The Alliance For Natural Health

Regulatory Framework

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Compounding has recently undergone a regulatory overhaul by Congress and the FDA. In November 2013, the Drug Quality and Security Act (DQSA) was signed in to law, amending the federal Food, Drug, and Cosmetic Act (FDCA) and overhauling the regulation of compounding. In July 2014, the FDA released rules and guidances and other documents implementing these new laws.

Compounding pharmacies are regulated on the state and federal level and are now divided into two categories—Section 503A of the FDCA includes smaller pharmacies and 503B includes large “outsourcing facilities.”

Generally, state boards of pharmacy are the primary regulators of 503A, state-licensed pharmacies that compound drugs. The FDA also retains some control over 503A pharmacies, regulating areas such as the adulteration or misbranding of drugs compounded under section 503A, or false or misleading statements in the labeling or advertising of such drugs.

Large outsourcing facilities are subject to federal regulation, including compliance with good manufacturing requirements, inspection by the FDA, and other conditions, such as reporting adverse events and providing the FDA with certain information about the products they compound.

While some provisions of the DQSA have been beneficial in providing clarity to prescribers and pharmacists, several sections limit patient access to compounded medication and impinge of the practice of medicine.

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