HHS Peptide Enforcement Discretion Policy, Explained

On October 30, 2026, the Federal Register published a notice from the Secretary of Health and Human Services announcing an Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (FR Doc. 2026-22192, 91 FR 68526, docket HHS-OASH-2026-0496). The notice was filed on October 28. The policy itself is posted on hhs.gov.

In one sentence: HHS says it does not intend to take enforcement action against a state-licensed pharmacy, federal facility or licensed physician that compounds a drug from one of six listed peptides, as long as ten conditions are met, until FDA finishes rulemaking on each peptide.

That is a real change for operators, and a narrower one than most coverage suggests. This guide sets out what the policy text says and flags what it does not settle.

What changed between October 28 and October 30

Before this policy, none of the six peptides met any of the three routes section 503A allows for a bulk drug substance. Under the statute, a 503A compounder may use a bulk ingredient only if it has a USP or NF monograph, is a component of an FDA-approved drug, or appears on the 503A bulks list that FDA develops by regulation. The six peptides have no monograph, are not in any approved drug, and are not on the list.

The policy does not change that. The peptides are still not on the 503A bulks list. What changed is HHS's stated enforcement posture. Until a peptide "is addressed in a final rule as being included or not included on the 503A bulks list," HHS says it does not intend to act against covered compounders who meet every condition.

HHS gives two reasons in the policy. It says there is "significant interest" in these peptides based on the July 2026 Pharmacy Compounding Advisory Committee meeting and utilization data. And it says the policy is meant to discourage the widespread use of "research-use-only" peptides supplied by foreign manufacturers, by giving patients a more controlled alternative.

The six peptides, their covered forms and routes

Appendix A lists six peptides. Appendix B narrows each one to a specific salt form and specific routes of administration. Condition 2 of the policy requires the bulk substance to match that identity and those route limits.

Three details matter here:

• The salt form is specific. Appendix B covers BPC-157 acetate, not the free base, even though FDA reviewed both forms. The same is true of KPV. Semax is the opposite: the free base is covered, not the acetate.
• The route is specific. Injectable TB-500 is covered; topical TB-500 is not listed. KPV is listed for topical and oral use only, not injection. Semax is listed for intranasal use only.
• Oral products carry an extra burden. If a peptide is compounded in an oral form, the compounder is expected to keep documentation that the specific formulation "achieves an adequate level of oral bioavailability in humans." That applies to oral BPC-157 and oral KPV.

Appendix B also gives each peptide's amino acid sequence, molecular formula and molecular weight, and HHS's reasons for including it. For each of the six, HHS notes that FDA's drug center (CDER) had recommended against listing and that the advisory committee voted in favor.

Who is covered, and who is not

The policy names three kinds of compounder:

• a state-licensed pharmacy,
• a federal facility, and
• a licensed physician.

It is written for section 503A, the provision for traditional, prescription-based compounding. Outsourcing facilities registered under section 503B are not among the compounders it names.

Prescribers, telehealth companies and med spas are not "covered" in their own right, but their orders and purchasing decide whether the compounder can meet the conditions.

The ten conditions

HHS's non-enforcement applies only "when all of the following circumstances are present." In summary:

1. On the list. The peptide appears in Appendix A.
2. Correct identity and route. The bulk substance has the identity (sequence, structure, molecular weight and formula) and route limits in Appendix B.
3. Characterization. The bulk substance comes from a facility registered with FDA under section 510 and has a valid certificate of analysis (COA) with test results meeting the criteria in Appendix B, covering identity, purity, potency, endotoxins, heavy metals, microbial contamination and impurities.
4. Original manufacturer. The original manufacturer, not a later packer or distributor, is registered under section 510, complies with CGMP, and has its facility location listed on the COA. If the compounder buys through a registered repacker or reseller, that entity must have validated the manufacturer and its COA.
5. Reporting. The compounder reports products compounded, serious adverse events (whether or not considered drug related) and product quality issues to FDA's MedWatch program and to the states where products are compounded and sent. Product reports include the ingredient and strength, the original manufacturer with its facility identifier, and the dosage form and route. The patient labeling must explain how to report adverse events and quality problems.
6. Label statement. The labeling includes: "This is a compounded drug product. Not for resale."
7. One active ingredient. The product contains a single active pharmaceutical ingredient from Appendix A. HHS says this makes adverse events easier to attribute.
8. Oral bioavailability. Oral products need documentation of adequate oral bioavailability in humans.
9. Delivery device. The only device co-packaged with or containing the drug is an FDA 510(k)-cleared syringe.
10. Everything else in the law. The product is compounded in compliance with all other applicable FD&C Act requirements, including the ban on insanitary conditions and section 503A's patient-specific prescription requirement.

