Peptide Legal Status Tracker
The FDA's rules on peptides are changing fast in 2026 — and most sites report it wrong. Here's what's actually true right now, in plain English.
Last updated: October 1, 2026
| Peptide | Also known as | Status | What that means today |
|---|---|---|---|
| PT-141 | Bremelanotide, Vyleesi | FDA-approved | FDA approved Vyleesi in June 2019 for premenopausal women with acquired, generalized hypoactive sexual desire disorder. |
| Semaglutide | Wegovy, Ozempic | FDA-approved | FDA approved Wegovy for chronic weight management in June 2021, and FDA reports the semaglutide shortage is resolved, ending the period when broad compounding of copies was tolerated. |
| Tesamorelin | Egrifta | FDA-approved | FDA approved Egrifta in November 2010 for reducing excess abdominal fat in HIV-infected patients with lipodystrophy. |
| Tirzepatide | Zepbound, Mounjaro | FDA-approved | FDA approved Zepbound for chronic weight management on November 8, 2023, and FDA reports the tirzepatide shortage is resolved. |
| Retatrutide | LY3437943, triple agonist | In FDA trials | As of October 2026 retatrutide is not FDA-approved; Lilly said in July 2026 it plans to submit for FDA approval in the first quarter of 2027, and it runs a narrow compassionate-use program. |
| BPC-157 | Body Protection Compound 157 | PCAC recommended | FDA moved BPC-157 off its Category 2 restricted list in April 2026, and on July 23, 2026 the PCAC voted 8-6 (1 abstention) to recommend it for the 503A Bulks List for ulcerative colitis; FDA must still publish a proposed rule; none appeared in the Federal Register as of October 1, 2026. |
| Epitalon | Epithalon, Ala-Glu-Asp-Gly | PCAC recommended | On July 24, 2026 the PCAC voted 7-4 (1 abstention) to recommend Epitalon for the 503A Bulks List for insomnia; FDA must still publish a proposed rule; none appeared in the Federal Register as of October 1, 2026. |
| KPV | Lys-Pro-Val tripeptide (alpha-MSH 11-13) | PCAC recommended | On July 23, 2026 the PCAC voted 8-6 (1 abstention) to recommend KPV for the 503A Bulks List for wound healing and inflammatory conditions; FDA must still publish a proposed rule; none appeared in the Federal Register as of October 1, 2026. |
| MOTS-c | Mitochondrial-derived peptide | PCAC recommended | On July 23, 2026 the PCAC voted 7-5 (2 abstentions) to recommend MOTS-c for the 503A Bulks List for obesity and osteoporosis; FDA must still publish a proposed rule; none appeared in the Federal Register as of October 1, 2026. |
| Semax | ACTH(4-7)-Pro-Gly-Pro | PCAC recommended | On July 24, 2026 the PCAC voted 8-5 (1 abstention) to recommend Semax for the 503A Bulks List for cerebral ischemia, migraine and trigeminal neuralgia; FDA must still publish a proposed rule; none appeared in the Federal Register as of October 1, 2026. |
| TB-500 | Thymosin beta-4 fragment | PCAC recommended | After TB-500 left FDA's Category 2 list in April 2026, the PCAC voted 8-6 (1 abstention) on July 23, 2026 to recommend it for the 503A Bulks List for wound healing; FDA must still publish a proposed rule; none appeared in the Federal Register as of October 1, 2026. |
| Sermorelin | GHRH(1-29), formerly Geref | Compoundable | FDA withdrew the Geref approvals in June 2009 at the maker's request and determined in March 2013 that they were not withdrawn for safety or effectiveness reasons, which compounders cite as the basis for 503A compounding. |
| GHK-Cu | Copper tripeptide-1 | Awaiting FDA review | Injectable GHK-Cu was removed from FDA's Category 2 list in April 2026 but is not on the 503A Bulks List; the PCAC is scheduled to review it at a meeting before the end of February 2027. |
| CJC-1295 | Long-acting GHRH analog (with or without DAC) | Not recommended | On December 4, 2024 the PCAC voted 0-13 against adding CJC-1295 (free base) to the 503A Bulks List, agreeing with FDA, and the related salt forms were also rejected. |
| DSIP | Emideltide, delta sleep-inducing peptide | Not recommended | On July 24, 2026 the PCAC voted 6-7 (1 abstention) against adding emideltide (DSIP) to the 503A Bulks List for opioid withdrawal, insomnia and narcolepsy, the only peptide rejected at that meeting. |
| Ipamorelin | Ghrelin receptor agonist (GH secretagogue) | Not recommended | On October 29, 2024 the PCAC voted 0-12 (1 abstention) against adding ipamorelin to the 503A Bulks List, and as of FDA's April 2026 update ipamorelin acetate remains on the Category 2 list for 503B outsourcing facilities. |
How we got here — the 2026 timeline
- Feb 27, 2026HHS Secretary announces intent to loosen restrictions on several peptides (policy direction, not a rule).
- Apr 15, 2026FDA formally updates its Section 503A list — 12 peptides removed from Category 2.
- Apr 23, 2026BPC-157 officially comes off the Category 2 restricted list.
- Jul 23–24, 2026PCAC votes to recommend 6 of 7 peptides for the 503A Bulks List: BPC-157, KPV, TB-500, MOTS-C, Semax and Epitalon. DSIP is not recommended. The votes are advisory.
- NextFDA notice-and-comment rulemaking to formally add the recommended peptides. As of mid-September 2026, no proposed rule has been published.
Common questions
Is BPC-157 legal in 2026?
As of April 23, 2026, BPC-157 is no longer on the FDA’s Category 2 restricted list, and on July 23, 2026 the Pharmacy Compounding Advisory Committee (PCAC) voted 8-6 to recommend adding it to the 503A Bulks List. That vote is advisory: the FDA still has to complete rulemaking, and as of mid-September 2026 no proposed rule had been published. It is not an FDA-approved drug and is not a legal over-the-counter supplement. The safest route is a prescription from a licensed provider filled by a compounding pharmacy.
What does “Category 2” mean?
Category 2 was the FDA’s list of bulk drug substances with significant safety concerns that compounding pharmacies could not use. Being removed from Category 2 is one step — it is separate from being approved for 503A compounding, and separate again from full FDA drug approval.
Are compounded semaglutide and tirzepatide still available?
Semaglutide and tirzepatide are FDA-approved as branded drugs (Wegovy/Ozempic and Zepbound/Mounjaro). Availability of compounded versions has shifted with FDA shortage determinations — check with a licensed telehealth provider for current options.