Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?

Regulations often make use of a concept known as “grandfathering” to soften a given deadline so that it is easier for companies to meet.  When allowed, grandfathering allows a company to continue doing something after a regulatory deadline that mandates a change, as long as one or more pre-conditions apply.  For example, Section 582(a)(5)(B) of

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2 thoughts on “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?”

  1. Dirk, I googled the word “Commerce” to make sure I had my meaning correct. Commerce means, “The activity of buying and selling, especially on a large scale”…..The act of buying and selling to me would clearly mean that the product identifier needs to be on the package when the manufacturer “buys or sells” his/her product.

    I think it’s important to help the industry understand and interpret what they need to do and by what dates, both from a Legal/Regulatory point of view as well as a Commerce/Business Process point of view and not create confusion.

    1. Anoymous,
      Yes, I see I have confused you. I provided the link to my essay “The DSCSA Product Identifier On Drug Packages” and then assumed everyone either already knew what the “DSCSA Product Identifier” was, or they would read that essay to find out. Here is what it means.

      It is a new barcode that the DSCSA mandates on all drugs that are not exempt by November 27, 2017. The barcodes must include the NDC, a unique serial number, the lot number and the expiration date. It is the serial number that makes this so hard to do and therefore so costly.

      So my essay was not about whether ANY product Identifier is required or grandfathered, raher, it was about whether manufacturers can use the DSCSA-specific grandfathering clause in a very particular situation to avoid putting this new barcode on some of their product. Of course, in that situation, the old, existing linear barcode containing the NDC product identifier would still be on that product, as it is on all drug product in the US market today.

      I used the term “Product Identifier” because that’s the term that Congress has given to this new barcode. I generally try to use the phrase “DSCSA Product Identifier” to indicate that I am specifically trying to refer to that Congress-defined term. But sometimes I may forget to do that. Sorry for the confusion.

      Dirk.

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