On December 24, 2014, the FDA released guidance for the requirement under the Drug Supply Chain Security Act (DSCSA) that requires information concerning the purchase and sale of prescription pharmaceutical products to be transmitted by the manufacturer to the wholesaler and from the wholesaler to the dispenser. The Act took effect January 1, 2015, and provides for a full implementation process over a period of 10 years. The Act imposes requirements on manufacturers, wholesaler drug distributors, repackagers and dispensers to verify that all pharmaceutical products in the supply chain are legitimate, utilizing identification and tracing procedures as well as maintaining systems that recognize and report suspect counterfeit products.

The enforcement date of this requirement was moved to May 1, 2015 by the FDA. The previous effective date was January 1, 2015. The guidance making this change can be found at the following
link:

http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM427867.pdf

As of May 1, 2015, Pharmedix®™ is now compliant with its manufacturers and wholesale suppliers to receive and transmit data regarding the transaction history concerning the prescription products you purchase from Pharmedix®™. Pharmedix® ™ Company will be providing access to the required Drug Supply Chain Security Act information via email and our website. The information on the website is available in a printable PDF format but only for a limited time. Please contact customer service at 1-800-486-1811 to create an online account if you do not currently have access to our website so you can access your DSCSA information. It is your responsibility to retain this information for a period of 6 years and, if necessary, transmit the required information to your down-stream customers as required by the Drug Supply Chain Security Act.

Please be aware that this new federal Track and Trace system will supersede all state pedigree programs (e.g. Florida). These state pedigrees will be removed from the Pharmedix®™ system by July 1st.

Pharmedix®™ is also currently updating its standardized operating procedure (SOP) for identifying counterfeit drugs which it has had in place for over 3 years.