FDA Peptide Legal Status Tracker
Current FDA regulatory status for every peptide in the database. Updated as regulations change.
Last updated: April 2026. Reflects the FDA Category 1 restorations that took effect in early 2026, returning several peptides (BPC-157, TB-500, GHK-Cu, and others) to compoundable status.
| Peptide | FDA Status | FDA Category | Prescription? |
|---|---|---|---|
| AOD-9604 | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Argireline | Over-the-Counter | -- | No |
| BPC-157 | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| CJC-1295 | Compoundable (Rx) | -- | Rx (compounded) |
| Dihexa | Research Only | -- | No |
| DSIP | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Epitalon | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| FOXO4-DRI | Research Only | -- | No |
| GHK-Cu | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| GHRP-2 | Research Only | -- | No |
| GHRP-6 | Research Only | -- | No |
| Humanin | Research Only | -- | No |
| Ipamorelin | Compoundable (Rx) | -- | Rx (compounded) |
| Kisspeptin-10 | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| KPV | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Liraglutide | FDA Approved | -- | Yes |
| LL-37 | Research Only | -- | No |
| Matrixyl 3000 | Over-the-Counter | -- | No |
| Melanotan II | Research Only | -- | No |
| MOTS-c | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Oxytocin | FDA Approved | -- | Yes |
| PT-141 | FDA Approved | -- | Yes |
| Retatrutide | In Clinical Trials | -- | No |
| Selank | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Semaglutide | FDA Approved | Prescription Drug | Yes |
| Semax | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Sermorelin | Compoundable (Rx) | -- | Rx (compounded) |
| SS-31 | In Clinical Trials | -- | No |
| TB-500 | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Tesamorelin | FDA Approved | -- | Yes |
| Thymosin Alpha-1 | Compoundable (Rx) | Category 1 (restored 2026) | Rx (compounded) |
| Tirzepatide | FDA Approved | -- | Yes |
Understanding FDA Peptide Categories
FDA Approved
Peptides that have completed full clinical trials and received FDA approval for specific indications. These are manufactured by pharmaceutical companies and dispensed at pharmacies with a prescription. Examples: semaglutide (Ozempic/Wegovy), tirzepatide (Mounjaro/Zepbound), PT-141 (Vyleesi).
Compoundable (Category 1)
Peptides listed on the FDA Category 1 bulk substance list, meaning licensed compounding pharmacies can legally prepare them with a valid prescription. In 2026, the FDA restored several previously restricted peptides to Category 1 status, including BPC-157, TB-500, GHK-Cu, Semax, Selank, and others. Compounded peptides are not FDA-approved drugs but are legally produced under pharmacy compounding regulations.
Research Only
Peptides that are legally available for research purposes only. They are not approved for human use and cannot be legally prescribed or dispensed for therapeutic purposes. Regulatory enforcement varies.
In Clinical Trials (Pipeline)
Peptides currently undergoing Phase 1, 2, or 3 clinical trials but not yet approved. These are available only through clinical trial enrollment. Example: retatrutide (Eli Lilly, Phase 3).
Status Legend
Legal & Medical Disclaimer
The legal status information on this page is provided for educational purposes only and may not reflect the most current regulatory changes. Peptide regulations change frequently and vary by jurisdiction.
This information does not constitute legal or medical advice. Always verify the current legal status of any peptide with a licensed healthcare provider or pharmacist in your jurisdiction before purchasing or using any peptide product. The responsibility for compliance with local laws rests with the individual.