The Food and Drug Administration announced Thursday that it is upholding its previous ruling that the scarcity of tirzepatide, the active component of Eli Lilly’s weight-loss and diabetic medications Zepbound and Mounjaro, has ended.
Due to the ruling, the majority of compounding pharmacies will have to cease producing the drug’s compounded forms within ninety days.
The use of compounded tirzepatide has increased dramatically as consumers look for less expensive substitutes for name-brand medications.
In essence, compounded drugs are copies created by a certified pharmacist and typically prescribed by a physician. Although pharmaceutical companies have strongly contested the validity of this practice, it is allowed for pharmacists to create compounded copies of brand-name medications that are in short supply during FDA-declared shortages.
When the Outsourcing Facilities Association, a trade association for compounding pharmacies, filed a lawsuit, arguing that the medicine was still in short supply, the FDA reconsidered its initial October declaration that the tirzepatides crisis was gone.
The FDA stated that it would permit pharmacists to continue producing compounded forms of tirzepatide during its reevaluation.
Compounding pharmacies have until February 18 to disperse the remaining stock of the compounded medications, according to a statement released by the FDA on Thursday.
Nonetheless, 503B compounding facilities—pharmacists that make the medications in large quantities—will be granted an extra month, with a deadline of March 19.
“FDA may still take action regarding violations of any other statutory or regulatory requirements, such as to address findings that a product may be of substandard quality or otherwise unsafe,” a spokeswoman stated.
A request for comment was not immediately answered by an Outsourcing Facilities Association representative.
The FDA’s ruling isn’t the end of the tale, according to Scott Brunner, CEO of Alliance for Pharmacy Compounding, another trade association.
“Though the agency is doubling down on its October 2 shortage resolution, there’s still litigation out there,” Brunner stated.
The FDA reports that there is still a scarcity of semaglutide, the main ingredient in Novo Nordisk’s diabetes and weight-loss medications Ozempic and Wegovy.
Lilly, which insisted throughout the lawsuit that the shortage had been fixed, won a significant victory with Thursday’s ruling. Additionally, it has opposed compounded forms of the medications.
In a statement released Thursday, a Lilly representative stated that “anyone marketing or selling unapproved tirzepatide knockoffs must stop.”
Two months before to the FDA’s original ruling that the tirzepatide shortage was fixed, Lilly had first stated in August that it will be resolved shortly.
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