Almost a year after announcing the re-creation of its Pharmacy Compounding Advisory Committee (PCAC), the US Food and Drug Administration (FDA) has announced that it has selected 12 experts who will serve on the influential committee as it considers how best to regulate the pharmaceutical compounding sector.

Background

The re-creation of the PCAC was called for under the Drug Quality and Security Act (DQSA), which sought to update the way in which FDA regulated pharmaceutical compounding following a deadly outbreak of fungal meningitis linked to compounded products.

Unlike more traditional pharmaceutical manufacturers—think Pfizer, for example—compounding pharmacies make custom versions of already-approved pharmaceuticals with the stated purpose of meeting unique patient needs. A compounding pharmacy might make a smaller dose of a drug than is commercially available, for example.

The PCAC is set to play a central role in helping FDA to more tightly regulate the pharmaceutical compounding sector.

For example, the PCAC will be advising FDA regarding a list of drugs known as the "difficult-to-compound" list, which compounders will not be allowed to make. As Regulatory Focus has previously reported, this list will potentially be a source of controversy as brand-name pharmaceutical manufacturers try to argue their products are "difficult to compound" in order to stave off compounded competition.

Read about how manufacturers are trying to add their drugs to the "difficult-to-compound" list to stave off potential competition here.

While FDA is drafting up a list of candidates for the difficult-to-compound list, it will consult with the PCAC before issuing a final difficult-to-compound list by regulation.

As announced in January 2014, the committee is set to be made up of 12 voting members selected from the National Association of Boards of Pharmacy (NABP) and the United States Pharmacopoeia (USP), and representatives of patient and public health advocacy organizations. The committee will also include non-voting representatives from the pharmaceutical industry and a voting consumer representative.

Members will serve four-year terms.

And the Committee Members Are…

On 16 December 2014, FDA announced that it has finally chosen all members of the new PCAC.

Jurgen Venitz, MD, PhD (Chairperson)

Expertise: Pharmacology

Associate Professor, Virginia Commonwealth University

Ned S. Braunstein, MD (Industry Representative)

Expertise: Molecular Immunology, Clinical Rheumatology

Vice President and Head of Regulatory Affairs, Regeneron Pharmaceuticals, Inc.

Michael A. Carome, MD, FACP (Consumer Representative)

Expertise: Consumer Advocacy

Director, Health Research Group, Public Citizen

Gigi S. Davidson, BSPh, DICVP

Expertise: Clinical Pharmacy

Director, Clinical Pharmacy Services, North Carolina State University

Robert DeChristoforo, MS, FASHP

Expertise: Pharmacy

Chief, Clinical Center Pharmacy Department, NIH

John J. DiGiovanna, MD

Expertise: Dermatology

Staff Clinician, National Cancer Institute, NIH

Padma Gulur, MD

Expertise: Anesthesiology

Professor, University of California

Stephen W. Hoag, PhD

Expertise: Pharmaceutical Science

Professor, University of Maryland

William A. Humphrey, BSPharm, MBA, MS

Expertise: Clinical Pharmacy

Director, Pharmacy Operations, St. Jude Children’s Research Hospital

Elizabeth Jungman, JD

Expertise: Public Health Advocacy

Director of Drug Safety and Innovation, The Pew Charitable Trusts

William Mixon, RPh, MS, FIACP (Industry Representative)

Expertise: Pharmacy Compounding

Owner-Manager, The Compounding Pharmacy

Katherine Pham, PharmD, BCPS

Expertise: Pediatric Clinical Pharmacy

Neonatal Intensive Care Unit Pharmacy Specialist, Children’s National Medical Center

Allen J. Vaida, BSc, PharmD, FASHP

Expertise: Medication Safety

Executive Vice President, Institute for Safe Medication Practices

Donna Wall, PharmD

Expertise: Clinical Pharmacy

Clinical Pharmacist, Indiana University Hospital

FDA Statement

PCAC Webpage