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1/21/1999

FDA Issues Draft Memorandum of Understanding on Compounded Drug Products

The FDA published a notice in the Federal Register on January 21, 1999, that announced the availability of a draft Memorandum of Understanding (MOU) describing the responsibilities of the FDA and the states in enforcing the provisions of the Food and Drug Administration Modernization Act of 1997 (FDAMA) dealing with the interstate distribution of compounded drugs.

The MOU, developed by the FDA in consultation with the National Association of Boards of Pharmacy, provides for a cooperative program between state agencies and the FDA. It describes the responsibilities of each in terms of investigating and responding to complaints about compounded drug products distributed outside of the state in which they were compounded. It also sets forth respective responsibilities in responding to the interstate distribution of inordinate amounts of compounded drugs. 

One aspect of the MOU that is particularly noteworthy is the definition, found on page 6 of the MOU, of the term "serious adverse drug experience." 

 

The FDA will accept comments on the draft MOU until March 22, 1999. If you would like more information on this issue, e-mail the ASHP Government Affairs Division at gad@ashp.org, or call 301-657-3000, ext. 1306.