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:10/12/2017)... ... October 12, 2017 , ... First ... compliance program management, will showcase a range of technology and learning solutions at ... (NCAL) Convention and Expo to be held October 14–18, 2017 at the Mandalay ...
(Date:10/12/2017)... ... October 12, 2017 , ... The company has developed ... consumer and regulatory authorities worldwide. From Children’s to Adults 50+, every formula has ... highest standard. , These products are also: Gluten Free, Non-GMO, Vegan, Soy ...
(Date:10/12/2017)... ... , ... Asante, a nationally recognized health system in southern ... home health joint venture through an agreement, effective October 1, 2017, to create ... health company with Asante, delivering clinically integrated care, for the past eight years. ...
(Date:10/12/2017)... ... 2017 , ... HMP , a leader in healthcare events and education, today ... Digital Award for ‘Best B-to-B Healthcare Website.’ Winners were announced during the Eddie & ... award competition recognizes editorial and design excellence across a range of sectors. This year’s ...
(Date:10/12/2017)... Mich. (PRWEB) , ... October 12, 2017 , ... ... has been named one of Michigan’s 2017 Best and Brightest in Wellness® by ... Brightest in Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to ...
Breaking Medicine News(10 mins):
(Date:10/11/2017)...  BioPharmX Corporation (NYSE MKT: BPMX) researchers were part ... way to use nonlinear optical imaging to confirm the ... A presentation ... how researchers from BioPharmX and the Wellman Center for ... suite of imaging techniques in what is called "Pharmacokinetic ...
(Date:10/10/2017)... received FDA 510(k) clearance in May 2017 for its highly anticipated ... for endoscopy environments. An innovative secondary monitor solution, ZeroWire Mobile ... the improvement of patient outcomes, procedural efficiency, and the lowering of ... ... By ...
(Date:10/4/2017)... 2017  South Korean-based healthcare product Development Company I.M. ... on Kickstarter. The device will educate the user about ... better efficiency compared to the dated and pricey CPR ... efficacy of the compression for a more informed CPR ... to raise $5,000. ...
Breaking Medicine Technology: