Are peptides legal in the United States?

How the rules work

A substance becomes a legal medicine in the United States through FDA approval of a specific product for a specific use. Approval attaches to the product, not the molecule: Wegovy is approved for weight management, and a vial of semaglutide powder from a website is not, even if the peptide inside is identical.

Between approval and illegality sits compounding. Licensed pharmacies (section 503A of the Food, Drug and Cosmetic Act) and outsourcing facilities (503B) may prepare medicines from bulk substances for individual prescriptions, but only from substances the FDA has placed on a permitted list or is still evaluating. In 2023 the agency put most of the peptides discussed online — BPC-157, ipamorelin, CJC-1295, AOD-9604 and others — in "Category 2", a designation meaning significant safety concerns and no compounding.

That position moved in 2026. After a February announcement by the Secretary of Health and Human Services, the FDA removed twelve peptide nominations from Category 2 on 22 April 2026 and sent seven of them to its Pharmacy Compounding Advisory Committee. On 23–24 July 2026 the committee, against the recommendation of FDA's own reviewers, voted to recommend BPC-157, KPV, TB-500 and MOTS-c (8–6, 7–5) and, the next day, semax and epitalon; it rejected emideltide (DSIP). The votes are not binding. The FDA must decide whether to accept them and then go through rulemaking before any of these can be added to the 503A bulks list. As of September 2026 none has been, and none is an approved drug.

Two peptides stay firmly closed: ipamorelin acetate and kisspeptin-10 remain in Category 2, and the committee voted 0–12 against ipamorelin and AOD-9604 in late 2024 and excluded CJC-1295. GLP-1 copies are a separate story: compounded semaglutide and tirzepatide were tolerated only while the branded products were in shortage; the FDA declared those shortages resolved (tirzepatide December 2024, semaglutide February 2025) and ended its enforcement discretion in April and May 2025.

Buying, importing and "research use only"

Selling a peptide labelled "for research purposes" or "not for human consumption" does not change what it is if it is marketed to people who will inject it. The FDA has sent warning letters to companies selling semaglutide, tirzepatide, retatrutide, survodutide and mazdutide under those labels, and has stated that retatrutide and cagrilintide "cannot be used in compounding under federal law" and "have not been found safe and effective for any condition".

Personal importation of unapproved drugs is not permitted in general; FDA and Customs may detain and destroy shipments. Enforcement in practice concentrates on sellers and on telehealth prescribers rather than on individual buyers, but the legal position is not a grey area.

By 31 May 2026 the FDA had logged 990 adverse-event reports for compounded semaglutide and more than 730 for compounded tirzepatide — the regulator's own argument for why compounding was never meant to be a parallel supply chain.

Compound by compound

What changed, and when

1. 29 Sep 2023FDA places GHRP-2, GHRP-6, ipamorelin, CJC-1295, AOD-9604 and others in Category 2 of the interim 503A bulks list; BPC-157 and kisspeptin-10 already listed.
2. 29 Oct 2024Advisory committee votes 0–12 against ipamorelin.
3. 4 Dec 2024Committee excludes all five CJC-1295 forms and votes 0–12 against AOD-9604.
4. 21 Feb 2025Semaglutide shortage declared resolved; compounding discretion ends 22 April (503A) and 22 May 2025 (503B).
5. 27 Feb 2026HHS announces a review of peptide compounding restrictions.
6. 22 Apr 2026FDA removes twelve peptides from Category 2, listing them as "nominated but withdrawn" pending review.
7. 23–24 Jul 2026Committee recommends BPC-157, KPV, TB-500, MOTS-c, semax and epitalon; rejects emideltide. Non-binding.

Questions

Sources

1. 1
   FDA — Safety risks associated with certain bulk drug substances nominated for use in compounding (Category 2 list; current as of 22 Apr 2026)fda.gov
2. 2
   FDA — Pharmacy Compounding Advisory Committee meeting, 23–24 July 2026 (agenda and briefing documents)fda.gov
3. 3
   FDA — FDA's concerns with unapproved GLP-1 drugs used for weight loss (updated 1 Sep 2026)fda.gov
4. 4
   AJMC — FDA panel backs six peptides for compounding (vote counts), July 2026ajmc.com
5. 5
   Sheppard Mullin — What to watch: status update on peptide regulation, 15 June 2026sheppard.com
6. 6
   Drugs.com — Retatrutide approval history and Lilly's stated filing plandrugs.com

LYO summarises the law for research and educational purposes. It is not legal advice; rules change and enforcement varies. Corrections through the contact page.