In February, the U.S. FDA released five draft documents concerning drug compounding and repackaging in an effort to ensure relevant entities comply with key public health regulations. These documents follow the enactment of the Drug Quality and Security Act (DQSA) in November 2013. Products compounded in outsourced facilities under certain conditions may be exempt from provision of the Food, Drug, and Cosmetic Act.
One document details the regulatory impact of registering as an outsourcer. Another document explains how FDA will respond to repackaging violations by entities falling under the DQSA. A third document describes conditions under which the Agency will not take action for certain regulatory violations that occur due outsourcing facilities mixing, diluting and repackaging biologics. A fourth explains adverse reporting steps for recognized outsourcing facilities. And a fifth, a draft Memorandum of Understanding, outlines a state’s responsibilities when signing the MOU to investigate complaints regarding compounded drug product.
Comments on all of these documents, except the MOU are due May 20. MOU comments are due June 19.