Federal · HHS notice, FR Doc. 2026-22192

BPC-157 and five other peptides: HHS says it won't take enforcement action against pharmacies that compound them under set conditions

Filed Oct. 28, 2026 · Scheduled for Oct. 30, 2026 Federal Register · Comments open about two weeks

Published October 29, 2026 · Last updated October 29, 2026

This explainer does not take a side. It describes what the policy says, using the notice filed with the Federal Register and the policy document posted by HHS. It is not medical advice.

What it does

The background. Compounding is when a licensed pharmacist or doctor mixes or alters ingredients to make a medication for an individual patient. Section 503A of the federal Food, Drug, and Cosmetic Act lets compounded drugs skip FDA approval only if, among other things, they are made from bulk ingredients that meet an official USP or NF standard, are part of an FDA-approved drug, or appear on a list FDA sets by regulation (the “503A bulks list”). The drug must also be made for a specific patient with a valid prescription. (HHS policy, Background; 21 U.S.C. 353a)

The policy. “Until a peptide bulk drug substance is addressed in a final rule as being included or not included on the 503A bulks list,” HHS “does not intend to take action against a State licensed pharmacy, Federal facility, or licensed physician” compounding one of the six listed peptides when all of these are true: (HHS policy, Interim Enforcement Policy)

1. The peptide is on the list in Appendix A: BPC-157, Epitalon, KPV, MOTS-c, Semax and TB-500.
2. It matches the chemical identity and the allowed routes in Appendix B (see below).
3. It comes from an FDA-registered facility with a valid certificate of analysis showing tests for identity, purity, strength and contaminants such as endotoxins, heavy metals and microbes.
4. The original manufacturer is FDA-registered and follows good manufacturing practices, and its location is on the certificate. Repackers and resellers must have checked the manufacturer and its certificate.
5. The compounder reports the products it makes, serious adverse events and product quality problems to FDA’s MedWatch program and to the states where products are made and sent, and the patient label explains how to report problems.
6. The label says: “This is a compounded drug product. Not for resale.”
7. The product has only one active ingredient from the list.
8. For pills or other oral forms, the compounder keeps records showing the specific formula is absorbed well enough by mouth in humans.
9. The only device packaged with it is an FDA-cleared (510(k)) syringe.
10. It meets all other federal requirements, including clean conditions and the patient-specific prescription rule.

Allowed routes (HHS policy, Appendix B):

• BPC-157: injection under the skin or into muscle, oral, or topical.
• TB-500: injection under the skin or into muscle.
• Epitalon: injection under the skin or into muscle, given in intermittent courses.
• MOTS-c: injection under the skin or into muscle.
• Semax: nasal use.
• KPV: topical and oral.

Why HHS says it is doing this

• HHS says the policy “will discourage the continued, widespread use of certain research-use-only peptides supplied by foreign manufacturers that pose a safety risk to US patients” and gives patients “a more controlled alternative.” (HHS policy)
• HHS cites FDA’s Pharmacy Compounding Advisory Committee and data on peptide use, and says it believes there is “significant interest” in these peptides. (Notice, Background)
• For each of the six, Appendix B says FDA’s drug center (CDER) had recommended against adding it to the list, and the advisory committee voted in favor. HHS says newer testing records and documented use support the interim policy. (HHS policy, Appendix B)

Who it affects

• Compounding pharmacies, federal facilities and licensed doctors who compound these peptides. The policy is about federal enforcement; it covers state-licensed pharmacies and licensed physicians. (HHS policy)
• Patients who are prescribed one of these peptides by a licensed prescriber.
• It does not cover “research use only” products sold outside a pharmacy, which the policy says it aims to discourage. (HHS policy)

What it means for you

• A prescription is still required. The policy keeps the patient-specific prescription requirement. (HHS policy, condition 10)
• These are not FDA-approved drugs. “Compounded drugs are not FDA-approved, which means FDA does not review their safety, effectiveness, or quality before they are marketed.” (Notice, Background)
• It is not permanent and not binding. HHS may revisit the policy, in whole or in part, if “a safety signal or product quality issue arises,” and the notice says the policy “does not establish any rights for any person and is not binding on HHS or the public.” (Notice, Background)
• Look for the label. A product made under the policy should say “This is a compounded drug product. Not for resale.” and explain how to report problems. (HHS policy, conditions 5–6)

How to comment

Comments can be submitted on regulations.gov, Docket No. HHS-OASH-2026-0496, until 2 weeks after the notice is published in the Federal Register. With publication scheduled for October 30, 2026, that would be about November 13, 2026. (Notice, Addresses)

Current status

Notice of availability filed for public inspection October 28, 2026 and scheduled for publication October 30, 2026 (FR Doc. 2026-22192; Docket No. HHS-OASH-2026-0496; RIN 0910-ZD94). The notice also calls the policy a draft and an interim policy. It is not a final rule and does not add anything to the 503A bulks list. (Notice)

What happens next

FDA’s future rulemakings “may propose adding some or all of these peptides to the 503A bulks list based on the available evidence.” The policy lasts for each peptide until a final rule decides whether it is on the list. HHS says to check its website for the most current version of the policy. (Notice, Background and Electronic Access; HHS policy)

Sources

• Federal Register: “Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances,” HHS notice of availability, FR Doc. 2026-22192 (on public inspection Oct. 28, 2026; scheduled for publication Oct. 30, 2026)
• HHS: Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances, with Appendices A and B (PDF)
• FDA: Human Drug Compounding

Every statement above is drawn from the official source text linked here; section references are shown in grey. This is a plain-English summary, not legal advice. Spot an error? Tell us.