How Risky Are Compounding Pharmacies?Kotz, Deborah
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The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular GLP-1 drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have registered un...
However, the APC said in its statement that Novo Nordisk does not have total control over the supply chain and that other FDA-registered manufacturers can produce semaglutide and provide it to compounding pharmacies. “Compounding is authorized in federal law and in all 50 states —...
However, some custom formulations, like the company’s chewable tablets and combination therapies, aren’t FDA-approved themselves, even though their individual components are FDA-approved and the compounding pharmacies that make them are FDA-regulated....
The FDA allows and even encourages compounding pharmacies to produce and sell copycats when a drug is in short supply, and the wildly popular GLP-1 drugs have enduring shortages — first reported in March 2022 for semaglutide and in December 2022 for tirzepatide. The drugs have reg...
The state Boards of Pharmacy have been lax in regulating the practices of compounding pharmacies, like the New England Community Center, Framingham, Mass., implicated in the fungal meningitis outbreak. Instead, most of their enforcement actions have concentrated on complian...