Sunday, April 28, 2013

Arkansas Compounding Pharmacy Inspections and Reminders

In response to the recent outbreak of fungal meningitis due to the inappropriate compounding of products, the Arkansas State Board of Pharmacy reminded licensees of its inspection requirements. The Board has completed regular inspections
of its pharmacies for years and it makes every effort to inspect each one at least once annually. The Board’s review of the 2012 inspections shows that 667 of the 748 pharmacies in Arkansas were inspected between January 1 and December 7. This number does not include additional site visits for changes of location, new openings, or the multiple visits and walk- throughs that the Board con- ducts routinely for its major compounding pharmacies. All of the Board’s pharmacy inspectors, as well as executive and assistant directors, are licensed pharmacists with experience and expertise in various areas of pharmacy practice. Board staff has sought out and received training in United States Pharmacopeia standards such as Chapter 797 and has incorporated sterile com- pounding inspection surveys into the Board’s workflow for any pharmacies that are preparing sterile products. While the Board does not claim this to be an absolute safety net, the Board continues to pursue additional opportunities for training and learning opportunities to continually improve it  efforts in inspecting com- pounding pharmacies.
The Board notes that any pharmacies that are prepar- ing compounded products for distribution in or into Arkansas, should review Regulation 07-02: COM- POUNDING, pertaining to pharmacy compounding, which details Board require- ments for sterility, potency, and endotoxin testing that must be followed prior to dispensing or administration of products.

Quoted from source found here

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