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The committee is comprised of 14 members - 12 voting and two non-voting - who will provide advice on scientific, technical and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
“Advisory committees are a very important source of knowledge and advice for drug regulation,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “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.”
The members are experts in pharmaceutical compounding and manufacturing, pharmacy, medicine, and pharmaceutical regulation. The FDA solicited nominations for committee members, and more than 100 individuals were nominated. The FDA also identified some qualified candidates from its own pool of special government employees.
The committee includes voting members representing the United States Pharmacopeia (USP), a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines manufactured, distributed and consumed worldwide; the National Association of Boards of Pharmacy (NABP), a professional organization that supports the state boards of pharmacy in protecting public health; and one member identified with consumer interests. Two non-voting members represent the pharmacy compounding industry and the pharmaceutical manufacturing industry.
Candidates not representing a particular group were evaluated for conflicts of interest and to determine whether their qualifications matched the required areas of expertise.
