In the February 19, 2015, Federal Register, FDA released, for public comment, a draft standard MOU entitled "Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the State of [insert State] and the U.S. Food and Drug Administration." In order for a compounding pharmacy to qualify for exemption to certain requirements of the FDCA, its drug products must be compounded in a state that has entered into an MOU with FDA regarding distribution of such products. This draft standard MOU describes the responsibilities of a state that chooses to enter into the MOU with respect to investigating and responding to complaints related to compounded human drug products distributed outside the state and in addressing the interstate distribution of inordinate amounts of compounded human drug products. In connection with its issuance of the new draft standard MOU, FDA announced the withdrawal of an earlier draft standard MOU entitled "Memorandum of Understanding on Interstate Distribution of Compounded Drug Products," issued in January 1999. Comments due June 19, 2015.
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