The Food and Drug Administration mentioned Thursday it’s standing by its earlier choice that the scarcity of tirzepatide — the energetic ingredient in Eli Lilly’s diabetes and weight reduction medicine Mounjaro and Zepbound — is over.
The choice implies that most compounding pharmacies might want to cease making compounded variations of the drug inside 90 days.
Compounded tirzepatide has soared in reputation as individuals have sought cheaper alternate options to the brand-name medicine.
Compounded medicines are basically copies made by a licensed pharmacist and often prescribed by a physician. During FDA-declared shortages, it’s legal for pharmacists to make compounded versions of brand-name medicine in scarcity, although drugmakers have vehemently pushed again towards the legitimacy of this observe.
The FDA initially declared the tirzepatide shortage over in October however the Outsourcing Facilities Association, a commerce group for compounding pharmacists, sued, claiming the drug was still in shortage, which pushed the company to take one other look.
During its reevaluation, the FDA mentioned it would allow pharmacists to continue making compounded versions of tirzepatide.
In an announcement Thursday, an FDA spokesperson mentioned compounding pharmacies have till Feb. 18 to distribute their remaining provide of the compounded medicine.
However, pharmacists producing the medicine in bulk — often known as 503B compounding services — will get an extra month, with a deadline of March 19.
“FDA should still take motion relating to violations of some other statutory or regulatory necessities, reminiscent of to deal with findings {that a} product could also be of substandard high quality or in any other case unsafe,” the spokesperson mentioned.
A spokesperson for the Outsourcing Facilities Association didn’t instantly reply to a request for remark.
Semaglutide, the energetic ingredient in Novo Nordisk’s diabetes and weight reduction medicine Ozempic and Wegovy, remains to be in scarcity, in keeping with the FDA.
Thursday’s choice is a significant win for Lilly, which maintained via the lawsuit that the scarcity had been resolved. They’ve additionally pushed again on compounded variations of the medicine, claiming they’re “untested, unapproved knockoffs.”
Lilly had first indicated in August that the tirzepatide scarcity can be resolved quickly, two months earlier than the FDA’s preliminary choice that it was resolved.
