FDA Posts 3 New Draft Guidances RE: Human Drug Compounding

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Updated April 19, 2022

All the links broke in the original post.

You'll be interested in:

• Human Drug Compounding - FDA.gov
• Compounding Research - FDA.gov
• Compounding Quality Center of Excellence On-demand Training - FDA.gov

- - -  original post follows below  - - -

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Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 107KB)	Draft Guidance	12/02/13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Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act (PDF - 60KB)	Draft Guidance	12/02/13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Pharmacy Compounding of Human Drug Products Under Section 503A of the Federal Food, Drug, and Cosmetic Act (PDF - 91KB)	Draft Guidance	12/02/13

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