REGULATORY REQUIREMENTS

To aggregate or not to aggregate? DSCSA requirements in detail

JIM CUMMINGS Written by JIM CUMMINGS
12/10/2016

The Drug Quality and Security Act (DQSA), was signed into law on November 27, 2013.

Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines requirements regarding an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed in the United States. A great deal of effort is being put forth to serialize prescription pharmaceuticals individual saleable unit to meet the FDA’s November 2017 deadline. However, we have found that a large number of companies are confused as to the requirements at case level.

Case level serialization under the Drug Supply Chain Security Act (DSCSA)

It is very clear in the law that by 2023 units will be aggregated to cases and therefore cases will be by definition serialized. The commonly overlooked portion of the law is the requirement to serialize all homogenous cases by November 2017 alongside the individual saleable unit items. This is outlined in the act under SEC. 582. REQUIREMENTS of the DSCSA:

“In general, beginning not later than 4 years after the date of enactment of the Drug Supply Chain Security Act, a manufacturer shall affix or imprint a product identifier to each package and homogenous case of a product intended to be introduced in a transaction into commerce. Such manufacturer shall maintain the product identifier information for such product for not less than 6 years after the date of the transaction.”

To aggregate or not to aggregate?

The fact that the units are not required to be aggregated has in some cases provided the incorrect impression that only individualized saleable units, also referred to in the act as packages, are to be serialized. As we can see in the direct quote from the official act, that is in fact not the situation. All companies must serialize the cases in order to meet the mandated deadline. The information required for both is the same: SNI (standardized numerical identifier), lot, and expiration date.

Data matrix or linear bar code for aggregated units?

The format of the barcode while required to be a data matrix at the individual saleable unit can be either a data matrix or a linear barcode at the case level. There are customers who are producing both symbologies at the case level in order to support legacy 1D scanners in warehouse environments.  Read more about coding formats under the DSCSA

Before selecting a single case symbology it would be well advised to communicate your plan to your supply chain partners to ensure your products will flow through your supply chain network uninterrupted. Your trading partners may enact requirements above and beyond the DSCSA which could negatively affect you if you do not engage in these conversations sooner rather than later.

JIM CUMMINGS
JIM CUMMINGS

Jim Cummings is VP Americas at Adents. He has an extensive background in instrumentation, automation and information systems for manufacturing. He also was a founding member and chairman of the Control Systems Integrators Association (CSIA).

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