Thursday, December 12, 2013

Sixth Question of the Day December 12, 2013 NABP’s contractual agreement with the Iowa State Board of Pharmacy resulted in dual inspections of compounding pharmacies licensed by Iowa Board of Pharmacy. The inspections have been in process for some time now but we have only heard a few preliminary reports. Why? When will more data be available for the public? Have any outstanding compounding pharmacies been discovered?

“We’re moving full-bore ahead,” said Carmen Catizone, MS, RPh, DPh, NABP’s executive director, who summarized the preliminary findings of the inspections in an exclusive interview with PPN.Four of the six compounders were found to distribute non–patient-specific, preservative-free sterile injectables, which can be in violation of “traditional” compounding—that is, the preparation of medications prescribed in small quantities for specific individuals. Two of the pharmacies were producing large quantities of such drugs and shipping them across state lines, Dr. Catizone reported.
Asked who should be held accountable for the NECC violations that led to the nearly nationwide fungal meningitis outbreak, Dr. Catizone said that although it is easy to point fingers, “every single one of us was responsible for this tragedy. The regulatory system broke down, the pharmacy compounding system broke down, [and] the collaboration between FDA and the states broke down.” And he did not leave health-system pharmacy unscathed: Because facilities that purchased the steroids from NECC failed to exercise sufficient due diligence in vetting the vendor for safe manufacturing practices, “those transactions [also] broke down.”

quoted from the Drug Shortage Blog

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