Navigation Links
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

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 http://www.microtestlabs.com or call 1-413-786-1680 or toll-free 1-800-631-1680.
Available Topic Expert(s): For information on the listed expert(s), click appropriate link. Steve Richter, Ph.D. https://profnet.prnewswire.com/Subscriber/ExpertProfile.aspx?ei=42622


'/>"/>
SOURCE Microtest Laboratories
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Transitions Optical Offers Tips on How to Protect Eyes for Outdoor Sports Fans
2. Skinvisible Offers 8 Hour Photostablity for Parsol 1789
3. Geneva Offers First Cardiovascular Technology Graduate Program in the Nation
4. Automated, Wearable Kidney Offers Continuous Dialysis
5. Fairhope Vintners Offers First Release of Classically Styled Napa Valley Cabernet Sauvignon Wines
6. Vinson Hall Retirement Community Offers Glimpse into the Future of Retirement with Unique Innovative Model of Living
7. Ceridian LifeWorks Offers CareGiverHelper Service to Clients to Ease Stress of Family Caregiving
8. Kognitio CEO Offers Outsourced, Service-Based Data Warehousing as a New Approach to Large Scale Analytics
9. Handbooks in Health Care Company Offers Full Line of Inexpensive Educational Pocket Books
10. New Faces on Facebook(R): ADHD Moms Online Community Offers Tools for Moms of Children with ADHD
11. New Injectable Collagen Filler Offers Natural Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/24/2017)... ... May 24, 2017 , ... ... holistic pediatric dentistry options for its patients on Long Island, New York. ... physical well being, and is one of the biggest trends in dentistry today. ...
(Date:5/24/2017)... Shoreview, MN (PRWEB) , ... May 24, 2017 ... ... manufacturer of polyvinylidene fluoride (PVDF) based sleep diagnostics sensors, announced today it had ... network now consists of a mix of domestic and rest of world (ROW) ...
(Date:5/23/2017)... ... May 23, 2017 , ... Cambridge, MA, May 23, ... 2009, according to a Workers Compensation Research Institute (WCRI) study, a contrast from ... Carolina System: CompScope™ Benchmarks, 17th Edition looks at indemnity and medical payments ...
(Date:5/23/2017)... , ... May 23, 2017 , ... ... and Reconstructive Surgeon Dr. Kevin Sadati, is pleased to announce a new treatment ... collagen and elastin in their face, neck, and body through a virtually pain-free, ...
(Date:5/23/2017)... ... May 23, 2017 , ... New patients from Charleston, SC, are now welcome ... in Mt. Pleasant, SC, with or without a referral. A full mouth reconstruction can ... missing teeth in Charleston, SC. Those who suffer from gum disease, misaligned teeth ...
Breaking Medicine News(10 mins):
(Date:5/4/2017)... , May 4, 2017  A recent ... Control, Ultraviolet-C light as a means ... SmartUVC,s ability to reduce bioburden on anesthesia workstations. ... reduction on high-touch, complex medical equipment surfaces contaminated ... infections. "This study further validates the ...
(Date:5/4/2017)... and SAN DIEGO , ... and Gynecologists (ACOG) 2017 Annual Clinical and Scientific Meeting— ... self-contained, illuminating medical devices, today announced the launch of ... its OfficeSPEC and ER-SPEC vaginal ... addition of extra-small and extra-large sizes makes OBP Medical,s ...
(Date:5/4/2017)... , May 4, 2017  A new ... thermoplastics and other highly-engineered materials, is being launched ... tubing has been developed in recent years to ... therapies and surgical applications. More expensive materials such ... produce microextrusion tubing due to their ability to ...
Breaking Medicine Technology: