DCSCA – The product identifier and data contained in it

March 20, 2020By Behind the Shelf Blog, Focus on the Pharmacy Front End Blog, Preparing for Track and Trace blog series

By Brittany Benson, CLSSS, Lean Project and Research Specialist, for the Preparing for Track and Trace blog series

In our previous posts in the Preparing for Track and Trace blog series, we explained the Drug Supply Chain Security Act (DSCSA) and your responsibilities under the law as a dispenser. We also dove more deeply into details about T3 documentation, how to know when a drug is suspect or illegitimate, important dates to know, and serialized products. This post will examine the collaboration needed to develop and standardize the new required product identifier and data contained within it.

The FDA describes a product identifier as a standardized graphic in both human-readable and machine-readable forms that includes the standardized numerical identifier, lot number, and expiration date. (The FDA has also provided a decision tree to help the industry identify when this product identifier is required under the DSCSA).

To break that down, the new information that would be required on non-exempt packaging in this law needs to be represented in a machine-readable way (this “new” 2D barcode that you’ve been seeing and hearing about that can be scanned and contains DSCSA-required fields of data) and visible and readable to the human eye (typically you will see the required fields of data stored in the 2D barcode printed next to that barcode on the Rx packaging).

In the industry, lot number and expiration dates were understood. However, the standardized numerical identifier was a new development and needed to be created and standardized prior to manufacturers being able to generate and print this information on packaging.

The FDA describes a standardized numerical identifier this way – it is composed of the National Drug Code (NDC) combined with a unique alphanumeric serial number of up to 20 characters. So, to be DSCSA compliant, the product packaging needs to have the following information printed on it: the NDC, lot number, expiration date, and this new serial number, plus the new 2D barcode containing that information. Most Rx product packaging already has a linear 1-dimensional barcode (UPC), NDC, and lot number, but those can apply to more than one Rx bottle (bottle is being used here as just one example of a packaging type). Now it needs to have another unique identifier on it so that the supply chain can track where each bottle currently is or has been. The new serial number is unique to each package and means that within a lot, each package has the same lot number but its own unique serial number (similar to how an NDC can have multiple lot numbers).Pharmacist scanning box

With the fields defined and understood, the industry still had to figure out 2-dimensional (2D) data matrix barcodes in order to start generating and printing product identifiers. You may be most familiar with a QR code, which is a type of 2D barcode, but they are not the same. “The 2D data matrix barcode encodes specific product information and has been adopted as a data carrier for the healthcare sector,” per the FDA. Application standards exist for this technology in the form of GS1 DataMatrix Guidelines and ISO/IEC 16022 technical standards. Manufacturers were originally supposed to have all these elements ready to go and begin affixing them to packaging beginning November 27, 2018. However, the FDA ended up moving that out a year to November 27, 2019 to allow more time for everyone to be compliant.

In the next post we’ll be covering trading partner roles.