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Nonprescription Drugs: Over the Counter and Underemphasized

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Report Type Reports and Testimonies
Report Date Jan. 10, 1992
Report No. PEMD-92-9
Subject
Summary:

In reviewing Food and Drug Administration (FDA) regulations, GAO discovered several differences in how the agency ensures the safety and effectiveness of over-the-counter versus prescription drugs. GAO found that (1) unlike prescription drugs, many over-the-counter drugs have not been required to demonstrate their safety and effectiveness before being made available to the public; (2) during FDA inspections for compliance with current good manufacturing practices, FDA has statutory authority to inspect records and documents of prescription drug manufacturers but not those of over-the-counter drug manufacturers; and (3) FDA collects less postmarketing surveillance information and conducts fewer product performance analyses for over-the-counter drugs than for prescription drugs. Postmarketing analyses routinely conducted for prescription drugs include patterns of usage, the magnitude of any identified problem and the appropriate level of response, and trends in adverse reactions.

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