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Grandfathered Products? Keep Your Records!

How will trading partners know which products are grandfathered after Nov. 27?

With the DSCSA enforcement date approaching, I’ve heard confusion among some pharmaceutical manufacturers. Wholesalers can accept non-serialized product after Nov. 27 if it was packaged before that date. But how do they know what product is legitimately grandfathered?

We asked serialization expert Scott Pugh, Principal at Jennason. While it’s not a legally binding interpretation of the law, he highlighted some important points in the FDA’s guidance documents and stressed the need for manufacturers to keep documentation on when items were packaged, which should be standard operating procedure anyway.

In essence, Pugh explains, “Pharma manufacturers will need to maintain records which can prove items were packaged prior to Nov. 27, 2018 in order for those products to be 'grandfathered' and subsequently wholesalers are exempt from the requirement of only transacting with serialized items when dealing with grandfathered product (where proper documentation exists).”

Documentation

Pugh says it’s important to define what additional information may be requested after Nov. 27 to prove a product is truly grandfathered. 

He points to the recent guidanceGrandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier:

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