FDA appoints Pharmacy Compounding Advisory Committee

December 18, 2014

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.

Several leading pharmacists and pharmacy educators were recently appointed to the U.S. Food and Drug Administration’s (FDA) Pharmacy Compounding Advisory Committee.

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, 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.” 

Appointees include William Humphrey, director of pharmacy operations at St. Jude Children’s Research Hospital in Memphis, Tenn.; Katherine Pham, PharmD, BCPS, neonatal intensive care unit pharmacy specialist with the Children’s National Medical Center in Washington, D.C.; Allen J. Vaida, PharmD, FASHP, executive vice president of the Institute for Safe Medication Practices in Horsham, Pa.; Donna Wall, PharmD, clinical pharmacist with Indiana University Hospital in Indianapolis, Ind.; William Mixon, RPh, owner and manager of The Compounding Pharmacy in Hickory, N.C.; Jayne E. Peterson, BS Pharm, with the FDA’s Center for Drug Evaluation and Research; Ned S. Braunstein, MD, vice president and head of regulatory affairs at Regeneron Pharmaceuticals; Michael A. Carome, MD, director of the Health Research Group at Public Citizen; Gigi S. Davidson, BSPh, director of clinical pharmacy services at North Carolina State University’s College of Veterinarian Medicine; Robert DeChristoforo, MS, FASHP, chief of the Clinical Center Pharmacy Department at the National Institutes of Health; John J. DiGiovanna, MD, staff clinician with the Center for Cancer Research, National Cancer Institute at the National Institutes of Health; Padma Gulur, MD, professor at the University of California, Irvine; Stephen W. Hoag, PhD, professor in the University of Maryland, Baltimore’s Department of Pharmaceutical Science; and Elizabeth Jungman, JD, director of drug safety and innovation for The Pew Charitable Trusts in Washington, D.C.

The committee’s chairperson is Jurgen Venitz, MD, PhD, associate professor with the Virginia Commonwealth University School of Pharmacy in Richmond, Va.