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FDA Announces Pharmacy Compounding Advisory Committee Members

The FDA took another step forward in the implementation of the compounding provisions of the Drug Quality and Security Act (DQSA) today by announcing the membership of the Pharmacy Compounding Advisory Committee which will play a central role in shaping the regulation of compounding pharmacies. The 14 members of the Committee (12 voting, 2 non-voting) are experts in pharmaceutical compounding and manufacturing, pharmacy, medicine, and pharmaceutical regulations and include representation from the National Association of Boards of Pharmacy (NAPB) and United States Pharmacopeia (USP). The FDA will consult with the Committee for advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. For instance, DQSA requires the FDA to consult with the Committee before issuance of certain regulations including the publication of the list of drugs that present demonstrable difficulties for compounding and the list of bulk drug ingredient that can be used to compound under 503B.