FDA Panel Backs 6 of 7 Peptides for Compounding — Vote Is Not Binding
The Pharmacy Compounding Advisory Committee met on July 23–24, 2026 and voted to recommend six of the seven peptides it reviewed for the Section 503A bulk drug substances list — the list that governs what compounding pharmacies may legally prepare. BPC-157 and KPV each cleared 8–6, with TB-500 and MOTS-c also backed. On the second day Epitalon was recommended and Semax 8–5, while Emideltide (DSIP) was rejected 6–7. The panel voted against the recommendation of the FDA’s own scientists, who had argued the human safety data was insufficient.
What's official: the advisory committee has voted and its recommendations are on the record. Six peptides were backed for the 503A list, one was rejected.
Nothing has changed legally. The vote is a non-binding recommendation. Until the FDA completes rulemaking, these peptides remain off the 503A list, compounding them is still not permitted, and selling them for human use still violates the FDCA.
Peptide Laws in United States
US · Americas · 24 peptides tracked
Are Peptides Legal in United States?
The United States regulates peptides under FDA oversight. On April 16, 2026, the FDA published Federal Register notice 2026-07361 formally scheduling the Pharmacy Compounding Advisory Committee (PCAC) to review 12 peptides for possible inclusion on the Section 503A bulk drug substances list. HHS Secretary Kennedy confirmed that BPC-157, TB-500, Epitalon, GHK-Cu, MOTS-C, DSIP, Dihexa, MK-677, Melanotan II, KPV, Semax, and LL-37 are being removed from Category 2 (barred from compounding). Five peptides (CJC-1295, Ipamorelin, Thymosin Alpha-1, AOD-9604, Selank) were previously referred in September 2024. The first PCAC meeting is July 23-24, 2026. No peptides have been DEA-scheduled as controlled substances. Compounding is not yet legal — PCAC review is advisory only. The FDA continues to aggressively enforce against compounded GLP-1 drugs (semaglutide, tirzepatide), with 85+ warning letters issued. Research peptide labeling requirements (For Research Use Only) are fully enforceable since January 2026.
3
Legal16
Grey Area5
PrescriptionCan You Buy Peptides in United States?
3 peptide(s) are legal to buy in United States, including NAD+, Glutathione, Vitamin B12. 5 peptide(s) require a valid prescription, including Tirzepatide, Semaglutide, HGH, Liraglutide, PT-141. 16 peptide(s) fall into a legal grey area: MOTS-c, Retatrutide, Selank, AOD-9604, TB-500, and 11 more. These may be available for research purposes but their legality for personal use is ambiguous.
Traveling to United States with Peptides
When traveling to United States with peptides, the legality depends on each peptide's classification. Prescription peptides (Tirzepatide, Semaglutide, HGH, Liraglutide, PT-141) typically require documentation such as a prescription or doctor's letter when crossing borders. Enforcement in United States is rated as "Moderate." Always declare pharmaceutical products at customs and carry documentation of any prescriptions.
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Peptide Regulations in United States
| Peptide | Status | Rx Required | Schedule | Detail | Source |
|---|---|---|---|---|---|
| Tirzepatide | Prescription | Yes | Not Scheduled | FDA-approved prescription drug. Brand names: Mounjaro (diabetes), Zepbound (obesity). Dual GIP/GLP-1 agonist. Same compounding enforcement pattern as semaglutide. | Official |
| MOTS-c | Grey Area | No | Not Scheduled | Mitochondrial-derived peptide. Not FDA-approved and not separately scheduled. The Pharmacy Compounding Advisory Committee voted on 23 Jul 2026 to recommend it for the 503A bulks list. The vote is non-binding and the FDA has not acted, so it may not be compounded. | Secondary |
| Retatrutide | Grey Area | No | Not Scheduled | Investigational new drug. Not FDA-approved. Not yet on Category 2 list. Available from research chemical vendors. FDA has not specifically targeted retatrutide enforcement yet. Framework: selling an unapproved new drug for human use violates 21 U.S.C. 331(d) and 355(a). A bare violation is a misdemeanour under 333(a)(1); adding intent to defraud or mislead under 333(a)(2) makes it a three-year felony. No peptide is a federally scheduled controlled substance as of the DEA list revised 27 August 2026. | Official |
| Selank | Grey Area | No | Not Scheduled | Not specifically regulated by FDA. Available as research peptide. Originally developed in Russia where it is an approved anxiolytic. Minimal US enforcement attention. | Secondary |
| AOD-9604 | Grey Area | No | Not Scheduled | On FDA Category 2 list. Cannot be compounded. Available from research vendors. Anti-obesity peptide (GH fragment). | Secondary |
| TB-500 | Grey Area | No | Not Scheduled | Not scheduled and not FDA-approved. On the FDA Category 2 do-not-compound list; legal to possess, illegal to sell for human use. The Pharmacy Compounding Advisory Committee voted on 23 Jul 2026 to recommend it for the 503A bulks list. The vote is non-binding and the FDA has not acted. | Secondary |
| GHK-Cu | Grey Area | No | Not Scheduled | Not specifically targeted by FDA. Available as research peptide. Topical formulations widely sold in cosmetics. Less enforcement attention than BPC-157/TB-500. | Secondary |
| Ipamorelin | Grey Area | No | Not Scheduled | Same status as CJC-1295. Removed from Category 2 list Sept 2024. Under PCAC review. Cannot be legally compounded pending outcome. | Unofficial |
| Semaglutide | Prescription | Yes | Not Scheduled | FDA-approved prescription drug. Brand names: Ozempic (diabetes), Wegovy (obesity). Compounding was temporarily allowed during shortage but FDA cracking down on compounded versions. Novo Nordisk actively suing compounding pharmacies. | Official |
