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

AGAWAM, Mass., Sept. 23 /PRNewswire/ -- Though the new USP 797 regulations, which become effective June 1st, ease testing requirements, the impact of following the new minimums has the potential of creating new hazards for compounding pharmacy directors, warns Steven Wieczorek, Supervisor, Environmental Sciences, Microtest, Inc.

Issued by the U.S. Pharmacopoeia, the new version of USP 797 establishes bi-annual environmental sampling and testing as a minimum requirement, in place of the former monthly frequency. The regulations continue to require that pharmacies preparing compounded sterile preparations must have an effective plan and program that incorporate best practices and provide a clean, sterile working environment free of contamination.

Potential Hazards from Hidden Impacts

But Wieczorek says that adopting a bi-annual environmental testing program may impact a facility's capability to maintain compliance. "Compounding pharmacy directors need to recognize the series of potential hazards lurking for them within the 'hidden impacts' of the new regulations." Those hazards, he said, include:

-- Bi-annual testing will not capture seasonal blooms of yeast, fungi, and bacteria.

-- Problem tracking, diagnosis, and resolution will be difficult if environmental testing is conducted at six month intervals.

-- The development of trend data that shows important seasonal fluctuations will be impossible when conducting bi-annual environmental testing.

-- If a failure occurs during a bi-annual testing program, investigating up to 6 months of compounding activities and justifying what may or may not have been affected will be nearly impossible and extremely time consuming.

-- With a monthly testing program, a failure will require investigation of only 3 to 4 weeks of data and will be significantly easier -- saving large amounts of time and money. It will also help insure that the compounds prepared in your facilit
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SOURCE Microtest Labs
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