The FDA has requested nominations of bulk drugs (i.e., raw active substances) to be included on a “positive list” of ingredients allowed for outsourcers to use in creating compounds for dispensing to individual clients, or for veterinarians to use as in-office stock for administration purposes.
The AVMA has requested an extension of the comment period to allow us ample time to work with members to provide thorough and substantive comments. Commenters must not only identify the medically necessary bulk drug substances that should be included on the “positive list,” but also compile supporting data to show how these drugs are needed to treat the numerous species of animals.
As we said in a letter to the FDA dated Wednesday, “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 FDA currently has scheduled the comment period to end August 17. Our letter requests an extra 90 days.
Continuing member input needed
We’ve had a great deal of input from AVMA members on this critical issue thus far, and we look forward to continuing to work with you to craft a response that reflects all veterinarians’ varied needs. Our strength is in our numbers and diversity, and by joining forces to work together, we are all able to improve veterinary medicine and the health and welfare of all animals. This summary from the AVMA (PDF) contains key information on this issue.
Do you have scientific data to share to support a bulk drug being added to a list? We appreciate email suggestions to help us share with FDA why certain drugs are needed to avoid patient death or suffering; why the FDA-approved versions would not work; and what safety and efficacy data (e.g., peer-reviewed literature) exist to support specific bulk drug nominations.
Please email your input to us at email@example.com, with the words “FDA bulk compounding guidance” in the subject line.