| CJC-1295 | Grey Area | No | Not Scheduled | Removed from Category 2 prohibited list Sept 2024 after nominators withdrew. NOT cleared for compounding — under PCAC review. Cannot be legally compounded pending review outcome. | Unofficial |
| Semax | Grey Area | No | Not Scheduled | Not FDA-approved. Originally developed in Russia, where it is a registered medicine. The Pharmacy Compounding Advisory Committee voted 8-5 on 24 Jul 2026 to recommend it for the 503A bulks list for cerebral ischaemia, migraine and trigeminal neuralgia. The vote is non-binding and the FDA has not acted. | Secondary |
| BPC-157 | Grey Area | No | Not Scheduled | Not a controlled substance and not FDA-approved. Sale for human use violates the FDCA; possession is not criminal. On the FDA Category 2 do-not-compound list. The Pharmacy Compounding Advisory Committee voted 8-6 (1 abstention) on 23 Jul 2026 to recommend it for the 503A bulks list, against the advice of FDA scientists. The vote is non-binding and the FDA has not acted, so compounding remains impermissible. | Official |
| NAD+ | Legal | No | Not Scheduled | NAD+ (nicotinamide adenine dinucleotide) has unique status. Oral supplements (NMN/NR precursors) sold freely as dietary supplements. IV NAD+ infusions offered at wellness clinics under medical supervision. Not specifically targeted by FDA for enforcement. | Secondary |
| DSIP | Grey Area | No | Not Scheduled | Not FDA-approved and not a controlled substance. Referred to the Pharmacy Compounding Advisory Committee as Emideltide, which on 24 Jul 2026 voted 6-7 (1 abstention) AGAINST recommending it for the 503A bulks list - the only one of the seven peptides reviewed to be rejected. It therefore remains ineligible for compounding. | Official |
| Epithalon | Grey Area | No | Not Scheduled | Not FDA-approved. Was on Category 2 (do-not-compound) list. HHS announced Feb 2026 reclassification to Category 1 (pending). Not a controlled substance. Sold as research chemical. | Official |
| Glutathione | Legal | No | Supplement | Oral form: GRAS status (GRN 000244), sold as dietary supplement under DSHEA. Injectable form: No FDA-approved product. Available via compounding pharmacies with prescription. FDA has sought to restrict compounded glutathione (PCAC 2022 review). | Official |
| HGH | Prescription | Yes | Not Scheduled | FDA-approved (Genotropin, Norditropin, Humatrope, Omnitrope, Saizen, Skytrofa, Sogroya). Not DEA-scheduled but distribution for non-medical use is a federal felony under 21 USC 333(e) (up to 5 years imprisonment). Compounding permitted under 503A with USP monograph. | Official |
| KPV | Grey Area | No | Not Scheduled | Not a controlled substance and not FDA-approved. FDA has noted that no human exposure data exists. The Pharmacy Compounding Advisory Committee voted 8-6 (1 abstention) on 23 Jul 2026 to recommend it for the 503A bulks list. The vote is non-binding; the FDA has not completed rulemaking and compounding remains impermissible. | Official |
| Liraglutide | Prescription | Yes | Not Scheduled | FDA-approved: Victoza (diabetes, 2010), Saxenda (weight, 2014). Generic liraglutide approved 2024 (Victoza) and Aug 2025 (Saxenda). Category 2 (do-not-compound). Compounding discretion windows closed (503A Apr 2025, 503B May 2025). | Official |
| Melanotan II | Grey Area | No | Not Scheduled | Not FDA-approved. FDA has issued explicit warnings about Melanotan products as unapproved drugs and misbranded cosmetics. Was on Category 2 list. HHS announced Feb 2026 reclassification to Category 1 (pending). Enforcement actions include seizures and warning letters. | Official |
| PT-141 | Prescription | Yes | Not Scheduled | FDA-approved: Vyleesi (bremelanotide, June 2019) for HSDD in premenopausal women only. Not a controlled substance. Category 2 (do-not-compound). HHS announced Feb 2026 potential reclassification to Category 1 (pending). | Official |
| MK-677 | Grey Area | No | Not Scheduled | Not FDA-approved. Not DEA-scheduled. Investigational New Drug (Merck). FDA issued warning letters Dec 2025 to companies marketing MK-677 as supplements. Sold as research chemical. | Official |
| Vitamin B12 | Legal | No | Supplement | Oral/sublingual: GRAS dietary supplement (21 CFR 184.1945). Injectable: FDA-approved prescription drug (cyanocobalamin injection). Nasal spray (Nascobal) also Rx. | Official |
| Epitalon | Grey Area | No | — | Not FDA-approved and not a controlled substance. The Pharmacy Compounding Advisory Committee voted 7-5 (1 abstention) on 24 Jul 2026 to recommend it for the 503A bulks list for insomnia. The vote is non-binding and the FDA has not acted, so it may not be compounded. | Unsourced |
About the sources on this page
Entries marked Official cite a government regulator, legislation or an official gazette. Entries marked Secondary rest on consultancy, law firm, news or academic reporting rather than the regulator itself. Entries marked Unofficial rest on sources that are not authoritative — which may include commercial sellers, medicine-import services or independent websites. Some entries currently carry no source at all.
We show these entries rather than hiding them, but they should not be relied on. Nothing on this site is legal advice. Verify against the national regulator before acting, and if you can point us at a better source please submit an update.
Data is researcher-verified but not legal advice. Always consult local regulations before purchasing, importing, or traveling with peptides. Last verified: 2026-02-28.