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Facts About FDA's Guidance for Industry #256

Background

FDA’s Center for Veterinary Medicine (CVM) recently issued draft guidance (GFI #256) that, if finalized, threatens to have serious and damaging ramifications for your practice and your patients. You may recall in 2015, FDA introduced guidance (GFI #230) that was substantially similar on the compounding of animal drugs from bulk drug substances. Following significant pushback from the veterinary and pharmacy community and intervention from members of Congress, FDA formally withdrew that Guidance in 2017.

Drug Quality and Security Act Does Not Apply to Veterinary Compounding

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While the Drug Quality and Security Act (DQSA) provided a new regulatory framework for compounded medications for use in human medicine, it does not apply to veterinary compounded medications. There has been some confusion in the industry, but veterinary compounded medications are still regulated by state pharmacy authorities, while FDA retains enforcement discretion over activities that raise the kind of concerns associated with a drug manufacturer. FDA has stated that it intends to develop new policy guidance with respect to veterinary compounding.

Pharmacy or Manufacturer? Size Doesn't Matter.

Proposed regulations intended to improve the safety of compounded medications often use quantity measurements as a “marker” for safety.

The more compounds prepared, these laws reason, the less safe the compounds. So, by this rationale, the quantity of compounds made by a compounder ought to be part of a formula that distinguishes between a “traditional compounder” and a “compounding manufacturer.”