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Forest Park Pharmacy owner Brad Hart may have to stop dispensing compounded weight loss drugs, which are cheaper, easy to find copies of the in-demand pharmaceuticals.He has been filling prescriptions for the compounded version of drugs like Ozempic and Wegovy since the federal government declared a shortage in 2022. Then, in February, the Federal Drug Administration announced the shortage was over. Hart is among the pharmacists concerned that people who need the medication now won’t have access to an affordable, readily available alternative. Semaglutide decreases blood sugar and leads to weight loss. The compounded versions contain the active ingredient of the name brands but are cheaper and easier to find. “Only about 9% of patients have a chance to actually get the medication in the first place on their insurance, and if people are getting it off of insurance it’s basically unaffordable,” Hart said. “It’d be $1,200 a month.”However, because the FDA does not review these compounded drugs to evaluate their safety, effectiveness, or quality before they reach patients, they are not FDA-approved.When semaglutide was classified as being in short supply, U.S. regulators allowed compounded pharmacies to manufacture copies of the brand-name drugs. A Texas-based trade association that represents FDA-registered compounding facilities filed a lawsuit against the government over its decision ending the shortage. Registered outsourcing facilities that compound the drug are what Hart calls the “big guys,” and are the facilities where pharmacies like Forest Park get their drugs. The Feb. 24 lawsuit accuses the FDA of removing the drug from the shortage list without evidence. The lawsuit goes on to call the FDA’s decision to declare the shortage over as “reckless and arbitrary” and takes away from patients “a vital treatment for Type 2 diabetes, obesity, cardiovascular disease, and other serious medical conditions.”“The agency confirmed that there remains a semaglutide shortage and that ‘many’ patients cannot access semaglutide production,” the lawsuit reads. A form filed with the Securities and Exchange Commission Feb. 5 said “supply constraints” and “drug shortage notifications” for semaglutide will continue into the foreseeable future, according to the lawsuit. The outsourcing facility that Hart gets the medication from is part of the association filing the lawsuit. “They’ve been keeping us updated on how it’s going on their end with the litigation,” Hart said. “They’re certainly spinning as fast as they can to get this going.”The FDA likely will not enforce the shortage until the lawsuit is settled, Hart said. The government should soon file a response to an injunction request, according to the Alliance for Pharmacy Compounding.What is the future of compounded semaglutide?The FDA has established deadlines for compounders, saying the agency does not intend to take action against compounders for violating federal law until then. Enforcement actions can include imposing money penalties, injunctions and seizures.State-licensed pharmacies or physicians that compound, distribute or dispense copy semaglutide injection products such as Forest Park Pharmacy have until April 22, or until the date of the district court’s decision on the outsourcing facilities association preliminary injunction motion — whichever is later — to comply. Outsourcing facilities have until May 22 to comply.As things currently stand, compounding pharmacies and outsourcing facilities will not be able to prepare semaglutide copies again, said Scott Brunner, CEO of Alliance for Pharmacy Compounding. The FDA also approves drug compounding if a prescriber decides they want a different dosage form, strength or combination for a patient than what is commercially available. The FDA’s decision does not affect this practice, Brunner said. “FDA has a guidance document that pharmacies must adhere to. It basically says the FDA is not going to question the medical judgment of a prescriber,” Brunner said. Forest Park Pharmacy sends compounded semaglutide all over Texas, and Hart expects patients won’t be able to fill prescriptions for the name-brand drugs when facilities can no longer make compounded copies. Demand for semaglutide drugs is only growing, Hart said. The list of FDA-approved treatments  has expanded to include reducing the risk of heart attacks and strokes. “I suspect the medication being removed from shortage is probably going to get upheld, and then I imagine it’ll go back to shortage pretty soon after that,” Hart said. “They won’t be able to keep up.”Kathryn Miller is a reporting fellow at the Fort Worth Report. You can contact her at kathryn.miller@fortworthreport.org. At the Fort Worth Report, news decisions are made independently of our board members and financial supporters. Read more about our editorial independence policy here.