NABP e-News October 20, 2006
DEA Solicits Comments on Regulations to Implement New Pseudoephedrine Restrictions
The Drug Enforcement Administration (DEA) is soliciting comments on its interim final regulation, published in the Federal Register on September 26, 2006, to implement elements of the Combat Methamphetamine Epidemic Act of 2005. Comments are due by November 27, 2006, and must reference “DEA-291I.” Comments can be e-mailed to dea.diversion.policy@usdoj.gov or submitted online.
The Act establishes new requirements for retail sales of over-the-counter products containing ephedrine, pseudoephedrine, and phenylpropanolamine, which can be used to manufacture methamphetamine illegally. DEA is promulgating this rule to incorporate the statutory provisions and make its regulations consistent with the new requirements. This action establishes daily and 30-day limits on the sales of scheduled listed products to individual patients and requires record keeping on most sales.
NABP Discusses Drug Pedigree, Wholesale Regulation, and Multistate Licensure at NASPA Meeting
NABP staff discussed drug pedigree requirements and the lift of the Prescription Drug Marketing Act (PDMA) pedigree stay, effective December 1, 2006, during a presentation at the National Alliance of State Pharmacy Associations (NASPA) meeting on October 7, 2006, in Las Vegas, NV. Addressing executive directors of the state pharmacy associations, NABP discussed the state boards' responsibility in protecting patients from counterfeit drugs, as well as various states’ progress to-date in establishing safeguards.
Highlights included the need for more effective regulation of wholesale drug distributors in states that have not addressed this issue, as well as NABP’s Verified-Accredited Wholesale Distributors® (VAWD®) program as a method of standardizing the practice. The discussion also covered multistate licensure and the recommendations of 2005-2006 Task Force on Telepharmacy and the Implementation of the Medicare Drug Benefit Medication Therapy Management Provisions.
2007 NAPLEX/MPJE Letters of Agreement en Route to State Boards
Within the next few weeks, the state boards of pharmacy will receive letters of agreement for the 2007 North American Pharmacy Licensure Examination (NAPLEX) and, as applicable, the 2007 Multistate Pharmacy Jurisprudence Examination (MPJE). At the request of several boards and to reduce the workload of board staff, NABP will lengthen the term of the agreements. The initial term will be one year and will be renewable for additional one-year periods through December 2011. NABP also will update the language in the agreements to reflect current processes (for example, candidates will now be able to use credit cards to pay examination fees). Signed agreements are due to NABP by December 1, 2006.
Denver, PA Wholesale Distributor Joins Ranks of VAWD-Accredited Facilities
Henry Schein, Inc, of Denver, PA was recently accredited through NABP's Verified-Accredited Wholesale Distributors® (VAWD®) program. A worldwide distributor of health care products to office-based practitioners, Henry Schein, Inc, is the 11th wholesale distributor to receive VAWD accreditation. A full listing of VAWD facilities is available in the VAWD section of NABP’s Web site, www.nabp.net.