Monday, December 2, 2013

FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

The FDA just published 3 new draft guidances related to compounding. 


In a nutshell, they cover: earlier guidance prohibitions; "outsourcing facilities" (OF) voluntary registration; and how OF's should report their compounded drugs.


Category Title Type Date
Procedural Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB) Draft Guidance 12/02/13
Procedural Registration for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB) Draft Guidance 12/02/13
Procedural Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB) Draft Guidance 12/02/13

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