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Report Language for FDA Appropriations Bill Includes Directions About Compounding

Includes language on FDA GFI #256

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.

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Alliance for Pharmacy Compounding Reacts to Release of NASEM Studies

Studies about pain creams and hormone replacement

APC finds flaws in both studies

FDA extends comment period on GFI #256 to October 15, 2020.

The MyMedsMatter coalition of compounding pharmacies worked closely with APC and members of Congress in making their requests.

The comment period for the FDA draft Guidance #256 has been extended by 120 days, to October 15, 2020, at the request of organizations, Congressional veterinarians.

FDA extends comment period on GFI #256 to October 15, 2020.

The MyMedsMatter coalition of compounding pharmacies worked closely with APC and members of Congress in making their requests.

The comment period for the FDA draft Guidance #256 has been extended by 120 days, to October 15, 2020, at therequest of organizations, Congressional veterinarians.

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.
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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.
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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.
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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

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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