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Pharmedix Notice to Our Clients

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 are legitimate, utilizing identification and tracing procedures as well as maintaining systems that recognize and report suspect 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™. However, depending on the vendor, prescription products purchased prior to May 1^st 2015 when DSCSA regulations took place, may have incomplete track and trace histories.  Effective July 1^st 2015, 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 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.  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.

Pharmedix™ will continue to supply pedigrees to states that require pedigree papers (where pedigrees are still available) until May 1^st 2015, even though this new legislation supersedes any and all state pedigree requirements.