RDC’s ePedigree Initiative

Thank you for visiting RDC’s Track & Trace resource page.  Our partnership with TraceLink helps our customers track, store, and access our ePedigrees.

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How to Enroll on TraceLink

To view RDC’s ePedigrees, you must first enroll on the TraceLink website.  Please take 2 minutes and complete this form. The screen requires basic information about your store including which staff member you choose as a Company Administrator.  After completing this survey, TraceLink will contact you within a few business days to complete the enrollment process.

How to Use TraceLink

Click here to print instructions – Or, view Tracelink video tutorials –> TraceLink Tutorials

What is Track & Trace?

Since March 1, 2016, pharmacies have been required to comply with “Track and Trace”, an FDA regulatory compliance program based on the “Drug Quality and Security Act” of 2013 (DQSA).  Read more about the act here.

Track and Trace is an FDA regulatory compliance program requiring every member of the supply chain to track and append electronic product pedigrees (ePedigrees).  The 9 year roll-out launched on January 2, 2015.  The initial program requires lot-level ePedigrees to be delivered to dispensers.  In 2017, new regs will convert the system to individualized package serialization. 

Below are current requirements affecting you and your suppliers.

All wholesalers must:

  • receive or create electronic ePedigrees from trading partners
  • verify lot number receipts against ePedigrees
  • quarantine any products that do not match against epedigrees
  • report quarantined product to the FDA
  • append ePedigrees with receipt information
  • store ePedigrees for 6 years
  • forward ePedigrees to customers (pharmacies) who purchase the product

All pharmacies must:

  • receive ePedigrees from wholesalers and alternate source suppliers
  • verify lot number receipts against ePedigrees
  • quarantine any products that do not match against ePedigrees
  • report quarantined product to the FDA
  • store ePedigrees for 6 years
  • be prepared for FDA audit of specific NDC’s and/or lots

In response to these requirements and the challenges of implementation in the retail pharmacy environment, RDC partnered with TraceLink, a leader in pharmaceutical and supply chain traceability since 2003.

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By enrolling on the TraceLink website, RDC customers have access to a private cloud-based network between us, our manufacturers, and you.  Here you will be able to view and print RDC’s ePedigrees, a convenient solution which eliminates your need to download ePedigrees into your store and retain them for 6 years.

Our partnership with TraceLink ensures that RDC meets all regulatory requirements of the DSCSA law.  We believe it is the best solution to make DSCSA compliance as easy and professional for our customers as possible.

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To view RDC’s ePedigrees, you must first enroll on the TraceLink website.  Please take 2 minutes and complete the form at this <link>.

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Is RDC ready for Track and Trace?

  • Yes, since January 2, 2015, we have been capturing and storing both electronic and paper ePedigrees on incoming shipments from manufacturers.
  • We have provided a solution for our customers for storing and printing ePedigrees at store level.

What is an ePedigree?

  • An ePedigree is an electronic document created by a drug’s manufacturer for a particular item lot or serialized identification.  The document must include the “3T’s” and must be appended by downstream trading partners to track an item’s complete supply chain history.

What are the 3T’s?

To comply with DSCSA law, each ePedigree must contain the “3T’s”

  • Transaction Statement (TS) – statement of authenticity by FDA Authorized Trading Partner
  • Transaction History (TH) listing of chain of custody transfers
  • Transaction Information (TI) – product information including lot number

Who is TraceLink?tracelink-LSCloud-logo

  • Read more about TraceLink here.  TraceLink is dedicated specifically to the healthcare industry and have contracted with most of RDC’s major pharmaceutical manufacturers.  They provide complete support for all state-level and Federal pedigree mandates and are certified by GS1, an EPC global standards organization. 

Why do I need Tracelink?

  • The FDA will submit requests for information for recalls or suspect product investigations.  To comply, each supply chain company including pharmacies must produce ePedigree Transaction Histories for each product sold from the specified lot.  Pharmacies have 48 hours to produce the compliance documentation.
  • In addition, insurance companies may require ePedigree information during supply chain audits.

