A federal court ruling in Texas mandates that compounding pharmacies halt the production of compounded versions of Wegovy and Ozempic, as the FDA has determined there are no shortages of these medications. The ruling affects both traditional 503A and outsourcing 503B compounding facilities, with enforcement actions anticipated against those that continue production. This decision follows a legal challenge from the Outsourcing Facilities Association, which contends that evidence supports the existence of an ongoing shortage, a claim the court declined to consider.
The federal court ruling by Judge Mark Pittman upholds the FDA's assessment that the shortage of semaglutide is resolved, impacting compounding pharmacies.
Lee Rosebush from the Outsourcing Facilities Association asserted that the supply data indicates an ongoing shortage of the metabolic medicines despite the court's decision.
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