FDA

Report Language for FDA Appropriations Bill Includes Directions About Compounding

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The report language for the bill that funds the Food and Drug Administration (FDA) has been released by the U.S. House of Representatives Committee on Appropriations. While this language does not have the force of law, it instructs federal agencies on actions to take as part of accepting new funding from Congress.

Here are excerpts that relate to compounding pharmacy: 

Déjà vu all over again: Veterinary Drug Shortages

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Drug shortages have been a perennial issue for veterinarians.

The issue is again gaining interest because demands related to treating COVID-19, the disease caused by the Novel Coronavirus, is causing pressure on the supply of drugs for animal health. Here’s a blog post written in 2012 by a veterinary ophthalmologist on one of our sponsor’s websites that reviews the causes of drug shortages in veterinary medicine. It’s just as relevant and instructive today as it was when first published.

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In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments.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:
 

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