Saturday, March 9, 2013

How is Wedgewood Pharmacy PCAB-Accredited With The Issues Found By the FDA in the Latest Inspection Report?


On Wedgewood Pharmacies website, it states:


Wedgewood Pharmacy is PCAB-Accredited.
As the demand for compounded medications has increased, the pharmacy profession saw a need for a system of standards by which each compounding pharmacy can test its quality processes. Compounding pharmacists also wanted a mechanism to allow them to know that they are producing a high-quality compound, and in doing so, providing the best quality to their patients. PCAB Accreditation gives patients, pet owners and prescribers payers a way to select a pharmacy that meets or exceeds the U.S. Pharmacopeia's high quality- standards. We meet or exceed these standards

Source found here    States such as New Jersey now have proposed legislation suggesting that all compounding pharmacies doing business in the state have to first be PCAB-Accredited.  While this legislation is still pending, the recent inspection of Wedgewood Pharmacies--a PCAB-Accredited Pharmacy- and release of that report by the FDA--begs the questions of how Wedgewood can be PCAB-Accredited but receive the criticisms that it did from the FDA.  See here  Do readers see an issue here?  How can a pharmacy pass what is required to become  PCAB=Accredited but fail an FDA inspection?  Should states be tying their compounding legislation to PCAB-accreditation.  Is that right, when PCAB is a private accrediting agency?

1 comment:

Kenneth Woliner, MD said...

Fourteen (14) pages pf violations identified by the FDA. The PCAB gave this pharmacy a "clean bill of health". Yep. There is a disconnect here.