Peptide Regulatory Status Tracker
The Peptide Regulatory Status Tracker provides a current overview of FDA approval status, compounding legality, and DEA scheduling classification for peptides commonly used in therapeutic settings. This resource helps patients, providers, and pharmacists understand the legal landscape for peptide therapies, which varies by substance and jurisdiction. Regulatory status is reviewed monthly and updated whenever federal or state actions affect peptide availability.
| Peptide Name | FDA Status | Compounding Legal | Schedule Status | Last Updated |
|---|---|---|---|---|
| Semaglutide | FDA Approved | Restricted (shortage list dependent) | Prescription only | |
| Tirzepatide | FDA Approved | Restricted (shortage list dependent) | Prescription only | |
| BPC-157 | Not FDA Approved | Legal under state pharmacy boards | Not scheduled | |
| TB-500 | Not FDA Approved | Legal under state pharmacy boards | Not scheduled | |
| CJC-1295 | Not FDA Approved | Legal under state pharmacy boards | Not scheduled |
Frequently Asked Questions
What does FDA approval mean for a peptide?
FDA approval means the peptide has completed clinical trials demonstrating safety and efficacy for specific medical indications. Approved peptides can be prescribed by physicians and dispensed by pharmacies.
Can non-FDA-approved peptides be legally prescribed?
In many cases, yes. Compounding pharmacies can legally prepare non-FDA-approved peptides under state pharmacy board regulations, particularly under section 503A and 503B of the Federal Food, Drug, and Cosmetic Act.
How often is the regulatory status updated?
We review regulatory status monthly and update this page whenever FDA, DEA, or state pharmacy board actions affect peptide availability or legal status.