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New USP 797 Regulations May Create New Hazards for Compounding Pharmacy Directors
Date:9/23/2008

y are sterile and will provide a safer final product for patients.

-- Testing at a higher frequency will provide peace of mind. You will know that your controlled compounding environment(s), policies, and technicians are under control and in compliance. This will help reduce infections and save lives.

Wieczorek and Microtest (Agawam, Mass., http://www.microtestlabs.com/usp797) will continue to recommend a monthly testing regimen for all pharmacies compounding sterile preparations.

"A monthly testing regimen will continue to provide critical environmental and trend data of a pharmacy as the seasons change. Monthly testing will better reflect continued control of the compounding environment. It also will enable rapid problem resolution at a time when facilities are most vulnerable to non-compliance issues," Wieczorek said.

"Under the regulations, the pharmacy director holds quality control responsibility and is accountable for the facility's compliance performance. We believe that embracing best practices to create a plan that meets the pharmacy's specific environment will achieve the greatest success," he said.

Pharmacies failing to comply with USP 797 risk exposure to patient lawsuits as well as the potential loss of The Joint Commission's (JCAHO) accreditation.

Free Facility-Gap-Analysis Audit

To help pharmacy directors set a benchmark, Microtest offers a free facility-gap-analysis audit to help compounding pharmacies determine their USP 797 compliance level and corresponding preparation. The audit includes an examination of the compounding pharmacy service's physical facility footprint, drug compounding procedures, operational policies and training programs. Microtest experts will determine the level of compliance achieved, existing level of risk exposure, and recommendations to achieve compliance to USP 797.

"The audit will recommend the designa
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SOURCE Microtest Labs
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