December 18, 2014
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FDA announces members of its Pharmacy Compounding Committee

The FDA has announced the roster of its new Pharmacy Compounding Advisory Committee, the agency announced in a press release.

The 14-member committee includes a lineup of experts in pharmaceutical compounding and manufacturing, pharmacy, medicine and pharmaceutical regulation. The committee members were selected after a call for qualified candidates yielded more than 100 nominations, and the FDA also selected some members from its own consortium of special government employees.

The committee will consist of 12 voting and two non-voting members, all of whom will provide guidance on scientific, technical and medical matters pertaining to drug compounding under sections 503A and 503B of the Federal Food, Drug and Cosmetic Act.

Among the organizations represented by the voting members are the United States Pharmacopeia (USP), a nonprofit organization that regulates the identity, strength and purity of medicines manufactured, distributed and consumed around the world; the National Association of Boards of Pharmacy (NABP), a professional organization that works with state boards of pharmacy to safeguard public health; and one member affiliated with the interests of consumers. The two non-voting members are representatives of the pharmacy compounding industry and the pharmaceutical manufacturing industry. Nominees who did not represent a particular group were assessed for potential conflicts of interest and level of expertise.

“Advisory committees are a very important source of knowledge and advice for drug regulation,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, in the press release. “This is a key step toward implementing the compounding provisions of the Drug Quality and Security Act, and I expect we will benefit greatly from the advice and recommendations the members of the committee provide.”