The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' This draft guidance is intended to inform entities that are considering registering as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as added by the Drug Quality and Security Act (DQSA), of the regulatory implications of registration as an outsourcing facility.
Document
Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Entities Considering Whether to Register as Outsourcing Facilit...
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80 FR 8871
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“Guidance for Entities Considering Whether To Register as Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability,” thefederalregister.org (February 19, 2015), https://thefederalregister.org/documents/2015-03416/guidance-for-entities-considering-whether-to-register-as-outsourcing-facilities-under-section-503b-of-the-federal-food-d.