Navigation Links
FDA-USP workshop to preview updated OTC standards
Date:8/15/2011

Rockville, Md., August 15, 2011 Updated public standards incorporating new tests for impurities as well as more modern technologies to help ensure the quality of over-the-counter (OTC) ingredients and products will be key areas of focus for a September 8-9, 2011, workshop co-sponsored by the U.S. Food & Drug Administration (FDA) and the U.S. Pharmacopeial Convention (USP).

In addition to providing updates on new standards for acetaminophen and diphenhydraminetwo very commonly used OTC ingredientsthe FDA-USP OTC Drug Substances and Drug Products Workshop will solicit feedback on broader activities that will impact the OTC segment of the pharmaceutical industry, including future priorities for products and ingredients that require modernized quality standards and a path forward for developing standards for categories of products not currently addressed by USP such as mouthwashes and medicated shampoos. Janet Woodcock, M.D., director of FDA's Center for Drug Evaluation and Research (CDER), will keynote the event.

The workshop is an extension of a joint initiative of FDA, USP and the Consumer Healthcare Products Association (CHPA) to modernize specific USP monographs for OTC products and ingredients by adding impurities/degradants tests where no tests exist and/or incorporating modern analytical techniques and technologies for those that are outdated by today's scientific standards. The effort is part of a larger USP initiative to modernize a significant subset of its written standards, or monographs, contained in its drug compendia, the United States PharmacopeiaNational Formulary (USPNF). Drug and ingredient manufacturers marketing products, including OTC products, in the United States are required by law to adhere to existing USPNF monographs. These standards are enforceable by FDA, and are also used in more than 130 countries around the world.

Under this initiative, FDA prioritized acetaminophen (pain and fever relief), diphenhydramine (antihistamine) and other ingredients for modernization, in part due to concerns regarding the toxicity of certain impurities (e.g., p-aminophenol in acetaminophen). USP has advanced work on these ingredient monographs, which, once final, will have widespread impact due to the ubiquity of products containing these ingredients. Among the areas USP would like feedback on is the process for revising the dosage form (finished drug product) monographs. For acetaminophen alone, USP currently has 37 individual monographs for various liquid and solid dosage forms.

"Prescription and many over-the-counter drugs are regulated differently under the law, but it is equally important for both categories of products to be of high quality, supported by up-to-date, scientifically sound public standards that all manufacturers must adhere to," said CDER Director Dr. Woodcock. "Over-the-counter medicines are unique in that they are heavily relied upon across the patient population, are often used without healthcare provider oversight, and are available in a wide variety of dosage forms. All these factors make updating public standards for these medicinesstarting with those that are most widely usedall the more critical."

"Modernization of over-the-counter medicines and ingredients is an important public health activity, and it is one that will be optimally achieved through a robust partnership among regulators, industry and USP," said Karen Russo, Ph.D., vice president of small molecules at USP. "As we determine the most productive path forward for tackling these updates, we seek input that will allow us to proceed in the most efficient mannerin order to maximize the benefit to patient health. USP is considering a number of approaches for addressing dosage forms of these medicines, and how we proceed will impact industry significantly. This workshop is a critical way for us to solicitand for industry, consumer groups and others to providethe feedback we need."

In addition to Dr. Woodcock, day one of the workshop will feature opening remarks from Scott Melville, chief executive officer of CHPA and Roger Williams, M.D., chief executive officer of USP. During the day, attendees will get an overview of FDA's OTC drug monograph system, USP's OTC monographs, the larger USP monograph modernization initiative (and FDA's and CHPA's roles in this), and information on progress of FDA's priority monographs of acetaminophen and diphenhydramine. Day two of the workshop will focus on the future of USP monographs for OTC products, including FDA expectations, industry challenges and different approaches for monograph development to allow USP to keep current with advances in the industry. Impurities in OTC drugs will also be a major topic for the day.

Registration for the workshop is $595 for industry and $495 for academia, association and government, with discounts for groups, students and USP Expert Committee members. USP will host a pre-workshop course, "Understanding the USP Compendial Process: Monographs, General Chapters and General Notices," which is recommended for attendees who are not familiar with USP's standards-setting process. Bundled discount pricing is available for those who choose to take the course along with the workshop.


'/>"/>

Contact: Francine Pierson
fp@usp.org
301-816-8588
US Pharmacopeia
Source:Eurekalert

Related medicine news :

1. KPA and TK Carsites offer HR, OSHA and Internet Marketing Workshops at the NADA Convention and Expo 2010
2. Learn to Dance in a Day -- Beginner Workshop Launches Modern Jive in Toronto
3. Carnegie Mellon to host workshop about basics of technology entrepreneurship
4. Rutgers University Offers Fundamentals of Finance and Accounting Workshop at Mount Laurel, New Jersey Location Aimed at Non-Financial Managers
5. Carnegie Mellon to host crisis management workshop
6. FDA, SNM and RSNA host April 13-14 two-topic imaging workshop
7. Free CME/CE Lecture and Workshop on Multiple Sclerosis: Boise, ID
8. Social Media Network Analysis Workshop
9. NHLBI to hold workshop on health consequences of sickle cell trait
10. Solid tumor modeling focus of workshops
11. Omega Design Presented Pharmaceutical Packaging Solutions at the Healthcare Packaging Conference & Workshop 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:3/24/2017)... ... March 24, 2017 , ... ... spark a conversation on the current obstacles facing infection prevention and offer strategies ... deaths caused by these infections. , The print component of “Fighting Infection” ...
(Date:3/24/2017)... ... 2017 , ... Texas Physical Therapy Specialists (TexPTS) is pleased to announce ... The clinic is the group’s 7th location in San Antonio and 23rd in Texas. ... provide care from the clinic, which opened March 22, 2017. , The ...
(Date:3/24/2017)... ... 2017 , ... As the standards bearer of advanced cancer ... positions them as the go-to thought leader in all matters concerning oncology nursing. ... always-on, always-fresh news, views and advocacy engine, called ONS Voice. , The ONS ...
(Date:3/24/2017)... ... March 24, 2017 , ... Gastro Health (“GH”) ( ... patients for colonoscopy at the HyGIeaCare® Center that is to be located adjacent ... , The HyGIeaCare® Prep, cleared by the U.S. Food and Drug Administration ...
(Date:3/24/2017)... ... , ... “Vintage and Harvest A Cultivation of Christian Love” is the creation ... North Carolina with his wife, Anna Marie. He and his wife are the proud ... also the author of “Shadow and Substance.” , “Love, the agape kind, is seen ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... , March 23, 2017  HealthMine surveys with 9,250 ... revealed that health plan members want help from their ... stay engaged in their health, 2) help closing gaps ... platform for health and 5) relevant, real-time guidance. Meeting ... lowering healthcare costs. A Reason ...
(Date:3/24/2017)... , March 23, 2017  Provectus Biopharmaceuticals, Inc. ... "Company"), a clinical-stage oncology and dermatology biopharmaceutical company, ... Financing Commitment Term Sheet (the "Definitive Financing") it ... of the Company,s stockholders, who are referred to ... a Form 8-K filed with the Securities and ...
(Date:3/24/2017)... 24, 2017 The Board of Directors of ... Report 2016 including the complete 2016 Annual Accounts with notes. ... Nordic Nanovector,s website in the section Investor Relations/Reports and presentations/Annual ... ... Kvåle, Chief Financial Officer Cell: +47-91-51-95-76 Email: ir@nordicnanovector.com ...
Breaking Medicine Technology: