Current Good Manufacturing Practice —Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD & C Act Guidance for Industry

The Food and Drug Administration (FDA or the Agency) is announcing the availability of a revised draft guidance entitled “Current Good Manufacturing Practice—Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act. ” This revised draft guidance describes FDA's po

Source: FDA Center for Drug Evaluation and Research - What's New - January 22, 2020 Category: Drugs & Pharmacology Authors: FDA Source Type: news