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FDA announces availability of final guidance and updates to the Inactive Ingredient Database

from Division of Drug Information

FDA announces availability of final guidance and updates to the Inactive Ingredient Database Division of Drug Information The FDA is announcing the availability of a final guidance for industry titled, "Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products." This guidance describes the conditions under which FDA generally does not intend to take action regarding required stability studies for repackaged products and the expiration date to assign under those conditions. This guidance finalizes the revised draft guidance issued in August 2017. READ MORE

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