March 11, 2022

FDA plans final version of GFI #256

Earlier this year, seven members of Congress wrote to FDA, asking that the agency release the next version of its Guidance for Industry #256 on animal compounding as a draft rather than a final GFI.

On Wednesday, FDA responded to that letter with one of its own. Notably, the agency says the guidance will be final when it’s issued — not a draft as requested. (And it’s expected soon.) But that final version, FDA says, has been substantively amended based on stakeholder input.

We look forward to learning exactly what that means.