Regulatory dispatch
What is the PCAC?
Background
The Pharmacy Compounding Advisory Committee (PCAC) is a federal advisory committee that advises the U.S. Food and Drug Administration on the regulation of compounded drugs. According to the FDA’s committee page, the PCAC “provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act” (FDA — PCAC).
The committee was created by the Drug Quality and Security Act (DQSA), enacted in November 2013 in the wake of the 2012 New England Compounding Center fungal-meningitis outbreak. The DQSA added section 503B to the FD&C Act and directed FDA to consult an advisory committee on compounding before placing substances on certain regulatory lists, which is reflected in the PCAC’s standing role under sections 503A and 503B (FDA — PCAC).
Composition
The PCAC charter describes the committee as a panel of 12 voting members appointed by the FDA Commissioner. Per FDA’s committee page, members include “representatives from the National Association of Boards of Pharmacy (NABP), the United States Pharmacopeia (USP), pharmacists with current experience and expertise in compounding, physicians with background and knowledge in compounding, and patient and public health advocacy organizations” (FDA — PCAC).
The charter also provides for one or more non-voting industry representatives and consumer-oriented members (PCAC Charter). The current Designated Federal Officer is Takyiah Stevenson, PharmD, who manages public participation and committee logistics (FDA — PCAC). The current voting roster is published on the PCAC Roster page.
What the PCAC does
The PCAC’s role is advisory: it reviews FDA briefing documents, hears public comment, deliberates in open session, and votes on recommendations. The FDA is not bound by PCAC votes, but in practice the committee’s recommendations heavily inform the agency’s subsequent rulemaking on the 503A and 503B Bulks Lists.
The committee’s most consequential recurring task is reviewing nominated bulk drug substances. Under section 503A of the FD&C Act, a state-licensed pharmacy or physician may compound a drug from a bulk substance only if the substance (a) is the subject of a USP or NF monograph, (b) is a component of an FDA-approved drug, or (c) appears on a list developed by FDA after consultation with the PCAC and USP. The 503A Bulks List is that third pathway.
The public process
PCAC meetings follow the Federal Advisory Committee Act and are run as open public hearings. Each meeting is announced in the Federal Register, and a public docket is established for written comments. The FDA’s announcement page for the July 23-24, 2026 meeting outlines the public-comment timing and the option to participate in person, via teleconference, or by webcast (FDA — July 23-24, 2026 PCAC meeting).
The typical meeting agenda has four phases per substance under review: (1) FDA presents its briefing document and a recommendation, (2) the substance’s nominator may present supporting evidence, (3) the public comment period is read into the record, and (4) the committee deliberates and votes. Briefing documents are posted to the FDA’s Advisory Committee Calendar in advance of the meeting and are typically released roughly two weeks before the convene date (FDA — Meeting of the PCAC).
The agency provides a free live webcast of meetings and an option for the public to participate via teleconference or video conference (FDA — PCAC). Transcripts and slide decks are posted to the meeting materials page after the event.
The July 23-24, 2026 meeting
The next PCAC convening is scheduled for July 23-24, 2026, at FDA’s White Oak Campus in Silver Spring, Maryland, with a virtual attendance option. According to the FDA’s meeting announcement, the committee “will discuss the following bulk drug substances being considered for inclusion on the 503A Bulks List: BPC-157-related bulk drug substances, KPV-related bulk drug substances, TB-500-related bulk drug substances, and MOTs-C-related bulk drug substances” (FDA — July 23-24, 2026 PCAC meeting).
What’s at stake
The 503A Bulks List determines which bulk drug substances state-licensed compounding pharmacies may legally use when no USP/NF monograph exists and the substance is not a component of an FDA-approved drug. Inclusion on the list opens a regulated compounding pathway for the substance; exclusion effectively closes that pathway. For peptides such as BPC-157, KPV, TB-500, and MOTs-C — none of which are FDA-approved as finished drugs and none of which currently have USP monographs — the PCAC’s July 2026 recommendation is the principal procedural step before any of them can be lawfully compounded as a bulk substance under section 503A.