HHS will not act against pharmacies compounding listed peptide drugs

The Department of Health and Human Services has announced that it does not intend to take enforcement action against pharmacies and physicians who compound drugs from a defined list of peptide ingredients, while the formal list of substances allowed in compounding is still being written. HHS published the notice of availability for its "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances" in the Federal Register on 30 October 2026, under docket number HHS-OASH-2026-0496 [s1]. The document is signed by the Secretary of HHS, Robert F. Kennedy, Jr. [s1].

What compounding is, and what the gap is

Compounding is the practice in which a licensed pharmacist, a licensed physician, or, in an outsourcing facility, a person under a pharmacist's supervision, combines, mixes or alters the ingredients of a drug to make a medication tailored to an individual patient [s1]. Compounded drugs are not FDA-approved, which means the agency does not review their safety, effectiveness or quality before they are marketed; HHS states plainly that while such drugs can serve an important medical need, they may also pose risks to patients [s1].

Section 503A of the Federal Food, Drug, and Cosmetic Act governs this traditional pharmacy compounding. Under it, a bulk drug substance may be used in compounding only if it appears on a list that the FDA develops through rulemaking — the "503A bulks list" [s1]. That list is still being developed, and this policy is explicitly an interim measure for the period while the rulemaking proceeds [s1].

What the policy does

The core of the announcement is a statement of enforcement intent. HHS says that, to expand and improve patient access, it "does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a peptide bulk drug substance found in Appendix A" [s1]. The agency says it reached this position based on the Pharmacy Compounding Advisory Committee's meetings and data on the utilisation of peptides, which indicated significant interest in using these peptides in compounding given the lack of available approved products [s1].

The document points to a published appendix on the HHS website for the specific substances it covers [s1]. HHS also signals where this may lead: the FDA's future rulemakings "may propose adding some or all of these peptides to the 503A bulks list based on the available evidence" [s1]. The enforcement policy, in other words, is a bridge to a possible permanent listing, not a substitute for it.

The conditions attached

The policy is bounded. HHS says it may revisit the application of the interim policy, in whole or in part, if, among other things, a safety signal or a product-quality issue arises with a compounded drug product within its scope [s1]. And the agency is explicit about the document's legal weight: the draft policy "does not establish any rights for any person and is not binding on HHS or the public" [s1].

The notice also opens a short comment window. Written comments can be submitted until two weeks after the date of publication through the federal rulemaking portal on docket HHS-OASH-2026-0496 [s1]. The policy contains no new collection of information, so it did not require clearance under the Paperwork Reduction Act [s1].

Why it matters

Peptides are a large and growing class of drug ingredients, and compounding has become a route by which patients obtain versions of medicines that are in short supply or not otherwise available in an approved form. By declining to enforce against compounding from the listed peptides, HHS is choosing to keep that route open in the near term, on access grounds, while reserving the ability to pull back if safety problems emerge [s1].

What is settled and what is not

What is fixed is that a dated interim enforcement policy now exists, it is signed by the HHS Secretary, it identifies an appendix of covered peptide substances, and it states that the department does not intend to enforce against compounding from those substances for now [s1].

What is not settled is the permanent status of these ingredients. The 503A bulks list is still being developed through rulemaking, and whether any of these peptides are ultimately added to it will depend on the evidence the FDA weighs in that process [s1]. The policy is interim and non-binding by its own terms, and HHS has reserved the right to withdraw it if a safety or quality signal appears — so it describes the government's current enforcement posture rather than a settled legal permission [s1].