Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the States and the Food and Drug Administration; New Proposed Draft; Availability

The Food and Drug Administration (FDA or the Agency) is announcing the availability for public comment of a draft standard memorandum of understanding (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.'' The draft standard MOU describes the responsibilities of the State that chooses to sign the MOU in 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. FDA is also announcing the withdrawal of an earlier draft standard MOU entitled ``Memorandum of Understanding on Interstate Distribution of Compounded Drug Products,'' which was issued in January 1999. The January 1999 draft standard MOU is superseded by the new draft standard MOU.