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FDA Guidance for Industry: Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA,

This guidance states the circumstances under which the Food and Drug Administration (FDA) intends to exercise its enforcement discretion and does not intend to take enforcement action against such repackagers for failure to conduct stability studies to support expiration dates for these unit-dose repackaged products.

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