Drug expiration

From Wikipedia, the free encyclopedia

Drug expiration is the date after which a drug might not be suitable for use as manufactured. Consumers can determine the shelf life for a drug by checking its pharmaceutical packaging for an expiration date.

Drugs which are past their shelf life can decompose[1] and either be ineffective[2] or even harmful.[2] Standard advice from drug manufacturers and some health organizations is to dispose of drugs after the expiration date printed on the packaging. However, the published expiration date is not an absolute indication that a drug has spoiled. Consumers and organizations sometimes use expired drugs for medical treatment either as a cost saving measure or because they otherwise cannot access drugs which are not expired. Medical authorities find it difficult to discuss when consumers can safely use drugs after the printed expiration date because it is difficult to obtain clear information. [3]

Manufacturers print expiration dates on drug bottle labels.[4] The labeled expiration date is a manufacturer's promise for a time until which the drug will have full efficacy and be safe as manufactured.[4] The labeled expiration date is not an indication of when a drug has become ineffective or unsafe to use.[4] Many drugs are effective for years after their expiration dates.[4] However, it is difficult for anyone including researchers and physicians to find information to verify how much any given drug will degrade in efficacy or become unsafe over time.[4][5] Drug manufacturers never support the use of drugs after the expiration date because that could make them liable if something went wrong.[6]

The expiration date printed on drug packaging will differ from the date when the drug will become ineffective.[7] Before the true expiration of a drug, its active ingredient will retain its potency.[8] Also before expiration, no components of the drug will degrade to become harmful.[8] Since products continually change over time, the characteristics of any drug are not unchanging but instead estimated with assay measurements to be within the specification required by the government regulator where the drug is sold.[7] As a general estimate, a drug is deemed to be unfit for use when 10% of the active ingredient is degraded.[9][10]

Before choosing an expiration date to print the manufacturer must decide a true expiration date.[7] After a manufacturer has decided what true expiration date it has set, then it will decide another date to make public and advertise on the packaging of the drug.[7] The printed expiration date will always be sooner than the true expiration date, because the drug should always be effective and safe before the labeled expiration date if kept properly.[7]

Options for expired drugs

Shelf Life Extension Program

References

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