Preparing for and Responding to an FDA Inspection

Over the decades, there has been an uneasy truce between pharmacies and the FDA. Pharmacies are regulated by their state boards; the FDA steps in when it concludes that the pharmacy has crossed the line over into the manufacturing arena. However, the FDA is becoming increasingly aggressive in attempting to assert jurisdiction over pharmacies. There are several reasons for this with the main reason being the FDA’s concern that state pharmacy boards are not adequately overseeing compounding pharmacies. In addition, the New England Compounding Center tragedy has cast a spotlight on compounding pharmacies. This program will discuss the legal basis upon which the FDA can assert jurisdiction over pharmacies, the legal arguments against such an assertion of jurisdiction, existing and potential legislation that addresses the FDA’s authority over pharmacies, the steps that the pharmacy can take to prepare for an FDA inspection, and the steps that the pharmacy can take to respond to an FDA inspection/enforcement action.

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