Wedgewood Pharmacy Leads More Action to Advocate for Access to Compounded Medication

Wedgewood Pharmacy again took the lead in an industry-wide effort to make FDA’s Draft Guidance #256, Compounding Animal Drugs from Bulk Drug Substances, workable

Wedgewood Pharmacy provided the resources needed for the leading industry association, Alliance for Pharmacy Compounding, to submit a detailed, annotated mark-up of FDA’s proposed Guidance

34 members of Congress ask FDA to cite statutory authority for GFI #256

Ask for modification or withdrawal

members of the U.S. House of Representatives write to Food and Drug Administration Commissioner, Stephen Hahn, M.D., expressing their concerns about the FDA’s draft Guidance for Industry #256

Video: FDA drafts guidance to restrict type of pet medication

From 12 WBOY TV Clarksburg WV

A new Food and Drug Administration draft guidance seeks to put restrictions on an animal medicine practice called compounding.

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The comment period for the FDA draft Guidance #256 has been extended by 120 days, to October 15, 2020, at therequest of organizations, Congressional veterinarians.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The comment period for the FDA draft Guidance #256 has been extended by 120 days, to October 15, 2020, at the request of organizations, Congressional veterinarians.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

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.
 

National survey of veterinarians demonstrates negative impact of opioid shortages on veterinarians, pet owners, and pets.

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A nationwide survey shows that there are unintended consequences for veterinary medicine caused by the Drug Enforcement Administration’s (DEA) efforts to address the national opioid crisis. Opioids in animal medicine are the foundation, and often the only method, of pain control and anesthesia.

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