[20160829]IF10463_非处方药监管.pdf

https:/crsreports.congress.gov August 29, 2016Regulation of Over-the-Counter (OTC) DrugsThe Food and Drug Administration (FDA) regulates the safety and effectiveness of drug products sold in the United States. FDAs regulatory authority covers both prescription and nonprescription (i.e., over-the-counter, or OTC) drugs, among other things. Legislative Background The Pure Food and Drug Act of 1906 prohibited the interstate commerce of adulterated and misbranded drugs, but it did not provide FDA with the authority to review and approve products before they enter the market. Thus, drugs introduced between 1906 and 1938 were considered “pure” but with unknown safety and effectiveness. In 1938, Congress passed the Federal Food, Drug, and Cosmetic Act (FFDCA), which authorized FDA to regulate the safety of drug products sold in the United States. In 1951, the FFDCA was amended to include a prescription-only category of drugs. While prescription drugs require health practitioner supervision (due to drug toxicity, potential harmful effect, and/or method of use), OTC drugs can be used without a prescribers authorization, provided that they have an acceptable safety margin, low potential for