HHS peptide compounding policy faces evidence questions before comment deadline

The HHS peptide compounding policy rests in part on evidence the department describes but does not publish, a pharmacist argued in an analysis posted November 5. Scott Gavura, a registered pharmacist in Ontario, wrote that HHS cites human studies and a lot specific test certificate for BPC 157 without naming or releasing either. The interim policy lets licensed pharmacies compound six unapproved peptides under ten conditions. HHS is taking public comments until November 13, 2026.

What the HHS enforcement discretion notice allows

HHS Secretary Robert F. Kennedy Jr. announced the interim policy on October 28, and the notice ran in the Federal Register on October 30, according to Gavura. It covers BPC 157, epitalon, KPV, MOTS c, Semax and TB 500. The enforcement discretion notice says HHS does not intend to act against state licensed pharmacies, federal facilities or licensed physicians who compound with these peptides when every condition is met. The HHS peptide compounding policy runs until a final rule decides whether each peptide joins the list of bulk substances that pharmacies may use under section 503A. HHS says it may revisit the policy if a safety signal or a product quality problem appears. None of the six peptides is an FDA approved drug.

The conditions focus on supply and tracking. Each bulk peptide must come from an FDA registered facility with a certificate of analysis that reports identity, purity and contaminant tests, and the original maker must follow current good manufacturing practice. Each product may hold only one active ingredient and needs a patient specific prescription. Pharmacies must report the products they make, serious adverse events and quality problems to the FDA MedWatch program and to the states involved. Labels must say the product is compounded and not for resale. Oral forms need records showing adequate absorption in people, and the only device allowed in the pack is an FDA cleared syringe, the enforcement policy document states.

Evidence HHS cites for BPC 157 compounding

The case of BPC 157 compounding shows how far HHS moved from its own drug reviewers. According to the policy appendix, BPC 157 sat in Category 2 from September 2023 until April 22, 2026, a status that did not change its legal position under section 503A. The FDA Center for Drug Evaluation and Research advised against listing it, while the Pharmacy Compounding Advisory Committee voted in favor in July. HHS gives three reasons for going ahead. It says historical use is now documented and quantified, along with multiple human studies. It says a lot specific certificate from an FDA registered facility now supplies the identity, impurity, endotoxin, microbial and solvent results that reviewers found missing. It says the policy conditions control the remaining risks.

Gavura wrote that the policy does not identify the studies, give references or release the certificate, so outside readers cannot check the evidence behind the decision.

Gavura wrote that the policy does not identify the studies, give references or release the certificate, so outside readers cannot check the evidence behind the decision. He also pointed out that being registered with the FDA is different from winning FDA approval. A test certificate, in his view, can be trusted only as far as the lab work and quality controls that produced it are sound. The appendix follows the same pattern for the other five peptides, each placed in the policy against the advice of FDA reviewers. For BPC 157, the covered forms are injectable, oral and topical products made from tested ingredient lots. An earlier Peptide Zone review found that research on all six rests mostly on animal and cell studies.

MOTS c and TB 500 safety rests on indirect data

For MOTS c, the appendix points to a randomized, placebo controlled trial of a MOTS c analogue that reported no serious adverse events, plus rodent studies that found metabolic benefit without systemic toxicity. For TB 500, HHS says the safety concerns CDER raised are inferential, that the parent protein has a controlled human safety record, and that the fragment breaks down quickly in human serum. For Semax, covered only for nasal use, HHS cites a human record of several hundred subjects that CDER itself compiled. For KPV, HHS says the CDER safety finding reflects missing information rather than an observed signal. The appendix text does not cite the studies behind these claims.

Gavura called this indirect evidence. A trial of an analogue, or data on a parent protein, could inform a safety review, he wrote, but neither shows that the compounds pharmacies would actually use are safe. He added that without meaningful surveillance, a lack of reported harm should not reassure anyone. He welcomed the reporting condition, noting that pharmacies compounding under section 503A do not generally report to the FDA. But he wrote that the notice does not explain how HHS will verify that pharmacies comply. Among his open questions are whether adverse event and quality data will be made public, and who decides what counts as a safety signal. The FDA Category 2 list flagged thin safety data for these peptides in 2023.

Comments on the 503A bulks list path close November 13

HHS frames the policy as a way to steer people away from gray market vials. The document says the policy will "discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers." Gavura accepted that logic in principle. A product made under prescription, with controlled sourcing and documented testing, should offer more safeguards than an untested vial bought online, he wrote. But he said the case depends on compliance and on checks that it happens. It also assumes that buyers will switch to compliant suppliers and can tell them apart. He warned that pharmacy access could draw in people who would not otherwise try these peptides because they may now feel safer, and said the policy describes no assessment of that risk.

Anyone may file a comment under docket HHS-OASH-2026-0496 on the federal regulations portal, and the window shuts on November 13. HHS says comments may supply evidence the FDA can weigh in rulemaking on some or all of the six substances. The HHS peptide compounding policy is not FDA approval and does not add any peptide to the 503A bulks list, which still requires a final rule. In his analysis for Science Based Medicine, Gavura asked HHS to publish the BPC 157 studies and test records. He also asked how HHS will judge whether gray market use has fallen and whether the FDA will count prescriptions and patients exposed. The documents reviewed for this story give no date for a final rule.

Conclusion

The HHS peptide compounding policy gives pharmacies a conditional path to make six unapproved peptides, but it does not settle whether any of them work or are safe. HHS lists the evidence it relied on without publishing it, according to the policy text and Gavura's review. The ten conditions may improve tracking if pharmacies follow them. Readers who want to weigh in have until November 13. This report is for research and news purposes and is not medical advice.