FDA Regulation of Compounding Pharmacies: Unsolved Mysteries: BakerHostetler

The U.S. Food and Drug Administration (FDA) has been busy since the passage of the Drug Quality and Security Act (DQSA) in November 2013. In just five short months, the FDA has issued six warning letters referencing the DQSA’s outsourcing facility provisions, published three draft guidance documents outlining its authority and enforcement priorities under Sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act (FFDCA) and conducted an “Inter-Governmental Working Meeting on Pharmacy Compounding” with officials from state boards of pharmacy and national trade organizations to discuss implementation of the DQSA. The FDA also welcomed the addition of almost 40 newly registered “outsourcing facilities” that have voluntarily registered with the FDA in exchange for the opportunity to compound drugs without a prescription for office use and to ship compounded drugs across state lines without restriction. But this flurry of activity also has resulted in several important unanswered questions under the DQSA, particularly as to where certain entities fit in relation to Section 503A, which governs traditional compounding pursuant to identifiable patient prescriptions, and Section 503B, which governs the newly created outsourcing facilities.

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