Historical Background
At one time, most drugs were available without a prescription. Before the federal Food and Drug Administration (FDA) existed, just about anything could be put in a bottle and sold as a sure-fire cure. Alcohol, cocaine, marijuana, and opium were included in some OTC products without notification to users. The Food, Drug, and Cosmetic (FD&C) Act, enacted in 1938, gave the FDA some authority to issue regulations, but the act did not provide clear guidelines as to which drugs could be sold by prescription only and which could be sold over the counter.
An amendment to the FD&C Act in 1951 attempted to clarify the difference between OTC and prescription drugs and to deal with issues of drug safety. Prescription drugs were defined as compounds that could be habit forming, toxic, or unsafe for use except under a doctor's supervision. Anything else could be sold over the counter.
As noted by the FD&C Act of 1962, OTC drugs were required to be both effective and safe (see Section 2, Chapter 10). However, determining effectiveness and safety can be difficult. What is effective for one person may not be for another, and any drug may cause unwanted side effects (also called adverse effects or adverse drug reactions (see Section 2, Chapter 15)). There is no organized system for reporting the side effects of OTC drugs. Consequently, the FDA and drug manufacturers have virtually no way of knowing how common or serious the side effects are.
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