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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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