The Clock Is Ticking for the FDA’s Peptide Decision

A new legal analysis from Orrick previews the July 23–24 Pharmacy Compounding Advisory Committee meeting, where seven peptides are being considered for possible inclusion on the Section 503A Bulk Drug Substances List: BPC-157, KPV, TB-500, MOTS-c, Emideltide (DSIP), Semax and Epitalon. The public docket has reportedly attracted around 1,860 comments, turning the meeting into a major battle over the future of peptide compounding in the United States. FDA staff recommended against all seven The FDA’s briefing documents reach the same proposed conclusion for every peptide: do not add it to the 503A Bulks List. FDA staff assessed each substance using four factors: Physical and chemical characterisation. Historical use in compounding. Evidence of effectiveness. Safety. Recurring concerns included inconsistent naming, missing quality information, inadequate characterisation, little or no reliable clinical evidence and unresolved safety risks. The article highlights: No human data at all for KPV, TB-500 and MOTS-c. Small or poorly controlled studies for BPC-157, Emideltide and Semax. Potential immunogenicity risks. Adverse-event reports involving BPC-157. WADA-prohibited status for MOTS-c and TB-500. That recommendation places FDA career staff at odds with Health Secretary Robert F. Kennedy Jr., who has publicly supported broader access to peptides. Most public submissions reportedly support inclusion According to Orrick, most docket submissions favour adding the peptides. Organisations supporting inclusion include: The Alliance for Pharmacy Compounding. Empower Pharmacy. Hims & Hers Health. The American Institute for Compounded Therapeutics. The Texas Pharmacy Association. Peptide AI. The American Academy of Peptide Medicine. One of the most common arguments is that restrictions will not eliminate demand. Instead, patients may be pushed further into the unregulated grey market, where supply chains are harder to verify. Supporters argue that regulated pharmacy compounding would be the comparatively safer option. Several major organisations oppose inclusion Opponents include: PhRMA. The Partnership for Safe Medicines. The American Pharmacists Association. They argue that the evidence is insufficient, that supply-chain risks remain serious and that enforcement capacity is limited. The article also says opponents raised concerns about Chinese fentanyl-precursor manufacturers moving into peptide sales. PhRMA reportedly argued that the committee may not be free from conflicts of interest, that the FDA’s four-factor standard supports exclusion and that the agency cannot lawfully rely on interim enforcement policy while formal rulemaking remains unfinished. The National Association of Boards of Pharmacy stayed neutral The National Association of Boards of Pharmacy did not take a position on whether the peptides should be included. Instead, it identified five regulatory infrastructure gaps and recommended that the FDA address them before or alongside any final rule. Orrick predicts the committee may reject FDA staff’s recommendation The most interesting section is Orrick’s prediction. The FDA announced a reconstituted PCAC with at least eight new members, some of whom have links to peptide clinics or businesses. Based on the committee’s new composition, Orrick believes the most probable outcome is that PCAC will recommend adding some or possibly all seven peptides, despite FDA staff recommending against every one of them. That would be a major departure from previous PCAC decisions. Even a favourable vote would not settle it A committee vote in favour would only be a recommendation. The FDA would still have to decide whether to accept it, publish a proposed rule, allow public comments, typically for 60 to 90 days, and then issue a final rule. Orrick says the full process normally takes around 12 to 24 months. The administration may try to accelerate matters or use interim enforcement discretion, including a Category 1 designation, as a temporary bridge. However, the formal rulemaking process cannot be avoided entirely. Five more peptides are expected to follow A second PCAC meeting is expected before the end of February 2027. That meeting is expected to consider: LL-37. GHK-Cu. Dihexa acetate. Melanotan II. PEG-MGF. So this week’s meeting is not the end of the peptide debate. It may only be the first major test of whether the newly reconstituted committee is prepared to go against the FDA’s own scientific staff. https://www.orrick.com/en/Insights/2026/07/FDA-Peptide-Compounding-Vote-What-to-Watch-at-the-July-PCAC-Meeting