AVMA, Congressional Veterinarians ask FDA to Extend GFI #256 Comment Period Again.

Cite Coronavirus pandemic as delaying efforts to seek constituent input.

AVMA and Congressional veterinarians ask for further extension in comment period from 120 days to six months.
FDA Logo

Alliance for Pharmacy Compounding Asks FDA To Extend GFI #256 Comment Period Again.

Cites stakeholders' attention to COVID-19 responses

Alliance for Pharmacy Compounding asks FDA to extend GFI #256 comment period by 180 days.

FDA Issues Temporary Guidance for Human Health Compounding

FDA has issued an Emergency Guidance for Industry.

FDA has issued an Emergency Guidance for Industry, “Temporary Policy for Compounding of Certain Drugs for Hospitalized Patients by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health.”

Déjà vu all over again: Veterinary Drug Shortages

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

USP grants appeals, remands chapters for "further engagement."

A great win for continued patient access to pharmacy compounding

A USP Appeals Panel's has granted appeals by APC and two other groups related to beyond-use date restrictions in the new <795> and <797> chapters and has remanded the chapters to USP's Compounding Expert Committee.
FDA logo

Pharmacy Coalition Pushes Back on FDA Draft GFI #256

The regulatory scheme proposed in GFI #256 will have a severely negative impact on animal health.

Wedgewood Pharmacy and several other pharmacies that specialize in preparing compounded medication for animal patients submitted formal comments today to FDA about its proposed guidance, Compounding Animal Drugs from Bulk Drug Substances.
Seal of the Supreme Court of the United States

Pharmacy Groups Unite to Fight PBMs in Landmark Supreme Court Case

Case seeks to clarify if the states can regulate runaway corporate middlemen

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 a

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

American Veterinary Medical Association Asks FDA to Delay GFI #256 Comment Period

AVMA requests at least 120-extension

AVMA tells FDA indicate there are several areas of draft GFI # 256 where further information is needed to gauge the impact of the draft guidance on the veterinary profession.

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.

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

FDA Continues Proposed Extra-Statutory Authority Over Compounded Animal Drugs

0 comment(s)
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.
 

Pages