Navigation Links
New White Paper Details What Compounding Pharmacies Must Know to Prepare for FDA Inspections

AGAWAM, Mass., April 16, 2013 /PRNewswire/ -- In anticipation of new US Food and Drug Administration (FDA) regulations, many companies are working toward correcting potential problems and attaining USP <797> compliance. A new white paper addresses the issues that compounding pharmacies must address prior to undergoing an FDA or state inspection. Titled, "Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA," it is available to download at from Microtest Laboratories.

"The FDA requires all compounding pharmacies to comply with USP section <797>, which outlines the different standards and regulations for environmental control, testing, and personnel training. Currently, the operations of large-scale compounders do not fall under the scrutiny and regulation of the FDA. However, these facilities may now face inspections from both the state regulatory authorities and the federal government," said white paper author Steven Richter , Ph.D., president and scientific director of Microtest Laboratories -- and a former FDA official.

In the white paper, Dr. Richter advises compounding pharmacies on the critical issues to resolve prior to an FDA or state inspection, including sterile compounding regulations, quality testing, sterility testing of compounded articles, disinfectant validations, and endotoxin testing.

"In the aftermath of the NECC case, FDA and state actions regarding compounding pharmacies are relatively certain: regulations and inspections will both tighten and increase. The FDA, in some instances, will assume the role of lead auditor for the compounding pharmacy's operations," Dr. Richter said. "It is critical for compounding pharmacies to maintain a state of control in their controlled environments. While there may always be excursions, it is the actions that are undertaken after the excursions that will influence an inspector's responses and observations during an on-site investigation and inspection."

Download a copy of "Compounding Pharmacy Inspections: What You Must Know to Prepare for the FDA," at Or, request a copy by calling Microtest Laboratories 1-413-786-1680 or toll-free 1-800-631-1680.

Microtest Laboratories is a Massachusetts-based, FDA-audited company with a history of exceptional regulatory compliance. Microtest Labs' environmental sciences group helps clients maintain control of their controlled environments and is a proven resource for contamination testing needs arising from the manufacturing of medical devices or pharmaceuticals, as well as sterile compounding in hospital pharmacies.

About Microtest Laboratories
Microtest Laboratories is a leader in testing services and contract manufacturing for the medical device, pharmaceutical, and biotechnology industries. Based in Agawam, Massachusetts, USA, the company provides expertise and flexible processes that enhance product safety and security, accelerate time to market, and minimize supply chain disruption. For more information, visit or call 1-413-786-1680 or toll-free at 1-800-631-1680. Follow Microtest Laboratories on Twitter @MicrotestLabs at

Available Topic Expert: For information on the listed expert, click appropriate link.
Steve Richter , Ph.D.

SOURCE Microtest Laboratories
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. New White Paper, "Five Biggest Myths about Medical Products Outsourcing," Finds OEMs Concerns are Often Unfounded
2. Long-Term Use of Blood Pressure Medications that Promote Sun Sensitivity May Increase Risk of Lip Cancer in Non-Hispanic Whites
3. Pharma IQs Laboratory Informatics Whitepaper
4. Lance Armstrong Update: Arrogant Even After Conceding Doping Charges, Asserts Former White House & WADA Spokesman Robert Weiner; Victory for Clean Sport but "Dark Message" Is Science Must Catch Up to Masking Agents Allowing Cheating
5. New Jensen Dental White Paper Reveals How Dental Laboratories Can Increase Productivity, Profitability with a Multi-Function Pressing Furnace
6. White Paper Details Five Things to Consider Before Buying Spiral Bevel Gear Drives
7. MEI Pharma Announces Retirement Of Chairman Bryan Williams From Board Of Directors And Appointment Of Christine White As Lead Director
8. Heraeus Expands Its Venus White Line of Whitening Maintenance and Oral Care Products
9. Scott & White to Open Emergency Hospital in Cedar Park
10. TeamHealth White Paper Examines Telemedicine Risks, Risk Management Strategies
11. Disinfectant Qualification Questions are Answered for Sterile Drug Manufacturers in New White Paper
Post Your Comments:
(Date:6/23/2016)... June 23, 2016 Bracket , a leading ... next generation clinical outcomes platform, Bracket eCOA (SM) 6.0, ... June 26 – 30, 2016 in Philadelphia ... Clinical Outcome Assessment product of its kind to fully integrate ... Bracket eCOA 6.0 is a flexible platform for electronic ...
(Date:6/23/2016)... and INDIANAPOLIS , June 23, 2016 ... Lilly Diabetes Tomorrow,s Leaders Scholarship is any indication, the ... announced today online at by the ... diabetes stand in the way of academic and community ... Foundation,s scholarship program since 2012, and continues to advocate ...
(Date:6/23/2016)... -- Revolutionary technology includes multi-speaker listening to ... leaders in advanced audiology and hearing aid technology, has ... the world,s first internet connected hearing aid that opens ...      (Photo: ) , ... firsts,: , TwinLink™ - the first dual ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... , ... "With 30 hand-drawn hand gesture animations, FCPX users can easily customize ... Pixel Film Studios. , ProHand Cartoon’s package transforms over 1,300 hand-drawn pictures into ... Simply select a ProHand generator and drag it above media or text in the ...
(Date:6/25/2016)... ... June 25, 2016 , ... Conventional wisdom preaches the benefits of ... of the latter, setting the bar too high can result in disappointment, perhaps even ... progress toward their goal. , Research from reveals that behind ...
(Date:6/24/2016)... ... June 24, 2016 , ... The Pulmonary ... Dallas that it will receive two significant new grants to support its work ... marked its 25th anniversary by recognizing patients, medical professionals and scientists for their ...
(Date:6/24/2016)... ... June 24, 2016 , ... People across the U.S. are sharpening their ... Award, an essay contest in which patients and their families pay tribute to a ... the 2016 National Society of Genetic Counselors (NSGC) Annual Education Conference (AEC) this September. ...
(Date:6/24/2016)... ... ... National recruitment firm Slone Partners is pleased to announce the ... as Vice President of North American Capital Sales at HTG Molecular . ... team in the commercialization of the HTG EdgeSeq system and associated reagents in North ...
Breaking Medicine News(10 mins):