Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities; Draft Guidance for Industry; Availability

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The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled "Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities." This guidance describes the conditions under which FDA does not intend to take action for violations of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), when a state-licensed pharmacy, a Federal facility, or an outsourcing facility repackages human drug products. When this guidance becomes final, the Agency may also consider withdrawing or revising other guidance documents that address human drug repackaging, including section 446.100 of the Compliance Program Guidance (CPG) Manual, entitled "Regulatory Action Regarding Approved New Drugs and Antibiotic Drug Products Subjected to Additional Processing or other Manipulations," which was issued in January 1991, and section 460.100 of the CPG Manual, entitled "Hospital Pharmacies-- Status as Drug Manufacturer," which was issued in October 1980.