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NABP e-News October 31, 2007
NAPLEX and MPJE Test Vendor to Change Effective January 2008
Effective January 2, 2008, NABP will utilize Pearson VUE as the vendor for administration of the North American Pharmacist Licensure Examination™ (NAPLEX®) and the Multistate Pharmacy Jurisprudence Examination® (MPJE®). Pearson VUE offers a professional testing environment for candidates through its network of Pearson VUE-owned and operated testing centers in the United States and its territories. NABP has been working closely with Pearson VUE to structure testing administration services for NABP examinations, and to facilitate a seamless transition to Pearson VUE. Registration for Pearson VUE testing centers will begin on January 2, 2008; candidates wishing to sit for an examination prior to that date will register through the Association’s current test vendor, Prometric.
Proposed Rule Modifies Combat Meth Act to Add Non-registrants’ Self-Certification Fee
The Drug Enforcement Administration (DEA) Department of Justice recently posted a Federal Register notice proposing a self-certification fee for sellers of scheduled listed chemical products who are not registered with DEA. The Combat Methamphetamine Epidemic Act of 2005 requires “regulated sellers,” or persons and entities selling scheduled listed chemical products at retail locations, to self-certify with DEA, relative to certain requirements of the CMEA. Under the Controlled Substances Act, the Diversion Control Program is required to recover the full costs of the certification process. DEA is proposing a self-certification fee for regulated sellers who are not DEA registrants as a means of recovering those costs. DEA is accepting comments on the proposed rulemaking (Docket No. DEA-298P) through November 30, 2007. More information is available in the Federal Register at http://www.regulations.gov.
FDA Acts to Ensure Thyroid Drugs Maintain Potency until Expiration Date
FDA is tightening the potency specifications for levothyroxine sodium, used to treat underactive thyroid glands and other thyroid conditions, to ensure the medication retains its potency over its entire shelf life. FDA is taking this action in response to concerns that the potency of the drug may deteriorate prior to its expiration date. The revised potency specifications require levothyroxine sodium drug products to maintain 95% to 105% potency until their expiration date. Previously, these products were allowed a potency range of 90% to 110%. FDA has given manufacturers and marketers two years to comply with the revised specification.
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 211 as of October 26, 2007. A full listing of VAWD facilities is available under Accreditation on the NABP Web site.
- Anda Pharmaceuticals buys generic pharmaceuticals manufactured by third parties and sells them to independent pharmacies, pharmacy chains, pharmacy buying groups, alternative care facilities, and physicians’ offices. The company received accreditation for its Groveport, OH facility.
- Anda, Inc, buys generic pharmaceuticals manufactured by third parties and sells them to independent pharmacies, pharmacy chains, pharmacy buying groups, alternative care facilities, and physicians’ offices. The company received accreditation for its Weston, FL facility.
- Astellas Pharma Manufacturing, Inc distributes only Astellas pharmaceutical products and is licensed to operate in all states requiring licensure. The company received accreditation for its Grand Island, NY facility.
- Bio Rx, LLC, dba Bio Rx, specializes in providing clinics and physicians with Factor and IVIG products for use in treating hemophiliacs and immunology patients. The company received accreditation for its Cincinnati, OH facility.
- BioPharm Distribution, Inc provides physician-based practices with antibiotic injectables, IV fluids, anesthetics, and other injectable pharmaceutical agents. The company received accreditation for its Altamonte Springs, FL facility.
- b, provides veterinary drugs, including approximately 400 human prescription drugs, and supplies to veterinarians, animal hospitals, and clinics. The company received accreditation for its Indianapolis, IN facility.
- DRxPharmaceutical Consultants, Inc, dba DRx – the Doctors ’ Dispensing Network, repackages and relabels prescription and over-the-counter products and then distributes them to practitioners, clinics, and pharmacies. The company received accreditation for its Skokie, IL facility.
- Dispensing Solutions, Inc manufactures, repackages, and relabels legend medications including controlled substances (Schedule II-V), vitamins, and nutraceuticals. It also offers private label and custom packaging services. The company received accreditation for its Santa Ana, CA facility.
- McKesson Medical-Surgical, Inc distributes prescription medications, medical supplies, and health information technology solutions to primary care and surgical centers. The company received accreditation for its Livonia, MI facility.
