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:6/25/2016)... (PRWEB) , ... June 25, 2016 , ... First ... United States, named Dr. Sesan Ogunleye, as the Medical Director of its new Mesquite-Samuell ... facility Medical Director of our new Mesquite location,” said Dr. James M. Muzzarelli, Executive ...
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... June 24, 2016 , ... Marcy was in a crisis. Her son James, eight, ... at his family verbally and physically. , “When something upset him, he couldn’t control his ... it. He would throw rocks at my other children and say he was going to ...
(Date:6/24/2016)... ... June 24, 2016 , ... Comfort Keepers® of San Diego, CA ... the Road To Recovery® program to drive cancer patients to and from their cancer ... ensure the highest quality of life and ongoing independence. Getting to and from ...
(Date:6/24/2016)... ... June 24, 2016 , ... ... proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon and ... women in the world, and the most handsome men, look naturally attractive. Plastic ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... , June 24, 2016   Pulmatrix, Inc ., ... developing innovative inhaled drugs, announced today that it was ... Investments reconstituted its comprehensive set of U.S. and ... "This is an important milestone for Pulmatrix," said Chief ... shareholder awareness of our progress in developing drugs for ...
(Date:6/24/2016)... KNOXVILLE, Tenn. , June 24, 2016 /PRNewswire/ ... market providing less invasive and more durable cerebrospinal ... million in funding.  The Series-A funding is led ... the Lighthouse Fund, and other private investors.  Arkis, ... less-invasive neurosurgical instrumentation and the market release of ...
(Date:6/23/2016)... DUBLIN , June 23, 2016 ... "Dialysis Devices Global Market - Forecast to 2022" report ... is the treatment method for the patients with kidney failure, ... and excess fluid from the patient,s blood and thus the ... sodium, potassium and chloride in balance. Increasing ...
Breaking Medicine Technology: