FDA Drug Expiration Date Rules

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The FDA has the power to regulate drug expiration dates.
The FDA has the power to regulate drug expiration dates. (Image: drugs image by alimat from Fotolia.com)

The Food and Drug Administration (FDA) regulates the expiration dates on all medical drugs. The Federal Food, Drug, and Cosmetic Act gives the FDA the power to regulate drugs. The laws regulating expiration dates and other aspects of medical drugs protect consumers from ineffective drugs.

Expiration Date Rules

Drug expiration dates are meant to indicate the date at which the drug's potency begins to diminish. The drug does not usually become harmful after the expiration date listed on the box or bottle, but rapid degradation of certain drugs, such as insulin or liquid antibiotics, is possible. Any drug that contains an organic compound is also susceptible to decay. However, most drugs in pill form remain effective beyond the expiration date. The purpose of this expiration date is to inform consumers about the potency and effectiveness of the drug at the time of purchase.

Expiration Date Determination

The FDA mandates that all drug companies test the expiration process of their drugs. A closed-container system is used by these companies to study how the drug ages. Scientists observe the rate at which the drug remains chemically potent. The closed-container environment must mimic the containers the drugs are bought and sold in. The tests also mimic the ideal storage areas the drug should be placed in, usually a cool, dry area.

FDA Exemptions

The FDA grants some exemptions for certain drugs. Any drug that uses a company's previous stock of tested chemicals can accelerate the testing process. This saves the company time and money. At one point the FDA gave an exemption to drug companies that had to reduce the amount of iron in their medications. The iron in the drugs needed to be reduced, but in order to minimize manufacturer burdens the FDA allowed drug companies to skip shelf-life testing.

FDA Tips

Even if it is relatively safe to ingest some medications after the expiration, the FDA and doctors do inform consumers about the dangers of ingesting some expired drugs. Some expired drugs may become discolored or become powdery after a certain amount of time and should be discarded. Expired drugs that are emitting an odor should be thrown out.

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