As GLP-1 supply issues resolve, FDA clarifies policies

The shortage of certain GLP-1s like tirzepatide (Mounjaro/Zepbound—Eli Lilly) has been resolved, according to FDA.  

Lilly’s supply of the GLP-1 medication can now meet current and projected national demand, the agency said. Tirzepatide has been in short supply since 2022 due to soaring demand. 

In its announcement, FDA also clarified its policies regarding compounded GLP-1 drugs. “Compounded drugs are not approved by FDA. FDA-approved drugs go through FDA’s rigorous review for safety, effectiveness, and quality as part of the premarket approval process,” the agency said.  

FDA noted that compounded medications must meet certain conditions to be eligible for exemptions under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act. FDA said that compounded drugs sold by 503B pharmacies “may not be identical or nearly identical to an FDA-approved drug unless the approved drug is on FDA’s drug shortage list.” 

As for other GLP-1s, FDA said dulaglutide injection, semaglutide injection, and liraglutide injection are all still in shortage.  

FDA noted that they will continue to work with manufacturers to help resolve the current shortages and, as shortages resolve, “will closely monitor the situation and provide any assistance we can to help manufacturers ensure an adequate supply.”