DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?

Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA).  But be careful.  Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA.  In fact, many products that have historically been referred to as “medical

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2 thoughts on “DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?”

  1. Dirk,
    Would it help if these “kits” were aggregated?
    If they contain various ethical drugs, wouldn’t that make sense?

    1. Lee,
      Thanks for your comment. I don’t think aggregation would help in most scenarios but perhaps it would in one. I outlined five different scenarios.

      1. True convenience kits: These are already exempt so there is no need to aggregate.
      2. Repackaged drugs: Assuming only a single DSCSA product is enclosed, there is no reason to aggregate. If multiple drugs are enclosed, you probably don’t want to mix repackaging with any of the other scenarios, so I don’t think aggregation helps here.
      3. Not a DSCSA Product: These are exempt from the DSCSA because they are not DSCSA Products, so aggregation doesn’t help.
      4. Combination products: These are drug-device or biologic-device combinations that the FDA classifies as having either a Primary Mode Of Action (PMOA) of a drug, a device, or a biologic. If the PMOA is a drug or a biologic, then the entire combination product must be treated as a single drug or a single biologic under the DSCSA. Aggregation doesn’t help.
      5. Everything else: Sorry for putting you though numbers 1-4 above. I know you were talking about just this type of product but I wanted to cover those too because others reading this might assume you meant all cases. Anyway, if the “collection of separately regulated products” includes multiple drugs and/or biologics, aggregation might help. The only potential problem I see with it, is that aggregation implies that the buyer can dis-aggregate the aggregation and have sellable units. Your “sellable unit” is the collection, for which you would voluntarily establish a GTIN and serialize so its contents can be aggregated. Your customers (and their customers all the way down to the dispenser) would need to be able to recognize the aggregation information and make use of it to build the necessary TI/TH/TS documentation. That is, the TI/TH/TS would have to be documented at the level of the individual products contained within the aggregation, but since it is being sold as a single product (the “kit”), it could get confusing. The “kit” (collection…) itself would not be regulated by the DSCSA, only the individual drug/biologic component(s).

      Yes, I think it could be done, but the “kit” assembler would need to make sure their downstream trading partners are aware of the special characteristics of this product and how they would need to handle them to remain in compliance.

      Thanks for raising this interesting approach.

      Dirk.

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