Microtest Labs: July 2008

AGAWAM, MASS. – July 29, 2008 – 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

Microtest’s free facility-gap-analysis 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 designated sterile compounding risk level of the pharmacy service as well as establish an accurate baseline for compliance program next-action development. With the audit in hand, pharmacy directors can then create a service plan.

Complete USP 797 Compliance Solutions

Microtest offers pharmacy directors a single source of complete USP 797 compliance solutions – as advice, assistance, or complete implementation – available in an incremental approach or as a comprehensive, turnkey solution. Microtest’s services include:

Program Implementation
Onsite Training
Custom SOP Documentation
Clean Room Design
Environmental Monitoring
CSP Product Testing

“Microtest delivers professional, compliance-specific experience and expertise, comprehensive in-house capabilities, and full follow-through,” Wieczorek said. “Our veteran team includes a full-range of expertise: microbiologists, chemists, clean room specialists, and project managers – many of whom have spent years working for the FDA.”

To learn more, on the Web, visit http://www.microtestlabs.com/usp797 or call toll-free 1-800-631-1680.

About Microtest
Microtest is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company's expertise and flexible processes enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.

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