fs22\super\insrsid5470775\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5470775 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Dr. Mark Donaldson, VMD. Interview on File with Author. Conducted on February 7, 2005 in Unionville, PA.
\par }}}{\f2\fs22\insrsid14746761\charrsid2450573   }{\f2\fs22\insrsid10233123\charrsid2450573 
\par }{\f2\fs22\insrsid14746761\charrsid2450573 What could account for this disparity of knowledge?  First, Dr. Donaldson has only been practicing for ten years, so }{\f2\fs22\insrsid11883889\charrsid2450573 the off}{\f2\fs22\insrsid13501581\charrsid2450573 
-label use of animal drugs has been legal as long as he has been }{\f2\fs22\insrsid11883889\charrsid2450573 a }{\f2\fs22\insrsid13501581\charrsid2450573 practicing veterinarian}{\f2\fs22\insrsid11883889\charrsid2450573 .}{
\f2\fs22\insrsid5470775\charrsid2450573   Dr. Sweeney, in contrast, has}{\f2\fs22\insrsid11883889\charrsid2450573  been working at New Bolton Center s}{\f2\fs22\insrsid13501581\charrsid2450573 ince he graduated }{\f2\fs22\insrsid5470775\charrsid2450573 
from }{\f2\fs22\insrsid11883889\charrsid2450573 the school himself}{\f2\fs22\insrsid5470775\charrsid2450573  }{\f2\fs22\insrsid11883889\charrsid2450573 twenty-five years ago.  He was therefore a}{\f2\fs22\insrsid13501581\charrsid2450573 
 practicing veterinarian for many years prior to the}{\f2\fs22\insrsid11883889\charrsid2450573  passage}{\f2\fs22\insrsid13501581\charrsid2450573  Animal Medicinal Drug Use Clarif}{\f2\fs22\insrsid5596820\charrsid2450573 ication Act of 1994\rquote s p
assage}{\f2\fs22\insrsid5470775\charrsid2450573 , whereas Dr. Donaldson never practiced during the era in which the off-label uses drugs in animals was illegal}{\f2\fs22\insrsid5596820\charrsid2450573 .   }{\f2\fs22\insrsid11883889\charrsid2450573 
\par }{\f2\fs22\insrsid5596820\charrsid2450573 Second, Dr. Sweeney asked detailed questions about the }{\f2\fs22\insrsid11883889\charrsid2450573 content of the }{\f2\fs22\insrsid5596820\charrsid2450573 interview prior to the interview. }{
\f2\fs22\insrsid10233123\charrsid2450573  }{\f2\fs22\insrsid2450573\charrsid2450573 I suspect based on the notes 
he was examining during the interview that he did some research on the Animal Medicinal Drug Use Clarification Act of 1994 as well as on Acepromazine Maleate prior to the interview.  }{\f2\fs22\insrsid10233123\charrsid2450573 
Dr. Donaldson, in contrast, did not ask any questions about the content of the interview prior to the interview, so he had no chance to }{\f2\fs22\insrsid11883889\charrsid2450573 research}{\f2\fs22\insrsid10233123\charrsid2450573  information. }{
\f2\fs22\insrsid5470775\charrsid2450573  }{\f2\fs22\insrsid11883889\charrsid2450573 
\par }{\f2\fs22\insrsid5470775\charrsid2450573 This disparity of knowledge }{\f2\fs22\insrsid11883889\charrsid2450573 between Dr. Sweeney and Dr. Donaldson }{\f2\fs22\insrsid5470775\charrsid2450573 also arose in regards to the }{
\f2\fs22\insrsid11883889\charrsid2450573 labeled}{\f2\fs22\insrsid5470775\charrsid2450573  uses of Acepromazine Maleate.}{\f2\fs22\insrsid11883889\charrsid2450573  }{\f2\fs22\insrsid5470775\charrsid2450573  Dr. Sweeney readily listed all of }{
\f2\fs22\insrsid794183\charrsid2450573 the }{\f2\fs22\insrsid11883889\charrsid2450573 labeled}{\f2\fs22\insrsid794183\charrsid2450573  uses}{\f2\fs22\insrsid5470775\charrsid2450573 , whereas Dr. Donaldson }{\f2\fs22\insrsid794183\charrsid2450573 
summarized }{\f2\fs22\insrsid5470775\charrsid2450573 the labeled uses as: \'93}{\f2\fs22\insrsid794183\charrsid2450573 Acepromazine Maleate is }{\f2\fs22\insrsid5470775\charrsid2450573 a }{\f2\fs22\insrsid1474121\charrsid2450573 tranquilizer}{
\f2\fs22\insrsid5470775\charrsid2450573 /sedative for horse}{\f2\fs22\insrsid794183\charrsid2450573 s ... }{\f2\fs22\insrsid5470775\charrsid2450573 I [think]}{\f2\fs22\insrsid794183\charrsid2450573  it i}{\f2\fs22\insrsid11883889\charrsid2450573 
s for restraint purposes?}{\f2\fs22\insrsid5470775\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid5470775\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5470775 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Mark Donaldson, VMD. Interview on File with Author. Conducted on February 7, 2005 in Unionville, PA.}}}
{\f2\fs22\insrsid16663731\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid4016371 {\f2\fs22\insrsid11883889\charrsid2450573 N}{\f2\fs22\insrsid794183\charrsid2450573 either veterinarian seems to have a problem}{
