Definition of Compounding (Resolution No. 100-10-04)

April 28, 2004 2:20 PM Topics: Resolutions

Resolution No. 100-10-04
Title: Definition of Compounding
Action: Passed

Whereas, pharmacy compounding is an integral part of pharmacy practice and its use is increasing; and

Whereas, the definition of compounding is important in the regulation and enforcement of the practice of pharmacy and appropriate oversight of compounding activities; and

Whereas, the Food and Drug Administration (FDA) is seeking to clearly define the differentiation between compounding and manufacturing;

THEREFORE BE IT RESOLVED that NABP and the FDA review the existing memorandum of understanding between FDA and NABP, which defines and addresses the regulation of pharmaceutical compounding, to more clearly define the practices of compounding and manufacturing.

(Resolution passed at NABP’s 100th Annual Meeting, Chicago, IL)