FDA Peptide Status Tracker 2026
A dated record of where commonly discussed peptides stand with FDA, compounding rules and WADA. Updated when something changes. Last checked .
By [Author name]. Licensed pharmacist review: pending. Last updated .
Status at a glance
“Compounding” means whether a licensed US pharmacy may prepare it. None of this changes the status of products sold online as “research use only”, which FDA treats as unapproved drugs when the context shows human use.
| Compound | FDA approval | Compounding | WADA |
|---|---|---|---|
| Semaglutide | Approved (Ozempic, Wegovy, Rybelsus) | Shortage over (Feb 21, 2025); copies generally not allowed. Salt forms not the approved ingredient. | Not prohibited |
| Tirzepatide | Approved (Mounjaro, Zepbound) | Shortage over (Dec 19, 2024); copies generally not allowed. | Not prohibited |
| Retatrutide | Investigational (Phase 3), not approved | Cannot be compounded | S0 (non-approved) |
| Tesamorelin | Approved (Egrifta) for one indication | Approved product; research material is not it | S2, prohibited |
| Sermorelin | Formerly approved (Geref), discontinued 2008 | Depends on 503A criteria; ask a pharmacist | S2, prohibited |
| BPC-157 | Not approved | Category 2 since 2023. PCAC 2026 vote recommended listing; interim policy pending. | S0, prohibited (named) |
| TB-500 / thymosin beta-4 | Not approved | PCAC 2026 recommended listing; interim policy pending. | S2, prohibited (named) |
| MOTS-c | Not approved | PCAC 2026 recommended listing; interim policy pending. | S0 (non-approved) |
| KPV | Not approved | PCAC 2026 recommended listing; interim policy pending. | S0 (non-approved) |
| Epitalon | Not approved | PCAC 2026 recommended listing; interim policy pending. | S0 (non-approved) |
| Semax | Not approved in the US | PCAC 2026 recommended listing; interim policy pending. | Check current list (approved in Russia) |
| CJC-1295 / ipamorelin | Not approved | Category 2 (2023) | S2, prohibited |
| GHK-Cu | Not approved as a drug (cosmetic ingredient) | Depends on FDA bulk substance categories; check current list | Not named |
| NAD+ | No approved injectable product | Prepared by compounding pharmacies under their own rules | Not prohibited (IV volume limit applies) |
Timeline
Newest first.
HHS and FDA send an interim peptide access policy to the White House
The draft would let pharmacies compound BPC-157, TB-500, KPV, MOTS-c, Epitalon and Semax under enforcement discretion while formal rulemaking runs. It is not final. It covers licensed pharmacies, not "research use only" sellers, and it does not cover retatrutide or tirzepatide.
FDA warning letters to five online peptide sellers
CDER wrote to Peptide Partners, Peak Performance Peptides, Royal Peptides, NuScience Peptides and Tex Peptides. Products named include retatrutide, semaglutide, tirzepatide, tesamorelin and ipamorelin. FDA said "research use only" labels did not change intended use and pointed to the overall context of the sites, including peptide calculators shown next to products, bacteriostatic water sold for reconstitution, and dosing information.
Advisory committee votes to recommend six peptides for the compounding list
FDA's Pharmacy Compounding Advisory Committee recommended adding BPC-157 (by an 8-6 vote), KPV, TB-500, MOTS-c, Epitalon and Semax to the 503A bulk drug substances list. A recommendation is advisory; listing requires rulemaking, which commentators expect to run into 2027 or later.
FDA warning letter to Wholesale Peptide
Another letter in the 2026 series to online sellers of research-labeled peptides.
First 2026 wave of warning letters to research-peptide sellers
FDA wrote to Gram Peptides and other sellers. The letters treated "research use only" labeling as no defense where the site's content (calculators, dosing information, GLP-1 products, testimonials, coded product names) showed the products were meant for people.
Semaglutide shortage declared over
FDA removed semaglutide from the drug shortage list. Grace periods for compounders ended April 22, 2025 (503A pharmacies) and May 22, 2025 (503B outsourcing facilities).
Tirzepatide shortage declared over
FDA removed tirzepatide from the drug shortage list. Grace periods ended February 18, 2025 (503A) and March 19, 2025 (503B).
FDA places BPC-157 and other peptides in Category 2
FDA listed BPC-157 and a number of other nominated peptides as bulk drug substances that may present significant safety risks in compounding (Category 2), citing limited safety data and risks such as immunogenicity and impurities.