federal_register: 2013-28962

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-28962 Draft Guidance for Industry on Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability Notice The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act.'' The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA). The draft guidance is intended to assist human drug compounders that choose to register as outsourcing facilities (outsourcing facilities) in registering with FDA. The draft guidance provides information on how an outsourcing facility should submit facility registration information electronically. 2013-12-04 2013 12 https://www.federalregister.gov/documents/2013/12/04/2013-28962/draft-guidance-for-industry-on-registration-for-human-drug-compounding-outsourcing-facilities-under https://www.govinfo.gov/content/pkg/FR-2013-12-04/pdf/2013-28962.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic...

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