federal_register: 2013-28960

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2013-28960 Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability Notice The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic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 The draft guidance addresses new provisions in the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality and Security Act (DQSA), and sets forth an interim electronic submission method for human drug compounders that choose to register as outsourcing facilities (outsourcing facilities). 2013-12-04 2013 12 https://www.federalregister.gov/documents/2013/12/04/2013-28960/draft-guidance-for-industry-on-interim-product-reporting-for-human-drug-compounding-outsourcing https://www.govinfo.gov/content/pkg/FR-2013-12-04/pdf/2013-28960.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Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ``Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug,...

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