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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

Suggested Veterinary Products

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.

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