Regulatory watch
Regulatory actions
FDA, PCAC, DEA, and FTC actions affecting the peptide market, updated as new filings surface. Each entry links to the primary source document.
2026
- PCAC · watchJul 23
PCAC to consider seven peptides for 503A compounding eligibility
The Pharmacy Compounding Advisory Committee is scheduled to meet July 23–24, 2026 to consider seven peptides for inclusion on the 503A compounding list, including BPC-157, KPV, TB-500, MOTS-C, DSIP, Semax, and Epitalon. The committee's recommendation is advisory, not binding; FDA acts on it separately.
- PCAC · watchJul 9
Public comment deadline for the PCAC peptide docket (FDA-2025-N-6895)
The public comment window for the Pharmacy Compounding Advisory Committee peptide docket closes ahead of the July 23–24, 2026 meeting at which the committee will consider several peptides for 503A compounding eligibility.
- FDA · majorMay 1
FDA proposes permanent 503B bulks exclusion for semaglutide, tirzepatide, liraglutide
FDA proposed excluding semaglutide, tirzepatide, and liraglutide from the 503B Bulks List, finding no clinical need for outsourcing facilities to compound them from bulk API. If finalized, large-scale compounding would remain blocked even if shortage conditions returned. Federal Register docket 2026-08552; the comment period closed June 29, 2026.
- FDA · majorApr 23
FDA removes about a dozen peptides from the Category 2 compounding restriction
FDA updated its 503A bulk-substances status to remove roughly a dozen peptides from the Category 2 restricted list, effective April 23, 2026, and scheduled a Pharmacy Compounding Advisory Committee meeting. Removal from Category 2 is not the same as Category 1 authorization: these substances remain in a regulatory gray zone pending the committee's review.
- FDA · majorMar 31
FDA challenges the 'research use only' defense in peptide-vendor warning letters
FDA issued same-day warning letters to several research-peptide vendors, advancing a consistent legal theory: product pages describing physiological effects establish drug intent regardless of "research use only" disclaimers.
- FDA · majorMar 3
FDA warns 30 telehealth companies over misleading compounded GLP-1 marketing
FDA issued warning letters to 30 telehealth companies for advertising that claimed compounded GLP-1 products were the same as approved drugs and used branded labeling that obscured the compounder. FDA characterized the letters as swift action against misleading claims.
2025
- FDA · majorSep 9
FDA and HHS issue 50+ warning letters to GLP-1 compounders and telehealth firms
In the first major post-shortage enforcement wave, FDA and HHS issued more than 50 warning letters citing claims of equivalence to branded GLP-1 products and labeling that obscured the actual compounder.
- FDA · majorSep 5
FDA launches GLP-1 API 'Green List' and Import Alert 66-80
FDA announced a "Green List" of inspected active-pharmaceutical-ingredient manufacturers and issued Import Alert 66-80, authorizing detention at the border of GLP-1 API shipments from sources not on the list. The action targets unverified overseas API used by compounders during the shortage period.
- FDA · watchFeb 26
FDA warns USApeptide.com over unapproved, misbranded peptide drugs
FDA issued a warning letter to USApeptide.com for marketing unapproved new drugs and misbranded peptide products. The letter is part of a broader pattern of enforcement against direct-to-consumer peptide vendors.
- FDA · majorFeb 21
FDA removes semaglutide from the drug shortage list
FDA declared all doses of semaglutide (Ozempic, Wegovy) no longer in shortage, a status in effect since 2022. Shortage-based compounding grace periods were set for April 22, 2025 (503A) and May 22, 2025 (503B), after which the compounding exemption lapses.
- FDA · majorFeb 18
Tirzepatide compounding grace periods end as FDA affirms shortage resolved
FDA affirmed the tirzepatide shortage was resolved and set end dates for shortage-based compounding: February 18, 2025 for 503A pharmacies and March 19, 2025 for 503B outsourcing facilities. After these dates, compounding tirzepatide is no longer covered by the shortage exemption.