Issue link: http://osercommunicationsgroup.uberflip.com/i/365686
C h a i n D ru g s to re D a i l y 3 9 Tu e s d a y, Au g u s t 2 6 , 2 0 1 4 INDUSTRY AND GOVERNMENT RESPOND TO EPA'S NODA ON "HAZARDOUS WASTE MANAGEMENT AND THE RETAIL SECTOR" Regulatory agencies have a lot to consid- er in how they move to classify retail returns and regulate them under haz- ardous waste rules. The proof is in responses to the EPA's Notice of Data Availability (NODA), "Hazardous Waste Management and the Retail Sector: Practices to Enhance Effectiveness to the Resource Conservation and Recovery Act Program." Close to 50 responses were filed by stakeholders, including national retailers, retail and other associations, waste man- agement companies, regulatory agencies and Inmar by the time the comment peri- od closed at the end of May. Among the state and county agen- cies participating, a Connecticut agency suggests that all retailer returns should be managed as "universal wastes." "The problem with this solution is that the vast majority of returns received by Inmar facilities are not even destined for disposal," says Richard Seig, Regulatory Counsel at Inmar. "So, they certainly should not be considered 'wastes.' Hopefully EPA will clarify its longtime and consistent interpretation that such returns with 'potential value' are not 'wastes.'" It will be critical for the regulatory agencies to visit and understand reverse logistics operations. They should have a thorough understanding of the central- ized collection of consumer product returns, how consolidation through the reverse supply chain creates sustainable opportunities and how the practice encourages innovation. Tools such as Inmar's Haz App facil- itate returns processing through a sort-and-stage system for the return of unsaleable products that are regulated as hazardous waste. With the ability to identify, apply waste cate- gorization and storage guidance while facilitating reporting and records management, such tools increase the identification and appropriate han- dling of returns with regard to regulations and allow retailers and manufacturers to retain value where it exists. Without reverse distribution, retail- ers would not be incentivized to liquidate products, more material would end up in landfills, and the carbon footprint of the retail sector would be much greater. Finally, overregulation of the retail sector would have major "Environmental Justice" impact as well. It would discour- age liquidation of products from the pri- mary market to the secondary market, which is an important resource for low- income consumers. Some of the regulatory agencies get it. For a safety recall, it is critical for the recalled product to be removed from the shelves and from commerce in general. However, beyond safe- ty, other issues emerge that make it a less-simple prospect. Imagine such a process without reverse distribution. The DEA has relied on the secure nature of reverse distribution in its efforts to prevent the diversion of drugs. EPA also appears to be embracing security in reverse distribution in its delayed efforts to regulate hazardous waste pharmaceuti- cals as universal wastes. Returns should not necessarily become waste universally, especially if they have "potential value" arising out of manufacturer's credit and they are in the reverse distribution channel. It is the most efficient solution to the retail waste issue and it is protective of human health and the environment. Inmar's experienced regulatory team works closely with retailers and manu- facturers to ensure compliance with reg- ulatory requirements. Visit Inmar at booth 2849. For more infor- mation, email learnmore@inmar.com or call 866-440-6917. ASCEND LABORATORIES: EVOLVING FOR A BETTER TOMORROW Ascend Laboratories launched itself into the generic marketplace in early 2008. Young in age but staffed with many industry veterans, IMS in one study last year named Ascend Labs as one of the fastest growing generic companies in the United States. With a seasoned sales team and a robust pipeline, Ascend is poised to continue this growth for many years to come. Infrastructure for Success Ascend's parent company Alkem Laboratories Ltd. is one of the top seven pharmaceutical companies in India. The company has shown consistent growth and expects to exceed the billion dollar annual revenue mark by 2015. Alkem is a vertically integrated pharmaceutical company with both API and finished dosage formulation capabilities. The company has 15 manufacturing sites located throughout India, of which four are U.S. FDA approved and exclusively serve the U.S. market, including one ded- icated to cephalosporins. Alkem has state of the art R&D centers located in Mumbai and Bangalore where they are engaged in formulation development, API process research and biosimilars. Currently Alkem has over 40 ANDAs pending approval, including Paragraph IV filings and first to file ANDAs. The company plans to file 12-15 ANDAs per year and has in excess of 100 products across different dosage forms, under development. Ascend's legacy business includes its own organic ANDAs and strategic marketing partnership with other companies looking to take advan- tage of Ascend's strong sales team and position in the market. Currently Ascend is marketing 16 products that have a combined SKU count of over 80. Ascend brings these products to all classes of trade through one of the most experi- enced sales groups in the industry. Planning for Tomorrow through Service and Commitment Today Customer service and relationships are the hallmarks of Ascend's success. Each mem- ber of the Ascend sales team has many years of generic industry experience. John Dillaway, EVP of Sales and Marketing, said, "Our goal is to help our customers excel by providing prompt efficient service and industry information that may be helpful. In a multisource environment the only way we can distin- guish ourselves is through superior serv- ice. Our sales executives are part of the product we offer to our customers, and we choose them with careful consideration." Substantial investments have been planned in the areas of controlled sub- stances, transdermals and other NDDS technologies as the company looks to con- tinue to add to its capabilities to provide future growth and service to customers in these important areas. With over 7,000 employees and 500 scientists continuing its ANDA pipeline development, Alkem has anchored Ascend into one of the most dynamic emerging generic companies. The combined entity will realize its poten- tial by evolving its combined resources into a better tomorrow for all. Visit Ascend at booth 2416. For more information, go to www.ascendlabo ratories.com or www.alkemlabs.com.