GFI

FDA extends comment period on GFI #256 to June 17, 2020.

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UPDATE: February 14, 2020

 
In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments. The initial comment period is scheduled to end on February 18, 2020, but FDA will be reopening the comment period using the same docket number. Otherwise, the submission process remains unchanged.
 
The new deadline to receive comments will be June 17, 2020.
 

Three Pharmacy Associations Ask FDA to Extend Comment Period for GFI #256

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On February 3, 2020, the American Pharmacists Association, the Alliance for Pharmacy Compounding, and the National Community Pharmacists Association sent this letter to the FDA:

Dockets Management Food and Drug Administration 
5630 Fishers Lane, Rm 1061 
Rockville, MD 20852
 
RE: FDA-2018-D-4533
 
To Whom It May Concern: