FDA To Revise Compounding Guidelines

The Compliance Policy Guide of up for revision by the FDA.

The Food and Drug Administration plans to revise its Compliance Policy Guide on veterinary pharmaceutical compounding and offer it up for public comment.

The FDA reports the move comes in response to numerous letters of concern and complaints from veterinarians, pet owners, compounding pharmacists and associations.

According to the FDA, many letters expressed concern over the lack of clarity on circumstances in which compounding, especially of bulk drugs, is permitted. Others disagreed with FDA’s legal authority in the current policy and complained about the lack of prior public comment, stated the FDA.

The FDA reports the draft revision should be available for comment this fall, at which time notice will be published in the Federal Register and a draft will be viewable on the FDA’s Center for Veterinary Medicine Web site.

The FDA’s current guidelines on veterinary pharmaceutical compounding were published in July 2003.


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