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How Are Over-The-Counter Drugs Regulated to Help Ensure Safety?

Many Florida residents don't give much thought to the safety of their over-the-counter medications. What they may not realize is the safety of these drugs is the responsibility of the U.S. Food and Drug Administration.

The FDA has a process for review and approval of drugs sold over the counter before they can be marketed to consumers. In an increasing number of cases, they have allowed drugs that previously required a prescription from a physician to be available to the general public without a prescription.

The FDA's Center for Drug Evaluation and Research, along with the Nonprescription Drug Advisory Committee, work to evaluate the safety of more than 300,000 OTC drugs. The CDER deals with more than what most of us consider medications. It regulates products including sunscreens, antiperspirants, fluoride toothpaste and dandruff shampoos.

There are a number of requirements that must be met by manufacturers of OTC drugs in order to sell them without further review by the FDA. The FDA has drug monographs that detail labeling requirements as well as dosages, ingredients, formulations and the safety of these OTC drugs. They cover more than 80 individual therapeutic drug classes.

Despite these regulations, OTC medications can sometimes cause illnesses that were not anticipated. In addition to that, there are sometimes instances of tampering or contamination of OTC drugs that can cause harm or even death. The Tylenol tampering case back in 1982 near Chicago resulted in many of the product protection safeguards that many people have grown up with.

Those who believe that they or a loved one suffered harm or worse as the result of consuming a dangerous drug would be wise to seek legal guidance. By taking steps to hold the manufacturer accountable, they may be able to recover compensation to cover medical bills and other damages and also protect other consumers from similar harm.

Source: U.S. Food and Drug Administration, "Drug Applications for Over-the-Counter (OTC) Drugs," accessed May. 19, 2015

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