FDA peptide compounding tracker
Selected peptides on FDA's 503A and 503B bulk drug substance lists, with category and route restrictions.
Not legal or medical advice.
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| Substance | Pathway | Category / Status | As of | Source |
|---|---|---|---|---|
| BPC-157 | 503A | Category 2 — significant safety risk | 2024-09-27 | FDA 503A list |
| BPC-157 | 503B | Not listed / not approved component | 2025-03-21 | FDA 503B list |
| Ipamorelin acetate | 503B | Category 2 — significant safety risk | 2025-03-21 | FDA 503B list |
| Ipamorelin | 503A | Not on bulk list (PCAC recommended against) | 2024-10-29 | PCAC briefing |
| GHK-Cu | 503A | Cat 1 except injectable; Cat 2 injectable | 2024-09-27 | FDA 503A list |
| Melanotan II | 503A | Category 2 — significant safety risk | 2024-09-27 | FDA 503A list |
| Sermorelin acetate | 503B | Category 1** (component of approved drug) | 2025-03-21 | FDA 503B list |
Sources
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503A
U.S. Food and Drug Administration · Agency list · FDA-2015-N-3534
- Bulk Drug Substances Nominated for Use in Compounding Under Section 503B
U.S. Food and Drug Administration · Agency list · FDA-2015-N-0030
- FDA Briefing Document: Ipamorelin-Related Bulk Drug Substances (PCAC October 2024)
U.S. Food and Drug Administration · Advisory committee briefing
Last updated: 2025-03-01
Next update: 2025-06-01