Recently, several of the larger U.S. wholesale distributors have sent letters to their suppliers to review what they expect from them relative to the Drug Supply Chain Security Act (DSCSA). You may recall that these companies have provided requirements in advance of earlier DSCSA deadlines (see “U.S. Drug Wholesale Distributors Provide Direction To Manufacturers“). These expectations are aimed at the November 27, 2017 serialization requirements and beyond.
From my observation, each wholesale distributor articulates their requirements in their own words, but overall, they are basically the asking for the same things. Some of them go into more detail than the others, but effectively, they are still saying the same thing. If you believe that one wholesale distributor is demanding something beyond what the others are demanding, let me know. Or, just re-read their letters to make sure you have not mis-interpreted something.
Cardinal Health’s letter, date February 22, 2017 includes their latest expectations for the manufacturer’s 2017 serialization deadline and the 2019 wholesale distributor requirements that result in DSCSA-triggered business requirements for drug manufacturers.
Cardinal Health expects drug manufacturers to follow GS1 Standards as well as the barcode and serialization guidelines published by the Healthcare Distribution Alliance (HDA). And they expect suppliers to follow future FDA final guidance regarding grandfathering. Cardinal Health plans to accept non-serialized drugs after November 27, 2017 that meet the criteria specified in that future guidance (see “Will Manufacturers Be Able To Grandfather Products In Their DC And 3PL?“, “FDA Forfeits Opportunity To Guide Industry“, and “Is The FDA Intentionally Delaying Publication Of The Overdue DSCSA Guidance?“).
Cardinal Health is apparently still receiving paper forms of DSCSA transaction documents (TI, TH, TS) and their letter informs manufacturers that they will return shipments of drugs that do not provide electronic transaction documents after November 27 of this year in accordance with the DSCSA (see “DSCSA: Transaction Information“, “DSCSA: Transaction History“, “DSCSA: Transaction Statement“, and “DQSA: Getting To Electronic Transaction Data Exchange“).
The letter states that, effective November 27, 2019, Cardinal Health will not accept DSCSA products that are not serialized. This is the DSCSA deadline that forces wholesale distributors to stop accepting all non-serialized product, whether previously grandfathered at the manufacturer or not (see “Is Your Drug Exempt From The Federal Drug Supply Chain Security Act?“, and “Who Will Enforce The DSCSA 2017 Serialization Mandate?“).
As far as the wholesale distributor DSCSA saleable returns requirements that kick-in on November 27, 2019, Cardinal Health’s letter offers two options that were originally set forth by the HDA pilot: Aggregation data, or the Verification Router Service (VRS). Manufactuers who choose to send them aggregation data should begin to send that data in GS1 Electronic Product Code Information Services (EPCIS) format by January of 2019. The letter acknowledges that the VRS has a long way to go before it is usable and they offer to keep their suppliers updated on its progress (see “DSCSA: Saleable Returns Verification“, “Aggregation –> Chargeback Accuracy –> ROI” and “First Meeting of the HDA Verification Router Service Task Force“).
Cardinal Health’s letter encourages manufacturers to let them test all new barcodes planned for DSCSA compliance before they are distributed into the supply chain (see “DSCSA ‘Serial Numbers’“). This is a very valuable service and I commend Cardinal Health for offering it. Send your sample barcodes to email@example.com. They will accept full label samples as well as just barcode samples.
For more information about Cardinal Health’s expectations, including their excellent Trading Partner Technical Guide for serialization, see their Pharmaceutical Tracing web page. You can reach Cardinal Health’s serialization team directly at firstname.lastname@example.org.
McKesson does not post their letters regarding the DSCSA so you can’t see it unless you received a copy from them. They were kind enough to share it with me for this essay (thanks). I can tell you about it but I cannot post it.
McKesson’s letter is more detailed than the Cardinal Health letter, but, as I said above, I don’t see anything distinctly different from what I believe the two companies mean to say (except maybe the aggregation requirement…see below). McKesson specifically says that they expect suppliers to continue supplying DSCSA-compliant EDI 856 ASNs for TI, TH and TS right up until November 27, 2023. In addition to the manufacturer’s DSCSA serialization deadline they also point out that the serialization deadline for repackagers is November 27, 2018.
McKesson offers the same two options for helping them meet their 2019 DSCSA saleable returns requirements: aggregation data and the HDA VRS. But, they say that suppliers will need to use “one or both” of these options for verification with McKesson. If a manufacturer chooses to send aggregation data, that data must be supplied in GS1 EPCIS format following the most recent version of GS1 Healthcare US Implementation Guideline (the current version is 1.2, see “The New GS1 US DSCSA Implementation Guidance Suite“). Further, suppliers must begin sending all DSCSA data in EPCIS format by November 2022 to allow ample opportunity for testing.
McKesson acknowledges that this will result in a parallel path for the same data but it will be necessary to ensure compliance through the transition to EPCIS-only data after November 2023 (see “HDMA DMC Serves Sizzling Steak With A Small Side Of Snake Oil“).
Even though McKesson allows companies to choose HDA’s VRS for saleable returns verification, they still expect suppliers to provide aggregation data from saleable units, to cases and all the way to pallets. So much for the “choice” they referred to for saleable returns verification! This seems inconsistent to me. I think they will need to explain this better in their next letter.
McKesson points out that the DSCSA requires the addition of a new 2D Datamatrix barcode on all DSCSA products after November 27 of this year, but they also correctly point out that the linear barcode that has historically been on those packages must remain there (see “FDA Still Receives Requests For Exemptions From 2006 Barcode Rule“).
Wholesale distributors will need to know exactly which products fall under the DSCSA and which are exempt. McKesson’s letter points out that companies introducing new Rx products to the market must fill out the HDA’s New Product Form. They are particularly interested in the answers to the following questions on that form:
- Do you meet the DSCSA definition of “manufacturer”?
- Is the product exempt from the DSCSA?
- Is the product repackaged and do you purchase directly from the manufacturer?
- Are you instead the manufacturer’s exclusive distributor?
Finally, McKesson points out that the expiry included in EPCIS events, barcodes and the barcode human readable should have a non-zero “day” (see USP General Chapter 7, Labeling).
McKesson’s letter came with five attachments that cover various technical topics.
You can contact McKesson’s serialization team directly at TraceabilityTeam@McKesson.com.
Unfortunately I don’t receive AmerisourceBergen letters but you can reach their serialization team directly at email@example.com. You can find their public postings regarding the DSCSA at their Knowledge Driven website. Just click on the “topics” along the left margin, “DQSA”, “Track and Trace” and “Secure Supply Chain”.
Sadly, from here on to the November 27 deadline for serialization, and perhaps even beyond that, the best source of information about DSCSA compliance is not the FDA. Rather it is the larger wholesale distributors themselves. If you can’t find the information you are looking for there then make sure you check out the HDA’s DSCSA resources page. And of course, I recommend my book, “The Drug Supply Chain Security Act Explained“, available on Amazon.com.