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Over the Counter Drugs: Gaps and Potential Vulnerabilities in the Regulatory System

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Report Type Reports and Testimonies
Report Date April 28, 1992
Report No. T-PEMD-92-8
Subject
Summary:

While over-the-counter drugs are a common part of daily life, not all such drugs that reach the marketplace are safe or effective. GAO testified that (1) unlike prescription drugs, many over-the-counter drugs have not been proven safe or effective before being made publicly available; (2) the Food and Drug Administration (FDA) has statutory authority to inspect records and documents of prescription drug manufacturers, but not those of over-the-counter manufacturers; and (3) FDA collects less postmarketing surveillance information and conducts less product performance analysis for over-the-counter drugs than for prescription drugs.

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