NABP e-News December 13, 2006

December 13, 2006 12:00 am

Secondary Wholesalers Win Court Order Extending Stay on PDMA Pedigree Requirement
A decision December 4 by United States District Court Judge Joanna Seybert in New York thwarted the Food and Drug Administration’s (FDA) plan to lift the stay on pedigree requirements outlined in the Prescription Drug Marketing Act (PDMA). Judge Seybert granted a preliminary injunction to delay the PDMA’s pedigree requirement scheduled to take effect December 1. The injunction was requested by a group of secondary wholesalers, who claimed that the PDMA’s pedigree requirements would bankrupt them and, further, that the requirements violated federal due process and equal protection laws. To date, no timetable has been set for the disposition of the litigation. While this decision does have a clear impact on the federal pedigree system, it does not appear to impact current or future state level pedigree systems. NABP will continue to monitor the status of the litigation and will provide updates as they become available.

Three Facilities Awarded VAWD Accreditation
NABP recently accredited three new facilities through its Verified-Accredited Wholesale Distributors® (VAWD®) program, bringing the total number of accredited facilities to 26. A full listing of VAWD facilities is available in the VAWD section of NABP's Web site, http://www.nabp.net.

• Henry Schein, Inc, is a worldwide distributor of health care products to office-based practitioners. The company received VAWD accreditation for its Grapevine, TX facility.
• J Knipper and Company, Inc, services include sample support, literature disbursement, and crisis management. The company received accreditation for its Lakewood, NJ facility.
• Physician Sales and Service, Inc, is a national distributor of medical products to physicians and elder care providers. The company received accreditation for its Louisville, KY facility.

FDA Warns Pharmacies to Stop Compounding Anesthetic Creams for General Distribution
The Food and Drug Administration (FDA) issued warnings to five pharmacy groups to stop compounding standard preparations of topical anesthetic creams for general distribution. The firms receiving the warning include Triangle Compounding Pharmacy, University Pharmacy, Custom Scripts Pharmacy, Hal’s Compounding Pharmacy, and New England Compounding Center. FDA allows compounding only in response to a physician's prescription to create a medication tailored to the specialized needs of an individual patient, FDA says in its warning letters. FDA indicated that, by compounding standardized preparations for general distribution, however, these pharmacies were acting as manufacturers producing and selling the equivalent of an unapproved new drug. FDA’s Compliance Policy Guide on compounding is available at http://www.fda.gov/ora/compliance_ref/cpg/cpgdrg/cpg460-200.html.

e-News Takes a Holiday
NABP’s e-News will not be published on December 27. The next issue of e-News will be released on January 10, 2007. Happy holidays and happy New Year to you and yours from NABP.