AVMA requests compounding comment period extension

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

After reviewing the FDA’s draft guidance for the preparation of compounds from bulk active ingredients, the AVMA has requested the FDA extend the comment period to provide ample time for us to work with our members to formulate a comprehensive response that would ensure the availability of compounds needed for veterinarians to protect animal health and welfare.

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 regulatorycomments@avma.org, with the words “FDA bulk compounding guidance” in the subject line.

3 thoughts on “AVMA requests compounding comment period extension

  1. I used to purchase 6.4 ounce 10 gram tetracycline oroducts and mix them for shoats calves and other pediatric patients this option no longer exists

  2. All drugs that are off patent should be available for compounding. Otherwise the patent never wears off. This will kill research and development of new drugs. Look at what has happened to the price of phenobarbital. That is what the future holds for all low volume drugs. I also think compounded drugs are moe actually dosed. I cringe when I see people cutting pills.
    If compounding is so bad STOP importing beef from Canada and Mexico. McDonalds imports all their beef from Mexico who allows compounding. Who is the FDA protecting? The Drug Companies or the public. Looks like the drug companies have the FDA in their hip pockets.

  3. Well… let us back up here and find out if the FDA truly has a legal say on the compounding of veterinary drugs. The FDCA of 1938 has been ruled against in at least 3 appellate court cases that have challenged the FDA’s veterinary drug compounding regulatory authority. The judges have stated that they believed and ruled that the 1938 act does NOT pertain to veterinary drug compounding. So if we are pushed for a list I think we should request having every drug available from our nationally compounded veterinary drug sources on the FDA to compound list. For example I know for a fact that the FDA wants to do away with all transdermal drug preparations…just listen to the Senate subcommittee hearing on SB959. Truthfully, maybe some medications are not efficacious by this route. How do new APIs get added to the permitted to compound drug list? The short answer is they will not be added!
    The bottom line is we critically need compounded drugs as a safety net for the ever increasing manufacturer back orders and exorbitant human generic drug price increases. We as a profession must protect our compounded drug privilege.