OK, I’m on TraceLink.  How do I see ePedigrees?

Will RDC’s Tech Support know my TraceLink login credentials? 

  • No.  TraceLink login instructions are private and will not be accessible or recorded by RDC staff.

How can I see ePedigrees from other suppliers? 

  • A number of other wholesalers are also partnering with TraceLink.  In that case, you will be able to see both their ePedigrees and RDC’s on the same TraceLink login page.
  • If your other wholesalers have not partnered with TraceLink, they will most likely provide another solution or website to look-up your ePedigrees.
  • Alternate source suppliers and telemarketers should also send you ePedigrees, or provide a solution similar to TraceLink.

Are Invoice line item pedigrees good?

  • No.  ePedigrees must contain the 3T’s, which is too much information for old style invoice line pedigrees.  ePedigrees not containing the 3T’s are unacceptable according to FDA regs.

What if my supplier does not store ePedigrees for me?

  • You will need to download ePedigrees from that supplier and store them for 6 years.

What if my supplier is not going to provide ePedigrees?

  • That supplier will be out of compliance with FDA requirements and supply chain safety measures.

How can I validate product coming from alternate sources?

  • Three things are needed to ensure product safety after it has traveled through multiple parties.  1.)  You must receive an ePedigree containing the 3T’s from the supplier.  2.)  You must be able to open and view the original manufacturer’s shipment and lot information on that ePedigree, and 3.)  you must verify that the lot numbers on your product match the ePedigree.  This is the only way to validate the product’s entire life cycle back to the manufacturer and be in compliance with the FDA.  If at any point any of these steps fail, the product should be treated as suspect and is subject to a quarantine process.

Can I download ePedigrees into my pharmacy system?

  • Yes, depending on your pharmacy system vendor.  If you prefer to receive ePedigrees directly, TraceLink can provide an automated interface using EDI, EPCIS, or XML formats.  To learn more about an automated integration with TraceLink, please contact TraceLink directly at NetworkServices@tracelink.com.

Does RDC expect to be audited by the FDA?

  • Yes.  Because this is an FDA regulatory compliance initiative designed to protect American consumers from counterfeits and diverted product, we intend to fully comply with every requirement of DSCSA law.
  • We expect to be audited on our compliance measures, as well as individual lot number investigations.  We don’t know when this will happen, but when it does we will account for every pharmaceutical shipment that left our building.

Where can I see the DSCSA law?

Is product serialization coming?

  • Yes, in 2017.  The current plan is that each and every pharmaceutical package will have its own unique serialized scan code containing the lot number, expiration date, and other types of information.  This will require significant changes to our internal systems, and possibly how you receive product at your store.  RDC and TraceLink will be working on solutions for that when the time comes.

Can RDC recommend some in-store “best practices”?

  • Ensure your pharmacy’s safety by checking with each supplier to make sure they provide electronic pedigrees containing the 3T’s.
  • If your suppliers store ePedigrees for you, find out how long.  FDA requirement is 6 years.
  • If your suppliers do NOT store ePedigrees, create an electronic folder (with back-up) for storing their ePedigrees inside your pharmacy for 6 years.
  • Create a central listing of your ePedigree sources – supplier websites, etc.  Record usernames and passwords, and instructions how to access ePedigrees.
  • While FDA has not yet issued guidance for transfers, returns or other types of transactions, you can create your own tracking system.  Example, for store transfers, print your supplier’s original ePedigree.  Document as much information as possible about the package – lot number, NDC, etc – even take a photo.  Ask the receiving pharmacy to sign your Pedigree.  Then store completed forms in a physical folder for 6 years.
  • Prepare for FDA audit.  Create your own monthly or quarterly “mock audit” in which you pull various product from your shelves and search for the corresponding ePedigrees.

 Resources:

  • Download this Track and Trace PowerPoint presentation given at PSSNY LogoPSSNY’s Mid-Winter Conference on January 10, 2015.  –>  Track and Trace 

a-Questions-1Please email us with any questions you have.

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Updated October 22, 2015

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