HHS Will Not Stop Pharmacies Compounding BPC-157 and Five Other Peptides: What the Policy Allows

On 28 October 2026, the US Department of Health and Human Services (HHS) said it will not take action against pharmacies and doctors that compound six unapproved peptides: BPC-157, TB-500, KPV, MOTS-c, Semax and Epitalon. The notice appeared in the Federal Register on 30 October.¹ It is the policy we first reported on in early October, when its contents were still unknown.

It is not FDA approval, and the peptides have not been added to the list of substances pharmacies may legally compound with. HHS has said, in writing, that it will not enforce the law against this compounding while certain conditions are met. Those conditions are narrower than most of the headlines suggest.

This article covers what the policy allows, what it leaves out, and what to check if a clinic or telehealth service now offers you one of these peptides. It is not legal or medical advice and gives no dosing information.

What HHS actually published

The Federal Register notice is short. Its key sentence is: "to expand and improve patient access, HHS 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."¹

A few details in the notice matter:

• It comes from the HHS Secretary, not FDA. Robert F. Kennedy Jr. signed it, and it was filed under the Office of the Secretary (docket HHS-OASH-2026-0496).¹ It carries the same regulation number (RIN 0910-ZD94) as the "Interim Access Policy for Compounding Using Certain Peptides" that FDA sent for White House review on 14 October.¹¹² Lawyers at Hyman, Phelps & McNamara noted that the policy "makes no mention of FDA's position" and is "wholly framed as authored by HHS."⁴
• It calls itself a draft. The notice announces "a draft" policy and takes written comments until 13 November 2026.¹² It does not give a separate start date.
• It is not binding. The policy "does not establish any rights for any person and is not binding on HHS or the public."¹
• It can be withdrawn. 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."¹
• It is a stopgap. It applies while FDA decides, through formal rulemaking, whether to add these peptides to the 503A bulks list. FDA's "future rulemakings may propose adding some or all of these peptides."¹ According to a summary by Hyman, Phelps & McNamara, the policy lasts for each peptide until it is "addressed in a final rule."⁴

The full policy, with two appendices, is posted on the HHS website and on regulations.gov.² The table and conditions below are taken from that document as quoted and summarised by three law firms, whose accounts agree.³⁴⁵

The six peptides, and only in certain forms

The policy names each peptide in a specific chemical form and limits how it may be given. A pharmacy making a form or route not listed here is outside the policy.

Sources: HHS policy, Appendix B, as reported by BakerHostetler and Hyman, Phelps & McNamara.³⁴

Note that Semax is covered only as a nasal product, and KPV has no injectable form under the policy. The appendix also fixes each peptide's identity (amino acid sequence, structure, molecular weight and formula), so a product that does not match it is not covered.⁴

The seventh peptide FDA's advisers reviewed in July, emideltide, is not included. The panel voted against it.⁶

The conditions

Under the policy as summarised by the three law firms, compounding is covered only when all of these apply³⁴⁵:

1. The right compounder. A state-licensed pharmacy, a federal facility or a licensed physician. The policy covers compounding under section 503A, the pharmacy route. Outsourcing facilities registered under section 503B are not covered.³
2. A prescription for a named patient. BakerHostetler lists a valid patient-specific prescription as a condition.³ Section 503A compounding is tied to individual prescriptions in any case.⁹
3. One active ingredient. Each product may contain only one of the six peptides.³⁴⁵
4. Registered sources with test results. The raw peptide must come from a manufacturer registered with FDA and compliant with current good manufacturing practice (CGMP). It must arrive with a valid certificate of analysis that names the manufacturer's site and includes the testing set out in Appendix B. If it passes through a reseller or relabeller, that business must check both the manufacturer and the certificate.⁴
5. Reporting. Serious adverse events and product-quality problems must be reported to FDA's MedWatch programme and to the relevant states.³⁴ The policy also asks for reports on the products themselves (ingredient and strength, manufacturer, dosage form and route). Hyman, Phelps & McNamara notes that it is unclear whether every compounded product must be reported.⁴
6. A plain label. The label must say "This is a compounded drug product. Not for resale." and explain how to report problems.³⁴⁵
7. No devices beyond a syringe. The only delivery device allowed with or containing the product is an FDA-cleared syringe. HHS says more complex devices "introduce additional patient risk."⁴⁵
8. Evidence for oral forms. A compounder making an oral product must keep documents showing the formulation is adequately absorbed in people.³⁵
9. Everything else in the law still applies, including the sanitary conditions required of any compounding pharmacy.³⁵

