Lawsuits and enforcement actions against pharmaceutical compounders producing copies of popular diabetes and weight loss drugs, such as semaglutide (Wegovy/Ozempic/Rybelsus, Novo Nordisk) and tirzepatide (Mounjaro/Zepbound, Eli Lilly), are likely to have little effect on 503B outsourcing facilities. Very little of this compounding is done in the 503B setting, according to industry representatives.

“The data that we have reviewed signals that compounding of most GLP-1 [glucagon-like peptide 1] agonists is performed by state-licensed pharmacies,” said Marc Wagner, general counsel for the Outsourcing Facilities Association (OFA). “In the most recent 503B product report, which covers the period from June to December 2023, there were a total of three 503B facilities compounding semaglutide, and none compounding tirzepatide.” 

Mr. Wagner also stressed that none of the ongoing litigation over compounding of these drugs involves any 503B facilities.

With some forms of semaglutide and tirzepatide still listed on the FDA’s drug shortage list as of late February, compounding of these drugs by 503B outsourcing facilities is permitted, but the agency has warned of illegally marketed versions that could be counterfeit and/or may not contain the same active ingredient as FDA-approved semaglutide products and may be the salt formulations.

Both Novo Nordisk and Eli Lilly have filed suit against multiple pharmacies that they allege are selling unauthorized versions of their drugs. In September 2023, Lilly sued eight U.S. companies that it claims are selling compounded versions of tirzepatide; it followed that lawsuit with an October complaint to the U.S. International Trade Commission against 11 online pharmacies, including several overseas companies, that it alleges are importing or selling unauthorized copies of the drug.

This February, Novo Nordisk reached a settlement with two of the companies it had sued: Cosmetic Laser Professionals Med Spa and Nuvida Rx Weight Loss, both based in Florida. Under the terms of the settlement, the companies are permanently banned from claiming that their compounded drugs are medicines approved by the FDA.

Legal actions against other companies, including compounding pharmacies Wells Pharmacy and Brooks Pharmaceuticals, are ongoing.

In a statement issued Nov. 29, 2023, Novo Nordisk warned against the “significant health risks” that might be associated with these unauthorized compounded drugs. “Following several analyses of compounded drugs claiming to contain semaglutide, we have seen concerning levels of unknown impurities as high as 33% and lower levels of strength than labeled in the compounded products, which could potentially put patients’ health at risk,” said Jason Brett, the executive director for medical affairs. “Our priority is to protect patient safety and to ensure that patients have a safe and positive experience with our FDA-approved semaglutide medicines.”

Mr. Wagner reported no relevant financial disclosures other than his stated employment. 

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