FDA Peptide Status Tracker
Current regulatory status of every peptide compound in our database. Tracking FDA approvals, Category 2 restrictions, and the pending reclassification announced February 27, 2026.
Last updated: May 2026. This page is updated as regulatory changes are published.
20
Compounds tracked
5
FDA approved
4
Category 2 restricted
10
Pending reclassification
12 Peptides Reinstated to Category 1 — April 2026
In April 2026, the FDA formally moved 12 peptides from Category 2 back to Category 1, restoring compounding pharmacy access. Remaining Category 2 peptides (including BPC-157 and TB-500) are under review by the FDA Peptide Compounding Advisory Committee (PCAC), which meets July 23–24, 2026.
FDA Approved(5)
Approved through the FDA drug approval process with established safety and efficacy data.
| Compound | Status Note |
|---|---|
| Semaglutide Ozempic, Wegovy | Approved for: Type 2 diabetes (Ozempic, Rybelsus), Chronic weight management (Wegovy) |
| Tirzepatide Mounjaro, Zepbound | Approved for: Type 2 diabetes (Mounjaro), Chronic weight management (Zepbound) |
| PT-141 Bremelanotide, Vyleesi | Approved for: Hypoactive sexual desire disorder (HSDD) in premenopausal women (Vyleesi) |
| Sermorelin Geref, GHRH(1-29)NH2 | Approved for: Diagnosis of growth hormone deficiency (discontinued) |
| Tesamorelin Egrifta, TH9507 | Approved for: Reduction of excess abdominal fat in HIV-associated lipodystrophy (Egrifta) |
Clinical Trials(1)
Currently in Phase 2 or Phase 3 clinical trials. Not yet approved for any indication.
| Compound | Status Note |
|---|---|
| Retatrutide LY3437943, Triple Agonist | — |
Research Only(10)
Available for research. Not FDA-approved. May be available through compounding pharmacies (Category 1).
| Compound | Status Note |
|---|---|
| GHK-Cu Copper Peptide, Glycyl-L-histidyl-L-lysine:copper(II) | — |
| AOD-9604 Advanced Obesity Drug 9604, Anti-Obesity Drug 9604 | WADA prohibited |
| Epithalon Epitalon, Epithalone | — |
| Selank TP-7 | — |
| Semax MEHFPGP, Heptapeptide ACTH analog | — |
| MOTS-c Mitochondrial Open Reading Frame of the 12S rRNA-c | WADA prohibited |
| Melanotan II MT-2, MT-II | — |
| MK-677 Ibutamoren, Nutrobal | WADA prohibited |
| NAD+ Nicotinamide Adenine Dinucleotide, NAD | — |
| Thymosin Alpha-1 Tα1, Thymalfasin | — |
Category 2 (Restricted)(4)
Currently on FDA Category 2 list — compounding pharmacies cannot legally produce these. Pending reclassification.
| Compound | Status Note |
|---|---|
| BPC-157 Body Protection Compound-157, Bepecin | Pending reclassification to Category 1 |
| TB-500 Thymosin Beta-4, TB4 | WADA prohibited |
| CJC-1295 CJC-1295 DAC, CJC-1295 without DAC | Pending reclassification to Category 1 |
| Ipamorelin NNC 26-0161 | Pending reclassification to Category 1 |
Regulatory Timeline
FDA begins moving popular compounding peptides to Category 2, citing safety concerns and manufacturing impurity risks.
Category 2 list expands to 19 peptides. Compounding pharmacies forced to stop producing restricted compounds. Patient access disrupted.
RFK Jr. confirmed as HHS Secretary. Peptide community anticipates regulatory review.
RFK Jr. announces approximately 14 of 19 Category 2 peptides will return to Category 1 status.
NPR and mainstream media cover the pending reclassification. Industry anticipation builds.
FDA formally moves 12 peptides from Category 2 to Category 1, restoring compounding pharmacy access. BPC-157 and TB-500 remain restricted.
FDA Peptide Compounding Advisory Committee (PCAC) meets to review BPC-157, TB-500, and 5 additional peptides for the 503A compounding list.
Frequently Asked Questions
What is the FDA Category 2 peptide ban?
The FDA Category 2 list identifies drug substances that cannot be used by 503A compounding pharmacies. In late 2023, the FDA placed 19 popular peptides on this list, effectively banning their compounded forms. In April 2026, 12 were reinstated to Category 1.
Which peptides are still banned under Category 2?
As of May 2026, BPC-157, TB-500, and several other peptides remain on Category 2. These are under review by the FDA Peptide Compounding Advisory Committee (PCAC), which meets July 23-24, 2026.
Which peptides were moved back to Category 1 in April 2026?
The FDA reinstated 12 peptides to Category 1 in April 2026, including CJC-1295, ipamorelin, AOD-9604, selank, semax, GHK-Cu, MOTS-c, epithalon, and thymosin alpha-1. These can again be legally compounded by 503A pharmacies.
Do I need a prescription for compounded peptides?
Yes. All 503A compounded peptides require a valid prescription from a licensed healthcare provider. They are compounded for individual patient use based on a specific medical need.
Sources & Methodology
Status classifications are based on the FDA Bulk Drug Substances list under Section 503A, FDA drug approval databases, and official HHS/FDA communications. This tracker is updated as regulatory changes are published. Evidence ratings follow the PeptideMark 4-tier system.
Disclaimer: This tracker is for educational and informational purposes only. It does not constitute legal or medical advice. Regulatory status can change. Consult the FDA directly and your healthcare provider for the most current information regarding specific peptide compounds.