Patients often have questions about drug expiration dates: Can they take a medication if it has reached the drug expiration date?
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The expiration date is the final day that the manufacturer guarantees the full potency and safety of a medication. pharmaceutical manufacturers are required by law to place expiration dates on prescription products prior to marketing.
Drug expiration dates exist on most medication labels, including prescription, over-the-counter (OTC) and dietary (herbal) supplements. For legal and liability reasons, manufacturers will not make recommendations about the stability of drugs past the original expiration date.
The expiration date of a drug is estimated using stability testing under good manufacturing practices as determined by the Food and Drug Administration (FDA).
Drug products marketed in the US typically have an expiration that extends from 12 to 60 months from the time of manufacturer.
Once the original container is opened, either by the patient or the health care provider who will dispense the drug, that original expiration date on the container can no longer be relied upon.
At the pharmacy, "beyond-use" dates are often put on the prescription bottle label given to the patient.
These dates often say "do not use after..." or "discard after..." and are required by the Board of Pharmacy in many states.
These dates are typically one year from the date on the stock bottle. According to the manufacturer, the stability of a drug cannot be guaranteed once the original bottle is opened.
Therefore, the United States Pharmacopeia (USP), the body that sets the standards for pharmaceutical quality in the U. The "beyond use" date would never be later than the expiration date on the manufacturer's bottle.
The American Medical Association (AMA) concluded in 2001 that the actual shelf life of some products is longer than the labeled expiration date.
The AMA stated the best evidence resides in the Shelf Life Extension Program (SLEP) undertaken by the FDA for the Department of Defense.