Court Ruling Opens Door for FDA Action Against Ozempic Compounding Pharmacies.

A recent court ruling potentially clears the way for the Food and Drug Administration (FDA) to take action against pharmacies that compound versions of Ozempic. This development represents a potential victory for Novo Nordisk, the manufacturer of Ozempic. The court’s decision removes a legal barrier that previously complicated the FDA’s ability to regulate the compounding of Ozempic. Compounding pharmacies create custom medications, often when a drug is in short supply or a patient needs a specific formulation. Novo Nordisk has raised concerns about the safety and efficacy of compounded versions of its drug, which is approved for treating type 2 diabetes and, at a higher dose, for weight loss. Now, the FDA could potentially use the ruling to more aggressively pursue regulatory actions against compounders the agency believes are not adhering to quality and safety standards.

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Date: April 25, 2025

Author

Mark Chiang