Pharmacy Experts Join FDA Compounding Advisory Committee
To provide further guidance on issues concerning drug compounding, the FDA today announced that experts in pharmacy, pharmaceutical compounding and manufacturing, medicine, and pharmaceutical regulation will comprise the Pharmacy Compounding Advisory Committee.
To provide further guidance on issues concerning drug compounding, the FDA today announced that experts in pharmacy, pharmaceutical compounding and manufacturing, medicine, and pharmaceutical regulation will comprise the Pharmacy Compounding Advisory Committee.
The 14-member advisory committee includes voting members representing the US Pharmacopeia and the National Association of Boards of Pharmacy. Two non-voting members on the roster represent the pharmacy compounding and manufacturing industries, and one voting member identifies with consumer interests.
Members of the committee will offer recommendations to companies that prepare compounded medications under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, the FDA said.
“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. “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.”
More than 100 individuals were nominated for spots on the advisory committee, according to the FDA.
In a press release, David G. Miller, RPh, Executive Vice President/CEO of the International Academy of Compounding Pharmacists (IACP), said "We are glad to see that the FDA has put the Pharmacy Compounding Advisory Committee in place and we hope that this process will result in an implementation of DQSA that is more consistent with the intent of the law."
However, Miller continued, "While we are pleased that the advisory committee finally has been announced and that the members are well-qualified scientifically, IACP has serious concerns about the lack of representation on the panel of actual practicing compounding pharmacists. IACP submitted 24 nominees, many with extensive real-life compounding practice experience, to the FDA and only 1 was selected."
