Last month I wrote about an FDA advisory committee’s recommendation to add six peptides to the 503A bulks list. See that post for background on peptides and the planned route to enable access.
On October 28, HHS Secretary Robert F. Kennedy Jr. announced an interim enforcement-discretion policy for certain peptides used in 503A compounding. The policy was published in the Federal Register on October 30. It describes circumstances in which HHS does not intend to take enforcement action against specified compounders while FDA develops the 503A bulks list through rulemaking. The six compounds are are BPC-157, epitalon, KPV, MOTS-c, Semax, and TB-500. The notice says it doesn’t intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians who compound with them under set conditions.
What this isn’t
Not a change in the law: This policy does not amend section 503A or formally add these substances to the bulks list. Instead, HHS is announcing that it does not intend to enforce the existing restrictions against compounders who meet the specified conditions. It is not FDA approval or a formal change to the regulatory status of these substances.
Not an addition to the “bulks” list: This was the key issue of the FDA’s Pharmacy Compounding Advisory Committee this past July, where the PCAC recommended (contrary to the FDA staff’s advice) to add these compounds to the 503A “bulks” list, which is a list of substances pharmacies may use to compound drugs for individual patients.
Not binding: The notice says it creates no rights, and HHS may revisit it if a safety signal or product quality issue arises.
Conditions for non-enforcement
Non-enforcement is proposed to apply only when all of the following conditions are met:
- The substance must be one of the six on the 503A Interim Access List, and meet the identity and route-of-administration specifications in Appendix B.
- The bulk drug substance must come from an FDA-registered facility and have a certificate of analysis meeting the specified characterization and testing requirements.
- The original manufacturer must be FDA-registered and compliant with CGMP requirements. Any intermediary repacker or distributor must have performed appropriate manufacturer and certificate validation.
- Compounding must be based on a valid, patient-specific prescription.
- The product must contain only one active pharmaceutical ingredient from the list.
- Oral formulations require documentation that the specific formulation achieves adequate bioavailability in humans.
- The product must be labelled “This is a compounded drug product. Not for resale”.
- Compounders must report products compounded, serious adverse events and product quality problems to the FDA and the relevant states.
- Only FDA 510(k)-cleared syringes may be co-packaged with or contain the compounded drug.
- All other applicable requirements of the FD&C Act must be met, including sanitary compounding conditions.
The Rationale
HHS says:
The Secretary of HHS has determined that this limited enforcement-discretion policy will
discourage the continued, widespread use of certain research-use-only peptides supplied by
foreign manufacturers that pose a safety risk to US patients. By allowing limited compounding of the substances addressed in this guidance under appropriate safeguards, the policy provides patients with a more controlled alternative. Based on the available evidence, including the recommendations of a recent Pharmacy Compounding Advisory Committee, the Secretary has determined that the policy advances patient choice and freedom while appropriately protecting patient safety.
In short, the policy is meant to drive American consumers to licensed compounding pharmacies rather than (possibly) foreign suppliers, where there would be more oversight. That’s an important change. It isn’t designed to answer the efficacy question, but it does appear to position the system better for the collection of adverse events, which is currently lacking.
Departing from FDA’s own expert advice
HHS acknowledged but chose not to follow FDA staff advice. For example, for BPC-157 (my emphasis added):
BPC-157 (free base) and BPC-157 acetate were in Category 2 from September 2023 until
April 22, 2026, and neither the placement nor the removal changed their status under
section 503A; Center for Drug Evaluation and Research (CDER) recommended against
listing either form, and the Pharmacy Compounding Advisory Committee (PCAC) voted in
favor of inclusion. HHS’s justification for including BPC-157 on the interim policy is
threefold. First, historical use is now documented and quantified showing its use as well as multiple human studies. Second, the characterization record now includes evidence that
was not before CDER, namely a lot-specific certificate from an FDA-registered facility
reporting the identity, impurity, endotoxin, microbial, and residual solvent results CDER
found lacking. Third, the conditions of this policy address the risks through lot-level testing,
single-active pharmaceutical ingredient (API) products, and MedWatch reporting. Based on
the identified updated information, enforcement discretion for BPC-157 acetate is
appropriate for subcutaneous, intramuscular, oral, and topical dosage forms that are
compounded from API accompanied by a certificate of analysis (CoA) meeting the
conditions of this policy.
These evidence claims are asserted but not adequately documented. For BPC-157, HHS cites newly quantified historical use, “multiple human studies,” and a lot-specific certificate from an FDA-registered facility that supposedly addresses deficiencies identified by FDA reviewers. But the policy does not identify the studies, provide references, or make the certificate available. Readers cannot independently assess the evidence HHS says justifies its decision.
For MOTS-c, HHS also relies on a randomized trial of an analogue, rather than the peptide itself, along with animal research. For TB-500, it draws partly on the safety record of the parent protein. These are indirect forms of evidence. They may inform a safety assessment, but they do not establish the safety of the compounds being considered. Regardless, without meaningful surveillance, the absence of observed harms should not be reassuring. To be clear, the adverse event reporting condition is welcome, since 503A compounders don’t generally report to FDA, but the notice doesn’t say how compliance will be verified.
What to make of this
HHS’s rationale here is harm reduction. If people are intent on using peptides, a product compounded under these conditions, with a patient-specific prescription, controlled sourcing and documented testing, should offer more safeguards than an unverified research-use-only product purchased online.
That’s reasonable, in principle. But it depends on compliance with the conditions actually being verified. FDA registration is not FDA approval, and a certificate of analysis is only as reliable as the testing and quality systems behind it.
There’s another assumption here: that consumers will switch. Making these peptides available through compounding pharmacies could attract people who would not otherwise have used them. The policy doesn’t describe any assessment of that possibility.
Your opportunity to comment
Making a product safer when manufactured, does not make a peptide either safe or effective. These are the questions I think should be raised:
- What evidence supports the “multiple human studies” and the lot-specific certificate cited for BPC-157, and will the underlying studies and testing documentation be published?
- How will compliance with the reporting requirements be verified, and will adverse-event and product-quality data be made public?
- What constitutes a “safety signal” that would lead HHS to revisit the policy, and who makes that determination?
- What evidence will be used to judge whether the policy has displaced gray-market use?
- Will FDA collect and publish data on the volume of compounded peptides, including the number of prescriptions and patients exposed?
- How will HHS distinguish between evidence of safety and an absence of reported adverse events when evaluating whether this policy should continue?
Comments are open through November 13, 2026, on docket HHS-OASH-2026-0496 at regulations.gov. If you have concerns about this policy and approach, this is an opportunity to submit them.