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How are expiration dates established? FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an...
- Expiration Dating Extension
PAHPRA provides FDA with the explicit authority to extend...
- Expiration Dating Extension
PAHPRA provides FDA with the explicit authority to extend the expiration dating of eligible FDA-approved MCMs stockpiled for use in CBRN emergencies.
1 Μαΐ 2023 · After September 27, 1979, any drug product packaged is required by law to contain an expiration date. This expiration date would guarantee a medication's stability and efficacy up to that date in the original container. All expiration dates must be clearly printed on the label of medications.
§ 211.137 Expiration dating. (a) To assure that a drug product meets applicable standards of identity, strength, quality, and purity at the time of use, it shall bear an expiration date determined by appropriate stability testing described in § 211.166.
Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years. This can be done, as an example, by taking a...
21 Ιουλ 2023 · FDA regulations: The U.S. Food and Drug Administration (FDA) sets guidelines for expiration dating based on stability testing data provided by manufacturers. These guidelines help ensure that medications are safe and effective until their expiration date.
The concept of shelf life started more than 50 years ago (1979) when the health authority in the United States, the Food and Drug Administration (FDA), asked manufacturers to set a limitation date for use for pharmaceutical products to ensure they work safely and effectively for patients.
