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On this page: Approaches to Drug Product Expiration Date Extensions Initiated by the Manufacturer Shelf-Life Extension Program Emergency Use Authorities (including stockpiler-initiated) Enforcement Discretion MCM Expiration Dating Extensions Additional Information Approaches to Drug Product Expiration Date Extensions Initiated by the Manufacturer 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 in the NDA or ANDA