February 15, 2007

 

 FDA files appeal in drug compounding case - February 15, 2007

 

posted February 1, 2007
 

The Food and Drug Administration filed an appeal Dec. 1 in the case Medical Center Pharmacy, et al. v. Gonzalez, et al. in the U.S. District Court for the Western District of Texas, Midland-Odessa Division. The appeal was submitted to the U.S. Court of Appeals for the Fifth Circuit.

As a matter of policy, the FDA would not comment on the reason for the appeal, according to a spokesperson for the agency.

The appeal follows a court order by U.S. District Court Judge Robert Junell, which was filed Aug. 30, 2006, (see JAVMA, Oct. 15, 2006, page 1228). Among other rulings in the court order, Judge Junell ruled that compounded drugs, when created for an individual patient following a prescription from a licensed practitioner, are implicitly exempt from the "new drugs" definitions in the Federal Food, Drug and Cosmetic Act.

The case was initially filed in September 2004 by 10 state-licensed pharmacies against the FDA.

The AVMA offers numerous resources on drug compounding, including answers to frequently asked questions, AVMA position statements, and definitions, online at www.avma.org/issues/drugs/compounding.