NABP e-News October 3, 2007

October 3, 2007 12:00 AM

NAPLEX Reinstated in all Prometric Testing Centers, Effective October 5
NABP is pleased to announce that the North American Pharmacist Licensure Examination^™ (NAPLEX^®) program is being reinstated in all Prometric testing centers, effective October 5, 2007. Candidates who have been deemed eligible for the NAPLEX by their respective state boards of pharmacy will have the option of scheduling an appointment to sit for the examination from October 5 forward. Prometric’s customer service department began accepting calls from candidates for examination appointments and rescheduling of appointments on October 1. If a candidate has an existing appointment, either selected before the suspension of the NAPLEX or rescheduled by Prometric during the suspension, it will be the candidate’s responsibility to reschedule that appointment if the candidate desires an earlier appointment date and time. NABP cautiously estimates that reinstatement of the Georgia Multistate Pharmacy Jurisprudence Examination^® (MPJE^®) will occur in late November or early December.

Bush Approves Six-Month Delay in Implementing Tamper-Resistant Rx Pad Law
President Bush signed HR 3668 into law on September 29, 2007, delaying by six months the effective date of a law requiring Medicaid prescriptions to be written on tamper-resistant prescription paper. The President’s approval follows quickly on the heels of Congressional action on this issue. The Senate unanimously approved the bill, which includes delaying the tamper-resistant prescription paper requirement as part of a larger Medicare and Medicaid relief package, on September 25. The House passed a similar measure to delay the requirement as a stand-alone bill (S 2085) on September 26. In addition to many pharmacy stakeholders who appealed to lawmakers and the Centers for Medicare and Medicaid Services (CMS), NABP asked CMS in a July 27 letter to delay implementation of the measure. The requirement is included as Section 7002(b) of the US Troop Readiness, Veterans' Care, Katrina Recovery, and Iraq Accountability Appropriations Act of 2007, which was passed in May. CMS has posted answers to frequently asked questions related to the new guidelines on its Web site.

Bush Signs FDA Reform Bill; Legislation Provides for Establishment of Tracking Standards
President Bush signed HR 3580, the Food and Drug Administration Amendments Act of 2007, into law on September 27, 2007. Among other provisions, the law reauthorizes and expands the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act. The legislation expands Food and Drug Administration (FDA) authority to regulate marketed drugs, establish a surveillance system to monitor and assess the safety profile of drugs on the market, reauthorize and modify programs that evaluate the use of drugs and devices by children, and expand federal databases that track information on certain clinical trials. The law also requires the Department of Health and Human Services to establish a standardized numerical identifier that must be applied to prescription medications at the point of manufacture, and to develop standards to serve as guidelines in the implementation of track-and-trace and package-level identification technology to monitor prescription medications through the supply chain.

FDA Cracks Down on Companies Marketing Unapproved Hydrocodone Products
FDA will take enforcement action against companies marketing unapproved prescription drug products containing hydrocodone, the agency announced on September 28, 2007. The action does not affect other hydrocodone formulations, which have FDA approval. FDA requires companies marketing unapproved hydrocodone products labeled for use in children younger than 6 years of age to cease manufacture and distribution of the products on or before October 31, 2007. Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products by December 31, 2007 and must cease further shipment in interstate commerce by March 31, 2008. FDA warns that failure to meet these deadlines could subject violators to legal action. More information is available on the FDA Web site at www.fda.gov/cder/drug/unapproved_drugs/default.htm.

Two Additional Pharmacies Awarded DMEPOS Accreditation
NABP recently accredited two additional pharmacies through its durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) accreditation program. The DMEPOS program ensures that pharmacies supplying DMEPOS products meet the Centers for Medicare and Medicaid Services’ (CMS) quality and accreditation standards. A full listing of pharmacies accredited through the NABP DMEPOS program is available under Accreditation on the NABP Web site.

• NIPRO Healthcare, dba NIPRO Diabetes Systems, in Miramar, FL, specializes in diabetic equipment and is responsible for the design and manufacture of the Amigo insulin pump. In addition, Nipro Diabetes Systems is pursuing future innovations to improve the lives of people with diabetes.
• Swillings DeAnza Pharmacy, Inc, dba Royal Oak Pharmacy, in Ontario, CA, was accredited by NABP for items including commodes; diabetic equipment and supplies; pharmaceutical products; durable medical equipment; nebulizers; non-custom orthotics; urinals and bedpans; and walkers, canes, and crutches.

Nine Additional Facilities Awarded VAWD Accreditation
NABP recently accredited nine new facilities through its Verified-Accredited Wholesale Distributors^® (VAWD^®) program, bringing the total number of accredited facilities to 191 as of September 28, 2007. A full listing of VAWD facilities is available under Accreditation on the NABP Web site.

• AmerisourceBergen Drug Corporation distributes prescription products to pharmacies, hospitals, and practitioners. The company received accreditation for its Orlando, FL facility.
• Cook Incorporated designs, manufactures, and distributes an assortment of medical devices and apparatuses. Xylocaine is the only prescription drug the facility handles. The company received accreditation for its Bloomington, IN facility.
• Cook Medical Incorporated offers a synchronized service for the efficient purchase and distribution of all Cook medical devices. The company received accreditation for its Bloomington, IN facility.
• Dubin Medical Incorporated distributes prescription medications, over-the-counter products, and some medical devices to surgery centers, clinics, hospitals, and physicians. The company received accreditation for its San Diego, CA facility.
• Methapharm, Inc, distributes niche pharmaceutical products and devices in specific therapeutic categories both by direct sales to customers and through national wholesale distributors. The company received accreditation for its Coral Springs, FL facility.
• Publicis Selling Solutions, Inc, dba Pharmagistics, contracts with 18 pharmaceutical manufacturers to provide third-party logistic services relating to pharmaceutical drug samples and literature. The company received accreditation for its Somerset, NJ facility.
• Sage Products, Inc, services hospitals and nursing homes in 43 states. Chlorhexidine gluconate 0.12% oral rinse is the only prescription product the business distributes. The company received accreditation for its Cary, IL facility.
• Wyeth Pharmaceuticals Division of Wyeth distributes approximately 90% of Wyeth’s pharmaceutical products to 37 states and approximately 40% of Wyeth Consumer Healthcare’s over-the-counter products to 24 states. The company received accreditation for its Vonore, TN facility.
• UPS Supply Chain Solutions, Inc, provides pharmaceutical product warehousing, distribution, and transportation management services on behalf of clients to customers nationwide. The company received accreditation for its Louisville, KY facility.