FDA Schedules PCAC Review of 12 Peptides for Compounding Access
The FDA has published a Federal Register notice (Doc. 2026-07361) scheduling the Pharmacy Compounding Advisory Committee to review peptides for possible inclusion on the Section 503A bulk drug substances list. HHS Secretary Kennedy confirmed 12 peptides are being removed from Category 2 and referred for PCAC review, including BPC-157, TB-500, MOTS-C, GHK-Cu, and others. The first review meeting is scheduled for July 23–24, 2026 at FDA White Oak Campus. Five additional peptides (CJC-1295, Ipamorelin, Thymosin Alpha-1, AOD-9604, Selank) were already referred in 2024.
What's official: FDA Federal Register notice scheduling PCAC advisory meeting (July 23–24). Public comment period open until July 9, 2026.
Not yet legal: PCAC review does NOT equal approval. Compounding these peptides is still not permitted until the FDA formally adds them to the 503A list after PCAC recommendation.
Peptide Laws in United States
US · Americas · 23 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
Legal15
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. 15 peptide(s) fall into a legal grey area: Retatrutide, Selank, MOTS-c, TB-500, GHK-Cu, and 10 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 |
|---|---|---|---|---|
| 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. |
| 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. |
| 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. |
| MOTS-c | Grey Area | No | Not Scheduled | Mitochondrial-derived peptide. Not specifically regulated or targeted by FDA. Available as research chemical. Minimal enforcement attention. |
| TB-500 | Grey Area | No | Not Scheduled | Not scheduled. On FDA Category 2 prohibited compounding list. Same enforcement pattern as BPC-157. Legal to possess, illegal to sell for human use. |
| 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. |
| AOD-9604 | Grey Area | No | Not Scheduled | On FDA Category 2 list. Cannot be compounded. Available from research vendors. Anti-obesity peptide (GH fragment). |
| 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. |
| 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. |
| Semax | Grey Area | No | Not Scheduled | Not specifically regulated by FDA. Available as research peptide. Originally developed in Russia where it is an approved nootropic/stroke treatment. Minimal US enforcement attention. |
| 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. |
| 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. |
| BPC-157 | Grey Area | No | Not Scheduled | Not a controlled substance. FDA banned from compounding pharmacies (Category 2 list). Sold as 'research chemical' but FDA actively issuing warning letters (Dec 2024/2025). Possession not criminal. Sale for human use violates FDCA. |
| DSIP | Grey Area | No | Not Scheduled | Not FDA-approved. Was on FDA Category 2 (do-not-compound) list. HHS Secretary RFK Jr. announced Feb 2026 reclassification to Category 1 (pending formal publication). Not a controlled substance. Sold as research chemical. |
| 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. |
| 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). |
| 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. |
| KPV | Grey Area | No | Not Scheduled | Not FDA-approved. Was on Category 2 (do-not-compound) list. FDA noted no human exposure data exists. HHS announced Feb 2026 reclassification to Category 1 (pending). Not a controlled substance. |
| 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). |
| 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. |
| 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). |
| 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. |
| 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. |
Data is researcher-verified but not legal advice. Always consult local regulations before purchasing, importing, or traveling with peptides. Last verified: 2026-02-28.