Compounded Semaglutide and Tirzepatide: Legal Status Tracker
Where things stand
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.
Timeline
- · Regulatory
Warning letter on GLP-1 'combination' products
FDA warned Empower Pharmacy that compounded tirzepatide/niacinamide and semaglutide/cyanocobalamin products 'appear to be essentially copies' of FDA-approved drugs and, given the volumes, do not qualify for 503A exemptions.
FDA Warning Letter: Empower Clinic Services LLC dba Empower Pharmacy (MARCS-CMS 738238) - · Legal
Fifth Circuit upholds FDA shortage decisions
In OFA v. FDA (Nos. 25-10600, tirzepatide, and 25-10758, semaglutide), the Fifth Circuit affirmed the district court judgments upholding FDA's removal of both drugs from the shortage list. The semaglutide opinion was revised on 2026-09-01.
U.S. Court of Appeals for the Fifth Circuit, No. 25-10600 - · Regulatory
Warning letters to 'research use only' GLP-1 sellers
FDA warned five online vendors selling semaglutide, tirzepatide and retatrutide labeled 'for research use only'. FDA treated them as unapproved new drugs intended for human use.
FDA Warning Letter: Royal Peptides LLC (MARCS-CMS 734884) - · Regulatory
FDA proposes excluding GLP-1s from 503B Bulks List
FDA proposed not to include semaglutide, tirzepatide or liraglutide on the list of bulk substances outsourcing facilities may use. The comment period was extended to 2026-07-30; no final notice had been published as of 2026-10-24.
Federal Register 2026-08552 - · Regulatory
FDA reiterates 503A and 503B conditions
FDA updated its GLP-1 compounding page to remind compounders that neither drug is on the shortage list or the 503B Bulks List.
FDA: FDA clarifies policies for compounders as national GLP-1 supply begins to stabilize - · Company
Novo Nordisk and Hims & Hers agreement
Novo Nordisk said Hims & Hers would offer FDA-approved Ozempic and Wegovy and stop advertising compounded GLP-1s, and that Novo was dismissing its patent lawsuit against Hims & Hers.
Novo Nordisk company announcement (Mar 9, 2026) - · Regulatory
FDA warns 30 telehealth companies
FDA issued 30 warning letters over claims implying compounded GLP-1s are the same as FDA-approved drugs or hiding who compounds them.
FDA press announcement (Mar 3, 2026) - · Regulatory
FDA announces steps against non-approved GLP-1 drugs
FDA said it intends to restrict GLP-1 active ingredients used in non-FDA-approved compounded drugs marketed at scale and to act against misleading promotion.
FDA press announcement (Feb 6, 2026) - · Regulatory
503B enforcement discretion ends for semaglutide
The period during which FDA did not intend to act against outsourcing facilities compounding semaglutide ended.
FDA: FDA clarifies policies for compounders - · Legal
Court denies injunction in semaglutide case; 503A discretion ends
The Northern District of Texas denied a preliminary injunction in OFA v. FDA (4:25-cv-00174); FDA's 503A discretion for semaglutide (set for 2025-04-22, extended to the decision date) ended.
FDA: FDA clarifies policies for compounders - · Regulatory
503B enforcement discretion ends for tirzepatide
The period during which FDA did not intend to act against outsourcing facilities compounding tirzepatide ended.
FDA: FDA clarifies policies for compounders - · Legal
Court denies injunction in tirzepatide case; 503A discretion ends
The Northern District of Texas denied a preliminary injunction in OFA v. FDA (4:24-cv-00953); FDA's 503A discretion for tirzepatide (set for 2025-02-18, extended to the decision date) ended.
FDA: FDA clarifies policies for compounders - · Regulatory
Semaglutide shortage declared resolved
FDA determined the semaglutide injection shortage was resolved.
FDA: FDA clarifies policies for compounders - · Regulatory
FDA reaffirms tirzepatide shortage is resolved
After re-evaluating its 2024-10-02 decision during litigation, FDA reaffirmed that the tirzepatide shortage was resolved.
FDA: FDA clarifies policies for compounders
Questions
Can pharmacies still compound semaglutide or tirzepatide?
The shortages that allowed broad compounding are over and FDA's grace periods ended in 2025. Under 503A, a pharmacy may not compound drugs that are 'essentially copies' of approved drugs regularly or in inordinate amounts; FDA has applied this to products with added B12 or niacinamide.
What happened in the OFA v. FDA lawsuits?
The district court denied preliminary injunctions in March and April 2025, and on 2026-08-27 the Fifth Circuit affirmed in both the tirzepatide and semaglutide cases.
Are 'research use only' semaglutide or tirzepatide products legal?
FDA's August 2026 warning letters state that such labels do not change products' status as unapproved new drugs when the seller's marketing shows they are intended for human use.
Is the 503B Bulks List decision final?
No final notice was found in the Federal Register as of 2026-10-24. FDA's May 1, 2026 notice is a proposal not to include the three GLP-1s.
Regulatory status changes; check the linked primary source before relying on any entry. This tracker is information, not legal advice. Report an error.