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Guidance Extension for Dispensers 10-28-2015

Oct 30th, 2015

Dear MatchRX Member,

Of recent, many members have contacted us with questions about the 2013 Federal Drug Supply Chain Security Act (DSCSA) and how it impacts MatchRX.   Our executive team, led by Mike Galloway (COO), has been working with the FDA over the past 18 months in regards to the DSCSA and its impact on independent pharmacies.  We have traveled to Washington D.C. and met with congressional stakeholders, FDA staff, regulatory advisors at NCPA and APhA, and participated in an invitation only FDA meeting seeking public comment regarding the new law. As such, we have a good understanding of the law and how it relates to the independent pharmacy.

The DSCSA replaces a 50-state patchwork of pedigree requirements with one federal traceability solution for prescription medicines, and is phased in over a ten year period beginning November 27, 2013 (the day signed into law by President Obama).  Per FDA Guidance released October 28, 2015, March 1, 2016 (previously November 1, 2015) marks the day you are required to receive and retain the Transaction History (TH) in electronic or paper form with every delivery of prescription medications to your pharmacy.  The TH is a new term for “pedigree” that details the ownership transfer of the medication from manufacturer through the supply chain to your pharmacy.  Think of it as a bread-crumb trail.  The big three and larger secondary wholesalers plan to provide access to the TH electronically via their respective online portals.  Other authorized trading partners (dispensers, wholesalers, re-packagers, etc) will use other methods like email and paper.  The method used is important to know as you are required by the DSCSA to maintain this data for six years, and have quick access to the information should the FDA issue a notice of inquiry against a specific drug or NDC.  We are encouraging members to contact their wholesaler(s) and inquire how the TH will be passed before the March 1, 2016 deadline.

How does this impact members using MatchRX?  Per the DSCSA all product owned by you as of December 31, 2014 will be grandfathered, meaning there is no historical TH to pass to the buyer when a grandfathered item is sold to another pharmacy (since it was not required when originally purchased by your pharmacy).  Given that most product listed on MatchRX has been on a members shelf on average 10-12 months before being posted to the marketplace, this works in our members favor the first year.  As mentioned above, starting March 1, 2016 dispensers are required to receive and retain the TH in paper or electronic format for all new purchases.  Prior to the dispenser deadline, we will launch new functionality to identify grandfathered items and capture the TH when posting an item that is NOT grandfathered to the marketplace.  Until then, no additional work is needed to comply regarding transactions processed through the marketplace.

Click here to view FAQ’s regarding the DSCSA and MatchRX.

MatchRX is compliant with the Transaction Information (TI = MatchRX Packing Slip and/or Invoice) and Transaction Statement (TS = signed Packing Slip) requirement of the DSCSA.  For grandfathered product sold on MatchRX, the invoice generated by MatchRX satisfies the TH requirement.  For product that was purchased by your pharmacy between January 1, 2015 and March 1, 2016, the majority of this product may not have a TH and is not officially grandfathered per the Act.  In instances where TH is provided by your wholesaler for product purchased between January 1, 2015 and March 1, 2016, the DSCSA states it must be passed to the buyer.  New marketplace functionality will be released prior to the extension date to capture the wholesalers TH to be passed to the buyer.  However, since most of the product purchased by dispensers during this time-frame will not have TH, the FDA has stated in Guidance issued October 28, 2015 that the FDA will not take action against your pharmacy if you received product without the 3T’s, or fail to capture and maintain the 3T’s prior to March 1 2016.  Click here for the official Guidance document.

MatchRX understands the issues regarding security and reliability of pharmaceutical transactions that led to the enactment of the DSCSA.  We are continually working to provide our members with the resources they need to ensure the drugs in the supply chain are safe.  We take this responsibility seriously, as a safe and reliable drug supply is central to our members’ business and critical to the health and well-being of the patients they serve. We fully support these regulatory efforts and will continue to build functionality and safeguards that satisfy the DSCSA requirements as they are phased in over the next 10 years.

Please direct any questions to Mike Galloway (mgalloway@matchrx.com).  We will do our best to respond in a timely manner.  We will also continue to publish member communications as the DSCSA is implemented.

 

Thank you,

John Kello, CEO