FDA schedules July PCAC review for seven peptides as Category 2 compounding restrictions lapse

Key takeaways

• Twelve peptide bulk drug substances were removed from the FDA's Interim Category 2 list on 23 April 2026 following withdrawal of nominations and direction from HHS Secretary Robert F. Kennedy Jr.
• The Pharmacy Compounding Advisory Committee (PCAC) will publicly review seven of these — BPC-157, KPV, TB-500, MOTS-c, DSIP, Semax and Epitalon — across 23-24 July 2026 to consider whether to add them to the 503A Positive Bulk Drug Substances List.
• A second PCAC meeting before end of February 2027 will cover the remaining five.
• Removal from Category 2 is not authorisation to compound. Until the PCAC review concludes and any positive recommendation is formally adopted through rulemaking, compounding remains in regulatory limbo.
• Public comments may be submitted via regulations.gov under docket FDA-2025-N-6895. The comment window is open until 9 July 2026.

What changed on 23 April

On 22 April 2026 the FDA acted on a directive from HHS Secretary Kennedy to remove twelve peptide bulk drug substances from the agency's Interim Category 2 list. Category 2 had functioned as an unofficial "unsafe to compound" list since late 2023, prompting compounding pharmacies to wind down preparation of the affected substances. The removal took effect 23 April 2026, restoring the affected peptides to the same regulatory baseline as any other unscheduled compounding ingredient: not pre-approved, not pre-banned (Orrick, Hyman, Phelps & McNamara).

The twelve substances are BPC-157, LL-37, DiHexa, DSIP (also known as Emideltide), Epitalon, injectable GHK-Cu, KPV, PEG-MGF, Melanotan II, MOTS-c, Semax and TB-500 (Peptide Schedule).

What the PCAC meetings will and will not decide

The Pharmacy Compounding Advisory Committee is an independent panel of pharmacists, physicians and scientists that advises the FDA on compounding policy. Its role is consultative; it does not itself authorise compounding. PCAC reviews each substance individually against its mechanism of action, manufacturing controllability, available human safety data, and clinical use case (National Law Review).

The 23-24 July meeting at FDA's White Oak campus in Silver Spring, Maryland will cover seven of the twelve removed peptides: BPC-157, KPV, TB-500 and MOTS-c on day one; DSIP, Semax and Epitalon on day two. Sessions will be open to the public both in person and by teleconference (HealingMaps). The remaining five — LL-37, DiHexa, GHK-Cu (injectable), PEG-MGF and Melanotan II — will be considered at a second PCAC meeting scheduled before end of February 2027.

A positive PCAC recommendation alone does not authorise compounding. The FDA must then propose adding the substance to the 503A Bulks List through formal notice-and-comment rulemaking. That process typically takes additional months. Until then, the peptide sits in a regulatory grey area: not on the negative list, not on the positive list, and not yet approved as an active pharmaceutical ingredient.

Practical implications for research procurement

For UK research laboratories, the immediate practical effect of these changes is limited. UK regulation of research peptides falls under the MHRA framework, which already permits supply for laboratory and research use only, provided no therapeutic claims are made. The FDA's actions reshape the US compounding-pharmacy landscape but do not change the legal status of research-grade material in the UK.

What does change is the public discourse. Coverage of the reclassification has been substantial across STAT News, BioPharma Dive and trade press. Buyers in academic and private research settings should expect more questions about provenance, certificate of analysis (COA) accuracy and supply chain transparency, particularly given simultaneous FDA action against compounded GLP-1s and ongoing reporting on counterfeit material entering the consumer market.

Submitting comments

The FDA has invited written comments on whether the seven peptides under July review should be added to the 503A Bulks List. Comments should reference docket FDA-2025-N-6895 at regulations.gov and must be submitted before the close of business on 9 July 2026 to be considered alongside the meeting briefing materials. Useful comment content typically includes peer-reviewed clinical or preclinical data, manufacturing-grade specifications, and operational considerations from pharmacies or laboratories that work with the substance.

What to watch next

Three near-term inflection points are worth following. First, the PCAC briefing materials normally publish around two weeks before the meeting; their release in early July will give the first formal indication of how the agency is framing each substance. Second, the meeting transcripts and recommendations themselves on 23-24 July. Third, any subsequent FDA proposed rule following the meeting; this is what would actually establish a positive 503A authorisation for compounding the substance.

For UK suppliers and researchers, the relevant question is whether elevated US market activity around these specific peptides increases demand for documented research-grade material globally. The answer is likely yes; compounding pharmacies cannot use research-grade input, but academic and private research institutions in both countries are expected to follow the regulatory clarification with renewed interest in the underlying science.