federal_register: 2015-27269

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2015-27269 Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act; Draft Guidance; Availability Notice The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." The draft guidance describes FDA's interim regulatory policy regarding the use of bulk drug substances by licensed pharmacists in State-licensed pharmacies or Federal facilities and by licensed physicians to compound human drug products while FDA develops the list of bulk drug substances that can be used in compounding under the Federal Food, Drug, and Cosmetic Act (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/2015/10/27/2015-27269/interim-policy-on-compounding-using-bulk-drug-substances-under-section-503a-of-the-federal-food-drug https://www.govinfo.gov/content/pkg/FR-2015-10-27/pdf/2015-27269.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." The draft guidance...  

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