Regulatory
FDA Regulatory Tracker
Compounding category status based on publicly available FDA communications.
Status information based on publicly available FDA communications. Verify at FDA.gov for authoritative guidance.
Reclassification Announced — Awaiting Formal FDA Publication
Category 1 compounds may be legally prepared by licensed compounding pharmacies under a physician prescription. Category 2 compounds are restricted from compounding.
Last updated: 2026-02-27
Reclassification Timeline
2023-09-29
Category 2 Restriction
19 peptides placed on FDA Category 2 restricted list
2026-02-27
HHS Announcement
HHS announces ~14 peptides returning to Category 1
TBD
Formal FDA Publication
Formal reclassification published in Federal Register
2023-09-29
Category 2 Restriction
19 peptides placed on FDA Category 2 restricted list
2026-02-27
HHS Announcement
HHS announces ~14 peptides returning to Category 1
TBD
Formal FDA Publication
Formal reclassification published in Federal Register
Compound Status
| Compound | Category | Status |
|---|---|---|
| BPC-157 | Cat 2 | Cat 2 → Pending Cat 1 |
| TB-500 | Cat 2 | Cat 2 → Pending Cat 1 |
| GHK-Cu | Cat 2 | Cat 2 → Pending Cat 1 |
| AOD-9604 | Cat 2 | Cat 2 → Pending Cat 1 |
| Thymosin Alpha-1 | Cat 2 | Cat 2 → Pending Cat 1 |
| Ipamorelin | Cat 2 | Cat 2 → Pending Cat 1 |
| CJC-1295 (no DAC) / Modified GRF 1-29 | Cat 2 | Cat 2 → Pending Cat 1 |
| CJC-1295 (with DAC) | Cat 2 | Cat 2 → Pending Cat 1 |
| Semax | Cat 2 | Cat 2 → Pending Cat 1 |
| Selank | Cat 2 | Cat 2 → Pending Cat 1 |
| DSIP (Delta Sleep-Inducing Peptide / Emideltide) | Cat 2 | Cat 2 → Pending Cat 1 |
| Epitalon (Epithalon) | Cat 2 | Cat 2 → Pending Cat 1 |
| MOTS-C (Mitochondrial ORF of the 12S rRNA Type-C) | Cat 2 | Cat 2 → Pending Cat 1 |
| KPV (Lys-Pro-Val) | Cat 2 | Cat 2 → Pending Cat 1 |
| Kisspeptin-10 | Cat 2 | Cat 2 → Pending Cat 1 |
| 5-Amino-1MQ | Cat 1 | Category 1 |
| IGF-1 LR3 | Cat 1 | Category 1 |
| Melanotan II | Cat 2 | Remaining Restricted |
| GHRP-2 | Cat 2 | Remaining Restricted |
| GHRP-6 | Cat 2 | Remaining Restricted |
| LL-37 (Cathelicidin) | Cat 2 | Remaining Restricted |
| PEG-MGF | Cat 2 | Remaining Restricted |
| Semaglutide | Approved | FDA Approved |
| Tirzepatide | Approved | FDA Approved |
| Tesamorelin | Approved | FDA Approved |
| Retatrutide | Investigational | Investigational |
What This Means
Category 1 vs Category 2
Category 1 bulk drug substances may be legally compounded by licensed 503A and 503B pharmacies under a physician prescription. Category 2 substances are restricted from compounding due to insufficient clinical data or unresolved adverse event profiles.
“Announced” vs “Published”
The February 2026 HHS announcement stated that approximately 14 peptides would return to Category 1 availability. As of April 2026, the formal FDA reclassification has not been published in the Federal Register. Until published, Category 2 restrictions remain in effect.
Reclassification Is Not FDA Approval
Moving from Category 2 to Category 1 means a compound may be legally compounded — it does not mean the compound is FDA-approved for any specific indication. These remain off-label uses that require a physician prescription from a licensed compounding pharmacy.
Sourcing
Compounds sourced outside of licensed 503A/503B compounding pharmacies are unregulated and may contain contaminants, incorrect concentrations, or mislabeled substances. Peply does not endorse any vendor or sourcing channel.
Sources
- [1]FDA Bulk Drug Substances Used in Compounding Under Section 503A and 503B. Link
- [2]HHS Secretary Kennedy announcement on peptide reclassification, February 27, 2026.
Status information based on publicly available FDA communications. Verify at FDA.gov for authoritative guidance.