\f2\fs22\insrsid11883889\charrsid2450573  with the off-label use of Acepromazine Maleate for foxhunting purposes}{\f2\fs22\insrsid5470775\charrsid2450573 . }{\f2\fs22\insrsid10233123\charrsid2450573  }{\f2\fs22\insrsid10119674\charrsid2450573 
Dr. Sweeney is con}{\f2\fs22\insrsid4016371\charrsid2450573 fident that }{\f2\fs22\insrsid11883889\charrsid2450573 what is taking place}{\f2\fs22\insrsid4016371\charrsid2450573  }{\f2\fs22\insrsid10119674\charrsid2450573 is }{
\f2\fs22\insrsid11883889\charrsid2450573 entirely }{\f2\fs22\insrsid4016371\charrsid2450573 acceptable}{\f2\fs22\insrsid10119674\charrsid2450573 , with }{\f2\fs22\insrsid11883889\charrsid2450573 one}{\f2\fs22\insrsid4016371\charrsid2450573  }{
\f2\fs22\insrsid2377926\charrsid2450573 important}{\f2\fs22\insrsid4016371\charrsid2450573  caveat:}{\f2\fs22\insrsid10119674\charrsid2450573  \'93It is }{\f2\fs22\insrsid2377926\charrsid2450573 essential}{\f2\fs22\insrsid10119674\charrsid2450573  that it
}{\f2\fs22\insrsid4016371\charrsid2450573  [Acepromazine Maleate}{\f2\fs22\insrsid10119674\charrsid2450573 ] is }{\f2\fs22\insrsid4016371\charrsid2450573 used only }{\f2\fs22\insrsid10119674\charrsid2450573 at the discretion of a veterinarian, }{
\f2\fs22\insrsid4016371\charrsid2450573 who guides }{\f2\fs22\insrsid10119674\charrsid2450573 dosage }{\f2\fs22\insrsid4016371\charrsid2450573 administration and timing.\'94}{\cs17\f2\fs22\super\insrsid4016371\charrsid2450573 \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4016371 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Dr. Ray Sweeney, VMD. Interview on File with Author. Conducted on February 2, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid4016371\charrsid2450573   }{\f2\fs22\insrsid13568513\charrsid2450573 He also notes that }{\f2\fs22\insrsid4016371\charrsid2450573 
\'93the }{\f2\fs22\insrsid10119674\charrsid2450573 vet}{\f2\fs22\insrsid4016371\charrsid2450573 erinarian}{\f2\fs22\insrsid13568513\charrsid2450573  must}{\f2\fs22\insrsid4016371\charrsid2450573  }{\f2\fs22\insrsid10119674\charrsid2450573 have }{
\f2\fs22\insrsid4016371\charrsid2450573 a }{\f2\fs22\insrsid10119674\charrsid2450573 client-patient relationship, know the animal}{\f2\fs22\insrsid4016371\charrsid2450573 , and know the condition in which the drug}{
\f2\fs22\insrsid11883889\charrsid2450573  is being used}{\f2\fs22\insrsid10119674\charrsid2450573  so that he/she can make the judgment whether}{\f2\fs22\insrsid4016371\charrsid2450573  or not}{\f2\fs22\insrsid10119674\charrsid2450573 
 the animal can be used safely with the drug in its system.}{\f2\fs22\insrsid4016371\charrsid2450573 \'94}{\cs17\f2\fs22\super\insrsid4016371\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4016371 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Dr. Ray Sweeney, VMD. Interview on File with Author. Conducted on February 2, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid2377926\charrsid2450573   }{\f2\fs22\insrsid13568513\charrsid2450573 
\par }{\f2\fs22\insrsid2377926\charrsid2450573 Dr. Sweeney }{\f2\fs22\insrsid13568513\charrsid2450573 believes that Ace}{\f2\fs22\insrsid11883889\charrsid2450573 promazine Maleate}{\f2\fs22\insrsid13568513\charrsid2450573 
 is generally prescribed and used at completely appropriate levels.  He knows that many }{\f2\fs22\insrsid2377926\charrsid2450573 barns and ferriers}{\cs17\f2\fs22\super\insrsid2377926\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2377926 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 A ferrier is a person who comes and puts horseshoes on horses (a blacksmith).
\par }}}{\f2\fs22\insrsid13568513\charrsid2450573  keep}{\f2\fs22\insrsid2377926\charrsid2450573  Acepromazine Maleate }{\f2\fs22\insrsid13568513\charrsid2450573 around, though, and use it without a prescription. This practice, h}{
\f2\fs22\insrsid794183\charrsid2450573 e condemns}{\f2\fs22\insrsid11883889\charrsid2450573  as }{\f2\fs22\insrsid794183\charrsid2450573 \'93both wrong and illegal}{\f2\fs22\insrsid13568513\charrsid2450573 .\'94}{
\cs17\f2\fs22\super\insrsid13568513\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13568513 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Ray Sweeney, VMD. Interview on File with Author. Conducted on February 2, 2005 in Unionville, PA.
