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July 23, 2008

Circuit split and agency enforcement

The FDA Law Blog, in Fifth Circuit Medical Center Pharmacy v. Mukasey Decision Creates Circuit Split Over FDCA § 503A Pharmacy Compounding “Safe Harbor”, discusses a conflict between the Fifth and Ninth Circuits over the applicability of FDA rules concerning new drugs to drug compounding.  The last paragraph of this post highlights an all-too-common problem regarding agency enforcement in situations like this:

After the district court decision in Medical Center Pharmacy, FDA said it would honor the court's ruling in only that one district, which is geographically large but sparsely populated. It will be much more difficult for FDA to take the same tack with the Fifth Circuit decision.

EMM

July 23, 2008 in Admin Cases, Recent, Agency Enforcement | Permalink

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