federal_register: 2018-26724

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2018-26724 Current Good Manufacturing Practice-Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act; Draft Guidance for Industry; Availability Notice The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled "Current Good Manufacturing Practice--Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act." This revised draft guidance describes FDA's policies regarding compounders registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) as outsourcing facilities and the current good manufacturing practice (CGMP) requirements in FDA regulations. Based on feedback from stakeholders and comments received on the initial draft guidance, the guidance is being revised, in part, to reflect further consideration of how CGMP requirements should be applied in light of the size and scope of an outsourcing facility's operations. 2018-12-11 2018 12 https://www.federalregister.gov/documents/2018/12/11/2018-26724/current-good-manufacturing-practice-guidance-for-human-drug-compounding-outsourcing-facilities-under https://www.govinfo.gov/content/pkg/FR-2018-12-11/pdf/2018-26724.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Administration 221,199 The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled "Current Good Manufacturing Practice--Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C...

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