4 minute read | July.21.2026
As a follow-up to our April 2026 article on peptide compounding, this insight previews the Pharmacy Compounding Advisory Committee (PCAC) meeting on July 23 and 24, 2026. The Committee will evaluate whether seven peptides should be recommended for inclusion on the Section 503A Bulk Drug Substances List: BPC-157, KPV, TB-500, MOTs-C, Emideltide (DSIP), Semax and Epitalon.
The docket, FDA-2025-N-6895, has attracted approximately 1,860 comments and has become a significant flashpoint in the broader debate over the future of peptide compounding in the United States.
FDA's briefing documents propose the same conclusion for each of the seven peptides: do not add them to the 503A Bulks List.
The agency's career scientists applied the four-factor framework under 21 CFR 216.23(c)—physical and chemical characterization, historical use in compounding, evidence of effectiveness, and safety—and concluded that none satisfies the applicable criteria for inclusion. Recurring concerns include inadequate characterization of the substances, including inconsistent naming conventions, missing quality data; insufficient or absent human clinical trial evidence, including no human data at all for KPV, TB-500, and MOTs-C; small, poorly controlled studies for BPC-157, Emideltide, and Semax; and safety flags including immunogenicity risks, FAERS adverse event reports for BPC-157, and World Anti-Doping Agency (WADA)-prohibited status for MOTs-C and TB-500.
This recommendation puts FDA career staff at odds with HHS Secretary Robert F. Kennedy Jr., who has publicly signaled support for broader access.
Most docket submissions favor inclusion. Key institutional commenters supporting inclusion include the Alliance for Pharmacy Compounding, Empower Pharmacy, Hims & Hers Health, the American Institute for Compounded Therapeutics, the Texas Pharmacy Association, the real-world data platform Peptide AI, and the American Academy of Peptide Medicine.
A common thread across these submissions is the "gray market" argument: that restrictions do not eliminate demand but only displace it into unverifiable supply chains, making regulated compounding the comparatively safer option.
On the opposing side, PhRMA, the Partnership for Safe Medicines (PSM), and the American Pharmacists Association (APhA) each oppose inclusion of all seven substances. PhRMA argues that PCAC may not be free of conflicts of interest, that FDA's four-factor standard compels exclusion, and that FDA cannot lawfully authorize compounding via its interim policy while rulemaking is pending. PSM and APhA cite the absence of adequate human clinical evidence, limited enforcement capacity and supply chain risks, including Chinese fentanyl-precursor manufacturers pivoting into peptide sales.
The National Association of Boards of Pharmacy took a neutral position, declining to weigh in on inclusion but identifying five critical regulatory infrastructure gaps and recommending that FDA address them "before or alongside" any final rule.
FDA career staff align with the opponents, having recommended against inclusion for all seven substances in their briefing documents.
Perhaps the most significant variable is the PCAC itself.
On June 29, FDA announced PCAC's membership, which includes at least eight new members, some with ties to peptide businesses or clinics. Given the composition of the reconstituted committee, we believe the most probable outcome is that PCAC will recommend inclusion for some or all of the seven peptides, despite FDA staff's briefing documents.
This would represent a significant departure from prior PCAC precedent. The question then becomes what FDA does with that recommendation. Even if PCAC recommends inclusion, FDA must still determine whether to accept that recommendation before publishing a Notice of Proposed Rulemaking, accepting public comments, typically 60–90 days, and issuing a final rule. Thatprocess that typically takes 12 to 24 months.
The administration may attempt to accelerate this timeline or use interim enforcement discretion, such as Category 1 designation, as a bridge, but the formal rulemaking requirement cannot be bypassed entirely.
The PCAC vote is taking place this week (July 23-24) and will be followed by a second PCAC meeting that is expected to be scheduled before the end of February 2027.
The February meeting will address five additional peptides: LL-37, GHK-Cu, Dihexa acetate, Melanotan II, and PEG-MGF.
We will closely monitor developments and provide updates following the PCAC meetings and any subsequent FDA action.
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