FDA Scrutinizes Compounding Pharmacies Amid Surge in Demand for weight Loss Drugs
WASHINGTON – The Food and Drug Administration is increasing its oversight of compounding pharmacies that have been producing large quantities of popular weight loss drugs like Zepbound and Wegovy, as well as sleep medications, amid concerns about legality and patient safety. The agency,along with manufacturers Novo Nordisk and Eli Lilly,disputes the legal basis for these large-scale compounding operations,which initially flourished by providing an option supply when drugmakers faced shortages.
The increased scrutiny comes as demand for glucagon-like peptide-1 (GLP-1) receptor agonists-used for both diabetes and weight loss-continues to outpace supply. compounding pharmacies previously capitalized on this by obtaining the active pharmaceutical ingredients and creating their own versions, often allowing for individualized doses and larger batch sizes.Though, Novo Nordisk and Eli Lilly argue that this practice infringes on their intellectual property and raises questions about the quality control of these compounded drugs.
The issue is escalating at the state level,too. In Ohio, the Board of Pharmacy is implementing a new regulation limiting the amount of sterile injectable drugs, including weight loss medications, that pharmacies can produce in anticipation of prescriptions to 250 units per drug. This aims to curb the practice of large-scale production and ensure that compounding remains focused on meeting individual patient needs.
The FDA has not publicly detailed specific enforcement actions but has signaled its intention to address what it views as unauthorized compounding.The agency’s move reflects a broader effort to regulate the rapidly growing market for GLP-1 drugs and ensure patient access to safe and effective treatments. The future of compounded versions of these medications remains uncertain as the FDA and drug manufacturers continue to challenge their legality.
