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GAO discussed the Food and Drug Administration's (FDA) procedures for approving and monitoring over-the-counter (OTC) drugs sold in the United States. GAO noted that: (1) many OTC drug products, unlike prescription drugs, are not required to be demonstrably safe and effective before being made available to the public; (2) although the current good manufacturing practices regulation requires manufacturers of both OTC and prescription drugs to maintain customer complaint files, equipment maintenance logs, and other manufacturing records, FDA does not have the statutory authority to inspect the records of OTC drug manufacturers as it does those of prescription drug manufacturers; (3) FDA obtains less postmarking surveillance information and conducts less product performance analysis for OTC drugs than for prescription drugs; (4) FDA has been slow to develop monographs for OTC drugs and has only moved 36 of the 88 drug categories under consideration into final rules, as of April 1992; (5) FDA does not require manufacturers of OTC monograph drugs to report adverse reactions experienced by their customers; and (6) FDA does not know and is unable to determine the number of OTC products currently being marketed in the U.S. GAO believes that, since FDA may not know of adverse reactions to OTC drugs and is unable to determine the magnitude of problems it is made aware of, it is difficult to be sure that the FDA can fulfill its mission to protect the public health.

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