Automotive locksmith in U.S. Food and Drug Administration(240) 266-9112

 



A medical product is typically labeled by themanufacturer with an expiration date.  This reflects the time period during which the product is expected to remain stable, or retain its identity, strength, quality, and purity, when it is properly stored according to its labeled storage conditions.  Expiration dating can present challenges to  because that have reached their labeled expiration date in most cases cannot be used.  While this is important to ensure patient safety, it also means that the some of which might still be stable, must be replaced regularly, which can be very costly. 

Approaches to Drug Product Expiration Date Extensions

Initiated by the Manufacturer

Shelf-Life Extension Program

Emergency Use Authorities (including stockpiler-initiated)

Enforcement Discretion

Approaches to Drug Product Expiration Date Extensions

The manufacturer of an approved drug product may extend the expiration date for the drug product based on acceptable data from full, long-term stability studies on at least three pilot or production batches in accordance with a protocol approved

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