The US FDA has proposed an end to most types of compounding of semaglutide, tirzepatide, and liraglutide.

The agency said in a statement it has determined there is no longer a clinical need for certain compounded versions of the medications. At times in the last few years, these GLP-1 medications have been in short supply, due to the increasing demand for weight loss. 

But the FDA removed semaglutide from the drug shortages list in February 2025, and tirzepatide was removed in December 2024. Liraglutide is available from most manufacturers, although there are some shipping delays for certain forms of Victoza (Novo Nordisk). 

“When FDA-approved drugs are available, outsourcing facilities cannot lawfully compound using bulk drug substances unless there is a clear clinical need,” said FDA Commissioner Marty Makary, MD, MPH, in the statement. 

Under the proposal, compounders would be prohibited from making copies of the three GLP-1 medications under the 503B section of the Food, Drug, and Cosmetic Act. Compounding still might be available under the 503A section, which are medications essentially made specifically for individual patients.

The FDA said, before making a final decision, it would consider public comments on the proposal through June 29.

The Alliance for Pharmacy Compounding said in a statement it is currently reviewing the FDA’s proposal, but that it did not believe it changed the status quo. “Under existing law, compounding with these substances by outsourcing facilities is already limited and has primarily occurred in the context of drug shortages,” said the group.

The FDA has frequently taken issue with GLP-1 compounding. In February, it posted a list of concerns about illegal and unapproved GLP-1s, including compounded versions. A few months later, the FDA reiterated its concerns, but said it would not take enforcement action against a compounder that made a copy of a commercially available drug if that compounder filled four or fewer prescriptions monthly.

That may leave a loophole for medical spas and some telehealth companies, which have continued to sell compounded GLP-1s. Increasingly, these are offered with additives to “differentiate” from compounded versions that are strict copies of the brand-name medications, according to the market research firm IQVIA. 

In October, IQVIA reported that more than 80% of compounded semaglutide and tirzepatide prescriptions included supplemental ingredients such as B vitamins (B6, B12, B3) or levocarnitine. The additives “may serve as a rationale for continued compounding despite the FDA’s resolution of supply shortages,” wrote the IQVIA researchers. They added that “some compounders may be utilizing these modifications to differentiate their products or navigate regulatory ambiguity.”

Pharmaceutical manufacturers have frequently sued or threatened litigation against medspas and telehealth companies selling compounded versions of their GLP-1s. 

Two of the biggest telehealth companies are now moving away from compounded GLP-1s. Hims & Hers announced in March that it would be making Novo Nordisk’s semaglutide injections and pills available to subscribers. It said it would “offer access to compounded GLP-1s if a provider determines that a compounded product is clinically necessary.”

Ro struck a deal in April with Eli Lilly to prescribe its orforglipron (Foundayo) pill and also offers semaglutide pills and injections and tirzepatide injections to customers.

Alicia Ault is a Saint Petersburg, Florida-based freelance journalist whose work has appeared in many health and science publications, including Smithsonian.com. You can find her on X @aliciaault and on Bluesky @aliciaault.bsky.social.