Gottlieb Lays Out Risk-Based Approach For Compounding GMPs, State MOU

FDA Commissioner Scott Gottlieb told legislators Tuesday (Jan. 30) that FDA will take a risk-based approach to both the yet-to-be-finalized 503B-lite category of compounders and the new model agreement between states and FDA on oversight of compounders that ship products out of state. Gottlieb emphasized that FDA will tailor its requirements depending not just on the size of an operation but the products being compounded and their risk to patients. Gottlieb also faced questions regarding the newly finalized guidance on...