\par }}}{\f2\fs22\insrsid11150460\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid794183 {\f2\fs22\insrsid1527019\charrsid2450573 In regards to how safe it is to ride}{\f2\fs22\insrsid13568513\charrsid2450573  a horse after having}{
\f2\fs22\insrsid1527019\charrsid2450573  given it Acepromazine Maleate, Dr. Sweeney }{\f2\fs22\insrsid11883889\charrsid2450573 responds}{\f2\fs22\insrsid1527019\charrsid2450573 : \'93Safety is always a concern whenever you tranquilize an animal. You worry
 about danger to the rider, if the horse stumbles or falls. Of all the tranquilizers available, [Acepromazine Maleate] is the mild}{\f2\fs22\insrsid794183\charrsid2450573 est on the gate of a horse; [horses]}{\f2\fs22\insrsid1527019\charrsid2450573  don
\rquote t become uncoordinated as with other tra}{\f2\fs22\insrsid794183\charrsid2450573 nquilizers. In this}{\f2\fs22\insrsid1527019\charrsid2450573  regard, it is the safest.
 But it requires dose titration with every animal, as there is variability as far as how each horse is affected by the drug. Also, if the horse is already excited, the drug is not effective. Buy it is safe and legal for laypersons to use the drug as long 
as they follow the directions given to them by their veterinarian.\'94}{\cs17\f2\fs22\super\insrsid794183\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid794183 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Dr. Ray Sweeney, VMD. Interview on File with Author. Conducted on February 2, 2005 in Unionville, PA.}}}{
\f2\fs22\insrsid13568513\charrsid2450573 
\par }{\f2\fs22\insrsid794183\charrsid2450573 Dr. Donalds}{\f2\fs22\insrsid12208216\charrsid2450573 on reflects similar sentiments: \'93
There is a huge range of knowledge of horse owners, so I am selective in whether I prescribe Ace or not.  I base it on an assessment of the knowledge of the person I am dispensing it to.\'94}{\cs17\f2\fs22\super\insrsid12208216\charrsid2450573 \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12208216 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Dr. Mark Donaldson, VMD. Interview on File with Author. Conducted on February 7, 2005 in Unionville, PA.}}}{\f2\fs22\insrsid12208216\charrsid2450573   In regards to whether the drug is being overused, he }{\f2\fs22\insrsid11883889\charrsid2450573 
agrees with Dr. Sweeney that}{\f2\fs22\insrsid12208216\charrsid2450573  \'93overall, I believe the current levels of Acepromazine Malea}{\f2\fs22\insrsid2178137\charrsid2450573 te use are appropriate.  And i}{\f2\fs22\insrsid12208216\charrsid2450573 
t is used frequently}{\f2\fs22\insrsid11883889\charrsid2450573  }{\f2\fs22\insrsid12208216\charrsid2450573 \endash  it is a pretty widespread thing.\'94}{\cs17\f2\fs22\super\insrsid12208216\charrsid2450573 \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12208216 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573 
 Dr. Mark Donaldson, VMD. Interview on File with Author. Conducted on February 7, 2005 in Unionville, PA.
\par }}}{\f2\fs22\insrsid794183\charrsid2450573 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid351388 {\f2\fs22\insrsid351388\charrsid2450573 
\par }{\f2\fs22\ul\insrsid13762814\charrsid2450573 9}{\f2\fs22\ul\insrsid794183\charrsid2450573 . }{\f2\fs22\ul\insrsid351388\charrsid2450573 VETERINARIAN PERSCRIBING PRACTICES}{\f2\fs22\ul\insrsid12208216\charrsid2450573 :}{
\f2\fs22\ul\insrsid351388\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3345984 {\f2\fs22\insrsid2178137\charrsid2450573 
In addition to considering the appropriateness of the off-label uses of the drug, it is important to examine whether the prescribing veterinarians are}{\f2\fs22\insrsid3345984\charrsid2450573  following FDA }{\f2\fs22\insrsid11883889\charrsid2450573 
labeling }{\f2\fs22\insrsid3345984\charrsid2450573 guidelines.  All of the interviewees }{\f2\fs22\insrsid11883889\charrsid2450573 with whom I spoke said}{\f2\fs22\insrsid3345984\charrsid2450573  that the veterinarians from whom they received }{
\f2\fs22\insrsid11883889\charrsid2450573 the }{\f2\fs22\insrsid3345984\charrsid2450573 Acepromazine Maleate }{\f2\fs22\insrsid11883889\charrsid2450573 prescription }{\f2\fs22\insrsid3345984\charrsid2450573 
were their regular veterinarians with whom they have had an ongoing relationship.  }{\f2\fs22\insrsid11883889\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sb100\sa100\sbauto1\saauto1\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11883889 {\f2\fs22\insrsid3345984\charrsid2450573 Are the veterinarians }{\f2\fs22\insrsid2178137\charrsid2450573 me}{
\f2\fs22\insrsid3345984\charrsid2450573 eting the labeling requirements, however?}{\f2\fs22\insrsid2178137\charrsid2450573   }{\f2\fs22\cf1\insrsid2178137\charrsid2450573 The }{\f2\fs22\cf1\insrsid11883889\charrsid2450573 drug\rquote s container}{
\f2\fs22\cf1\insrsid2178137\charrsid2450573 
, according to Food and Drug Administration regulations, must bear the veterinarian's name, address, name of the drug (active ingredient), identification of the animal(s) to be treated, adequate directions for proper use, and cautions/precautions.}{
\cs17\f2\fs22\cf1\super\insrsid3345984\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3345984 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  American Veterinary Medicine Association Webpage. }{\field\flddirty{\*\fldinst {\f2\insrsid2450573\charrsid2450573 
 HYPERLINK "http://www.avma.org/issues/policy/prescription_drugs.asp" }{\f2\insrsid2450573\charrsid2450573 {\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000003900000068007400740070003a002f002f007700770077002e00610076006d0061002e006f00720067002f006900730073007500650073002f0070006f006c006900630079002f0070007200650073006300720069007000740069006f006e005f0064007200
7500670073002e006100730070000000e0c9ea79f9bace118c8200aa004ba90b7200000068007400740070003a002f002f007700770077002e00610076006d0061002e006f00720067002f006900730073007500650073002f0070006f006c006900630079002f0070007200650073006300720069007000740069006f006e
005f00640072007500670073002e006100730070000000}}}{\fldrslt {\cs27\f2\ul\cf2\insrsid2450573\charrsid2450573 http://www.avma.org/issues/policy/prescription_drugs.asp}}}{\f2\insrsid2450573\charrsid2450573 .  May 1, 2006.}}}{
\f2\fs22\cf1\insrsid2178137\charrsid2450573 
 This information may be on the label applied by the manufacturer, or on a label attached to the product by the veterinarian.  If there is inadequate space on the label for any of the other required information, the veterinari
an must provide the additional information on a separate sheet that accompanies the drug dispensed or prescribed.}{\f2\fs22\insrsid2178137\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid351388 {\f2\fs22\insrsid12208216\charrsid2450573 In order to}{\f2\fs22\insrsid351388\charrsid2450573  }{\f2\fs22\insrsid12208216\charrsid2450573 examine}{
\f2\fs22\insrsid11883889\charrsid2450573  compliance with labeling requirements }{\f2\fs22\insrsid12208216\charrsid2450573 more closely}{\f2\fs22\insrsid3345984\charrsid2450573 ,}{\f2\fs22\insrsid12208216\charrsid2450573  a}{
\f2\fs22\insrsid351388\charrsid2450573 nonymous Interviewee #4 }{\f2\fs22\insrsid3345984\charrsid2450573 provided }{\f2\fs22\insrsid351388\charrsid2450573 two Acepromazine Maleate }{\f2\fs22\insrsid11883889\charrsid2450573 packages}{
\f2\fs22\insrsid12208216\charrsid2450573  given to her by separate}{\f2\fs22\insrsid351388\charrsid2450573  veterinarian}{\f2\fs22\insrsid12208216\charrsid2450573 s}{\f2\fs22\insrsid351388\charrsid2450573 . }{\f2\fs22\insrsid16392797\charrsid2450573  }{
\f2\fs22\insrsid351388\charrsid2450573 The first }{\f2\fs22\insrsid12208216\charrsid2450573 prescription }{\f2\fs22\insrsid351388\charrsid2450573 said \'93}{\f2\fs22\insrsid94870\charrsid2450573 1ml I.M. 1/2 hour before excise}{
\f2\fs22\insrsid351388\charrsid2450573  (sic).\'94}{\cs17\f2\fs22\super\insrsid15495755\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15495755 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Prescription on PromAce Box #1.}}}{
\f2\fs22\insrsid351388\charrsid2450573   What exactly is excise? }{\f2\fs22\insrsid3345984\charrsid2450573  }{\f2\fs22\insrsid351388\charrsid2450573 Exercise? }{\f2\fs22\insrsid3345984\charrsid2450573  }{\f2\fs22\insrsid351388\charrsid2450573 
For what horse(s) does this prescription }{\f2\fs22\insrsid15495755\charrsid2450573 pertain}{\f2\fs22\insrsid351388\charrsid2450573 ? }{\f2\fs22\insrsid16392797\charrsid2450573  Clearly, this prescription does not comply with }{
\f2\fs22\insrsid3345984\charrsid2450573 labeling requirements}{\f2\fs22\insrsid16392797\charrsid2450573 . }{\f2\fs22\insrsid94870\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid16392797 {\f2\fs22\insrsid16392797\charrsid2450573 The second prescription reads: \'93For }{\f2\fs22\insrsid4733474\charrsid2450573 Wind}{
\f2\fs22\insrsid16392797\charrsid2450573 field -}{\f2\fs22\insrsid94870\charrsid2450573  }{\f2\fs22\insrsid16392797\charrsid2450573 give 1 to}{\f2\fs22\insrsid94870\charrsid2450573  1.5mls in the muscle as needed. Dr. Puchalski}{
\f2\fs22\insrsid16392797\charrsid2450573 .\'94}{\cs17\f2\fs22\super\insrsid15495755\charrsid2450573 \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\insrsid2450573\charrsid2450573 
\par }\pard \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3345984 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{\f2\insrsid2450573\charrsid2450573  Prescription on PromAce Box #2.}}}{
\f2\fs22\insrsid16392797\charrsid2450573  }{\f2\fs22\insrsid3345984\charrsid2450573  }{\f2\fs22\insrsid16392797\charrsid2450573 In this instance, the horse\rquote s name is }{\f2\fs22\insrsid12208216\charrsid2450573 actually }{
\f2\fs22\insrsid16392797\charrsid2450573 Winfield}{\f2\fs22\insrsid15688677\charrsid2450573 , not Windfield.}{\f2\fs22\insrsid3345984\charrsid2450573   How often is \'93as}{\f2\fs22\insrsid15688677\charrsid2450573  needed\'94?}{
\f2\fs22\insrsid3345984\charrsid2450573   }{\f2\fs22\insrsid15688677\charrsid2450573 This prescription}{\f2\fs22\insrsid12208216\charrsid2450573  also fails to comply}{\f2\fs22\insrsid15688677\charrsid2450573 
 with Animal Medicinal Drug Use Clarification Act of 1994 requirements. }{\f2\fs22\insrsid5385763\charrsid2450573  }{\f2\fs22\insrsid3345984\charrsid2450573 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\faauto\rin0\lin0\itap0\pararsid3345984 {\f2\fs22\insrsid5385763\charrsid2450573 If out of the two prescriptions}{\f2\fs22\insrsid1474121\charrsid2450573  I examined, neither meet}{
\f2\fs22\insrsid5385763\charrsid2450573  Animal Medicinal Drug Use Clarification Act of 1994 requirements, it appears that there is at least somewhat of a compliance problem}{\f2\fs22\insrsid11883889\charrsid2450573  here}{
\f2\fs22\insrsid5385763\charrsid2450573 . }{\f2\fs22\insrsid11883889\charrsid2450573  Without closer Food and Drug Administration regulation, however, nothing will change.}{\f2\fs22\insrsid8916737\charrsid2450573 
\par }\pard\plain \s23\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid4342212 \b\f2\fs44\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\insrsid8916737 
\par 
\par }{\insrsid8923144 
\par 
\par }{\insrsid13437027 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3345984 {\insrsid5205424 CHAPTER FOUR
\par }\pard \s23\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid5523418 {\fs28\ul\insrsid5205424\charrsid5523418 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\ul\insrsid3345984 
\par }\pard \s23\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid15156867 {\insrsid5205424 What}{\insrsid15156867 , if Anything, }{\insrsid6307569 s}{\insrsid15156867 hould }{\insrsid6307569 th}{\insrsid16478604 
e Food and Drug Administration d}{\insrsid6307569 o}{\insrsid15156867  about the Off-Label Use of Acepromazine Maleate}{\insrsid5205424 ?
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid11692284 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\f2\fs24\insrsid11692284 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid1662591 {\f2\fs22\insrsid2699986 In Chapter One}{\f2\fs22\insrsid13699899 , I}{\f2\fs22\insrsid2699986  provided readers }{
\f2\fs22\insrsid1662591 with a brief description of }{\f2\fs22\insrsid2699986 t}{\f2\fs22\insrsid1662591 he most }{\f2\fs22\insrsid16478604 important elements of this}{\f2\fs22\insrsid1662591  paper: }{\f2\fs22\insrsid16478604 
what Acepromazine Maleate is, }{\f2\fs22\insrsid1662591 how foxhunters use Acepromazine Maleat}{\f2\fs22\insrsid16478604 e in an off-label capacity}{\f2\fs22\insrsid1662591 , and how the Animal Medicinal Drug Use Clarification Act of 1994 affects th
e off-label use of }{\f2\fs22\insrsid16478604 the drug. Next, I provided readers with a roadmap of }{\f2\fs22\insrsid2699986 the}{\f2\fs22\insrsid13699899  }{\f2\fs22\insrsid2699986 paper. }{\f2\fs22\insrsid16478604 
I concluded the chapter with a literature review, explori}{\f2\fs22\insrsid1662591 ng }{\f2\fs22\insrsid16478604 how each of the various sources contributed to an understanding of the issues at hand}{\f2\fs22\insrsid1662591 .
