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C h a i n D r u g s t o r e D a i l y S u n d a y, A p r i l 2 1 , 2 0 1 3 1 4 By Keith Anderson, Senior Director, Regulatory Compliance With a heightened level of government scrutiny and rising fines, the manage- ment of hazardous product at the phar- macy level is critical to protecting patients, revenue and brand reputation. Not only are states levying more fines through increased enforcement efforts, but they also are creating and enforcing new regulations that are more stringent than those at the federal level. The result? The management and disposal of expired and unused pharmaceutical products is becoming more complex and carries a higher degree of risk. While the Environmental Protection Agency EPA has allowed that reverse distribution is a legitimate form of han- dling for the processing of unused and expired pharmaceuticals, it also has stat- ed that generators are not relieved of responsibility for making determinations about the discarding of materials as prod- ucts [Source: EPA RO 11606]. It is critical that the question of cred- it be considered when determining to return an item to a reverse distributor. Some items returned from a pharmacy that are not typically creditable are com- pounded formulations, IVs, patient con- tainers, "cookie jars" of dropped pills and liquid spill cleanups. These items should be managed through a disposal system in the pharmacy and must be handled according to EPA and state regulations. Making the situation more complex is that definitions of pharmaceutical haz- ardous products vary by state. In some cases, states have broader interpretations of what is hazardous. And, the risk in this area is significant as fines for improperly handling hazardous products in pharma- cies have reached to millions of dollars. Understanding the regulations for each state is imperative to the avoidance of fines and bad publicity. Within the pharmacy, the hazardous product stor- age system must address appropriate labeling, closure and compatibility segrega- tion to guard against unwanted reactions. When stored, hazardous product must be properly labeled and in appropriate containers. Like the interpretation of what is hazardous, the labeling required varies by state. And, the time limits for the storage of hazardous product depend on whether the generator is con- sidered large and small. The storage limit for large quantity generators is 90 days, while the limit for small quantity generators is 180 days. As a result, remaining in compliance regarding storage requires careful recordkeeping. One quickly determines that the once simple question of "Can I return this expired item to my distributor or my reverse distribution partner?" carries a new level of risk as the answer depends upon the state in which the pharmacy is located and if there is a reasonable expectation of credit for the item because the reverse system cannot serve as a substitute for a product management system. A solid regulatory pro- gram, an understanding of and commitment to compli- ance with evolving regula- tions and the right alliances with respect to pharmaceutical returns and hazardous product are critical to remaining in protecting reputation and avoiding fines. A company's regulatory department should be able to assist in the area of hazardous management. What's more, the pharmacy wholesaler and reverse distributor should be expected to communicate regarding current regulatory activities. For more information, please visit Meeting Space 330, email solutions@inmar.com or visit www.inmar.com. MANAGING HAZARDOUS PRODUCTS IN THE PHARMACY Teeth whitening has become a multi- million dollar business and at home kits have taken over for professional servic- es. With the new Plus White® Five Minute Premier Whitening System, consumers can effectively achieve and maintain a sparkling smile for one-fifth the cost of leading whitening strips. According to a recent American Academy of Cosmetic Dentistry sur- vey, consumers were asked what they would most like to improve about their smiles; the participants clearly wanted whiter and brighter teeth. The costs associated with a professional whiten- ing treatment and even whitening strips is astronomical. The new Plus White 5 Minute Premier Whitening System is a major breakthrough in teeth whitening that gives the consumer incredible whitening results for a fraction of the cost of other brands. CCA Industries recognized the need to help grow the category and realized that the launch of the new system offers consumers the most affordable option available. This will entice new users into the whitening category, sparking new incremental category growth. Plus White 5 Minute Premier Whitening System redefines the teeth whitening experience using a revolu- tionary new whitening process that helps bring dull or stained enamel back to a sparkling, pearly white. A quick and convenient way to whiten your teeth, it starts to work in just five min- utes. The easy-to-use system includes Plus White's 5 Minute Speed Whitening Gel, StainGuard® Rinse and a