Facts About FDA's Guidance for Industry #256


FDA’s Center for Veterinary Medicine (CVM) recently issued draft guidance (GFI #256) that, if finalized, threatens to have serious and damaging ramifications for your practice and your patients.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.


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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.”