Pharmaceutical compounding is the creation and dispensing of custom-made medications. It is at the root of the pharmacy profession and is often symbolized by the mortar and pestle. The practice involves mixing, measuring, and making safe, well-designed pharmaceutical dosage forms. It is an important practice for many patients who find it hard to take traditional medication such as paediatric patients, hospice patients, and patients allergic to common dyes and fillers.

Compounding has come under increasing regulatory examination over the past ten to fifteen years due to various risks involved in the practice. Traditional FDA regulation of compounding practice is not viable, given the time and resources needed for drug approval. However, FDA has the statutory authority and discretion to regulate the practice in this manner. New regulation, withdrawing compounding from traditional FDA regulation, is essential to protect patient access to this important practice. Moreover, pharmacists need clear guidelines for proper practice and patients need guarantees of product safety. (more…)