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.
12 Peptides Removed from Category 2
On April 15, 2026, HHS Secretary Kennedy announced that nominators withdrew 12 peptides from Category 2. Compounding pharmacies are no longer restricted from preparing these compounds. Each will undergo formal PCAC review beginning July 2026.
Last updated: April 15, 2026
Reclassification Timeline
2023-09-29
Category 2 Restriction
FDA places multiple peptides in Category 2 (Bulk Drug Substances that Raise Significant Safety Risks)
2026-02-27
HHS Review Intent
HHS announces intent to review Category 2 peptide classifications
2026-04-15
12 Peptides Removed
HHS Secretary Kennedy announces removal of 12 peptides from Category 2. PCAC evaluation begins July 2026.
July 2026
PCAC Evaluation
Pharmacy Compounding Advisory Committee begins formal review of removed compounds
Compound Status
Compounds grouped by current regulatory bucket. Linked names go to full detail pages with citations.
Removed from Category 2 (April 15, 2026)
Nominator-withdrawn peptides; await formal PCAC review.
| Compound | Status | Note |
|---|---|---|
| BPC-157 | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| TB-500 | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| GHK-Cu | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| MK-677 | Investigational | PCAC evaluation begins July 2026 |
| Semax | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| DSIP (Emideltide) | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| Epitalon (Epithalon) | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| MOTS-c | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| KPV (Lys-Pro-Val) | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| Dihexa Acetate | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| Melanotan II | Removed from Cat 2 | PCAC evaluation begins July 2026 |
| LL-37 | Removed from Cat 2 | PCAC evaluation begins July 2026 |
Category 2 — Pending Review
Still restricted but flagged for return-to-Category-1 evaluation.
| Compound | Status | Note |
|---|---|---|
| AOD-9604 | Cat 2 → Pending Cat 1 | Pending FDA reclassification — announced 2026-02-27 |
| Thymosin Alpha-1 | Cat 2 → Pending Cat 1 | Pending FDA reclassification — announced 2026-02-27 |
| Ipamorelin | Cat 2 → Pending Cat 1 | Pending FDA reclassification — announced 2026-02-27 |
| CJC-1295 (no DAC) | Cat 2 → Pending Cat 1 | Pending FDA reclassification — announced 2026-02-27 |
| CJC-1295 (with DAC) | Cat 2 → Pending Cat 1 | Pending FDA reclassification — announced 2026-02-27 |
| Selank | Cat 2 → Pending Cat 1 | Pending FDA reclassification — announced 2026-02-27 |
| Kisspeptin-10 | Cat 2 → Pending Cat 1 | Pending FDA reclassification — announced 2026-02-27 |
Category 2 — Remaining Restricted
Not on the April 15 removal list. Compounding pharmacies may not prepare these.
| Compound | Status | Note |
|---|---|---|
| GHRP-2 | Remaining Restricted | Cortisol and prolactin elevation |
| GHRP-6 | Remaining Restricted | Cortisol and prolactin elevation |
| PEG-MGF | Remaining Restricted | Insufficient human clinical data |
Category 1 — Permitted for Compounding
May be legally compounded by licensed 503A and 503B pharmacies.
| Compound | Status | Note |
|---|---|---|
| Sermorelin | Previously Approved | Permitted for 503A compounding |
| 5-Amino-1MQ | Category 1 | Permitted for 503A compounding |
| IGF-1 LR3 | Category 1 | Permitted for 503A compounding |
FDA Approved
Approved for one or more indications and commercially marketed.
| Compound | Status | Note |
|---|---|---|
| Semaglutide | FDA Approved | Ozempic, Wegovy, Rybelsus |
| Tirzepatide | FDA Approved | Mounjaro, Zepbound |
| Tesamorelin | FDA Approved | Egrifta SV |
FDA Approved (Limited Indication)
Approved for a narrow patient population only.
| Compound | Status | Note |
|---|---|---|
| PT-141 | FDA Approved (Vyleesi) | Vyleesi — HSDD in premenopausal women only |
Investigational
In active clinical trials; not yet FDA-approved.
| Compound | Status | Note |
|---|---|---|
| Retatrutide | Investigational | Eli Lilly — Phase 3 (TRIUMPH trials) |
What This Means
Removed from Category 2
Compounding pharmacies are no longer restricted from preparing these compounds. Nominators withdrew their Category 2 nominations, and the FDA will remove the compounds from the restricted list.
PCAC Review — July 2026
Each removed compound will undergo formal evaluation by the Pharmacy Compounding Advisory Committee (PCAC) beginning July 2026. Formal reclassification to Category 1 depends on the PCAC outcome.
Not FDA-Approved
Removal from Category 2 does not mean FDA-approved. These remain off-label uses that require a physician prescription from a licensed compounding pharmacy. They are not unregulated consumer products.
Remaining Restricted Compounds
Compounds not on the April 15 removal list remain Category 2 restricted. Compounding pharmacies may not prepare these substances until their status changes through separate FDA action.
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.
- [3]HHS Secretary Kennedy public statement on removal of 12 peptides from Category 2, April 15, 2026.
Status information based on publicly available FDA communications. Verify at FDA.gov for authoritative guidance.