CLS/MedTurn Exhibiting at NACDS Pharmacy & Technology Conference
CLS/MedTurn, will be exhibiting the upcoming NACDS Pharmacy & Technology Conference. The meeting will be held on August 26-30, 2006 in San Diego, CA. If you are planning to attend, please take time to stop by our booth located in space # 827.

If you would like to meet with a CLS/MedTurn representative, please contact one of the following CLS/MedTurn representatives that will be at the Conference:

Jennifer Mauldin, EVP jennifer.mauldin@inmar.com
Mike Umbach, VP, Product Development mike.umbach@inmar.com
Kelly McVey, Client Services/Business Development Manager kelly.mcvey@medturncom
Sue Willard, Business Development Manager, sue.willard@medturn.com
Steve Maki, Business Development Manager, steve.maki@inmar.com
Cheryl Scoggins, Business Development Manager, cheryl.scoggins@inmar.com
Robert Reid, Business Development Manager, robert.reid@inmar.com

FDA Moving Forward with a Nationwide, Mandatory Tracking System for Prescription Drugs
On June 9, 2006, the FDA issued a statement indicating that it is moving forward on its initiative to establish a nationwide, mandatory tracking system for prescription drugs. This system will be implemented with the hopes of preventing counterfeit and adulterated drugs from entering the market at various points in the supply chain. Proposed regulations regarding the tracking system date back as far as 1992, and are still in review. The FDA hopes to have a finalized regulation in place by December 2006, so that it may begin implementation of the program. However, no final decisions have been made with regards to the specifics of the program, and the related regulations will not impact the reverse logistics industry until the FDA is able to resolve several problems. The FDA is still accepting and reviewing comments from members of the industry regarding these issues.

What is an e-Pedigree?

An e-Pedigree is documentation of the chain of custody of drug products. The e-Pedigree will ultimately be tracked electronically, either by means of radio-frequency identification (RFID) or a barcode, and possibly mass serialization. (This method will be determined by the FDA in its December report.) Initial implementation of e-Pedigrees will be accomplished using a hybrid paper/electronic approach of recording pedigrees for the duration of the transition period.

Proposed Regulations Now in the Review Process

The legislation currently in review requires that all wholesalers, with the exception of “authorized distributors of record” (those wholesalers that frequently do business with major manufacturers and have an “ongoing relationship” with those manufacturers, e.g. AmerisourceBergen or McKesson) would be required to provide to the next recipient of the drug a statement identifying every prior sale, purchase, or trade of the drug, and the contact information of every party to those transactions. By December, the FDA hopes to resolve the following issues, brought to its attention by members of the industry:

• Who will fall into the category of “authorized distributors of record”, and what impact will their exemption from the tracking process have on other primary and secondary wholesalers? The proposed regulation indicates that if an authorized distributor of record is not required to report pedigree information, then any secondary distributor will not receive a full account of the drug’s distribution path, and will not be able to provide the required information to the next link in the chain. If that information is not provided, the secondary distributor could not legally sell the product.
• How will the FDA protect any personal health information that might potentially be exposed due to the tracking process? The main issue in question is whether or not the tracking device will be disabled once it reaches the retailer or consumer, or if the tracking process should continue.
• How will the FDA standardize the tracking process? (e.g. Specific or random numbers? Barcodes or RFID?)

Who Will be Affected First?

The FDA has indicated that the e-Pedigree Program will first be applied to those drugs that are considered high-risk, or fall into one of the following categories:

• High value in the US Market, as indicated by:
• High sales volume/price
• A “specialty” product used to treat serious or life-threatening illnesses (e.g. cancer or AIDS)
• High demand for the drug
• A shortage of the drug
• Prior indicators of risk of, or vulnerability to, counterfeiting or adulteration
• Reasonable probability of risk or vulnerability (for newly-approved drugs with a high priority review status)
• Other violations of law (i.e. drugs distributed by those wholesalers or distributors who are suspected of taking part in illegal activity)

Some of the drugs currently classified as high-risk include:

Changes in State Pedigree Legislation

The developments in the FDA e-Pedigree program have sparked further advancement in state programs as well. Florida, for instance, effectuated its e-Pedigree law on July 1, 2006. California and Indiana have also set deadlines for the implementation of their programs, and several other states are in the process of developing Pedigree legislation.

For a summary of each state’s program, click here .

Sources:

• FDA Counterfeit Drug Task Force Report: 2006 Update
• FDA Announces New Measures to Protect Americans from Counterfeit Drugs, June 9, 2006
• FDA Draft Compliance Policy Guide 160.900, Prescription Drug Marketing Act – Pedigree Requirements Under 21 CFR Part 203, June 2006

On-line Pharmacy Inventory Management System Can Save Your Pharmacist’s Time
With all the time constraints and administrative burden placed on pharmacists today, it takes valuable time away from their number one priority of servicing their customers. CLS/MedTurn has an on-line inventory management system that can streamline the returns process and alleviate the administrative burden. Those companies that have implemented the on-line returns inventory management program have received positive feedback from their pharmacists. It’s simple and easy to use and makes the return process quick and efficient.

If you want to learn more about how to take advantage of this on-line returns inventory management program, contact your business development manager or Mike Umbach, VP Product Development mike.umbach@inmar.com.

CLS/MedTurn Newsletter Will Be Published Quarterly
Based on feedback from the survey in our last newsletter, CLS/MedTurn will publish our Client Newsletter on a Quarterly Basis. The next edition will be October 2006.

Need Help With a Reverse Logistics Challenge?
If so, contact us and let us work with you to develop a solution that best fits your needs. Contact Jennifer Mauldin or Sharon Joyner-Payne.