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PostScription: The Wedgewood Case: What It Means for Pharmacies
Author(s): Gibbs Jeffrey N, Wasserstein Jeffrey N
Issue: Jan/Feb 2004 - Androgen Deficiency in Women
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Abstract: The authors, two attorneys, discuss implications for compounding pharmacists of a decision in In: The Matter of Establishment Inspection of: Wedgewood Village Pharmacy, Inc., that the US Food and Drug Administration has the jurisdiction to inspect pharmacies and may obtain inspection warrants to do so. Although the ruling affects only a narrow set of circumstances, the accompanying statements by the Magistrate Judge will, according to the authors, likely be used by the US Food and Drug Administration in future pharmacy compounding litigation. However, these statements will not have as much impact as one might at first think because the decision was only the decision of a magistrate judge, the statements about the US Food and Drug Administration’s authority to regulate pharmacy compounding and the Compliance Policy Guide were not essential to the holding of the court and the statements appear to stem from the court’s irritation with the arguments raised by Wedgewood’s counsel. The authors conclude by stating that one troubling aspect of the decision in this case is the court’s willingness to opine broadly on issues important to compounding pharmacies that were of no relevance to the issues to be decided in the case.
Related Categories: LEGAL