Navigation Links
Quality standards for widely used medicines strengthened
Date:3/21/2011

Rockville, Md., March 21, 2011 As part of its ongoing mission to protect public health, the U.S. Pharmacopeial Convention (USP) is working with the Food and Drug Administration (FDA) and the Consumer Healthcare Products Association (CHPA) to update quality standards for widely used medicines and ingredients. Several years ago, USP put in place an ambitious, long-term effort to assess written (or documentary) standards for prescription and over-the-counter (OTC) drugs published in the United States Pharmacopeia and National Formulary (USPNF) compendia, aimed at stepping up the pace of revising test procedures where needed to reflect scientific advances. Coupled with this is USP's ongoing commitment to make available official USP Reference Standards (physical samples) for procedures described in documentary standards. The working relationships with FDA and CHPA fit into that overall initiative, focusing on an initial list of priority medicines and ingredients identified by FDA. The USPNF provides specifications for the identity, as well as quality, purity and strength of drugs and their ingredients, which are enforceable by FDA in the United States. USP standards are used in more than 130 countries.

FDA Commissioner Margaret Hamburg, M.D., expressed support for USP's standards modernization project during her remarks at the USP Convention meeting in April of 2010, citing this effort as one of the most pressing tasks facing both USP and FDA given documented incidents of poor-quality prescription and OTC products. Updated test methodologies are crucial to help counter economically motivated adulteration (in which less expensive and potentially harmful ingredients are substituted for genuine medicines or their ingredients), and also to address the challenge of impurities that may go undetected with older, non-specific assays and tests.

"FDA and USP have a long-standing partnership in law that helps ensure the quality of the American drug supply," said Roger L. Williams, M.D., USP's chief executive officer. "In the current effort, we are pleased to be joined by CHPA as well, as this initiative would not be possible without the active participation of industry. FDA has identified a number of medications and ingredients commonly used in prescription and OTC products that may be vulnerable to economically motivated adulteration or are associated with other concerns, which has helped focus our efforts. USP is working to make sure the quality standards for these products are based on the best current analytical procedures and allied reference materials to resolve such concerns. American patients, consumers and practitioners have a right to expect this."

In addition to the first list of products and ingredients for USP's priority attention, FDA will continue to recommend candidate standards for updating. An example of an FDA recommendation is a test for impurities and degradants in products containing acetaminophenone of the highest-volume OTC drugs and one that is also used in many prescription medications. Other commonly used ingredients to be updated include dextromethorphan (a cough suppressant) and diphenhydramine (an antihistamine).

USP will consider all recommendations for updates through its well-established process, in which volunteer experts evaluate standards, solicit commentary from the stakeholder community and ultimately decide on changes to incorporate. USP invites and encourages all stakeholders to provide input into the modernization initiative, and is seeking comment from manufacturers of products and ingredients included in the priority list of standards to be updatedas well as from the practitioner and consumer advocate communities. FDA's priority list and background information on the standards modernization initiative may be found at www.usp.org/hottopics/monographs.html. Also on this Web page, USP has issued a call for volunteer experts for the Acetaminophen Monograph Expert Panel, which will provide recommendations for revisions to the Expert Committee.


'/>"/>

Contact: Laura Provan
lnp@usp.org
301-816-8268
US Pharmacopeia
Source:Eurekalert

Related medicine news :

1. Influence of pulp extraction technique on DPSCs quality and quantity
2. Electronic medical records improve quality of care in resource-limited countries
3. North African migrants health and quality of life
4. Alcohol abuse history influences quality of life following liver transplant
5. Severe Bunions Take Toll on Quality of Life
6. Sperm quality and counts worsening in Finland
7. Uterine Fibroid Treatments Seem to Boost Quality of Life
8. Effects of depression on quality of life improvement after endoscopic sinus surgery
9. Hashimotos thyroiditis can affect quality of life
10. ASGE recognizes 35 endoscopy units for quality and safety as part of its Endoscopy Unit Recognition Program
11. High-quality care associated with lower cost in trauma
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... ... (SOP) alumni Hannah Randall, PharmD ‘17, and Jennifer Huggins, PharmD ’17, along ... updates for the primary prevention of cardiovascular diseases during the 15th Annual ...
(Date:10/13/2017)... ... 13, 2017 , ... The Visiting Nurse Association (VNA) of Somerset Hills is ... vendors and unique items from across the nation, this holiday-themed event will raise funds ... by the VNA. The boutique will be open Saturday, November 4 (10:00 a.m. ...
(Date:10/13/2017)... ... 2017 , ... Talented host, actor Rob Lowe, is introducing ... new episode of "Success Files," which is an award-winning educational program broadcasted on ... subject in-depth with passion and integrity. , Sciatica occurs when the sciatic nerve ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... services for healthcare compliance program management, will showcase a range of technology and ... for Assisted Living (NCAL) Convention and Expo to be held October 14–18, 2017 ...
(Date:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... IsoComforter, Inc. ... products, announced today the introduction of an innovative new design of the shoulder pad. ... so you get maximum comfort while controlling your pain while using cold therapy. By ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... Oct. 10, 2017  NDS received FDA 510(k) clearance in May ... battery-powered display stand specifically designed for endoscopy environments. An innovative secondary ... a clinical solution to support the improvement of patient outcomes, procedural ... ... ...
(Date:10/4/2017)... 4, 2017  South Korean-based healthcare product Development Company ... "cprCUBE" on Kickstarter. The device will educate the user ... with better efficiency compared to the dated and pricey ... on efficacy of the compression for a more informed ... goal to raise $5,000. ...
(Date:10/2/2017)... 2017  Eli Lilly and Company (NYSE: ... third quarter of 2017 on Tuesday, October 24, 2017. ... day with the investment community and media to further ... call will begin at 9 a.m. Eastern time. Investors, ... webcast of the conference call through a link that ...
Breaking Medicine Technology: