The Regulation of Pharmaceutical Compounding and the Determination of Need: Balancing Access and Autonomy with Patient Safety

Abstract

Pharmaceutical compounding, the creation and dispensing of custom-made medications, is the root of the pharmacy profession often symbolized by the mortar and pestle. The practice involves mixing, measuring, and making safe, elegant pharmaceutical dosage forms. It is an important practice for many patients who cannot take traditional medication such as pediatric patients, hospice patients, and patients with allergies to common dyes and fillers. Compounding has come under increasing regulatory scrutiny over the past ten to fifteen years due to risks involved in the practice. Traditional FDA regulation of compounding practice is impracticable given the time and resources necessary for drug approval. Yet FDA has statutory authority and discretion to regulate the practice in this manner. New regulation, withdrawing compounding from traditional FDA regulation, is necessary to protect patient access to this important practice. Additionally, pharmacists need clear guidelines for appropriate practice and patients need assurances of product safety. This paper examines the history, need, and risks of pharmaceutical compounding, Congressional, state, and FDA attempts to fairly regulate the practice, and proposes guidelines for appropriate regulation by federal and state authorities as well as professional pharmacy organizations.