Monograph Drug User Fee Program

Description

The Over-The-Counter Monograph Drug User Fee Program (OMUFA) facility fee does not apply to entities detailed below:
▪ That only manufacture the active pharmaceutical ingredient (or API) of an OTC monograph drug, which do not meet the definition of an OTC monograph drug facility under section 744L(10)(A)(i)(II) of the FD&C Act.

ITB HOLDINGS LLC
390 North Orange Avenue, Suite 2300
Orlando, FL 32801
United States

T: +1 855 389 7344
T: +1 855 510 2240
T: +44 800 610 1577

https://www.itbhdg.com/drugs/