QUICK ANSWER

On October 28, 2026, HHS Secretary Robert F. Kennedy Jr. signed an interim policy saying HHS will not take enforcement action against state-licensed pharmacies, federal facilities and licensed physicians that compound six peptides: BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax. Discretion applies only if all ten conditions are met, including FDA-registered original API manufacturers, detailed COAs, single-ingredient products, listed routes only and MedWatch reporting. The peptides remain unapproved drugs. Research-use-only sellers, blends and 503B outsourcing facilities are not covered, and the policy lasts only until FDA finishes rulemaking.

---

The headline is bigger than the policy

If you sell, make or distribute peptides, your inbox probably lit up this week. HHS filed an interim policy covering six popular wellness peptides with the Federal Register on October 28, and it was published on October 30.

Some headlines read like the peptides were just legalized. They weren’t. HHS said it will not take enforcement action against certain compounders, and only if they meet ten specific conditions. The peptides are still unapproved drugs. The law did not change. What changed is who can make them without federal action, and under what rules.

What HHS actually did

The policy is “enforcement discretion,” an agency’s decision not to pursue specific violations under defined circumstances. It covers three groups only:

• State-licensed pharmacies compounding under section 503A
• Federal facilities
• Licensed physicians

It lasts until FDA finishes rulemaking on whether each peptide goes on the 503A bulks list. HHS can revisit it, in whole or in part, if a safety signal or product quality issue appears. The policy was signed by Secretary Kennedy, not issued by FDA.

That matters because FDA’s own process pointed the other way. At the July 2026 Pharmacy Compounding Advisory Committee meeting, FDA staff reviewers said none of the seven peptides had been studied enough to establish safety and effectiveness, according to STAT’s reporting. The committee voted for six of them anyway and rejected the seventh, Emideltide (DSIP).

The six peptides and their allowed routes

Each peptide is covered only in its named salt form and only by the routes HHS listed in Appendix B. Anything outside this table is outside the policy.

Peptide	Form	Allowed routes
BPC-157	Acetate	Subcutaneous, intramuscular, oral, topical
TB-500	Acetate	Subcutaneous, intramuscular
MOTS-c	Acetate	Subcutaneous, intramuscular
Epitalon	Acetate	Subcutaneous, intramuscular (intermittent courses)
KPV	Acetate	Oral, topical
Semax	Free base	Intranasal only

That means injectable KPV, oral TB-500 and nasal BPC-157 are not covered.

The ten conditions

Discretion applies only when every one of these is true:

1. Listed peptide. The substance is one of the six in Appendix A.
2. Exact identity and route. It matches the sequence, structure, molecular weight and formula in Appendix B, and is used only by the listed routes.
3. Tested API. The bulk substance comes with a valid certificate of analysis (COA) covering identity, purity, potency and contaminants such as endotoxins, heavy metals, microbes and impurities.
4. Registered original manufacturer. The company that made the API, not just the reseller, is registered with FDA, follows CGMP and is named with its facility address on the COA.
5. Reporting. The compounder reports the products it makes, serious adverse events (whether or not considered drug-related) and quality problems to FDA’s MedWatch program and to the states involved.
6. Label statement. The product carries the statement “This is a compounded drug product. Not for resale.”
7. Single ingredient. One listed peptide per product. No blends or stacks.
8. Oral bioavailability proof. Oral products need documentation that the specific formulation achieves adequate oral bioavailability in humans.
9. Syringe only. The only device that can be co-packaged with or contain the drug is an FDA 510(k)-cleared syringe. No pens or auto-injectors.
10. Everything else still applies. The product can’t be compounded under insanitary conditions, and a valid, patient-specific prescription is still required.

What is still off-limits

Research-use-only (RUO) sellers. Online vendors selling vials outside a pharmacy are not among the groups the policy covers. Expect enforcement against RUO sellers to continue.

Blends. Popular stacks such as BPC-157 with TB-500 fail the single-ingredient rule.

503B outsourcing facilities. They are not among the covered groups.

Other peptides. GHK-Cu, LL-37, Melanotan II and others are not included. Five more peptides are reportedly headed for a future advisory committee review.

State law. State pharmacy boards are not bound by federal discretion. A pharmacy still has to confirm its own state allows the compounding.

What is still unsettled

The Federal Register notice calls the policy a draft and says it is not binding. It sets no deadline for adverse event reports, and the channel and format for some reports are still to be worked out. Press reports say the Partnership for Safe Medicines has petitioned FDA to block compounding of these peptides and that Public Citizen has criticized the move. A policy this contested can change quickly.

What this means for your business

For the first time, there is a defined, lawful-looking path for these six peptides to reach patients. That path runs through licensed pharmacies, documented supply chains and formal safety reporting. Companies that can prove quality will win pharmacy business. Companies that can’t will be shut out, and the RUO channel stays exposed.

The conditions reach well beyond the pharmacy counter. Conditions 3 and 4 put new demands on every API maker and distributor that wants to sell into this channel. Condition 5 creates a pharmacovigilance duty that most of the peptide market has never had to meet. We cover both in the next two posts in this series.

Frequently asked questions

Did FDA approve BPC-157?

No. The policy is enforcement discretion. Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness or quality.

Can I sell these peptides online as research chemicals now?

No. The policy covers state-licensed pharmacies, federal facilities and licensed physicians. RUO sellers are not covered.

How long does the policy last?

Until each peptide is addressed in a final rule on the 503A bulks list, unless HHS revisits it sooner over safety or quality concerns.

Can I comment?

Yes. Comments go to docket HHS-OASH-2026-0496 on regulations.gov. The window runs two weeks from the October 30 publication, so plan on about November 13.

Book a 30-minute gap assessment with cPC. We’ll map the ten conditions to your SOPs, supplier files and reporting procedures and give you a prioritized fix list.

Sources

• HHS, “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” with Appendices A and B (Oct 2026)
• Federal Register, FR Doc. 2026-22192, Docket HHS-OASH-2026-0496 (published Oct 30, 2026)
• FDA, July 23-24, 2026 Pharmacy Compounding Advisory Committee meeting
• STAT, “Trump administration advances plan for peptide drugs favored by RFK Jr.” (Oct 15, 2026)
• Fierce Pharma, “Kennedy’s HHS relaxes enforcement on 6 popular wellness peptides” (Oct 2026)

This article is for general informational purposes and is not legal advice. Current Peptide Compliance provides regulatory and quality-system consulting; consult qualified counsel for legal questions.