Utahan Elected to U.S. Drug Standards Committee

Nelson Labs’ Amy Karren Joins a Select Group of International Experts

SALT LAKE CITY, Aug. 10, 2010—Amy Karren, SM(NRCM) and Director of Scientific Development at Nelson Laboratories, was recently elected to serve a five-year term on the United States Pharmacopeia Convention (USP) Small Molecules Monographs 1 committee, one of 20 Expert Committees of the USP. www.usp.org/goto/councilofexperts

 

Karren, a leading microbiologist and a 17-year veteran at Nelson Laboratories, was selected due to her expertise in microbiological testing and her expertise in antivirals, antimicrobials and antibiotics that she will help review, modernize and approve for small molecule monographs.



The Expert Committees comprise the standards-setting body at USP responsible for creating and revising the standards that appear in USP compendia. These are the United States Pharmacopeia—National Formulary (USP—NF), which are legally recognized books of standards for drugs and drug ingredients in the U.S.; the Food Chemicals Codex (FCC); and the Dietary Supplements Compendium (DSC). The standards help ensure the identity as well as the quality, purity, strength and consistency of a drug, food ingredient or dietary supplement product or ingredient.



“We are very pleased to see Amy recognized for her expertise and ability,” said Jeffery R. Nelson, President/CEO of Nelson Laboratories. “We are very committed to the development of our scientists. It serves our clients well to have experts like Amy participating on the committees that create testing standards. We are proud of her and look forward to celebrating her continued success.”



The USP Small Molecules Monographs 1 committee focuses on developing new monographs and revising existing ones as well as their associated reference standards for drug substances and dosage forms—specifically drugs that fall within the antibiotic, antimicrobials and antiviral areas.



The committee composes and approves monographs for generic drug product development when a patent ends based on the inventing drug company’s formulary. A monograph is similar to a recipe containing all the criteria that makes up the drug such as its chemical analysis, formula, testing, clarity and potency.

“By setting high standards within the monographs we write and update, we are helping achieve our most important goal of increasing patient safety,” said Karren. “Strong and updated monographs ensure that new manufacturers making generic versions of a drug match the formula and quality that is required by the USP.”



In a recent USP press release dated July 13, Roger L. Williams, M.D., USP’s chief executive officer said, “The new Expert Committee members bring a wealth of knowledge, experience and seasoned judgment to their work. They come from 22 countries, thereby also providing a truly international approach to standards-setting activities—a necessity in the increasingly globalized drug, food and supplements industries. I am both impressed and gratified by their willingness to volunteer their time and expertise to the vital work of helping to secure public health and confidence of patients, practitioners and consumers through quality standards.”



Karren’s committee, along with the Council of Experts and other Expert Committees at USP, will place a high emphasis on writing new standards and modernizing written standards where needed in order to strengthen the standards’ values.



Karren began working on the committee in July.



About Nelson Labs

Nelson Labs is one of the top providers of full, life-cycle microbiology testing services for medical devices, pharmaceuticals, and natural products. It has a national reputation for quality and rigorous testing standards. Its philosophy, The Science of Success™, looks beyond test results for its customers by helping them reach goals, be first to market, mitigate risk, and find success with their customers. For more information visit www.nelsonlabs.com and follow Nelson Labs on facebook and twitter.



About USP

The United States Pharmacopeial Convention (USP) is a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. USP’s standards are relied upon and used worldwide. For more information visit http://www.usp.org.