Appendix B adds a testing standard and the information each COA should carry, including the manufacturer's FDA Establishment Identifier and the grade "Intended for human drug compounding."

What the policy is not

• It is not FDA approval. The policy itself repeats that compounded drugs are not FDA-approved and that FDA does not review their safety, effectiveness or quality before marketing.
• It is not placement on the 503A bulks list. That still requires rulemaking. The notice says FDA's future rulemakings "may propose adding some or all" of the peptides.
• It is not binding. The notice states that the policy "does not establish any rights for any person and is not binding on HHS or the public."
• It is not a statement on state law. The policy addresses federal enforcement. It does not change what a state board of pharmacy or medical board allows.
• It is not permission for combinations. Condition 7 limits each product to one listed peptide.

How long it lasts

There is no end date. For each peptide, the policy runs until that peptide is addressed in a final rule, either adding it to the 503A bulks list or not.

HHS can also pull back sooner. The policy says HHS "may revisit application of this interim policy (in whole or in part)" if, among other things, a safety signal or product quality issue arises with a product within its scope.

The comment window

The notice invites written comments for two weeks after publication on regulations.gov, docket HHS-OASH-2026-0496. Regulations.gov lists the comment period as ending November 13, 2026 at 11:59 p.m. Eastern. Some listings show November 14 because the deadline falls at midnight in UTC; plan around November 13.

The policy says HHS believes public comments "may provide additional evidence" that FDA can consider in rulemaking. Operators with documented clinical experience or sourcing data have a short window to put it on the record.

What is still unsettled

• Draft or final. The Federal Register notice calls the document a "draft" policy and invites comments, while the policy text is written in the present tense. HHS has not said whether a revised version will follow the comment period. The notice says the HHS website carries the most current version.
• Rulemaking timing. Neither document gives a date for proposed or final rules on any of the six peptides.
• State response. Each state decides what its pharmacies and prescribers may do. The policy does not say how states will treat these peptides, and state positions may differ.
• Anticipatory compounding. The policy restates the patient-specific prescription requirement. It does not separately discuss how much a pharmacy may prepare in advance of prescriptions.
• Forms and routes outside Appendix B. The policy does not say how HHS will treat a covered peptide in an unlisted salt form or route. It simply does not extend to them.
• Withdrawal triggers. "Safety signal" and "product quality issue" are not defined, and HHS lists them as examples ("among other things").

For background on how the six peptides reached this point, see our explainer on the July 2026 advisory committee vote.

Frequently asked questions

Which peptides does the HHS policy cover?

Six: BPC-157, TB-500, KPV, MOTS-c, epitalon and Semax. Each is limited to one salt form and specific routes, listed in Appendix B of the policy and in the table above.

Does this mean the peptides are approved or on the 503A list?

No. The policy is enforcement discretion, which is a statement that HHS does not intend to take action in defined circumstances. The peptides are not FDA-approved and are not on the 503A bulks list. The policy is non-binding and can be revisited.

Can a 503B outsourcing facility compound these peptides under the policy?

The policy names state-licensed pharmacies, federal facilities and licensed physicians compounding under section 503A. Outsourcing facilities under section 503B are not among them.

Can a pharmacy combine BPC-157 and TB-500 in one product?

Not within the policy. Condition 7 requires a single active ingredient from Appendix A in each compounded product.

Does a patient still need a prescription?

Yes. Condition 10 keeps section 503A's patient-specific prescription requirement. A prescriber should issue one only when it is clinically appropriate and permitted in the patient's state.

How long will the policy last?

Until FDA addresses each peptide in a final rule on the 503A bulks list, unless HHS revisits it sooner, for example after a safety signal or product quality issue.

If you are planning a peptide program and want the clinical and state-by-state side handled properly, tell us what you are building. Our state compliance guides and compounding pharmacy map are good places to start.

*This article is general information, not legal or medical advice.*