Some Federal Courts of Appeal clearly think the volume of compounding matters and that it is reasonable for the FDA to use this as a means of deciding whether a compounder is in fact a manufacturer and that the district court didn't err in failing to instruct the jury on the state's definition of dispensing;

Previous post found here discussed the 10th Circuit Court of Appeals affirming Bader's conviction for importation from China of HGH.  The 10th Circuit decision can be read at http://caselaw.findlaw.com/us-10th-circuit/1607808.html The Tenth Circuit was clear:


As the Third Circuit noted:[W]e agree that the FDA's reliance on the apparent volume of compounding is a reasonable means of determining whether that pharmacy is compounding in the regular course of its business of dispensing or selling drugs or devices at retail.   Indeed, were we to adopt Wedgewood's view that the volume of compounding is irrelevant, much of the FDCA would become a nullity.   If a pharmacy could compound an unlimited quantity of drugs, supposedly in anticipation of individual prescriptions, then it could essentially act as a commercial drug manufacturer and totally circumvent the approval requirements of the FDCA.Wedgewood Vill. Pharmacy, Inc. v. United States, 421 F.3d 263, 274 (3d Cir.2005) (internal quotation marks omitted);  accord Food and Drug, supra, § 13:74, at 13–95 (3d ed. 2007). - See more at: http://caselaw.findlaw.com/us-10th-circuit/1607808.html#sthash.9A95fOGS.dpuf

 A previous post found here discussed the district court's action in this case.  To review the indictment in this case, click here.  To review the district court's order in the case, click here.