This topic comes up often.

We are 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 disappointment. I would not want to lower our compounding standards to meet the PCAB criteria, which seem more focused on how we’d ship something than whether we can prove it’s potency and sterility.

In the early stages of the PCAB program, the major insurer of pharmacies (Pharmacists Mutual) considered the benefits of PCAB participation. I was interviewed about it and gave my objective evaluation. The insurer was thinking about requiring accreditation – or at least discounting rates for pharmacies that had PCAB. The company requires neither today. There is little to no clinical or safety value to PCAB.

We can afford to do the accreditation but I chose NOT to. It is a foolish expense. We would have to raise all our prices to meet the cost of the process – not to mention we’d probably need at least one part-time employee to maintain the process. We are not going to spend $5,000+ for a site visit and another few thousand dollars per year to maintain it.

If PCAB becomes mandatory, The Compounder will stop compounding.

Back to the main issue – the quality of our preparations. We have proof that our preparations are accurately made and that they’re sterile when necessary. We do extensive in-house testing and we back up those tests with third-party 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 our pharmacy for unnecessary accreditation. In fact, The Compounder pharmacy is exemplary. PCAB examines policies and procedures. The Compounder pharmacy has exemplary policies and procedures, and we have proof that our compounds are sterile and that their potency is accurate.


For information regarding our Sterile Preparation Standards, please visit:
https://thecompounder.com/about-us/what-is-compounding/quality-checklist/clean-room-quality/


*Pharmacy Compounding Accreditation Board – PCAB – is a nonprofit organization that provides a voluntary accreditation program for compounding pharmacies nationwide. It was formed to promote, develop, and maintain principles, policies, and standards for improving the quality of pharmacy compounding nationwide.