How to Manage DSCSA Requirements with Pharmaceutical Software

This post is Part 6 and the last post of the Series: Understanding The Drug Supply Chain Security Act and What it Means for Pharmaceutical Distribution Companies. For a full list of all the topics in this series, please see the bullet points at the end of this post. 

In November 2013, former President Obama signed into law the “Drug Supply Chain Security Act (DSCSA)”. Throughout this series, we’ve reviewed the information included in the DSCSA and discussed the most applicable requirements that impact pharmaceutical wholesale distributors and their ability to comply with the outlined regulations. In this final post of the series, we will discuss how pharmaceutical wholesale distributors can benefit from implementing pharmaceutical software to help comply with DSCSA regulations and automate the process of managing data.

Wholesale distribution businesses across all industries require processes and systems for managing their business. At the onset, this usually involves installing an introductory accounting solution, such as QuickBooks, to manage a company’s core financials.   As a business grows and order volume increases, there will come a time when additional software is needed.  It is at this stage that a company start evaluating a fully integrated solution to handle a business’ entire operation – from accounting to order entry and processing, to inventory management, contact management, eCommerce and more. For pharmaceutical distribution businesses, this functionality is required in addition to industry specific tools.  For this reason, pharmaceutical businesses should look to implement proper ERP software with industry specific functionality from the get-go, as opposed to starting with introductory software. Not only do regulatory bodies require companies to comply with certain standards, but having proper software in place to manage these requirements also provides a sense of security and helps ensure trust for customers and vendors throughout the supply chain.

When it comes to DSCSA requirements, ERP software with pharmaceutical specific features provides functionality for:

Transaction Reporting (T3)

  • Automatic tracking of information stored to one level back and one level forward
  • Ability to enter complete transaction tracking for each product/lot back to the manufacturer
  • Automatic printing of Transaction Report (T3)
  • Easy email and printing of Transaction Reports to the lot level for each product for a given sales order
  • Ability for customers to access and print Transaction Reports remotely over the internet (from an online B2B portal)

Suspect and Illegitimate Product Handling and Notification

  • Quarantine of products to prevent them from being allocated/shipped
    • Transfer to a quarantine location
    • Changing status of the specific lot(s) to prevent them from being allocated
  • Suspicious order monitoring
  • Automatically placing a hold on any sales order considered suspicious
  • Ability to store Drug Notification Form FDA 3911 at the vendor or customer level

Product Identification and Serialized Numerical Identifier (SNI)

  • Ability to store and print the information in the Unique Product Identifier including the product’s Serial Numerical Identifier (SNI), lot Number and associated lot expiry date

Suspicious Order Monitoring

Ability to monitor sales orders and inform their DEA Field Division Office of any suspicious orders including;

  • Unusual size
  • Unusual order patterns
  • Monthly ordering frequency
  • Ratio of controlled vs. non-controlled quantities
  • Combinations of products
  • Items outside of scope of practice
  • Strength check
  • Product family combinations
  • Percentage of products from the same family

Saleable Returns – Verification Router Service

Allows you to verify that the unique product identifier on a returned product is authentic and includes barcode scanning functionality to read applicable 2D Datamatrix barcodes of the smallest saleable unit.

Managing Trading Partner Licenses

  • Storage of copy of the license(s)
  • Reporting of license(s) expiry dates
  • Association of allowable drug scheduling for each customer ship to and vendor ship from
  • License association to each customer/ship to
  • License association to each vendor ship from
  • Notification if license(s) are approaching expiry or have expired
  • Managing of a sales order or purchase order if license expired
  • Prevention of products being added to a sales order if applicable customer credential not achieved

As new requirements come into effect and continue to impact the daily operations of pharmaceutical wholesale distributors, it is important to ensure you have the industry specific functionality in place to comply with existing requirements and new ones as they continue to get rolled out. Download the Distributors Guide to DSCSA Compliance for must-have features to help you meet industry regulations.

Series: Understanding The DSCSA and What it Means for Pharmaceutical Distribution Companies