The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA

The FDA published draft guidance earlier this week that might seem a little confusing.  The full title is “The Effect of Section 585 of the FD&C Act on Drug Product Tracing and Wholesale Drug Distributor and Third-Party Logistics Provider Licensing Standards and Requirements:  Questions and Answers.  Guidance for Industry”.  Because it is in “draft” form,

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4 thoughts on “The New Draft Guidance On The Effect of Section 585 of the FD&C Imposed By The DSCSA”

  1. Not directly tied, but related. Many of the wholesalers and third party providers we work with in the industry, are not operating what pharmaceutical manufacturers would consider a validated systems environment.

    Previously, the logic in many of these circles, has been that without repackaging or “touching the actual product,” there may not be an impact to the product or efficacy itself, like with a manufacturer. What is your take here now, with the ultimate requirement of the systems providing interoperability and trace-ability, should 3rd party logistics providers and wholesalers, who currently don’t have supply chain systems (warehouse management systems, control systems, etc) prepared to meet CFR 21 Part 11 compliance, be readying their IT organizations to prepare their systems to meet that requirement along with the requirements of the DQSA?

    1. Ryan,
      No, I don’t agree that wholesale distributors and 3PLs should be expected to validate their WMS or other systems. My understanding is that validated systems are important to ensure that the product is made to specifications and then identified accurately so that healthcare workers and patients can count on the efficacy. The only argument I can think of where a legitimate wholesale distributor or 3PL could negatively affect the efficacy of a product is environmental (temperature, humidity, shock, cleanliness, etc.). Are there others I’m missing?

      In my view, validation is necessary only when a wholesale distributor does something to the product itself, or its identification. Repackaging and relabeling of any kind (adding barcodes or other information labels to the product packaging) are included in that.


      1. Agree on all parts there. I would agree that there is a requirement on temperature and humidity storage but their environmental control system should be able to provide adequate reporting there as well as systems within transport and their temp tales.

        The difference that I see now, and in talking to those in pharma system validation roles, is that if system reporting needs to be provided to FDA to meet compliance requirements, then these systems will need to be validated.

        Now, as 3PL’s serve pharmaceutical manufacturers and wholesale distributors are now required to potentially provide chain of custody reporting and the requirement that will come to validate with the manufacturers, that product is genuine, they will need to rely on their systems to validate chain of custody and authenticity at shipping and receipt, which could be used in reporting to the FDA.

        The other change is the increased importance of barcoding. Now there is added importance for 3PL’s to relabel product, in the event that a barcode is smudged or forked/damaged, there there is the rework requirement where they may need to repackage/relabel a carton or pallet. Then there is the business practice among wholesale distributors where they will add their own shipping labels to the product, that allow for efficiencies in material handling, sortation, picking, packing and shipping. This will then be the identifier and tracking number used to track product through their network and potentially beyond. So again, now that identifier will likely travel through multiple partners and be used to track product custody at shipping and receipt. That identifier too could be required in generating reporting to the FDA.

        Perhaps it is more conversational, but what constitutes repackaging now and at what level, and does/will the FDA require all systems performing regulatory reports or used in generating regulatory reports, be validated?

        If I also think about the impact of accurately decoding the serialized barcode to verify product, dating, etc and then direct product, assign product to be shipped to the right customer, and then potentially apply secondary labeling, should warehouse management, warehouse control, and associated systems meet FDA validation requirements.

        1. Ryan,
          It will be interesting to see if the FDA takes the view you propose. In my view, supply chain accuracy is much less important than product identification accuracy at the point of dispense and use, which I’ve always assumed was the point of today’s validation requirements. In fact, parties in the supply chain (except true repackagers) should never “fix” a smudged barcode on a package that would be used by a dispenser or healthcare professional during administration unless they have a validated system (which repackagers are required to have). Instead, those packages should be treated as “damaged” and returned to the manufacturer for destruction. Shipping labels applied by wholesale distributors do not replace or cover the product labels that are applied by the manufacturer and those shipping labels should never contain product identification information for this same reason.

          The DSCSA has a pretty clear definition of “repackager” so I don’t think that definition is expandable to include anyone who puts a shipping label on a case of product.

          Your case is strongest where you are concerned about the systems that are used by downstream trading partners to verify with the manufacturer that a product is genuine, but you have still not convinced me that those systems should go through the validation process. By the way, under the pre-2023 DSCSA requirements, that verification will only be necessary when a drug is under some kind of suspicion or is a salable return, not every drug on every shipment or receipt as you imply.

          You raise some interesting possibilities. It will be very interesting to see what approach the FDA takes on them.


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