How would your company respond to this DEA Notice?
…pursuant to 21 U.S.C. 823(f) and 824(a)(4), it is my preliminary finding that the continued registration of ABC123 Pharmaceutical Wholesale Company is inconsistent with the public interest.
…the Special Agents and Diversion Investigators of the DEA who serve this Order to Show Cause and Immediate Suspension of Registration are authorized to place under seal or to remove for safekeeping all controlled substances that Registrant possess . . .
Last month Harvard Drug Group responded by filing a plea in US District Court seeking relief from their Immediate Suspension Order. Before the week was over, DEA had reinstated Harvard’s CS III-V registration.
How did Harvard mitigate the DEA suspension so quickly? Court records indicate Harvard produced abundant evidence of the extraordinary measures they had taken to comply with DEA anti-diversion mandates, including the design and installation of “a comprehensive, state of the art suspicious order system to monitor orders for controlled substances.”
Does your company have the IT resources to hard code suspicious order analytic tools for your order management system? Are you comfortable with your 21 CFR 1301.74b SOM compliance?
If you have been thinking about an upgrade to your monthly averaging, thresholds, and exceptions reporting system, please consider SOMLink™ automated compliance toolset developed for CS II-V manufacturers and distributors. http://www.e-supplylink.com/som.htm
Benefits of SOMLink™ include seamless integration to suppliers’ existing Financial/ERP via XML, automatic notification of flagged orders via email, including notice of cause. SOMLink™ maintains a permanent record database for reporting verification activities, updates, and final disposition of flagged orders. The SOMLink™ repository is supplier-managed, and supports compliance with DEA mandates.
Please call to schedule a demo and receive a Quote. We think you will be impressed with the product and pleasantly surprised by the cost of ownership. 1.877.998.3645 or sales@e-supplylink.com
