The voice for compounding pharmacy | January 24, 2020
Comment on reclass of some NDAs as biologics
We've heard concerns from many of you about FDA's scheduled reclassification of some NDAs as biologics, set for March 23, 2020. Drugs reclassified as biologics may not be compounded without a biologics license, according to the FDA. It's not too late to submit comments to the FDA on that issue. We're making available here, two draft letters, one for providers and the other for patients, that you can customize and submit to the docket.