HHS Proposes Interim Enforcement Policy for Six Compounded Peptides

A notice filed October 28 in the Federal Register announces a draft HHS policy under which the department says it does not intend to take enforcement action against state-licensed pharmacies, federal facilities or licensed physicians that compound six unapproved peptides (BPC-157, epitalon, KPV, MOTS-c, semax and TB-500) while formal rulemaking over the compounding bulk list continues. The policy is a draft published for comment, and it states that it establishes no rights and is not binding. [1][2]

What the notice actually announces

The Federal Register entry is a notice of availability for a draft "Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances," issued from the Office of the Secretary at HHS. It was filed October 28 and is scheduled to publish October 30; written comments are due two weeks after publication, submitted through regulations.gov under Docket HHS-OASH-2026-0496. [1]

The draft policy states that, when all of its conditions are met, "HHS does not intend to take enforcement action against a State-licensed pharmacy, Federal facility, or licensed physician compounding a drug product using a bulk drug substance in Appendix A." That intent holds until each substance is addressed in a final rule on the 503A bulks list. [2]

The document calls itself an interim policy and says it may be revisited "if, among other things, a safety signal or product quality issue arises." It also states plainly that it "does not establish any rights for any person and is not binding on HHS or the public." [1][2]

The ordinary 503A rules still frame everything. None of the six peptides is FDA-approved, none is a component of an approved drug, and none is on the 503A bulks list. Adding a substance to that list requires formal rulemaking, which is the process now beginning. [2]

The conditions

The draft lists ten. The substance must appear in Appendix A and match the identity and route-of-administration limits in Appendix B. The bulk substance must come from an FDA-registered facility with a valid certificate of analysis covering identity, purity, potency and contaminants, and the original manufacturer must be FDA-registered and CGMP-compliant. The compounder must report the products it compounds, and must report serious adverse events and product quality issues to FDA's MedWatch program and to the states involved. Labeling must carry the statement "This is a compounded drug product. Not for resale." Products must contain a single active ingredient, no stacks. Oral forms require documented evidence of adequate human bioavailability. The only co-packaged delivery device permitted is an FDA-cleared syringe. And the underlying 503A requirements, including a patient-specific prescription, still apply. [2]

How it got here

In July, the Pharmacy Compounding Advisory Committee voted in favor of including the six substances in compounding, while FDA's drug center, CDER, recommended against listing them; the policy's own appendix records both positions. Press reporting adds that FDA scientists cited insufficient data on safety and effectiveness, and that the panel included new appointees with ties to the peptide industry. Last week, the Partnership for Safe Medicines filed a citizen petition urging the FDA to disregard the July recommendation. [2][3][4]

The document's stated rationale is the gray market: the policy, it says, "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 providing "a more controlled alternative." [2]

The reaction

Scott Brunner, CEO of the Alliance for Pharmacy Compounding, called the policy a "more accountable alternative" for patients now buying gray-market peptides, but said ingredient suppliers must first confirm their products meet the policy's requirements, and pharmacies must verify that. Joshua Fritzler, president of Olympia and Wesley Pharmaceuticals in central Florida, said only his company's smaller compounding facility will be able to make the peptides, and in small quantities: "I don't think all the [503]As in the country could meet the demand." [3]

Critics responded within hours. Dr. Robert Steinbrook of Public Citizen said the move "undermined the FDA and threatened public health." Dr. Peter Lurie, a former FDA official now at the Center for Science in the Public Interest, said the agency was "turning a blind eye" to widen access to unproven drugs. Shabbir Safdar of the Partnership for Safe Medicines said the decision exposes Americans to "untested, dangerous substances." The BBC noted the notice came from the secretary's office rather than the FDA itself, and that Health Secretary Robert F. Kennedy Jr. has described himself as a "big fan" of peptides. [3][4][5]

An announced intention not to enforce is not an approval, and this one is still a draft.

What it means for a clinic: This story will reach patients as "peptides are legal now." The document says something narrower: a draft, non-binding statement of enforcement intent, limited to 503A compounding of six named substances under ten conditions (registered facilities, lot-level certificates of analysis, MedWatch and state reporting, single-ingredient products, patient-specific prescriptions), with comments due two weeks after publication and a final rule still ahead. Nothing in it approves any substance, and it can be revisited at any safety signal. Keep the distinction between "not enforced against" and "approved" explicit in every patient conversation, and if a pharmacy offers these compounds, ask how it documents the Appendix B identity and certificate-of-analysis requirements before anything else.