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Capsule Newsletter, Issue 001, June 2006

In this issue:

First Reports From The Field: Drug Pedigree Sheds Previous Misconceptions
By Robin Koh, Chief Strategy Officer for SupplyScape Corporation
Electronic pedigree solutions promise a new level of anti-theft and anti-counterfeiting security, yet a cloud of myth surrounds the drug pedigree and the role played by supporting technologies such as RFID and RxASN. Myth busting is in order: electronic pedigrees do not depend on RFID, mass serialization, or RxASN to be secure and effective today.

"Secure, robust, efficient e-pedigree solutions clearly stand on their own merits. Other device and process decisions such as RFID vs. Barcode tagging, while certainly providing operational efficiency and supply chain visibility benefits, do not represent a precondition for realizing the business benefits provided by e-pedigree." Robin Koh, Chief Strategy Officer for SupplyScape Corporation

H. D. Smith, First E-Pedigree Compliant Distribution Center
By Jeff Durand, SupplyScape Vice President of Services
H. D. Smith, a leading pharmaceutical distributor and cutting-edge technology pioneer, will be rolling out electronic pedigrees at its Pompano Beach DC next month. The company is using SupplyScape electronic pedigree software to automate their current paper pedigree process and assure a safe and secure supply chain.

Florida Pedigree Rules Made Final
The Florida Department of Health has completed the pedigree regulations that will go into effect on July 1, 2006. All wholesale pharmaceutical transactions must be accompanied by a pedigree. The regulations are the first in the nation to specify an electronic pedigree procedure.

FDA Examines Role Of Pedigree In Combating Counterfeit Pharmaceuticals
In February 2006, the Counterfeit Drug Task Force of the U.S. Food and Drug Administration (FDA) held an open workshop to discuss techniques and technology for preventing counterfeit pharmaceuticals from entering the supply chain.

LATE-BREAKING NEWS:

FDA To Require Pedigrees in December
To combat counterfeit pharmaceuticals, the FDA will enforce the pedigree requirement of the Prescription Drug Marketing Act (PDMA) starting December, 2006. Wholesale distributors who are not authorized distributors of record (ADRs) will need to provide pedigrees for all drugs they distribute. The pedigree may be in electronic or paper form. Where state and federal pedigree laws overlap, the stricter requirement prevails.

California Pedigree Update
California passes into a law a delay in enforcing state pedigree requirements. The new deadline, January 1, 2009, gives companies more time to prepare their organizations for pedigree compliance.

SupplyScape - Safe and Secure

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