Navigation Links
USP announces new standards to protect patients from counterfeit and adulterated medicines
Date:2/4/2009

Rockville, Md., February 4, 2009 With counterfeit and adulterated medicines posing an increasing risk to patients in the United States and worldwide, the U.S. Pharmacopeial (USP) Convention today announces new standards for two widely used drug products that have been involved in episodes of adulteration resulting in patient deaths.

The release of these standards, for the blood thinner heparin and the sweetener glycerin, comes on the heels of recent and dangerous incidents involving the two products. More than 200 patients worldwide reportedly died after batches of heparin were adulterated with over-sulfated chondroitin sulfatewhich can be derived from the dietary supplement chondroitin and can mimic heparin's blood-thinning properties. Glycerin, used in many drugs and consumer goods such as cough syrups and toothpaste, has been involved in numerous episodes in which diethylene glycol, a poisonous chemical used in antifreeze, was added either intentionally or accidentally as a lower-cost substitute for glycerin, most recently in Nigeria in 2008.

"The tragedies involving heparin and glycerin demonstrate the shortcomings of 20th century safety nets in a 21st century global manufacturing supply chain," noted Roger L. Williams, M.D., USP's chief executive officer. "The reality is that with the decentralized, complex and global nature of today's manufacturing environment, it is too easy for an unscrupulous supplierdriven by economic or even more frightening motivesto add an ingredient to a drug product that shouldn't be there, putting us all at risk. These suppliers are increasingly sophisticated in their methods, resulting in a very dangerous situation. Rigorous quality standards such as the ones announced today form a line of defense that helps to protect the public. "

"These new USP quality standards provide better assurance of the quality of marketed products by using appropriate and modern analytical methods," says Moheb Nasr, Ph.D., director, Office of New Drug Quality Assessment (ONDQA), CDER, FDA. "This provides a considerable safeguard for citizens of the United States and the world by helping to prevent fraudulent suppliers from adding components that in the past have eluded existing identity tests due to similar properties. The new standards represent a significant improvement to the safety nets that keep substandard drugs from reaching the marketplace. FDA is pleased to have worked together with USP on this effort."


'/>"/>

Contact: Sandra Kim
sek@usp.org
301-816-8241
US Pharmacopeia
Source:Eurekalert

Related medicine news :

1. dLifeTV Announces New Season Programming and Celebrity Guests; Only Nationally-Broadcast Program About Diabetes Celebrates 5th Year and 200th Show
2. Cyberonics Announces Conference Call to Discuss Fiscal Year 2009 Third Quarter Financial Results
3. Neurobiological Technologies Announces Appointment of William A. Fletcher as Acting CEO
4. Cielo MedSolutions Announces Strong Revenue Growth in 2008
5. Express Scripts Announces Fourth Quarter 2008 Earnings Conference Call
6. Healthcare Realty Trust Announces Fourth Quarter Dividend
7. BD Announces Results of Shareholder Votes at Annual Meeting
8. UV Foundation Announces: February is Vitamin D Deficiency Month
9. Favrille Announces Name Change to MMR Information Systems, Inc. Following Completion of Merger With MyMedicalRecords, Inc.
10. Senesco Announces Results of Pre-Clinical Efficacy, Toxicology and Dose Ranging Studies for Multiple Myeloma Therapeutic Candidate
11. MAP Pharmaceuticals Announces Expiration of Hart-Scott-Rodino Waiting Period for Unit Dose Budesonide Collaboration with AstraZeneca
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2017)... Rosemont, Ill. (PRWEB) , ... June 27, 2017 , ... ... & Conditioning Association (NBSCA) have named Javair Gillett of the Houston Rockets the NBSCA ... recipient of the award is decided by NBSCA members who vote to select the ...
(Date:6/26/2017)... ... June 26, 2017 , ... Torrance dentist, Dr. Robert ... be one of the most noticeable aspects of a person’s appearance. A healthy, radiant ... is born with beautiful, balanced teeth, everyone can have the smile of their dreams ...
(Date:6/26/2017)... ... June 26, 2017 , ... A ... revolutionizing the way women look and feel about themselves and their sexual encounters. ... sexual dysfunction and urinary leakage head on with a ground breaking medical technique ...
(Date:6/25/2017)... ... June 25, 2017 , ... FCPX LUT Vintage Volume 2 ... vintage look. FCPX LUT Vintage Volume 2 contains 60 different color-grade presets, giving editors ... looks, vignettes and blurs to single out subjects, plus much more. FCPX LUT Vintage ...
(Date:6/25/2017)... CA (PRWEB) , ... June 25, 2017 , ... With a heatwave currently bearing down ... or hanging out at the pool. Being swimsuit ready is easy with laser hair removal. ... and repeat again can be a burdensome routine when all you want to do is ...
Breaking Medicine News(10 mins):
(Date:6/19/2017)... HORSHAM, Pa. , June 19, 2017  Researchers ... announced today that they will host a live, complimentary ... Perspectives from the benchtop to the real world" on ... PM EDT. This webinar will feature ... a rare look into the manipulation techniques abusers use ...
(Date:6/14/2017)... 2017  ivWatch LLC, a medical device company focused ... therapy, is pleased to announce it was the Bronze ... Supplies and Equipment at the 2017 Medical Design Excellence ... industry. The award was presented by Medical Device and ... in New York during MD&M ...
(Date:6/13/2017)... June 13, 2017 Zimmer Biomet Holdings, Inc. (NYSE ... announced that the U.S. Food and Drug Administration (FDA) has ... 2015 relating to its Zhejiang, China ... "The successful clearance of the Warning Letter related ... facility is a measure of the progress we have made ...
Breaking Medicine Technology: