Vets Get Extra Time to Weigh in on Bulk Drug List

Nominations must be made by Nov. 16, but comments on a draft compounding document are due Aug. 17.

Mixing two injectable drugs, preparing an oral paste or suspension from crushed tablets or adding flavoring to a drug are common ways that veterinary drugs are compounded.

ISABELLE FRANCAIS

The deadline to nominate bulk drugs that may be authorized for use in veterinary compounding across the United States has been extended to Nov. 16.

Comments on a related matter, the compounding document “Guidance for Industry No. 230,” are still due by Aug. 17.

The American Veterinary Medical Association had asked the U.S. Food and Drug Administration to extend both deadlines.

“This [nomination] 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,” the organization reported Tuesday.

AVMA is collecting nominations and relevant scientific literature at regulatorycomments@avma.org. The subject line should read “FDA bulk compounding guidance.”

Nominations also may be made through FDA at www.1.usa.gov/1PZBIxn.

Released in May, “Guidance for Industry No. 230” acknowledges that the compounding of animal drugs from bulk substances is currently illegal but may be an appropriate treatment option in some cases. Feedback on the draft document may be provided at www.1.usa.gov/1ImZiQq.

Leave a Comment

Comments

Your email address will not be published. Required fields are marked *

Register

Sign-up for your account with Veterinary Practice News. Your account gives you unlimited free access to our Newsletter Archives and our Digital Editions of Veterinary Practice News.
Please check the box below to confirm you would like to be added to Kenilworth Media’s various e-mail communications (includes e-newsletters, a survey now and then, and offers to the veterinarian industry*).
 

Leave this empty:

*We do not sell your e-mail address to 3rd parties, we simply forward their offers to you. Of course, you always have the right to unsubscribe from any communications you receive from us, should you change your mind in the future.