Peptide status tracker

Four peptides here are FDA-approved medicines. Since 28 October 2026, six more (BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax) can be compounded by a licensed pharmacist or physician for one patient with a prescription under an interim HHS policy, but they are still not FDA-approved. Products sold online as 'research use only' are not legal to sell for use in people.

Where each peptide stands in the U.S. after the October 2026 HHS interim policy: FDA-approved, allowed for prescription compounding, or not covered. Dated and sourced.

Approved, allowed on prescription, or not covered: every peptide in this section, checked and dated.

Key takeaways

• Legal status and evidence are different questions; this page covers status, the evidence ladder covers evidence.
• The 2026 policy is interim enforcement discretion, not FDA approval, and HHS says it may be revised or withdrawn.
• It covers licensed pharmacists and physicians making one peptide for one patient, not online 'research' sellers or blends.
• Each change to this tracker is logged with its date and source.

How to read the three columns

FDA-approved medicine means the FDA reviewed trial data for a specific use, and the product is made under federal manufacturing oversight with a reviewed label.

Allowed under the 2026 interim policy means the FDA has said it will not take action against a licensed pharmacist or physician who compounds that peptide for an individual patient with a valid prescription, under strict conditions. It does not mean the compound has been shown to be safe or effective.

Not covered means the compound is not approved in the U.S. and is not one of the six peptides in the policy.

What the policy requires

The conditions come from the HHS notice itself (Federal Register document 2026-22192).

• A valid prescription for an individual patient.
• Compounded by a licensed pharmacist or physician; large outsourcing facilities are not covered.
• One peptide per product, given only by the permitted route. Blends are not covered.
• The ingredient comes from an FDA-registered establishment, with a certificate of analysis.
• Serious side effects and quality problems are reported to FDA MedWatch.
• The label reads: "This is a compounded drug product. Not for resale."

What about compounded GLP-1 medicines?

Semaglutide and tirzepatide are FDA-approved. While they were in official shortage, pharmacies were temporarily allowed to make copies. The FDA declared the tirzepatide shortage over in late 2024 and the semaglutide shortage over on 21 February 2025, and the temporary allowance ended during 2025. Compounded GLP-1 products are not FDA-approved, and the FDA has warned about unapproved versions sold online.

What we are still checking

Beiing does not state anything it has not confirmed at a primary source. These items are open and will be added when confirmed:

• The anti-doping status of KPV, Epitalon and Semax, substance by substance.
• FDA's 2026 actions on compounded GLP-1 marketing, seen so far only in secondary sources.
• The exact closing date for public comments on the HHS notice.

Frequently asked questions

Is BPC-157 legal now?

Narrowly. Since 28 October 2026 a licensed pharmacist or physician can compound it for an individual patient with a prescription under the HHS interim policy. It is not FDA-approved, and 'research use only' BPC-157 sold online is still not legal to sell for use in people.

Does the interim policy mean these peptides are safe?

No. The HHS notice states that compounded drugs are not FDA-approved and that the FDA does not review their safety or effectiveness. FDA scientists raised safety concerns before the policy was issued.

How often is this tracker updated?

Whenever the rules change, and at least monthly. Every change is recorded in the update log on this page with its date and source.

Related on Beiing

• The evidence ladder - Status is not evidence: see how strong the research is.
• What changed, 2023 to 2026 - The timeline behind these columns.
• Compounding, quality and safety - Approved, compounded and grey-market supply compared.
• How Beiing rates peptide evidence - The five evidence levels used across this section.
• Peptides & Human Biology - The hub for every page in this section.
• Editorial Standards - How our content is researched and reviewed.

Sources

1. Enforcement Discretion Policy Regarding 503A Compounding Using Certain Peptide Bulk Drug Substances (Federal Register document 2026-22192, docket HHS-OASH-2026-0496) - U.S. Department of Health and Human Services, via the Federal Register
2. HHS 503A peptide enforcement discretion policy, Appendix B (PDF) - U.S. Department of Health and Human Services
3. FDA - Bulk Drug Substances Used in Compounding Under Section 503A - U.S. Food and Drug Administration
4. FDA - Human Drug Compounding - U.S. Food and Drug Administration
5. FDA - FDA's concerns with unapproved GLP-1 drugs used for weight loss - U.S. Food and Drug Administration
6. Drugs@FDA - approved drug products and labels - U.S. Food and Drug Administration
7. FDA winds down GLP-1 compounding policies (1 April 2025) - TechTarget Pharma Life Sciences
8. FDA ends compounding discretion for tirzepatide, maintains discretion for semaglutide (March 2025) - National Community Pharmacists Association
9. HHS enforcement discretion policy allows peptide compounding (28 October 2026) - STAT
10. HHS issues enforcement discretion policy regarding 503A compounding using certain peptide bulk drug substances - BakerHostetler
11. AP report: FDA scientists opposed the move to ease peptide access - Associated Press, via PBS NewsHour

Written by Beiing Editorial Team · Editorially reviewed by Research & Regulatory Review Desk · Published August 19, 2026 · Last reviewed October 31, 2026. Editorial and research review by Beiing writers and researchers. This is not medical or clinical review, and no clinician signs off on our content.

Educational content only - not medical advice. In a crisis, call or text 988 (US) or your local emergency number. See crisis resources.