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

In response to requests receieved

In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments

Two Veterinarian Members of Congress Ask FDA to Extend Comment Period for GFI #256

Request 9-day extension to May 18, 2020

Two Veterinarian Members of Congress Ask FDA to Extend Comment Period for GFI #256; express concerns about impact of provisions.

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

Request 90-day extension to May 18, 2020

Three pharmacy organizations representing thousands of independent and compounding pharmacists request extension of comment deadline for GFI #256 so they can seek more input from their constituencies

Pharmacy Groups Unite to Fight PBMs in Landmark Supreme Court Case

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Seal of the Supreme Court of the United States

ALEXANDRIA, Va. (Feb. 21, 2020) - The National Community Pharmacists Association (NCPA) and the Arkansas Pharmacists Association (APA), along with the American Pharmacists Association (APhA) and the National Alliance of State Pharmacy Associations (NASPA), announced today they will file an amicus curiae brief with the Supreme Court of the United States in support of a case that pits pharmacy benefit managers (PBM) against neighborhood healthcare providers.

FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs

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By Nancy E. Halpern, D.V.M., Fox Rothschild LLP Attorneys at Law
 
Without clear statutory authority, FDA has proposed to expand its legal authority over veterinarians and veterinary compounding pharmacies in its newly released “Revised Draft Guidance on Compounding Animal Drugs from Bulk Drug Substances,” (#256) as announced on November 19, 2019.
 

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