FDA compounding status of peptides
Regulatory fact: FDA 503A and 503B bulk substance categories. Last checked .
| Peptide | FDA status | Committee review | Source |
|---|---|---|---|
| Kisspeptin-10 | Category 2 For 503A pharmacies since September 29, 2023 | No review announced | FDA Category 2 pageChecked Oct 16, 2026 |
| MK-677 (ibutamoren) | Category 2 For 503B since December 29, 2022 and 503A since September 29, 2023 | No review announced | FDA Category 2 pageChecked Oct 16, 2026 |
| Ipamorelin | Category 2 For 503B outsourcing facilities since September 29, 2023. Its 503A nomination was withdrawn | No review announced | FDA Category 2 pageChecked Oct 16, 2026 |
| GHRP-2 | Category 2 For 503B, injectable and nasal use, since September 29, 2023 | No review announced | FDA Category 2 pageChecked Oct 16, 2026 |
| GHRP-6 | Category 2 For 503B since September 29, 2023 | No review announced | FDA Category 2 pageChecked Oct 16, 2026 |
| BPC-157 | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 6 for the bulks list on July 23, 2026 (reported). No proposed rule yet | FDA Category 2 pageChecked Oct 16, 2026 |
| TB-500 | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 6 for the bulks list on July 23, 2026 (reported). No proposed rule yet | FDA Category 2 pageChecked Oct 16, 2026 |
| KPV | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 6 for the bulks list on July 23, 2026 (reported). No proposed rule yet | FDA Category 2 pageChecked Oct 16, 2026 |
| MOTS-c | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 7 to 5 for the bulks list on July 23, 2026 (reported). No proposed rule yet | FDA Category 2 pageChecked Oct 16, 2026 |
| Epitalon | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 7 to 4 for the bulks list on July 24, 2026 (reported). No proposed rule yet | FDA Category 2 pageChecked Oct 16, 2026 |
| Semax | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 8 to 5 for the bulks list on July 24, 2026 (reported). No proposed rule yet | FDA Category 2 pageChecked Oct 16, 2026 |
| DSIP (emideltide) | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee voted 7 to 6 against adding it on July 24, 2026 (reported) | FDA Category 2 pageChecked Oct 16, 2026 |
| GHK-Cu | Category 1 For every route except injection, since May 14, 2026. The injectable nomination was withdrawn | FDA plans a committee review before the end of February 2027 | FDA 503A category listChecked Oct 16, 2026 |
| Melanotan II | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked Oct 16, 2026 |
| LL-37 | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked Oct 16, 2026 |
| Dihexa | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked Oct 16, 2026 |
| PEG-MGF | Withdrawn Nominated but withdrawn. Was in Category 2 | Committee review expected before the end of February 2027 (reported) | FDA Category 2 pageChecked Oct 16, 2026 |
| CJC-1295 | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked Oct 16, 2026 |
| AOD-9604 | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked Oct 16, 2026 |
| Selank | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked Oct 16, 2026 |
| Thymosin alpha-1 | Withdrawn Nominated but withdrawn. Was in Category 2 | Not reviewed in July 2026 | FDA Category 2 pageChecked Oct 16, 2026 |
| VIP | Category 1 Under evaluation for 503A | No review announced | FDA 503A category listChecked Oct 16, 2026 |
| Thymulin | Category 3 Nominated for 503A without enough supporting information | No review announced | FDA 503A category listChecked Oct 16, 2026 |