March 8, 2013
/PRNewswire/ -- Staying true to its commitment to patient safety, specialty pharmacy AnazaoHealth Corporation has announced continued investment in quality assurance measures, including full cooperation with the U.S. Food and Drug Administration (FDA) to assess and improve quality practices. The specialty pharmacy has been in the compounding pharmacy business for more than 15 years, and more than 95 percent of its business remains patient-specific. Because it does not mass-produce medications and fills patient-specific prescriptions from licensed physicians, the pharmacy is not regulated by FDA Manufacturing Guidelines – instead adhering to USP<797> standards developed specifically for the compounding pharmacy industry and adopted into law by the
Board of Pharmacy. Despite this, AnazaoHealth is fully cooperating with the FDA, who inspected AnazaoHealth alongside state agency inspectors who found no deficiencies. The pharmacy continues to seek other internal and external audits to ensure the highest standards of quality and patient safety.
"While the debate is being waged on what standards are most appropriate for the compounding pharmacy industry, we remain focused on promoting quality assurance of the highest standard, no matter what," said
Jacob J. Beckel
, chairman and CEO, AnazaoHealth. "That is why in addition to meeting or exceeding all standards of our regulating body -- the
Board of Pharmacy -- we are also implementing measures above-and-beyond, including actions based on some of the observations by the FDA."
Throughout its history, AnazaoHealth has regularly sought both internal and external audits performed by industry experts to evaluate and guide its industry-leading quality assurance program, helping the company to meet and / or exceed all USP <797> sterile compounding and USP <795> non-sterile compounding standards. AnazaoHealth was among the first in the country to be awarded accreditation from the Pharmacy Compounding Accreditation Board (PCAB) in 2008, and remains accredited today. Pharmacists serve as Corporate Quality Director, Corporate Quality Manager, and as divisional Clinical Quality Managers. The company's sterile compounding process involves no fewer than four different validation checks prior to completion of an order and makes extensive use of bar code technology, lessening chance of human error. AnazaoHealth is also planning further investment in enhancing its level of sterility testing, addressing some of the recommendations made during the recent FDA inspection.