\par In Chapter Two, I }{\f2\fs22\insrsid16478604 examined how}{\f2\fs22\insrsid13699899  the }{\f2\fs22\insrsid13699899\charrsid14436599 Food and }{\f2\fs22\insrsid13699899 Drug Administration regulates }{\f2\fs22\insrsid1662591 animal}{
\f2\fs22\insrsid2699986  drugs}{\f2\fs22\insrsid13699899 .  In doing so, I looked extensively at t}{\f2\fs22\insrsid13699899\charrsid14436599 he}{\f2\fs22\insrsid16478604  Center for Veterinary Medicine\rquote s}{\f2\fs22\insrsid13699899\charrsid14436599 
 approval process}{\f2\fs22\insrsid1662591  }{\f2\fs22\insrsid16478604 for animal drugs}{\f2\fs22\insrsid13699899\charrsid14436599 .  }{\f2\fs22\insrsid13699899 I then considered the off-label use of animal drugs. }{\f2\fs22\insrsid2699986  }{
\f2\fs22\insrsid13699899 In t}{\f2\fs22\insrsid16478604 his portion of the paper, I }{\f2\fs22\insrsid6627117 drew heavily}{\f2\fs22\insrsid16478604  on}{\f2\fs22\insrsid13699899\charrsid14436599 
 the legislative history behind the Animal Medicinal Drug Use Clarification Act of 1994, whose pu}{\f2\fs22\insrsid13699899 rpose was: "t}{\f2\fs22\insrsid13699899\charrsid14436599 
o amend the Federal Food, Drug, and Cosmetic Act to clarify the application of the Act with respect to alternate uses of new animal drugs and new drugs intended for human use, and for other purposes."}{\cs17\f2\fs22\super\insrsid13699899\charrsid14436599 
\chftn {\footnote \pard\plain \s16\ql \fi720\li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid13699899 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\f2\super\insrsid2450573\charrsid2450573 \chftn }{
\f2\insrsid2450573\charrsid2450573  140 Congressional Record, 103rd Congress, 2nd Session \endash  December 1994. CIS-NO: 94-PL103-396.
\par }}}{\f2\fs22\insrsid13699899\charrsid14436599   }{\f2\fs22\insrsid1662591 I}{\f2\fs22\insrsid13699899  }{\f2\fs22\insrsid6627117 paid particularly close attention}{\f2\fs22\insrsid16478604  in this portion of the paper}{\f2\fs22\insrsid6627117  to}{
\f2\fs22\insrsid1662591  }{\f2\fs22\insrsid13699899 the}{\f2\fs22\insrsid13699899\charrsid14436599  reasons behind the }{\f2\fs22\insrsid13699899 passage of the }{\f2\fs22\insrsid3609923 Act}{\f2\fs22\insrsid2699986 .}{\f2\fs22\insrsid13699899   }{
\f2\fs22\insrsid13699899\charrsid1662591 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3094054 {\f2\fs22\insrsid13699899 I}{\f2\fs22\insrsid1662591 n Chapter Three, I explored }{\f2\fs22\insrsid13699899 the}{
\f2\fs22\insrsid13699899\charrsid14436599  }{\f2\fs22\insrsid13699899 capacities}{\f2\fs22\insrsid13699899\charrsid14436599  }{\f2\fs22\insrsid13699899 in which }{\f2\fs22\insrsid13699899\charrsid14436599 and exactly how
 much Acepromazine Maleate fox hunters }{\f2\fs22\insrsid1662591 use}{\f2\fs22\insrsid13699899\charrsid14436599  in an off-label capacity}{\f2\fs22\insrsid3609923 , noting the limitations of}{\f2\fs22\insrsid1662591  t}{\f2\fs22\insrsid16478604 hese }{
\f2\fs22\insrsid3609923 figures.}{\f2\fs22\insrsid6627117   N}{\f2\fs22\insrsid13699899\charrsid14436599 o data}{\f2\fs22\insrsid16478604 , however,}{\f2\fs22\insrsid13699899\charrsid14436599  has even been collected on t}{\f2\fs22\insrsid16478604 his}{
\f2\fs22\insrsid13699899  subject matter in the past}{\f2\fs22\insrsid3609923 , so a}{\f2\fs22\insrsid13699899\charrsid14436599 lthough incomp}{\f2\fs22\insrsid3609923 lete }{\f2\fs22\insrsid16478604 this information}{
\f2\fs22\insrsid13699899\charrsid14436599  is }{\f2\fs22\insrsid6627117 nonetheless }{\f2\fs22\insrsid13699899\charrsid14436599 the first of its kind}{\f2\fs22\insrsid1662591 .}{\f2\fs22\insrsid3094054 
\par }{\f2\fs22\insrsid1662591 I }{\f2\fs22\insrsid13699899\charrsid14436599 then }{\f2\fs22\insrsid6627117 considered}{\f2\fs22\insrsid3094054  }{\f2\fs22\insrsid6627117 the }{\f2\fs22\insrsid3094054 off-label us}{\f2\fs22\insrsid13699899\charrsid14436599 
e of Acepromazine Maleate}{\f2\fs22\insrsid6627117  by foxhunters}{\f2\fs22\insrsid16478604  more closely}{\f2\fs22\insrsid13699899\charrsid14436599 . }{\f2\fs22\insrsid1662591  First, I explored the physiology }{\f2\fs22\insrsid3094054 
of the drug itself: how it affects the animal\rquote s body, its labeled uses, }{\f2\fs22\insrsid6627117 its }{\f2\fs22\insrsid3094054 side effects, and the dangers of using the drug}{\f2\fs22\insrsid6627117  while foxhunting}{\f2\fs22\insrsid3094054 
.  I }{\f2\fs22\insrsid16478604 made extensive use of }{\f2\fs22\insrsid14698595 the interviews I conducted }{\f2\fs22\insrsid4147705 with foxhunters}{\f2\fs22\insrsid16478604  in this portion of the paper}{\f2\fs22\insrsid4147705 , and scrutinized}{
\f2\fs22\insrsid3094054  how they feel about the off-label use of the drug.  }{\f2\fs22\insrsid6627117 
\par }{\f2\fs22\insrsid3094054 Finally, }{\f2\fs22\insrsid13699899\charrsid14436599 I }{\f2\fs22\insrsid6627117 explored the }{\f2\fs22\insrsid3094054 opinions of }{\f2\fs22\insrsid13699899\charrsid14436599 veterinarians at New Bolton Center
, the site of the University of Pennsylvania\rquote s School of Veterinary Medicine's teaching hospital for large animals}{\f2\fs22\insrsid14698595 .  I also wanted }{\f2\fs22\insrsid3094054 their }{\f2\fs22\insrsid14698595 opinion }{
\f2\fs22\insrsid3094054 on Acepromazine Maleate and the acceptability of its off-label use by foxhunters}{\f2\fs22\insrsid13699899\charrsid14436599 .}{\f2\fs22\insrsid3094054   }{\f2\fs22\insrsid13699899\charrsid14436599  }{\f2\fs22\insrsid3094054 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid2309741 {\f2\fs22\insrsid3094054 From the }{\f2\fs22\insrsid8937078 information }{\f2\fs22\insrsid6627117 gathered}{\f2\fs22\insrsid8937078  in }{
\f2\fs22\insrsid3094054 above chapters, I }{\f2\fs22\insrsid8937078 would now}{\f2\fs22\insrsid3094054  like to revisit the various questions posed at the beginning of the paper. }{\f2\fs22\insrsid6627117  }{\f2\fs22\insrsid14698595 
\par }{\f2\fs22\insrsid3609923 In this paper, I}{\f2\fs22\insrsid8937078  }{\f2\fs22\insrsid4147705 aime}{\f2\fs22\insrsid8937078 d to assess whether }{\f2\fs22\insrsid14698595 foxhunters are safe using}{\f2\fs22\insrsid13699899\charrsid14436599  }{
\f2\fs22\insrsid3094054 Acepromazine Maleate}{\f2\fs22\insrsid13699899\charrsid14436599  }{\f2\fs22\insrsid14698595 in an off-label capacity}{\f2\fs22\insrsid4147705 .  From my research, it appears 
that the answer to this question is, for the most part, yes.  The foxhunters themselves overwhelmingly believe that the off-label use of Acepromazine Maleate is safe, as long as the necessary precautions are taken.  And because most foxhunters have spent 
years and years around horses, they have the judgment}{\f2\fs22\insrsid10957508  to meet}{\f2\fs22\insrsid4147705 , if not exceed, this safety bar.  }{\f2\fs22\insrsid2309741 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid9182382 {\f2\fs22\insrsid10957508 V}{\f2\fs22\insrsid4147705 
eterinarians themselves are also quite confident in the safety of off-label Acepromazine Maleate }{\f2\fs22\insrsid9182382 use }{\f2\fs22\insrsid10957508 by foxhunters}{\f2\fs22\insrsid4147705 .}{\f2\fs22\insrsid10957508   They too believe that if the}{
\f2\fs22\insrsid2309741  proper precautions are take}{\f2\fs22\insrsid14698595 n, there is no problem with its frequent use}{\f2\fs22\insrsid2309741 .  }{\f2\fs22\insrsid9182382 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid12130238 {\f2\fs22\insrsid9182382 In regards to whether}{\f2\fs22\insrsid13699899\charrsid14436599  foxhunters }{\f2\fs22\insrsid9182382 are }{
\f2\fs22\insrsid13699899\charrsid14436599 capable of selecting and/or administering the appropriate dosage of }{\f2\fs22\insrsid12130238 Acepromazine Maleate}{\f2\fs22\insrsid13699899\charrsid14436599  (per }{\f2\fs22\insrsid9182382 
guidance from the veterinarian), the answer again appears to be yes. }{\f2\fs22\insrsid12130238  }{\f2\fs22\insrsid9182382 In not a single one of the fifty interviews }{\f2\fs22\insrsid14698595 I }{\f2\fs22\insrsid9182382 
conducted did a foxhunter report having }{\f2\fs22\insrsid12130238 had a riding accident }{\f2\fs22\insrsid9182382 related to }{\f2\fs22\insrsid12130238 their use of Acepromazine Maleate}{\f2\fs22\insrsid9182382 .  No}{\f2\fs22\insrsid14698595 
t a single interviewee}{\f2\fs22\insrsid9182382  }{\f2\fs22\insrsid12130238 even reported havin}{\f2\fs22\insrsid3609923 g heard of such an occurrence. My i}{\f2\fs22\insrsid12130238 nterviews with veterinarians painted a similar picture.}{
\f2\fs22\insrsid14698595  }{\f2\fs22\insrsid12130238  None of the veterinarians }{\f2\fs22\insrsid14698595 I interviewed }{\f2\fs22\insrsid12130238 had ever even}{\f2\fs22\insrsid3609923  heard of an}{\f2\fs22\insrsid12130238  }{\f2\fs22\insrsid3609923 
