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Drug Supply Chain Security Act (DSCSA)

Jul 28th, 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 June 30, 2015, November 1, 2015 (previously July 1) 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 November 1, 2015 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 November 1, 2015 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 and October 31, 2015, the majority of this product will 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 and October 31, 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 June 30, 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 November 1 2015.  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

 

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Drug Supply Chain Security Act (DSCSA) Definitions Pertaining to MatchRX:

 

Authorized Trading Partner – Dispensers (pharmacies) having a valid license under State law.

Grandfathered Product – Product owned by your pharmacy prior to January 1, 2015 that is posted to the marketplace.

Specific Patient Need – The purchase from one pharmacy to another to fill a prescription for an identified patient.

Transaction Information (TI): The MatchRX Packing Slip and/or Invoice –  A paper or electronic document containing the name of the product, strength, dosage form, NDC, container size, quantity, lot number, transaction date, ship date (if 24 hours beyond transaction date), buyer, and seller.

Transaction History (TH): The MatchRX Packing Slip and/or Invoice, plus the TH provided by the seller if required - A statement, in paper or electronic form, including the TI for each prior change of ownership going back to the manufacturer of the product.  TH for Grandfathered product will be the MatchRX Packing Slip and/or Invoice.

Transaction Statement (TS): The MatchRX Packing Slip – A statement, in paper or electronic form, that the seller is

a)    authorized under the DSCSA

b)    received the product from an entity authorized by the DSCSA

c)    received the TI and TS from the prior owner of the product

d)    did not knowingly ship a suspect product or illegitimate product

e)    had systems and processes in place to comply with the DSCSA verification requirements

f)     did not knowingly provide false transaction information; and

g)    did not knowingly alter the TH.

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