Nonprescription Drugs: Over the Counter and Underemphasized
PEMD-92-9
Published: Jan 10, 1992. Publicly Released: Feb 27, 1992.
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Highlights
Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) procedures for approving and monitoring over-the-counter (OTC) drugs, focusing on: (1) procedural vulnerabilities that could result in the approval and marketing of unsafe and ineffective drugs; and (2) procedures for approving prescription drugs compared to OTC drug procedures.
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Comparative analysisDrugsFood and drug lawMonitoringPharmaceutical industryPharmacological researchProduct safetyQuality assuranceSafety regulationSafety standards