comfortable mouth tray. The redesigned Premier Speed Whitening ® Gel tube features a needle-nose tip for a more pre- cise application. While whiten- ing strips can slip during the whitening process, Plus White's comfortable mouth tray holds the Speed Whitening Gel just where it's needed, giv- ing the consumer better and more complete coverage for optimal whitening results. The beauty and oral care categories are becoming more and more inter- twined. A beautiful, healthy and daz- zling smile is paramount to looking fabulous and feeling great. Consumers that whiten their teeth say it instantly takes years off their looks―and that is the recipe for trial, usage and ultimate- ly repeat purchases. The Plus White brand consists of several great sku's: The 5 Minute Premier Whitening System, The 5 Minute Premier Speed Whitening Gel and Xtra Whitening Toothpaste. There are several other whiten- ing products under this brand's umbrella. Plus White 5 Minute Premier Whitening System is now widely available at a consumer friendly price that will result in new users to entering the cate- gory nationwide. CCA Industries devel- ops, manufactures and markets high-quality, innovative health and beauty care products available at fine food, drug, discount and super- center stores everywhere. Other top brands include Bikini Zone, Nutra Nail, Nutra Nail Gel Perfect, Hand Perfection, Mega-T, Scar Zone, Lobe Wonder, Sudden Change and Shadow Shields. The brand team can be reached at 201- 935-3232 x233 or by visiting on the web at www.pluswhite.com. CCA Industries can be found at NACDS Annual Meeting at booth 222. CCA INDUSTRIES LAUNCHES INCREDIBLE PROFIT OPPORTUNITY WITH PLUS WHITE Amneal Pharmaceuticals' strategic investments in infrastructure―facilities, equipment, R&D and human capital―have built a strong foundation and enabled the generic drug maker to become one of the fastest-growing firms of its kind. The company has created a diverse portfolio of more than 250 gener- ic pharmaceuticals and high barrier-to- entry products across multiple therapeu- tic areas and dosage forms. Amneal generics are manufactured in five high-quality, high-volume produc- tion plants in the eastern U.S. with a total current capacity exceeding 18 billion units of oral solids and softgels and 10 million liquid units to assure customers a reliable supply. Each facility is fully DEA, FDA and cGMP-compliant to con- sistently deliver top product quality. Last year Amneal began a $120 mil- lion capital investment campaign to undertake major expansions at its manu- facturing sites in New York and New Jersey, which will double production vol- umes when combined with international expansions now underway. An additional 780,000 square feet of production space will be added at two of the U.S. facilities and two new plants in India to signifi- cantly increase the current capacity of 500,000 square feet. When these infra- structure upgrades are completed in 2014, Amneal will be able to produce more than 35 billion extended units annually. Also, a new packaging facility in East Hanover, N.J. and increasing Amneal's 115,000- square-foot sales operations and distribu- tion center in Kentucky to more than dou- ble current capacity and throughput will provide additional critical supply chain resources to maintain superb customer service levels. The planned expansions and enhancements at these Amneal locations anticipate the creation of more than 500 new U.S. jobs in manufacturing, R&D, distribution, and sales. Amneal continues to invest substan- tial resources in research and develop- ment. More than 130,000 square feet in two New Jersey and New York facilities and another 100,000 square feet in India are dedicated to R&D. The company's scientific team now counts more than 230 Ph.D. and M.D.-level scientists in the U.S. with a depth of expertise in regula- tory, clinical, intellectual property and other disciplines from both generic and branded pharmaceuticals. Amneal's strategic focus in this area has created a major product development advantage for the firm and its customers. Since 2008, Amneal has been build- ing an international presence. In India the company acquired and is expanding an API facility and added an R&D and man- ufacturing center as well as an API R&D facility. The newest India operations will mainly serve international markets but will produce some medications for the U.S. as well. These plants meet the same exacting U.S. FDA standards as Amneal's stateside facilities to assure the same outstanding product quality. As Amneal continues to drive growth in production capacity, R&D efforts, sales and distribution operations, and product offerings to meet surging market demand for generic medicines, the company remains dedicated to the passionate pursuit of quality in all aspects of its operations, total commitment to its employees and creating exceptional value for its pharmaceutical customers. Visit Amneal at meeting space 218 at the NACDS Annual Meeting, go online to www.amneal.com or call the company at 866-525-7270. INVESTMENTS IN INFRASTRUCTURE POWER AMNEAL'S GROWTH