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Based on feedback from member veterinarians and other stakeholders, the AVMA has compiled a list of key points to share with the FDA in our formal comments on the proposed FDA Draft Guidance for Industry #256: Compounding Animal Drugs from Bulk Substances. The deadline for commenting on the draft guidance is October 15, 2020. The AVMA has been gathering input from members and others since the proposed guidance was released in November 2019. AVMA’s formal comments to the FDA will include, among others, support for these provisions: Three sets of circumstances in which...

An AVMA blog post (New webinar explains proposed rules on bulk compounding) relays information about a new on-demand webinar on AVMA Axon that shares more information about the U.S. Food and Drug Administration’s (FDA) Draft Guidance for Industry #256, which addresses veterinary drug compounding from bulk substances. The webinar, presented by an FDA veterinarian, gives important background to help veterinarians provide informed feedback on FDA’s proposed guidance while it’s open for public comment. The AVMA requested an extension of the deadline for commenting and believe it will be granted this...

By: Ashley S. Morgan, DVM, CAE, Director | Division of State Advocacy, American Veterinary Medical Association In 2018, the United States Pharmacopeia (USP)—the organization that develops and disseminates public compendial quality standards for medicines and other articles—published proposed revisions to General Chapters <795> and <797> of Pharmaceutical Compounding regarding nonsterile and sterile preparations, respectively. The AVMA received input from our councils and committees, various species-specific veterinary organizations and members, then met with USP staff to provide feedback on the revisions. On June 1, 2019, the USP posted updated revisions, and AVMA...

The American Veterinary Medical Association respectfully requests at least a 120-day extension to the comment period for Docket ID: FDA-2018-D-4533; Compounding Animal Drugs From Bulk Drug Substances; Draft Guidance for Industry; Availability. The COVID-19 pandemic has required the AVMA to focus its efforts on ensuring veterinary practices are deemed essential businesses and providing information and resources for veterinarians so that they are able to continue protecting animal health and welfare and public health, while ensuring to the greatest extent possible the safety of their practice teams and clients. As such, we...

The CDC just notified us that the agency has posted an updated version of Interim Infection Prevention and Control Guidance for Veterinary Clinics Treating Companion Animals During the COVID-19 Response. Revisions were made to clarify PPE recommendations based on situational risk factors and to update guidance for returning to normal clinic practices. We sincerely appreciate the CDC's attention to AVMA members' concerns regarding the original document. A review of the updated version indicates CDC was able to accommodate many of our requested revisions and within a very short internal agency clearance...

For your information, IDEXX issued a press release this morning on its new commercially available IDEXX SARS-CoV-2 (COVID-19) RealPCR Test for animals. A link to that press release appears below, along with links to a diagnostic update, and FAQs and product information page. Press release: idexx.com/covid19testnews Diagnostic update:  idexx.com/covid19-dx-update FAQs and Product information page:  idexx.com/covid19-pet-test AVMA updated its website to include additional information on animal testing yesterday, including creating a new webpage Testing Animals for SARS-CoV-2,  as well as updating our FAQs. CDC has also updated its guidance here: Coronavirus Disease...

Ashley S. Morgan, DVM, CAE, Director of the Division of State Advocacy for American Veterinary Medical Association, shared the following: A few updates: (1) AVMA has launched a new (hopefully more user-friendly!) COVID-19 landing page: www.avma.org/coronavirus. Two items raised during previous discussions and now addressed on the website: the international perspective and the use of masks following CDC’s recommendation to wear cloth face coverings. This is what’s currently on the AVMA website regarding face coverings (but information related to COVID-19 seems to change rapidly so check back often or reach out to...

WILMINGTON, DELAWARE—The COVID-19 crisis has created unprecedented disruptions in veterinary practices and animal shelters, making it challenging for many professionals to deliver wellness care, as well as certain medical treatments, to patients. As veterinary practices and animal shelters strive to provide the best possible care for their patients, questions frequently arise about heartworm prevention, testing and treatment. To address these questions, the American Heartworm Society (AHS) has released recommendations to help clinics and shelters deploy optimal strategies for heartworm management in today’s challenging environment. “The COVID-19 pandemic has made it necessary for veterinarians and...

Existing SBA lenders can start accepting applications from small businesses and sole proprietors on April 3 As expected, the CARES Act cleared the Senate by a vote of 96-0 just before midnight on March 25, and the House passed the bill on Friday, March 27. President Trump signed the legislation Friday afternoon. Notably, the CARES Act represents the most significant stimulus package in our nation’s history. It contains many complicated and intersecting provisions that will take time to interpret, particularly as we await further clarifications from the Department of Treasury, Department of...

The Virginia-Maryland College of Veterinary Medicine has placed our Emergency Operating Procedures (EOPs) and an Individual Risk Management tool online and made them available to the community. The Infection Control Team, led by Dr. Jennifer Zambriski, have developed these over the last 3 weeks for use in our Veterinary Teaching Hospital and we believe they can be used as a guideline for how to help other clinics keep themselves and their clients safe. Please let us know if we can be of assistance in any way. Emergency Operating Procedures: https://www.vetmed.vt.edu/vth/eop/...

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