The Food and Drug Administration announced Thursday that it is upholding an earlier decision that the shortage of tirzepatide, the active ingredient in Eli Lilly’s diabetes and weight-loss drugs Munjaro and Zepbound, has been resolved.
This decision means that most compounding pharmacies will have to stop manufacturing compounded drugs within 90 days.
The popularity of the compound tirzepatide has skyrocketed as people seek cheaper alternatives to brand-name drugs.
Compounded medications are essentially copies made by a licensed pharmacist and are typically prescribed by a doctor. While the FDA declares a shortage, It is legal for pharmacists to manufacture combination drugs Branded drugs are in short supply, but pharmaceutical companies are fiercely opposed to the legitimacy of this practice.
The FDA initially declared tirzepatide The shortage will be resolved in OctoberHowever, the Outsourcing Facilities Association, an industry group for dispensing pharmacists, filed a lawsuit. medicine was still in short supplywhich prompted the agency to reconsider.
Upon re-evaluation, the FDA said it would allow pharmacists to continue manufacturing combination versions of tirzepatide.
An FDA spokesperson said in a statement Thursday that compounding pharmacies must distribute remaining supplies of the compounded drug by Feb. 18.
However, pharmacists who manufacture large quantities of drugs, known as 503B compounding facilities, will have an additional month, with the March 19 deadline.
“FDA may continue to take action regarding violations of other statutory or regulatory requirements, including addressing findings that products are of substandard quality or may be unsafe,” the spokesperson said. Ta.
A spokesperson for the Outsourcing Facilities Association did not respond to a request for comment.
Scott Brunner, CEO of the Alliance for Pharmacy Compounding, another industry group, said the FDA’s decision is not the end of the story.
“The agency is focused on resolving the October 2nd shortage, but litigation remains ongoing,” Brunner said.
According to the FDA, there is still a shortage of semaglutide, the active ingredient in Novo Nordisk’s diabetes and weight loss drugs Ozempic and Wigovy.
Thursday’s decision was a major victory for Lilly, which had argued that the shortage had been resolved through litigation. The company also plans to sell a combination version of the drug.
“Anyone marketing or selling unapproved tirzepatide counterfeit products must stop,” a Lilly spokesperson said in a statement Thursday.
The first thing Lily pointed out was in august That was two months before the FDA’s initial decision that the tirzepatide shortage would be quickly resolved.
