Wedgewood Village Pharmacy--District Court Case
WEDGEWOOD VILLAGE PHARMACY - FindLaw 3rd Circuit Case
WEDGEWOOD VILLAGE PHARMACY - FindLaw 3rd Circuit Case
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Thursday, October 23, 2014
Let's Not Forget the that the FDA Gained the Right to a General Inspection of all Pharmacies in the Wedgewood Village Pharmacy, Inc. Case. The underlying district opinion has some key language regarding the FDA's authority. The Third Circuit affirmed the district court decision, rejecting Wedgewood's move to quash an FDA warrant on grounds that FDCA prohibited the FDA from inspecting pharmacies compliant with state law. Both the district court decision and the Third Circuit case affirming should be read
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With the prescribing of a compounded drug, the Food Drug and Cosmetic Act is "rendered meaningless" for individual patients. While sometimes necessary, rendering the act meaningless is never trivial, even for a single patient.
Have you heard the story about the pharmacist that refused to compound a animal-derived injectable drug when he was unable to verify the purity and origin of a starting material? For all the promotional stories about compounding that saves the day, where are the stories of professional discernment and discretion? Are there pharmacists who both acknowledge the profit advantage of selling compounds versus FDA-approved products and ALSO write about the times when they refused to compound specific drugs? Pharmacists did this in response to the learnings from the Docs Pharmacy case (going forward, some pharmacists refused to make purportedly sterile drugs from non-sterile ingredients that provided no warranty on certificate of analysis result claims and that were destined for spinal administration). Where did those pharmacists go?
Throughout history, pharmacists have identified and prevented important prescribing and dispensing errors, sometimes raising the ire of physicians as they engaged in "ritualized clashes" of sometimes conflicting opinion. Healthcare systems rely on the outcomes of informed, critical debate to achieve well-vetted "truths" to inform and protect patient safety.
BUT, if pharmacists and physicians join together in an effort to IMPOSE unapproved drugs on patients, what will happen to this critical problem identification/investigation/debate/judgement and decision-making foundation and lifecycle?
It is a vulnerable situation for a patient to be in, naked but for the medical gown tied across their back, having to ask, "excuse me, but, does that syringe contain an FDA-approved drug?"
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