About two years later, federal regulators announced that the shortage of active ingredients in Mounjaro and Zepbound had been resolved.
Tirzepatide, the active ingredient in diabetes and obesity drugs Mounjaro and Zepbound, was declared in short supply in December 2022. The cause of the shortage is believed to be increased demand due to increased interest in GLP-1 therapeutics.
The Food and Drug Administration (FDA) acknowledged that: statement The shortage is believed to have been resolved by Wednesday.
“FDA has assured drug manufacturers that the availability and manufacturing capacity of their listed products can meet current and projected domestic demand,” the agency said in a statement. “Patients and prescribers may still experience intermittent localized supply disruptions as products move through the supply chain from manufacturers and distributors to local pharmacies.”
The drug shortage situation has allowed compounded versions, which drug companies derisively refer to as “copycat” versions, to be sold in clinics and through telemedicine platforms.
These compound versions have proliferated online, promising consumers the same active ingredients at a fraction of the cost. Although compounding pharmacies are regulated by the FDA, the products sold there are not, and obesity experts have expressed concern about the wide availability of these drugs.
In its shortfall elimination announcement, the FDA provided several clarifications about the combined GLP-1 drugs.
“Combined drugs are not approved by the FDA. Drugs approved by the FDA go through FDA's rigorous review for safety, efficacy, and quality as part of the premarket approval process,” the agency said.
There are two types of dispensing pharmacies: 503A and 503B. The telemedicine platform uses a 503B compounding pharmacy to source compounded GLP-1.
The FDA announced Wednesday that under the Federal Food, Drug, and Cosmetic Act, compounded drugs sold by 503B pharmacies “are not identical or nearly identical to FDA-approved drugs, unless the approved drug is on FDA's drug shortage list.” There's a possibility that there isn't,” he reiterated.
Tirzepatide is no longer in short supply, calling into question the ability of online companies to sell their own formulated versions. One such platform, Eden, was still selling its combination tirzepatide as of Wednesday night. The Hill has reached out to the company for comment.
Eli Lilly, the maker of tirzepatide, sued medispas and pharmacies that sell the combination version. The company previously said it was “deeply concerned about the prevalence of counterfeit, counterfeit, and other unapproved and untested incretin imitations.”
The Hill has reached out to Eli Lilly for comment.
