Comply with DSCSA using an efficient and thorough track and trace partner

As a retailer with a pharmacy, you face a federal mandate to process, track, and store drug pedigree data. The next deadline for retail pharmacies to comply with the Drug Supply Chain Security Act (DSCSA) is November 27, 2020.

By this date, your retail pharmacy will need to have a reliable solution in place so you can quickly identify and investigate suspect and illegitimate prescription drugs, down to the serialized package identifier, and electronically store tracing documentation for six years. This includes all prescription drug products purchased, not just that from your primary wholesaler, and you must be able to provide it to the FDA or any of your trading partners within days of their request.

Doing nothing to prepare for this deadline is not an option. Non-complying retailers may put themselves at risk for loss of license, hefty fines, and even imprisonment. Some retailers plan to hire new staff to create processes and systems to manage these new requirements and store the six years of transaction data, however, this is expensive and challenging to maintain. Plus, expecting pharmacists to conduct validation while a shipment is being received is unrealistic alongside all the other demands they face.

HRG’s Rx Track-and-Trace Compliance Service lightens the burden of the detailed oversight necessary to meet the new law. From large retail outfits down to independent and small chain retailers, our team of auditors actively monitor each client’s transactions to identify any alerts generated by the rules-based system to detect abnormalities in the transport of Rx drugs from the place of origin. The web-based interface also makes it easy for our clients to access from the internet if they wish. Here are some of the ways Rx Track-and-Trace Compliance Service meets DSCSA requirements to bring you peace of mind:

  • Collects Advanced Ship Notices (ASNs) from your suppliers.
  • Loads your data into Pedigree Repository where the rules-based engine checks for valid chain of custody between trading partners.
  • Makes searching and retrieving your T3 data efficient using an easily accessible web interface.
  • Uses a unique “Smart ASN” rules engine, flags pedigree issues and alerts auditors who review for issues.
  • Provides real-time alerts!
  • Securely stores the six years of transactions required in a dedicated repository

HRG has been entrenched in the pharmaceutical distribution channel since 1980 and offers the only track and trace service tailored to the needs of dispensers. Our technology partner, Advasur, LLC has worked for the U.S. government and the industry to audit for counterfeits, diversions, and establish medical supply systems.

Rx Track-and-Trace Compliance Service offers pharmacies everything needed to meet DSCSA requirements. Learn more by reading our blog series, Preparing for Track and Trace, or watching our video series, which describes important DSCSA information and deadlines, as well as more about our solution.

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