December 21, 2022

APC submits comments to FDA on DTE

“We respectfully request that the FDA immediately retract these letters [to NABP] and issue a correction: DTE is not a biological product because it does not meet FDA’s definition of biologic product.”

That’s APC’s message in a comment letter submitted yesterday to FDA. The letter follows FDA’s communications to NABP stating that Thyroid USP was a biologic and therefore ineligible for compounding.

Following circulation of those letters, APC requested a meeting with FDA to express its concerns about the unorthodox communication of and the faulty logic and science behind FDA’s DTE reclassification. In that meeting, CDER Director Gail Bormel requested that APC submit formal comments for the agency to have on record. This week’s comment letter was in response to that request.