found problems with PCAB had found no problems with. Is there anyway for PCAB to become credible again? Should state boards of pharmacies and the federal government come up with their own accrediting agency that is public rather than a private accreditation agency? What should that accreditation agency or model look like?
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"Mom and Pop" compounders often aren't PCAB accredited, due to the added coat of accreditation. Several Florida Board of Pharmacy members do compound drugs, but their pharmacies aren't PCAB accredited. Who is accredited by the PCAB? The "non-traditional compounders" (i.e. "manufacturers") who have the $$$ due to the high volume of compounding (manufacturing) they are doing.
I've never gone through a PCAB inspection, so I can only guess how it would play out. "You mean, after the thousands of dollars we paid you to inspect us, you're going to fail us on our inspection, causing the state board of pharmacy to fine us, and we lose a great deal of our business?" - to which the PCAB would reply, "Okay, we won't publish the list of deficiencies in any public space that anyone could see. Just clean up those "few" things before we come back 12-24 months from now to re-inspect you." (and the whole thing starts over again when there are deficiencies noted on the next inspection)
Kenneth Woliner, MD
www.holisticfamilymed.com
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