Regulatory status, tracked and dated
Fast-moving questions with a dated answer: what FDA, WADA and the companies involved have actually done, with every event linked to its source.
- Discussed by advisers; not yet listedVerified Oct 24, 2026
Peptides and FDA 503A Compounding: Status Tracker
As of 2026-10-24, no peptide reviewed at FDA's July 23-24, 2026 Pharmacy Compounding Advisory Committee has been added to the 503A Bulks List, and FDA has posted no minutes, vote results or decision. Trade and legal press reported that the committee voted to recommend several of the seven peptides it reviewed; FDA staff briefing documents concluded the criteria weigh against all seven. An HHS/FDA 'Interim Access Policy for Compounding Using Certain Peptides' (RIN 0910-ZD94) has been under White House (OIRA) review since 2026-10-14; its contents are not public.
Latest: Oct 14, 2026 · Interim peptide access policy sent to White House review
- Shortage over; mass compounding not permittedVerified Oct 24, 2026
Compounded Semaglutide and Tirzepatide: Legal Status Tracker
As of 2026-10-24, neither semaglutide nor tirzepatide is on FDA's drug shortage list, and FDA's enforcement-discretion periods for 503A pharmacies and 503B outsourcing facilities ended in 2025. On 2026-08-27 the Fifth Circuit affirmed FDA's shortage-resolution decisions for both drugs. FDA has proposed (2026-05-01) not to add semaglutide, tirzepatide or liraglutide to the 503B Bulks List; no final decision had been published as of this date.
Latest: Sep 18, 2026 · Warning letter on GLP-1 'combination' products
- Phase 3; US submission planned Q1 2027Verified Oct 24, 2026
Retatrutide: Path to FDA Approval Tracker
As of 2026-10-24, retatrutide (Eli Lilly's GIP/GLP-1/glucagon triple agonist) is investigational and not approved anywhere. Lilly has reported five positive Phase 3 readouts (TRIUMPH-4, TRANSCEND-T2D-1, TRIUMPH-1, TRIUMPH-2, TRIUMPH-3) and said on 2026-07-23 that it plans to submit a Biologics License Application to FDA in Q1 2027; no submission or FDA acceptance has been announced and Lilly has not given an expected decision date. FDA states retatrutide cannot be used in compounding and has warned sellers of 'research use only' retatrutide.
Latest: Aug 24, 2026 · FDA warns online sellers of 'research' retatrutide
- Prohibited at all times (S0/S2)Verified Oct 24, 2026
Peptides on the WADA Prohibited List: Tracker
As of 2026-10-24, the 2026 WADA Prohibited List bans non-approved peptides such as BPC-157 at all times under S0, and names growth-hormone fragments (AOD-9604), GHRH analogues (CJC-1295, tesamorelin), secretagogues (ipamorelin, GHRPs), kisspeptin, mechano growth factors and TB-500 under S2. The 2027 List, published 2026-09-21 and in force from 2027-01-01, adds 'peptides' as a named example in S0. GLP-1 receptor agonists such as semaglutide and tirzepatide remain not prohibited for 2027.
Latest: Sep 21, 2026 · WADA publishes 2027 Prohibited List