Court Refuses to Alter Compounding Decision

Published on: October 5, 2006

ePT--the Electronic Newsletter of Pharmaceutical Technology

Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.

Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice’s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.

The court ruled in Medical Center Pharmacy, et al. v. Gonzalez that compounded pharmaceuticals do not fit FDA’s definition of new drugs and that such products are therefore exempt from the new drug application process. The court further held that the agency could not block pharmacists from creating individually tailored drugs with bulk ingredients.