AVMA weighs in on FDA compounding guidance

The message from our members has been loud and clear: compounding is a necessary practice because there are, and always will be, a limited number of U.S. Food and Drug Administration (FDA)-approved drug products for the many species and conditions that they treat. But right now, the FDA contends that compounding from bulk drug substances (i.e., active pharmaceutical ingredients) for animals has been and continues to be illegal. That said, the FDA recognizes the medical need for compounding from bulk ingredients, instead of using the FDA-approved drug product, within certain areas of veterinary practice and under very specific circumstances. The FDA’s GFI #230 (PDF) is a draft and therefore not the final word on compounding, and clearly we have to do more advocating for members’ compounding needs.

Image by GOKLuLe (Own work) [CC BY-SA 3.0], via Wikimedia Commons

Image by GOKLuLe (Own work) [CC BY-SA 3.0], via Wikimedia Commons

While working on our other advocacy efforts at the state and federal level, we took the opportunity to help shape the FDA’s guidance document. Our letter (PDF) to the FDA was submitted on August 14, although the comment period has been extended until November 16. Thanks to our volunteers and members for guiding us on our comments! Here are some highlights:

• The use of compounded preparations is unquestionably necessary in species such as zoo animals, laboratory animals, exotic pets, wildlife, aquaria, and non-food aquacultural animals. We urge the FDA to carefully consider the critical need for access to compounded preparations within these species.
• The AVMA supports development of a user-friendly, easy-to-access form for reporting all adverse events related to compounded preparations, including lack of efficacy.
• There is a substantial need for both non-sterile and sterile compounded preparations to be maintained for office use in veterinary medicine.
• We believe the FDA should use the AVMA’s definition of “patient” which is an animal or group of animals examined or treated by a veterinarian. We have serious concerns with the verbiage “The drug is dispensed…for an individually identified animal patient…”
• Compounding from bulk drug substances in food-producing animals is medically necessary for certain poison antidotes, euthanasia, and depopulation medications. We ask the FDA to create a separate guidance for food-producing animals.
• We assert that compounding should be allowable if a change between the compounded preparation and FDA-approved drug product would produce a clinical difference, or if the approved drug product is not commercially available for other reasons (i.e., unavailable) and no therapeutic alternatives exist, or if the needed compounded preparation cannot be made from the approved drug product (such as preparation of metronidazole benzoate for use in a cat).
• We request that the FDA amend the document to allow a veterinarian to dispense a preparation compounded by a pharmacy or an outsourcing facility to the owner or caretaker of an animal under his or her care.
• We have reservations about the outline drafted in the guidance that would create a list for outsourcing facilities to use when compounding from bulk drug substances. If any such list is created, it needs to be maintained properly and updated to reflect the changing needs of veterinarians and their patients.
• Certain information should be incorporated into labels/packaging and all compounded preparations should be labeled that they are not FDA-approved drug products.
• The AVMA agrees with the requirement that any bulk drug substance used by either a pharmacy, veterinarian, or outsourcing facility is obtained from an FDA-registered manufacturer and accompanied by a valid certificate of analysis.
• A robust, nimble, current drug shortage list should be made publicly available and compounding in response to such shortages needs to be addressed by the FDA.

We continue our work to assess the feasibility of a bulk drug substance list, as the FDA seeks nominations of bulk drug substances for inclusion in Appendix A of GFI #230 through November 16. As always, we very much appreciate all feedback from our members so we can best advocate for your needs!

10 thoughts on “AVMA weighs in on FDA compounding guidance

  1. I am concerned by the list of types of animal populations that the AVMA made in the first paragraph. It does not say COMPANION ANIMALS or small animals or dogs and cats anywhere in the policy statement to the FDA.

    Many of the commercially available products, even veterinary ones are not the correct size for smaller dogs and definitely not for cats! So compounding is very necessary to dose these smaller animals correctly.

    Also, often the commercially available products are not pills that are easily cut into 1/2 a pill or a 1/4 of a pill or some other size that is needed to try to dose a smaller dog or a cat.

    I would really like the AVMA to correct this error by including companion animals that are seen by “small animal veterinarians” in their statement to the AVMA.

  2. At the moment, it is illegal for us to order compounded medicines to keep in the hospital and therefore illegal for us to use them to treat hospitalized patients, long -term boarders whose owners can’t be reached, the ubiquitous “hospital cat” or dog, puppies & kittens left on our doorstep in a cardboard box, and abandoned dogs & cats we are keeping until they can be re- homed. This is ethically unacceptable. If the law was changed to allow treatment of these patients, however, it would provide a loophole for us to order compounded medicines to keep on our shelf and dispense to whom we see fit. The solution: change the law to allow us to do exactly that!

  3. Compounding pharmacists are in it for the money also. Every time you dispense a compounded preparation, you, the dispenser assume full legal liability for that product. Most compounding pharmacies are not certified. as frustrating as the world of medication can be, I always will go for a patented preparation over a compounded one.

  4. Not only are many medications available for our use only as compounded formulations, but several of these are medicines that we as veterinarians may expect to need on an emergency basis. Therefore we must be able to keep an appropriate amount of them on the shelf, ready to administer or dispense immediately. Furthermore, several compounded medications are only economical for us to purchase if we buy enough for 5- 10 animal treatments at once. To make a medicine too expensive is the same as to deprive us of it. Therefore it is imperative to block the “individually identified” qualification from the ordering process and allow veterinarians to purchase & dispense compounded medicines to whichever patients under our care required them.

  5. Let’s be honest. Drug companies are profit-driven. Many of the staple, low-profit-margin drugs that we use every day in veterinary medicine are a low priority to them. This results in an almost constant problem with a lack of drug availability. In the last 2 to 3 years, I have seen back orders of diazepam, xylazine, lactated ringers, phenybutazone, diazepam again, and many other drugs. When this happens, our options are to treat with drugs that are less than the gold standard of medicine, or utilize compounded alternatives.
    I will always reach for an FDA approved product first, but, as time goes on, the FDA approved product companies have let me down much more often than the compounders have.

  6. I think all practitioners understand and are trained in drug resistance. Please don’t limit our ability yo treat animals by not allowing us to use compounded drugs

  7. Compounded drugs are the only alternative available for treatment of many illnesses in mixed animal practice. We also face shortages of many commonly used drugs today—5 liter IV saline and lactated ringers.

  8. “A robust, nimble, current drug shortage list should be made publicly available and compounding in response to such shortages needs to be addressed by the FDA.”

    Unbelievable Alice in Wonderland expectations from the Federal Drug Administration. I paid my AVMA membership dues so just tell the FDA they do not have the legal legislation backing them to institute and enforce a highly restrictive compounded drug guideline. However…. the AVMA and the FDA should jointly embrace a responsible cooperative proactive approach and apply uniform GMP and USP guidelines in all the US veterinary compounding pharmacies. I know our AVMA compounded drug subcommittee is hard at work formulating a solution like this but they need time. The FDA should work in an oversight capacity to insure our compounded drugs are safely compounded in all the 50 States. Within 2 days of NECC, our MN Board of Pharmacy surveyors were doing deep inspections in all compounding pharmacies especially USP 797 facilities. They did their job. Will the other 49 States of the Union admit that the Minnesota’s Board of Pharmacy can inspect and enforce good manufacturing practices and USP guidelines in our State’s compounding pharmacies and they cannot?

  9. I use a compounding pharmacy, Specialty Veterinary Pharmacy, for my beagle. She has Cushings disease, and the dose she needs isn’t available in the capsules. As a matter of fact, I spoke to my vet about half an hour ago with her latest test results. He is amazed at how perfect her cortisol levels are holding. I have a compounding pharmacy to thank for that. My girl will be healthy and happy for longer because this option is available.

    It’s not just pets that rely on the expertise of these pharmacists. I have recently been diagnosed with Hashimoto’s thyroiditis. In joining support groups, I have found that a lot of people need this option in order to optimize their hormone levels.

    To the FDA – Please don’t disregard what an important option a compounding pharmacy is to so many.