What the policy does not change

No "Wolverine stack" in one vial. The single-ingredient rule means a compounded product that combines BPC-157 and TB-500, a pairing often marketed as the "Wolverine stack", is outside the policy even though each peptide is covered on its own.³⁴

Research chemicals are still unapproved drugs. The policy does not cover products sold as "research use only" or as dietary supplements.³ In August 2026 FDA warned an online seller that "research use only" labels did not stop its products being treated as unapproved drugs for human use.¹⁵ Our explainer on what "research use only" means covers how that works.

No new evidence. The policy changes enforcement, not science. FDA's own reviewers recommended in July that none of the seven peptides be added to the compounding list.⁷ For BPC-157 they warned about "the potential for immunogenicity" of injectable forms and found "a lack of evidence to support the effectiveness" for the use reviewed.⁸ FDA has also said that for KPV, MOTS-c and several other substances it "has not identified any human exposure data."¹⁰

States can still act. State pharmacy boards license these pharmacies and are not bound by an HHS enforcement policy. Lawyers at Hyman, Phelps & McNamara call it "a big unknown" whether states will follow HHS or "make their own path."⁴

Sport rules are separate. WADA's prohibited list does not depend on US compounding policy. See our guide to WADA peptide rules.

Reactions

Supporters and critics split along familiar lines.

• HHS. An HHS official told the Associated Press the policy offers "a more controlled alternative through licensed U.S. compounders."⁶ Hyman, Phelps & McNamara reads the policy as aiming to draw people away from the "research use only" market.⁴
• Public Citizen. Robert Steinbrook, director of its health research group, said Kennedy "has acted recklessly and unilaterally to put Americans in danger."⁶
• Americans for Safe & Effective Medicines. Its chief policy officer, Fred Mills, said: "In fact, we believe this will worsen what we have already seen," pointing to "a lack of oversight to rein in bad actors."⁶
• Partnership for Safe Medicines. The group had already filed a citizen petition asking FDA to block compounding of all seven peptides reviewed in July "by any route."¹¹ FDA has not answered it publicly.
• Investors. Leerink Partners analyst Michael Cherny called the notice a "yellow light," and said it is "far from the 'green light'" a company such as Hims & Hers might need.⁶

If you are offered one of these peptides

Expect clinics and telehealth services to say these peptides are "now legal" or "approved." Neither is true. If a provider offers one, these questions follow from the policy's own conditions:

• Which pharmacy makes it, and is it state-licensed? Products shipped by an outsourcing facility, or sold as research chemicals or supplements, are outside the policy.³
• Is the prescription in your name?³
• Does the product contain one peptide only? A blend is outside the policy.³⁴
• Is it the form the policy names? For example, Semax is covered only as a nasal product and KPV only as an oral or topical one.³⁴
• Does the label say "This is a compounded drug product. Not for resale."?³⁵
• Who made the raw peptide, and can the pharmacy show the certificate of analysis?⁴
• How do you report a side effect? Anyone can report directly to FDA MedWatch.¹³

Our telehealth guide has more questions to ask before starting, and compounded peptides explains what compounding does and does not guarantee.

What happens next

1. Public comments close on 13 November 2026. Anyone can comment on docket HHS-OASH-2026-0496 at regulations.gov.² HHS can revise the policy afterwards.
2. FDA rulemaking. Adding any of the six peptides to the 503A bulks list needs a proposed rule, a comment period and a final rule.⁹ Hyman, Phelps & McNamara points out that in 15 years only six substances have completed that process from FDA's interim list.⁴
3. The next advisory meeting. FDA's compounding advisory committee is due to review LL-37, GHK-Cu, dihexa, Melanotan II and PEG-MGF before the end of February 2027.¹⁴ Those peptides are not covered by this policy.
4. Safety reports. HHS has said it may pull back if a safety signal or quality problem appears.¹ Whether pharmacies actually report, and whether anyone publishes those reports, will show whether that safeguard works.

For how the policy came about, see our panel vote explainer and the dated BPC-157 legal timeline.