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Microtest Offers New Services, Free Facility Audit, for Compounding Pharmacies Seeking USP 797 Compliance
Date:7/29/2008

AGAWAM, Mass., July 29 /PRNewswire/ -- Microtest Laboratories has launched a suite of services to assist the numerous compounding pharmacies in the U.S. that have yet failed to meet mandatory United States Pharmacopeia Chapter 797 (USP 797) regulations. Microtest also announced its offer of a free facility-gap-analysis audit to help compounding pharmacies determine their USP 797 compliance level and corresponding preparation.

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.

Microtest's launch of the new services, and its free audit offer, are timed with moves by the FDA to prompt more pharmacies to achieve USP 797 compliance. "As the FDA relaxes some restrictions, we expect overall enforcement efforts to increase. We're recommending that any pharmacy not now in full compliance move quickly to achieve full compliance," said Steve Wieczorek, supervisor of environmental services at Microtest (http://www.microtestlabs.com/usp797).

One example of the FDA's easing of regulations is that as of June 1st, in-house audits are no longer required monthly, but only twice a year, he noted. "But this could prove a double-edged sword, and pharmacies should look twice before loosening their internal controls -- despite the regulations."

"While the FDA may not require such audits monthly, reducing their frequency is contrary to what's needed given the demands -- and risks -- of operating compounding pharmacies today -- including the increasing intricacies of compounding prescriptions, and demands on pharmacy resources and personnel," Wieczorek said.

"Think of the risks involved -- and the possible consequences that could result -- from a situation that may not be discovered until the next audit -- perhaps six months later," he said.

Complimentary Audit

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SOURCE Microtest Laboratories
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