accident}{\f2\fs22\insrsid14698595  in any way related to the }{\f2\fs22\insrsid3609923 off-label }{\f2\fs22\insrsid14698595 use of }{\f2\fs22\insrsid12130238 Acepromazine }{\f2\fs22\insrsid3609923 Maleate.  If anything, }{\f2\fs22\insrsid12130238 
the drug }{\f2\fs22\insrsid14698595 may have }{\i\f2\fs22\insrsid12130238\charrsid14698595 prevented}{\f2\fs22\insrsid12130238  accidents.  By helping to calm otherwise }{\f2\fs22\insrsid14698595 antsy}{\f2\fs22\insrsid12130238  horses, the drug }{
\f2\fs22\insrsid14698595 may (and likely) }{\f2\fs22\insrsid12130238 i}{\f2\fs22\insrsid14698595 mproves }{\f2\fs22\insrsid3609923 safety on the }{\f2\fs22\insrsid2450573 hunt field}{\f2\fs22\insrsid3609923 .}{\f2\fs22\insrsid12130238 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid14698595 {\f2\fs22\insrsid12130238 What does deserve additional attention, however, is veterinarian compliance with }{\f2\fs22\insrsid3609923 
the Food and Drug }{\f2\fs22\insrsid2450573 Administration\rquote s}{\f2\fs22\insrsid3609923  labeling requirements}{\f2\fs22\insrsid12130238 .  Veterinarians are now permitted 
to prescribe drugs such as Acepromazine Maleate off-label, but they must be absolutely certain to provide horse owners with appropriate guidance in administering the drug. }{\f2\fs22\insrsid14698595  }{\f2\fs22\insrsid12130238 
Particularly with a drug like Acepromazine Maleate, whi}{\f2\fs22\insrsid14698595 ch is extremely sensitive}{\f2\fs22\insrsid12130238  }{\f2\fs22\insrsid14698595 to both timing and dosage, the drug can affect a horse radically differently depending on }{
\f2\fs22\insrsid12130238 when the drug is administere}{\f2\fs22\insrsid5056820 d}{\f2\fs22\insrsid12130238  as well as how much }{\f2\fs22\insrsid14698595 is }{\f2\fs22\insrsid3609923 given}{\f2\fs22\insrsid14698595 
.  Also, the line between giving a horse }{\f2\fs22\insrsid3609923 just }{\f2\fs22\insrsid14698595 enough Acepromazine Maleate }{\f2\fs22\insrsid12130238 to calm }{\f2\fs22\insrsid14698595 it }{\f2\fs22\insrsid12130238 down}{\f2\fs22\insrsid3609923 ,}{
\f2\fs22\insrsid14698595  and giving}{\f2\fs22\insrsid12130238  }{\f2\fs22\insrsid14698595 it }{\f2\fs22\insrsid3609923 a little bit }{\f2\fs22\insrsid14698595 too much, such that the }{\f2\fs22\insrsid3609923 horse\rquote s}{\f2\fs22\insrsid12130238 
 athletic ability}{\f2\fs22\insrsid3609923  }{\f2\fs22\insrsid2450573 is hindered}{\f2\fs22\insrsid14698595 , is an extremely fine one}{\f2\fs22\insrsid12130238 .  Foxhunters do not want to discover }{\f2\fs22\insrsid5056820 
that they gave their horse one too many CCs}{\f2\fs22\insrsid14698595  of Ace}{\f2\fs22\insrsid5056820  }{\f2\fs22\insrsid12130238 while jump}{\f2\fs22\insrsid14698595 ing}{\f2\fs22\insrsid12130238  over a five foot fence. }{\f2\fs22\insrsid5056820 
 This mistake could be dangerous and potentially life-threatening to both the rider and the horse. }{\f2\fs22\insrsid5643365  Given the inadequate labeling I }{\f2\fs22\insrsid3609923 encountered in my research}{\f2\fs22\insrsid5643365 
, veterinarians need to be much more meticulous in their prescribing practices.  }{\f2\fs22\insrsid14698595 They must be absolutely sure that the horse owner is competent and fully aware of the dangers of the drug.  
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0\pararsid3609923 {\f2\fs22\insrsid14698595 In this regard, the }{\f2\fs22\insrsid13699899\charrsid14436599 Food and Drug Administration }{
\f2\fs22\insrsid14698595 needs to be doing more.  Even before the passage of the Animal Medicinal Drug Use Clarification Act of 1994\rquote s passage, veterinarians were prescribing 
Acepromazine Maleate off-label on a regular basis because the Center of Veterinary Medicine was not enforcing the law.  Now that Congress }{\f2\fs22\insrsid3609923 has passed a more reasonable statute}{\f2\fs22\insrsid14698595 
, the current law needs proper }{\f2\fs22\insrsid13309113 enforcement}{\f2\fs22\insrsid14698595  to actually}{\f2\fs22\insrsid3609923  affect}{\f2\fs22\insrsid14698595  veterinarian behavior. Ultimately, this }{\f2\fs22\insrsid3609923 change }{
\f2\fs22\insrsid14698595 will enhance the safety of both horses and humans.}{\f2\fs22\insrsid4733474\charrsid3609923 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\f2\fs22\insrsid4733474\charrsid11692284 
\par }}