Is aggregation required for US DSCSA serialization?

Is aggregation required for US DSCSA serialization?

Some companies seem to be understandably confused as to whether aggregation is required to meet the US DSCSA requirement. Indeed, the question came up again on a recent GS1 call this week. So let me try to help clarify the situation.

Before I go any further, let me clarify what I mean by aggregation for the purposes of this discussion. Aggregation information is the information that describes the physical relationship between “parent” shippers, e.g. homogeneous cases, and the “children” contained inside them, e.g. secondary packages. Hence people will often talk about the “parent child relationships” when discussing aggregation. This information is typically constructed in electronic system databases during product packaging and distribution activities.

First of all, the US DSCSA legislation does not directly mandate aggregation. It only mandates the application of unique identifiers, often referred to for simplicity as serial numbers, to secondary packaging and homogeneous shipper cases by November 2017, and the reporting of this information to supply chain partners by the latest in November 2023. When asked recently at the FDA Public Meeting on Progress Toward Implementing the Product Identification Requirements of the DSCSA, they reiterated that aggregation was not mandated by the law and that this was a supply chain issue.

However, the reality of moving product in the supply chain, coupled with the need to understand where each unique identifier is, does require aggregation. The easiest way to think about this is to consider the situation where a company is selling a full case of product to a customer and the seller needs to communicate the serialization information about this product to the customer. If aggregation information is available to the seller, then the seller simply needs to scan the single case unique identifier when picking the sales order. They can then infer what is in the case from the aggregation information and transmit this information accordingly. However, if aggregation is not present, then the seller would have to break open the case and scan every single secondary pack in the case. This would clearly take much more time and create increased risk of error.

The wholesalers understand this practical necessity for aggregation and have therefore issued instructions to their suppliers that they will require serialization and aggregation from secondary package to pallet level. Therefore, whilst not mandated in the DSCSA Law, aggregation to the pallet level effectively becomes a requirement of the supply chain for many manufacturers.

Clearly, there are certain situations where aggregation would not be required. For example, where product is sold in less than full case quantities and shipped directly from manufacturer to patients or dispensers. Unfortunately, for many manufacturers, this is not the situation.

Therefore, for a significant number of manufacturers, aggregation becomes a requirement to be able to sell product into the US supply chain, and many are putting in capabilities accordingly.

If you would like to discuss your particular situation with regard to aggregation, or other aspects of serialization, please do not hesitate to contact me at Stephen.McIndoe@be4ward.com

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