FDA Current Good Manufacturing Practice—Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act

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Current Good Manufacturing Practice—Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act[附网盘链接]是于不久前发布的FDA标准，适用于U.S。

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Draft — Not for Implementation 1 Current Good Manufacturing Practice—Guidance for Human Drug 2 Compounding Outsourcing Facilities 3 Under Section 503B of the FD&C Act 1

4 Guidance for Industry 5 6 7 This draft guidance, when finalized, will represent the current thinking of the Food and Drug 8 Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not 9 binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the 10 applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible 11 for this guidance as listed on the title page. 12 13 14 15 16 I. INTRODUCTION 17 18 This guidance describes FDA’s policies regarding compliance with current good manufacturing 19 practice (CGMP) requirements for facilities that compound human drugs and register with FDA 20 as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act 21 (FD&C Act). Under section 501(a)(2)(B) of the FD&C Act, a drug is deemed to be adulterated if 22 it is not produced in accordance with CGMP. FDA’s regulations regarding CGMP requirements 2

23 for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA 24 intends to promulgate more specific CGMP regulations for outsourcing facilities. Until these 25 final regulations are promulgated, outsourcing facilities are subject to the CGMP requirements in 26 parts 210 and 211. This guidance provides for conditions under which FDA generally does not 27 intend to take regulatory action against an outsourcing facility regarding certain CGMP 28 requirements in parts 210 and 211 during this interim period. This guidance applies to drugs 29 compounded in accordance with section 503B. In addition, this guidance generally applies to 30 drugs that outsourcing facilities repackage and biological products that outsourcing facilities 3

31 mix, dilute, or repackage in accordance with relevant guidance for outsourcing facilities. 32 33 This guidance reflects FDA’s intent to recognize the differences between outsourcing facilities 34 and conventional drug manufacturers, while maintaining the minimum standards necessary to 1

This guidance has been prepared by multiple offices in the Center for Drug Evaluation and Research and in cooperation with the Office of Regulatory Affairs at the Food and Drug Administration. 2

Positron emission tomography (PET) drug products are subject to CGMP regulations at 21 CFR part 212 and are not covered by this guidance. 3

See guidances for industry Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities and Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application (Biologics guidance). To the extent that the policies in the Biologics guidance differ from this guidance (e.g., conditions concerning assigning a beyond-use date to repackaged biological products based on stability testing), the policies described in the Biologics guidance apply. FDA updates guidances periodically. For the most recent version of a guidance, check the FDA guidance web page at https://www.fda.gov/regulatory-

information/search-fda-guidance-documents.

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