PCAC

What does PCAC do?

PCAC advises FDA on scientific, technical and medical issues in drug compounding under sections 503A and 503B, and makes recommendations to the FDA Commissioner [1]. It has a core of 12 voting members, including representatives of the National Association of Boards of Pharmacy, the U.S. Pharmacopeia, compounding pharmacists and physicians, and patient and public-health advocacy groups, plus non-voting members with industry ties [1]. FDA solicited nominations for its 503A bulks list in 2015 and now evaluates them on a rolling basis through notice-and-comment rulemaking [2].

What did PCAC review in July 2026?

PCAC reviewed seven nominated substances over two meeting days: BPC-157, KPV, TB-500 and MOTS-c on July 23, and Semax-, epitalon- and emideltide-related substances on July 24 [3]. On July 23, it voted 8-6, with one abstention, to recommend BPC-157, KPV and TB-500, and 7-5, with two abstentions, for MOTS-c [4]. PharmExec reported the votes came over the objections of FDA career scientists [4]. The votes do not make the peptides FDA-approved drugs [4].

Why doesn't a PCAC vote put a substance on the list?

A recommendation is not a rule. PCAC advises the FDA Commissioner [1]; FDA adds substances to the 503A bulks list through notice-and-comment rulemaking, on a rolling basis [2]. Its first such rule, in February 2019, placed six substances on the list and declined four others [2]. The meeting page itself posts briefing documents and not vote results [3].