FDA grants compounding comment period extension

The FDA agreed yesterday to extend the deadline (PDF) for nominating drugs to the list of compounding ingredients that an outsourcing facility would be allowed to use to prepare compounds for veterinary office stock use, especially for urgent needs. The AVMA is pleased with this decision, as we requested an extension of the comment period to allow us more time to work with members to provide thorough and substantive comments. This extension allows us to work with our members to more fully identify the compounds needed for veterinarians’ office stock, which we know is critical for veterinarians’ ability to protect animal health and welfare.

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

As we said in a letter to the FDA (PDF) dated June 3, 2015, “Many areas of veterinary medicine rely on compounded preparations to maintain animal health and welfare, treat diseases, and prevent animal suffering, so to coordinate with the many interested parties to provide the most constructive, substantive comments will require a substantial amount of time and resources.”

The comment period will now end November 16, 2015. Please email your input to us, including any relevant scientific literature, at regulatorycomments@avma.org, with the words “FDA bulk compounding guidance” in the subject line.

The deadline is still August 17 for the comments on the actual guidance language and questions posed in one federal register notice. November 16 is the new deadline for the nominations of bulk drug substances (a second federal register notice).

3 thoughts on “FDA grants compounding comment period extension

  1. Many medications need to be compounded to provide an appropriate dose for small dogs & cats. In addition, cats can be very difficult to medicate, and this can only be resolved by compounding into formulations of the medicine that owners can administer. In addition to that, almost every month some different essential drug seems to go on indefinite manufacturer’s back order, during which time it can only be obtained from compounding pharmacies. I rely on compounding every day .

  2. I work with many small cats and kittens, and without compounding I am not able to provide appropriate doses of common and necessary drugs including antimicrobials, antifungals, and pain medications (just for example, and certainly not limited to, metronidazole, fluconazole, and gabapentin).

  3. In Phoenix area we would have to euthanize many more pets per year if we did not have access to compounded fluconazole.