What should you do if a Representative from the Food and Drug Administration(FDA) shows up to inspect your pharmacy? By David G. Miller, RPh, IACP Executive Vice President & CEO First, remember that, according to the Federal Food, Drug, and Cosmetic Act (FDC Act), FDA has the right to inspect your pharmacy. Section 704(a) of the FDC Act authorizes FDA to inspect facilities where drugs are stored, including pharmacies. Section 704(a) also provides some speciifc limitations on what the FDA may inspect in a licensed and compliant pharmacy. Refusing to allow FDA inspectors to enter the pharmacy during your normal business hours can violate Section 301(f) of the FDC Act as a “refusal” to allow inspection. Therefore, outright refusal during your business hours is almost never a viable option. However, the investigator does not have free rein to go everywhere in your facility or to see everything. Although FDA has broad powers to inspect drug manufacturers, the FDC Act restricts the scope of FDA inspections of retail pharmacies. Under Section 704(a)(2)(A), FDA’s inspections are far more limited when visiting a pharmacy than when auditing a drug manufacturer. FDA can only inspect at reasonable times, “all pertinent equipment, finished and unfinished materials, containers, and labeling therein.” Unlike with a drug manufacturer, it does not have the right to inspect the items in the third sentence listed in Section 704(a): “records, files, papers, processes, controls” or other related documents of a pharmacy that meets certain criteria. For a compounding pharmacy to qualify for this exemption, it must meet the following criteria: Pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs or devices, upon prescriptions of practitioners licensed to administer such drugs or devices to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the regular course of their business of dispensing or selling drugs or devices at retail. If a pharmacy does not compound, or compounds medication only in the normal course of pharmacy practice and meets the other criteria, FDA’s broad inspectional powers to inspect do not apply. FDA investigators generally are not trained to inspect pharmacies, and many investigators do not know that there is this exemption for pharmacies. Please email IACP with any questions. I A C P C U S T O M Rx C O N N E C T I O N I A C P R X . O R G 21
Custom Rx Connection August 2012
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