federal_register: 2015-27268

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts regulation_id_numbers
2015-27268 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." The draft guidance describes FDA's interim regulatory policy regarding outsourcing facilities that compound human drug products using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). When final, the guidance will reflect the Agency's current thinking on the issues addressed by the guidance. 2015-10-27 2015 10 https://www.federalregister.gov/documents/2015/10/27/2015-27268/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503b-of-the-federal-food-drug https://www.govinfo.gov/content/pkg/FR-2015-10-27/pdf/2015-27268.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Drug Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." The draft...  

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