HHS Draft Policy Eases Enforcement on 6 Compounded Peptides

Pharmacies and physicians that compound 6 unapproved peptides, including BPC-157, are not expected to face HHS enforcement action if they meet 10 conditions, according to a draft policy announced this week.^1,2

The policy, which HHS frames as enforcement discretion, applies to state-licensed pharmacies, federal facilities, and licensed physicians.¹ It is not an FDA approval. None of the 6 peptides is FDA-approved or on the bulk drug substances list under section 503A of the Federal Food, Drug, and Cosmetic Act, which governs compounding by licensed pharmacists and physicians for individual patients. The FDA has not yet proposed adding them to that list.^1,2 Compounded drugs are not FDA-approved, so the FDA does not review their safety, effectiveness, or quality before they are marketed.¹

The notice announcing the policy, signed by HHS Secretary Robert F. Kennedy Jr, is scheduled for Federal Register publication on October 30.² The policy is a draft and is not binding on HHS or the public.

Which Peptides Does the HHS Policy Cover?

Appendix A lists BPC-157, epitalon, KPV, MOTS-c, semax, and TB-500.¹ Discretion applies only to specific forms and routes of administration:

• BPC-157 acetate: subcutaneous, intramuscular, oral, and topical
• TB-500 acetate: subcutaneous or intramuscular
• Epitalon acetate: subcutaneous or intramuscular, in intermittent courses
• MOTS-c acetate: subcutaneous or intramuscular
• KPV acetate: topical and oral
• Semax free base: intranasal

What Conditions Must Compounders Meet?

HHS lists 10 conditions.¹ Bulk substances must come from an FDA-registered original manufacturer that complies with current good manufacturing practice and carry a certificate of analysis showing identity, purity, potency, and the absence of contaminants such as endotoxins and heavy metals. Compounders must report serious adverse events and product quality issues to FDA's MedWatch program and to the relevant states.

Each product may contain only 1 active ingredient, which must be one of the 6 peptides, and must be labeled as a compounded drug product that is not for resale. Any copackaged delivery device must be an FDA 510(k)-cleared syringe, and compounders of oral products must document adequate bioavailability. A patient-specific prescription is still required.

In the policy, HHS said it aims to discourage widespread use of research-use-only peptides from foreign manufacturers by offering patients "a more controlled alternative."

The policy follows a July vote by FDA's Pharmacy Compounding Advisory Committee, which voted 8-6, with 1 abstention, to recommend BPC-157, KPV, and TB-500 for the 503A bulk list on July 23.³ The committee ultimately recommended 6 of the 7 peptides it reviewed, overriding career FDA scientists who had recommended against all 7.

Appendix B acknowledges that FDA's Center for Drug Evaluation and Research recommended against listing each of the 6.¹ For TB-500, epitalon, and semax, HHS described the center's safety concerns as inferential or mechanistic rather than observed, and for KPV it said the concerns reflected an absence of information. HHS also cited new certificate of analysis data and documented historical use for each peptide.

What Does the Evidence Show?

FDA briefing materials found that available studies, including 5 studies of BPC-157, were short, small, and insufficient to establish safety or effectiveness.³

Use is rising despite that gap. In a preprint analysis of clinical notes from one database, newly confirmed BPC-157 users rose roughly 33-fold from 4 in early 2020 to 134 in early 2026.⁴ Among 205 users who documented a source, 36% obtained it through a compounding pharmacy and 35% through a gray-market vendor. Only 354 of 1039 confirmed users had a documented response, and 79% of those reported improvement.

Flynn McGuire, MD, of the University of Utah, who was not involved in the analysis, noted that it lacked a comparison group and that about half of users were also taking other drugs or undergoing other interventions. The FDA's adverse event reporting system has logged 10 serious reports tied to BPC-157 since 2021, 8 of them in 2026, though such reports do not establish causation.

Catherine Varney, DO, obesity medicine director at UVA Health, told The American Journal of Managed Care^® (AJMC^®) that gray-market peptides often contain 5% to 75% of the labeled amount and that some carry arsenic at up to 10 times acceptable levels.⁵

What Does the Policy Mean for Managed Care?

Compounded drugs generally fall outside standard pharmacy benefit coverage, so patients would likely keep paying out of pocket.³ In August, Shawn Hodges, PharmD, CEO of Revelation Pharma, a network of compounding pharmacies, told AJMC that prescribers and payers should request certificates of analysis, ask pharmacies to document how they qualify the suppliers of their active ingredients, or both.⁶

The policy stays in place for each peptide until the FDA addresses it in a final rule, and HHS may revisit the policy, including if a safety signal or product quality issue arises.^1,2 Written comments are due 2 weeks after Federal Register publication under Docket No. HHS-OASH-2026-0496.²

Formal notice-and-comment rulemaking can take 12 to 24 months.⁷ State responses vary. Louisiana, for example, passed a law effective August 1 that bars licensing boards from prohibiting prescribers from providing peptides from compliant 503A or 503B sources or pharmacists from compounding them in compliance with section 503A and USP-NF standards.⁸

References

1. US Department of Health and Human Services. HHS enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances, including Appendices A and B. Accessed October 29, 2026. https://www.hhs.gov/sites/default/files/hhs-503a-peptide-enforcement-discretion-policy-appendix-b.pdf
2. US Department of Health and Human Services. Enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances. Notice of availability. Docket HHS-OASH-2026-0496. FR Doc 2026-22192. Fed Regist. Scheduled for publication October 30, 2026. Accessed October 29, 2026. https://www.federalregister.gov/public-inspection/2026-22192/enforcement-discretion-policy-regarding-503a-compounding-using-certain-peptide-bulk-drug-substances
3. Steinzor P. FDA panel backs 6 peptides for compounding. AJMC. July 31, 2026. Accessed October 29, 2026. https://www.ajmc.com/view/fda-panel-backs-6-peptides-for-compounding
4. Steinzor P. BPC-157 "Wolverine peptide" use rose 33-fold despite scant evidence. AJMC. October 29, 2026. Accessed October 29, 2026. https://www.ajmc.com/view/bpc-157-wolverine-peptide-use-rose-33-fold-despite-scant-evidence
5. Atta H, Varney C. Unregulated peptides lack purity testing: Catherine Varney, DO. AJMC. October 5, 2026. Accessed October 29, 2026. https://www.ajmc.com/view/unregulated-peptides-lack-purity-testing-catherine-varney-do
6. Steinzor P. New nonprofit launches to develop peptide compounding quality standards. AJMC. August 5, 2026. Accessed October 29, 2026. https://www.ajmc.com/view/new-nonprofit-launches-to-develop-peptide-compounding-quality-standards
7. Atta H. 5 things to know about the FDA's peptide reversal. AJMC. August 21, 2026. Accessed October 29, 2026. https://www.ajmc.com/view/5-things-to-know-about-the-fda-s-peptide-reversal
8. Louisiana Act 374 (SB 253), 2026 Regular Session. La Rev Stat §37:23.5. Effective August 1, 2026. Accessed October 29, 2026. https://www.legis.la.gov/Legis/ViewDocument.aspx?d=1482494