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JULY 29, 2008 -- AGAWAM, MA -- Microtest Laboratories, a provider of testing and contract manufacturing services, is now offering a suite of services to assist compounding pharmacies in the U.S. that have 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 U.S. Food and Drug Administration (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," says Steve Wieczorek, supervisor of environmental services at Microtest.
One example of the FDA's easing of regulations is that as of June 1, in-house audits are no longer required monthly but only twice a year, he notes. "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."
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.
Microtest's services include: - Program implementation
- Onsite training
- Custom SOP documentation
- Cleanroom design
- Environmental monitoring
- CSP product testing
Wieczorek says, "Our veteran team includes a full-range of expertise: microbiologists, chemists, cleanroom specialists, and project managers -- many of whom have spent years working for the FDA."
Source: Microtest Laboratories
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