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In response to requests to extend the comment period for the revised draft guidance, “Compounding Animal Drugs from Bulk Drug Substances,” the FDA plans to provide an additional 120 days for the public to submit comments

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FDA indicate there are several areas of draft GFI # 256 where further information is needed to gauge the impact of the draft guidance on the veterinary profession.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

Also, without statutory authority, FDA requests input from the purportedly regulated community

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

In New National Poll, Veterinarians Report That FDA’s Proposed Guidance Will Have a Significant Negative Impact on Animal Patients.

Survey results available online.

A new nationwide poll of veterinary practices confirms that new guidance proposed by the Food & Drug Administration (FDA) would have a significant negative impact on their practices and their patients’ health if issued and enforced.

In New National Poll, Veterinarians Report That FDA’s Proposed Guidance Will Have a Significant Negative Impact on Animal Patients.

Survey results available online.

A new nationwide poll of veterinary practices confirms that new guidance proposed by the Food & Drug Administration (FDA) would have a significant negative impact on their practices and their patients’ health if issued and enforced.

Horse Racing Integrity Act has 218 House sponsors

Act creates Horseracing Anti-Doping and Medication Control Authority

New authority will create a set of uniform anti-doping rules, including lists of permitted and prohibited substances and methods in line with international anti-doping standards and veterinarian ethical standards.

Pharmacy Groups Unite to Fight PBMs in Landmark Supreme Court Case

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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.

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