Peptides first, paperwork later: HHS clears six for compounding ahead of Bulks List rulemaking

On October 28, 2026, the US Department of Health and Human Services (HHS) issued an interim policy under which it does not intend to take enforcement action against state-licensed pharmacies, federal facilities, or licensed physicians that compound drug products using six specified peptides, provided that all 10 circumstances described in the policy are present. The interim policy is intended to remain in place while the 503A Bulk Drugs List is amended to formally add the six peptides through rulemaking, although the policy may be amended in whole or in part at HHS’s discretion.

Background

Section 503A of the Federal Food, Drug, and Cosmetic (FD&C) Act exempts compounded drugs from premarket approval and certain other requirements if conditions are met, including that the bulk drug substances used comply with an applicable United States Pharmacopeia or National Formulary monograph, are components of US Food and Drug Administration (FDA)-approved drugs, or appear on the 503A Bulk Drugs List. The interim policy applies until the 503A Bulk Drugs List is updated through rulemaking. It is important to recognize that HHS’s interim policy here is distinct from FDA’s January 2025 guidance titled Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the FD&C Act, under which FDA does not intend to take action against compounders using nominated bulk drug substances that appear in Category 1 on FDA’s website, subject to certain conditions. Unlike the January 2025 guidance, the HHS interim policy is specific to the six peptides discussed below and imposes a separate, more detailed set of conditions.

As noted in our previous client alert, “Bulk-list bound? PCAC backs majority of peptides in two-day public meeting,” the Pharmacy Compounding Advisory Committee (PCAC) voted in July 2026 to recommend the inclusion of six peptides (BPC-157, KPV, TB-500, MOTs-C, Epitalon, and Semax) to the 503A Bulk Drugs List. The PCAC recommendation did not constitute a formal FDA approval or addition to the 503A Bulk Drugs List, which must be actioned through formal notice-and-comment rulemaking. As our client alert noted, it was possible that Secretary Robert F. Kennedy, Jr. would add the recommended peptides to Category 1 on an interim basis or otherwise promulgate statements signaling enforcement discretion pending final rulemaking. The interim policy does exactly that, which raises the question of whether HHS considers rulemaking to be in the near future. Because the policy achieves much of the same practical outcome as adding the six peptides to the 503A Bulk Drugs List, it may have been put in place in anticipation that any proposed rulemaking process would take a considerable period of time.

The interim policy

Enforcement discretion under the interim policy is limited to the six peptides listed in Appendix A, each of which the PCAC voted in favor of including on the 503A Bulk Drugs List. The policy does not extend to emideltide, the seventh peptide the committee considered but did not recommend at its July 2026 meeting. The six peptides, and the routes of administration for which Appendix B states that enforcement discretion is appropriate, are:

• BPC-157 (acetate): subcutaneous, intramuscular, oral, and topical.
• Epitalon(acetate): subcutaneous or intramuscular injection, dispensed in intermittent courses.
• KPV(acetate): topical and oral.
• MOTS-c(acetate): subcutaneous or intramuscular injection.
• Semax(free base): intranasal.
• TB-500 (acetate): subcutaneous or intramuscular injection.

HHS states that the policy is intended to discourage the continued widespread use of certain research-use-only peptides supplied by foreign manufacturers and to give patients a more controlled alternative. Until a peptide is addressed in a final rule, HHS does not intend to take action against a compounder using an enumerated peptide bulk drug substance when all of the following circumstances are present:

• The peptide bulk drug substance is one of the six enumerated peptide bulk drug substances.
• The peptide has the identity and the route-of-administration limits described in Appendix B.
• The bulk drug substance is from a Section 510-registered facility and is characterized in a valid certificate of analysis (COA) with test results consistent with the FDA criteria. (A Section 510-registered facility is an FDA-registered establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a drug, including the original manufacturer and all subsequent manufacturers of the bulk drug substance.)
• The original manufacturer is registered with FDA under Section 510, complies with current good manufacturing practice and other FD&C Act requirements, and has its facility’s physical location listed on the COA. Any FDA-registered repacker, relabeler, or reseller must have documented its own validation of the manufacturer and its COA.
• The compounder reports products compounded, serious adverse events, and product quality issues to FDA (with adverse events and quality issues reported through MedWatch) and to the states where the products are compounded and sent, and the patient labeling describes how to report such issues.
• The labeling states: “This is a compounded drug product. Not for resale.”
• The product contains only a single active pharmaceutical ingredient (API).
• For oral dosage forms, the compounder maintains documentation that the formulation achieves adequate oral bioavailability in humans.
• The only drug delivery device co-packaged with or containing the drug is an FDA 510(k)-cleared syringe.
• The drug is compounded in compliance with all other applicable FD&C Act requirements, including the prohibition on insanitary conditions and the patient-specific prescription requirement.

What does this mean for the compounding industry, particularly pharmacies and prescribers?

Before the policy, industry observers generally viewed the enforcement risk for these six peptides as low, based on enforcement practice trends. The policy provides more certainty, but it also conditions enforcement discretion on requirements that go beyond the baseline conditions of Section 503A, such as the single-API requirement, route-of-administration limits, and reporting obligations. These conditions also reach the supply chain: In addition to Section 503A’s existing requirement that the bulk drug substance come from a registered establishment, the original manufacturer’s facility location must appear on the COA, and any repacker or reseller must have validated the manufacturer and its COA. It remains to be seen whether these requirements will carry over into any final rule adding the peptides to the 503A Bulk Drugs List. Industry stakeholders should consider whether to prepare comments on any forthcoming proposed rule requesting that these requirements be modified as necessary.

For compounders, these conditions effectively de-risk the compounding of the six peptides, provided the compounding aligns with all 10 circumstances. Notably, the conditions exclude multiple-API compounded products that render common mixed formulations outside the scope of the enforcement discretion under the policy and potentially subject to regulatory oversight. Additionally, while oral dosage forms are not excluded per se, the requirement for oral bioavailability documentation may be a substantial hurdle for certain 503A compounding pharmacies. HHS has not yet provided clarification on the requirements for adequate documentation.

For prescribers, the FDA conditions essentially function as a diligence worksheet for confirming that the drugs they prescribe are appropriately compounded. Prescribers should keep in mind that state medical boards still retain broad enforcement powers to investigate conduct they deem as falling below the standards of care and failing to adhere to proper prescribing practices. Prescribers are encouraged to review their prescribing, consent, and care coordination and management policies to ensure that, as with any treatment, patients are being assessed and monitored appropriately.

The policy does not add these peptides to the 503A Bulk Drugs List or mean that they are FDA-approved, and HHS may revisit the policy if, among other things, a safety signal or product quality issue arises. State medical and other professional boards may also impose their own requirements applicable to prescribers. Compounders and prescribers should continue to monitor for updates.