AAWV Survey on FDA Draft Guidance for Compounding Animal Drugs from Bulk Drug Substances



The American Association of Wildlife Veterinarians (AAWV) is surveying wildlife veterinarians who order and administer drugs that are compounded from bulk drug substances to wildlife species. The intent of the survey is threefold: (1) to gather information about which bulk compounded drugs wildlife veterinarians use, the frequency and purpose behind their use, and the species to which they are administered; (2) to catalog where wildlife veterinarians order bulk compounded drugs from; and (3) to determine how draft FDA guidance may impact wildlife veterinarians’ reliance on bulk compounded drugs.

A bulk compounded drug is a pharmaceutical that is derived from bulk drug substances or raw active ingredients. It is not to be confused with standard drug compounding which involves the manipulation of an FDA-approved drug into a preferred form (e.g., creating an oral suspension from crushed tablets, diluting the concentration of an injectable solution, mixing two or more injectable solutions).

The FDA draft guidance, if finalized, would advise veterinarians on circumstances under which the FDA does not intend to take action for certain violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) when pharmacists and veterinarians compound or oversee the compounding of animal drugs from bulk drug substances. Circumstances in which the FDA will forego enforcement include the preparation, prescription, and administration of bulk compounded drugs for a specific individual or a group of non food-producing animals, for office stock for non food-producing animals if the drug is on the FDA’s list of approved drugs, and for food-producing animals if the drug is on the FDA’s list of approved drugs and only if used as an “antidote for treating toxicosis”.

Pharmacies and veterinarians may therefore be held liable when dealing with unapproved bulk compounded drugs for office stock for non food-producing animals, unapproved bulk compounded drugs for food-producing animals, and even approved bulk compounded drugs for food-producing animals if not used as an antidote against a toxin. With many wildlife species available for harvest and thereby considered food-producing animals, such guidance would dramatically limit the availability of bulk compounded drugs to wildlife veterinarians.

For more background information: https://www.fda.gov/animal-veterinary/cvm-updates/fda-releases-revised-draft-guidance-compounding-animal-drugs-bulk-drug-substances.

For the draft guidance document: https://www.fda.gov/media/132567/download.

An Opening Statement from the AAWV President, Mark Drew

Hello to all AAWV Members! I am honored to step into the role of President of AAWV, trying to follow in the able footsteps of Peregrine Wolff and Colin Gillin. I will be joined in the executive council by Vice President Tom Deliberto, Treasurer Jenn Ballard, and Secretary Lisa Shender. Peregrine Wolff will be retained as Immediate Past President and will head the Advisory Council. Members of that council will be determined in the near future. Other people that will be in the forefront include Clair Butkus, AAWV Student Representative to the Advisory Council and Ann Justice-Allen, Newsletter editor. As the organization progresses forward, my goals are to make the AAWV valuable for members in both contacts and content. You will have noticed the new and shiny website that was put together by Andrew Di Salvo; look for some changes to the newsletter with added content to the website. Please also check the website for news about student travel awards to US Animal Health Association and WDA conferences, as well as nominations for the Tom Thorne and Beth Williams Memorial Award, as well as the Al Franzmann Memorial Speaker. Our affiliation with other veterinary organizations remains one of our biggest challenges, largely from trying to make the voice of wildlife veterinarians heard. We have allied organization status with the US Animal Health Association and the American Veterinary Medical Association. We have a long-standing working agreement with the American Association of Zoo Veterinarians with whom we share several representatives to various AVMA Committees and the House of Delegates Advisory Board. If you are interested in any of these endeavors, please contact me or one of the officers. We greatly need the involvement of members in these activities. I would also ask that those of you who use social media to please contact Claire so that we can harness the power of these information avenues to our members. You should have also been reminded to renew your membership – if you have not done it yet, please take the time to do it now. I will try to communicate with you monthly if at all possible. If you have concerns about the organization or things that may impact wildlife veterinary medicine, please contact me. Cheers.

AAWV-WDA Joint Annual Meeting

San Cristóbal de las Casas, Mexico
July 23-28, 2017

Anne Justice-Allen

The meeting literally started off with a bang, and the fireworks punctuated several of the presentations throughout the conference – the city was celebrating one of several Saint’s days. After the opening ceremony by outgoing president Marcie Uhart, we were welcomed to San Cristóbal by Gerardo Suzán, from Kalaan-Kab and the Latin American Section of the WDA, our gracious host for the meeting.

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