HHS Secretary Kennedy Announces FDA Will Reclassify 14 Peptides for Pharmacy Compounding
HHS Secretary Robert F. Kennedy Jr. announced that the FDA will move approximately 14 peptides from Category 2 (barred from compounding) to Category 1, making them available through licensed compounding pharmacies with a valid prescription. Five peptides (CJC-1295, Ipamorelin, Thymosin Alpha-1, AOD-9604, and Selank) were already referred to the Pharmacy Compounding Advisory Committee (PCAC) for review in September 2024.
This is NOT law yet. This announcement was made on a podcast and has not been formalized through an official FDA rulemaking or Federal Register notice. The FDA's 503A bulk drug substances guidance has not yet been updated. Regulations may change — always verify current status before acting.
Peptide Laws in United States
US · Americas · 23 peptides tracked
Are Peptides Legal in United States?
Research peptides are technically sold as 'not for human consumption,' but the FDA is actively cracking down — issuing warning letters, banning 17 peptides from compounding pharmacies, and even pursuing criminal cases. Possessing peptides isn't a crime, but selling them for human use is illegal. Approved peptides like semaglutide and tirzepatide require a prescription, and compounded versions are being aggressively shut down. The walls are closing in fast, especially since late 2024.
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 "Lenient." 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.