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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:

 

A. Grandfathering Exemption from Certain Transaction-Related Requirements of Section 582 

 

1. Scope of Grandfathering Exemption 

 

“A package or homogenous case of product that is not labeled with a product identifier shall be grandfathered where there is documentation that it was packaged by a manufacturer or repackaged by a repackager before November 27, 2018. For example, if a package or homogenous case of product not labeled with a product identifier is accompanied by transaction information or a transaction history that includes a sale before November 27, 2018, that trading partner can reasonably conclude the product was packaged by a manufacturer or repackaged by a repackager before that date.”

 

If the transaction information or transaction history does not include a sale before November 27, 2018, “… since manufacturers and repackagers retain packaging date information in the ordinary course of business,19 they should provide the packaging date to any trading partner who owns the product if they request it.”

 

Footnote #19 identifies common documents such as batch records, required under cGMP regulations for finished pharmaceuticals, as being acceptable to show that product was packaged before Nov. 27.

 

Wholesaler distributor requirements

 

For wholesalers, Pugh references the following explicit language from the guidance:

 

“Wholesale distributors are exempted from two requirements of section 582 in circumstances where there is documentation that the product involved in the transaction was in the pharmaceutical distribution supply chain before November 27, 2018. 

 

“First, for this grandfathered product, wholesale distributors are exempted from section 582(c)(2), which requires that they engage in transactions involving only product encoded with a product identifier beginning November 27, 2019.

 

 

Key Takeaway

 

Pharma manufacturers must maintain records which can prove items were packaged prior to Nov 27, 2018 in order for those products to be “grandfathered.”