Wedgewood Village Pharmacy, Inc.: The 2005 Third Circuit Decision

The Wedgewood Village Pharmacy, Inc. (Wedgewood) decision, a critical case dealing with compounding and the FDA's jurisdiction, was rendered in the Third Circuit Court of Appeals in 2005.  The Third Circuit has appellate jurisdiction over,

District of Delaware

District of New Jersey

Eastern District of Pennsylvania

Middle District of Pennsylvania

Western District of Pennsylvania

The beginning of that case provides a good summary of what the case is about.  The beginning provides:

Wedgewood Village Pharmacy appeals the District Court's order affirming the Magistrate Judge's denial of Wedgewood's motion to quash an administrative warrant issued to agents of the Food and Drug Administration.   Wedgewood argues that it is exempt from FDA inspection under provisions of the Food, Drug, and Cosmetic Act (the “FDCA”), 21 U.S.C. § 301 et seq.   Wedgewood also contends that it was denied procedural due process.  For the reasons that follow, we hold that Wedgewood was not exempt from FDA inspection under the FDCA, and that issuance of the warrant did not deny Wedgewood procedural due process.  Accordingly, we will affirm the decision of the District Court.

To read the entire decision, click here.