PHARMACY

NACDS, RollStream to create tool for product safety rule compliance

BY Jim Frederick

ALEXANDRIA, Va. The National Association of Chain Drug Stores is teaming up with a high-tech communications specialty firm to help its retail, wholesale and supplier members comply with new consumer product safety standards.

NACDS will partner with RollStream, a leading provider of enterprise collaboration and management tools for business, to develop a network through which retailers, manufacturers and distributors can adapt to new document-sharing regulations imposed by the Consumer Product Safety Improvement Act of 2008, or CPSIA. The law requires marketers to conform to more stringent product safety, testing and certification standards, particularly for children ages 12 years and younger.

To that end, NACDS and RollStream will set up a Certificate Exchange Network. The goal: To “provide retailers, manufacturers and distributors a single, online platform to exchange certificates of conformity to demonstrate CPSIA of 2008 compliance by February 2010,” according to NACDS.

Under new CPSIA guidelines, noted the group, “All affected products must be accompanied by certificates of conformance, either in paper or electronic form stating that the product has been tested and meets appropriate standards.”

What’s more, added NACDS in a statement, “These certificates must accompany the product as they are distributed from the manufacturer to retailers and/or distributors.”

Through the Certification Exchange Network, manufacturers will be able to post certificates to the online platform, or provide a link to existing certificates of conformity that each product maker can store electronically elsewhere. The CEN will provide “a simple, easy-to-use browser interface,” according to NACDS, so that retailers can securely download on demand any product certificate needed to demonstrate CPSIA compliance.

“By providing a single location for the exchange of information, the CEN will help organizations boost efficiency and effectiveness of compliance efforts, reduce risks, and minimize costs,” noted both companies in a statement.

“We are pleased to work with RollStream to begin the process of delivering this important resource for our members to help them achieve compliance with CPSIA,” said NACDS president and CEO Steve Anderson. “The Certificate Exchange Network will provide transparency for retailers and suppliers, enabling them to access certifications for consumer products.”

RollStream CEO Kristin Muhlner said the two organizations are pursuing “a solution that enables the industry to reduce the risks and minimize the costs associated with compliance.”

To help educate manufacturers, suppliers, distributors and retailers about the new law and the Certificate Exchange Network, NACDS and RollStream are hosting a series of complimentary webinars each Wednesday in November at 3 pm EST. To register, visit: http://www.rollstream.com/news/category/webinars/.

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FDA approves Par’s chronic pain drug

BY Alaric DeArment

WOODCLIFF LAKE, N.J. The Food and Drug Administration has approved a generic version of a chronic pain drug.

Par Pharmaceuticals announced Monday the approval of tramadol extended-release tablets in the 100-mg and 200-mg strengths. The drug is a generic version of Johnson & Johnson’s Ultram ER, which has sales of $156 million per year, according to IMS Health. Ultram ER is used to treat chronic pain in adults who require around-the-clock treatment.

The U.S. District Court for the District of Delaware ruled in August that Par could market a generic version of the drug. Par plans to begin shipping the drug immediately.

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Addrenex acquired by Sciele Pharma

BY Alaric DeArment

DURHAM, N.C. The U.S. subsidiary of a Japanese drug maker has acquired a company that develops drugs for medical conditions related to the body’s adrenergic system.

Addrenex Pharmaceuticals announced Monday its acquisition by Sciele Pharma, the Atlanta-based subsidiary of Shionogi & Co., one of Japan’s largest drug companies, for $29 million. Sciele already held stock in Addrenex and licensed drugs from the Durham, N.C.-based company.

“Sciele has been a valuable partner and catalyst for the success of Addrenex,” Addrenex CEO Moise Khayrallah said in a statement. “Our initial business plan called for bringing innovative drugs to market and enabling our investors to achieve a positive return.”

Sciele had licensed Addrenex’s attention-deficit hyperactivity disorder drug Clonicel (clonidine) and the hypertention drug Jenloga XR (once-daily clonidine). Addrenex has four drugs in clinical trials and more than 400 possible drug candidates.

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