This topic comes up regularly.
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We do not and we will not be part of the PCAB program. I engaged in the initial talks about such an accreditation system before it happened. The original idea was great, a self-regulated accreditation that compounders could design and participate in.
In practice, PCAB is a joke. I would not want to lower my standards to meet their criteria. They seem more interested in how we’d ship something than whether we can prove it’s potent and sterile.
In the early stages of the PCAB program, the major insurer of pharmacies (Pharmacists Mutual) considered the benefits of participating in PCAB. I was interviewed about it and gave my objective evaluation. The company was thinking of requiring accreditation – or at least discounting for pharmacies that had PCAB. The insurance company requires neither today. There is no clinical or safety value to PCAB.
I can afford to do the accreditation but I chose NOT to. It is a foolish expense. I’d have to raise all my prices to meet the cost of the process – not to mention I’d need at least one full time employee to maintain the process. I am not going to spend $5,000 for a site visit and another $50,000 per year to maintain it.
If PCAB becomes mandatory, I’ll stop compounding.
Back to the main issue – the quality of our preparations. I have proof positive that our preparations are accurately made and that they’re sterile. We do extensive in-house testing and we back up those tests with lab work we contract for. Those outside labs have never discovered a dangerous compound – and we’ve been testing and submitting samples for over 20 years – dating back to a time when we were heavily involved in making IV preparations for use in the home.
I expect that this is good enough for those searching my pharmacy for an unnecessary accreditation. In fact it is exemplary, and far more than PCAB expects. PCAB examnes policies and procedures. We have better policies and procedures, and we also have proof that our compounds are sterile and that their potency is accurate.