DSCSA: What Wholesalers Want
Last November pharma manufacturers selling into the U.S. market had to meet a big serialization and verification deadline under the Drug Supply Chain Security Act (DSCSA). Now, pharma wholesale distributors in the United States are facing their own important deadline this coming November. Remember how manufacturers had to scramble and go through a lot of pain to achieve compliance in time? Your friendly neighborhood wholesale distributors—big and small—are going through that now. And the problem is…they can’t do what they need on their own. They need all drug manufacturers to do something so that they can be compliant with the DSCSA in November.
This is different. It’s a little like how many drug manufacturers were at the mercy of their contract manufacturing organizations (CMOs) to be compliant with their serialization requirement, but worse. I understand that a few of the largest drug manufacturers had to deal with hundreds of CMOs. Drug wholesale distributors need to work with many hundreds of suppliers to help them become compliant. Yes, I’ve written a little bit about this before, but I have some new resources to help drug manufacturers understand the problem and what the wholesalers want/need. (See “Most Companies Will Do DSCSA Verification Wrong”, “GS1’s Messaging Standard For Verification Of Product Identifiers”, “What’s So Hard About Unique Identifier Verification?”, “DSCSA Red Light Green Light: Verification Responses”, “DSCSA Verification and Suspect Product” and “DSCSA Serialization: What Wholesalers Expect”.)
The problem the wholesalers are facing is that the DSCSA requires them to “verify”, using the Standardized Numerical Identifier (SNI), every returned saleable drug package or homogeneous case they plan to redistribute, starting on November 27, 2019. The HDA has documented that 2-3% of all Rx drugs distributed by wholesale distributors in the U.S. are returned to those wholesalers in saleable condition. Congress recognized this as a weakness in the security of the supply chain so they made the first major serialization deadline for the wholesalers in 2019 to remove that weakness.
Regular readers of RxTrace already know that the term “verify” as used in the DSCSA is loaded. The DSCSA defines the term differently than you or I would probably define it, so unless you read and understand the definition Congress gave that term, you won’t know what the wholesalers must really do. For a full airing of this problem, see “Most Companies Will Do DSCSA Verification Wrong”. I’m not going to repeat it here (see also “Don’t Skip The DQSA Definition of Terms Section”).
Because they need to process so many returns, they need to know almost immediately whether or not each package or homogeneous case can be verified at the time they process them. That is a lot faster than the 24 hours the DSCSA gives manufacturers to respond to “requests for verification”. “Almost immediately” is defined by the wholesale distributors as “under one second”.
FDA has provided some draft guidance around verification and “systems for verification” (see “DSCSA: Verification Systems Draft Guidance” and “DSCSA Guidance: Definitions of Suspect and Illegitimate Product for Verification Obligations”), but the Healthcare Distribution Alliance (HDA) has contested a lot of that guidance using very solid arguments (see “HDA Makes A Strong Case For ‘Reframing’ Of FDA’s Draft Guidance On DSCSA Verification Systems”).
WHAT WHOLESALERS WANT
So given all that, what do wholesalers want from drug manufacturers now? For several years now they have been fairly consistent, through their industry association, HDA, and individually. To meet their DSCSA verification requirement in November, they need drug manufacturers to:
- Send them a list of each SNI, lot and expiration date in each shipment to them, and/or
- Participate in the Verification Router Service (VRS) system that is currently being developed. (See “First Meeting of the HDA Verification Router Service Task Force”.)
Notice the “and/or” part. Originally, this was just an “or”, but slowly some of the wholesale distributors started saying “and”. It started with McKesson and now I’ve heard it from others. For a full explanation, see “FDA DSCSA Public Meeting #2, Still A Gulf”.
There are several new resources that I wanted to pass on to those who are grappling with this issue, or who just want to learn more about it from the wholesalers. First, Cardinal Health holds a DSCSA call for their suppliers on the first Monday of every month that I can highly recommend for drug manufacturers. I am told that the quality of these calls has increased over the years they have held them and that they are dense with helpful information, including open Q&A on every call. I’m told it is only open to actual CAH suppliers. If you are one of those and you are not on those calls, just send an email to email@example.com to be added to the invitation.
My source told me that Cardinal Health has been asking their suppliers to provide them with a list of their Rx Global Trade Item Numbers (GTINs) by March 1st, 2019. Apparently they only received a small percentage of the expected information by the due date. If your company did not respond, send an email to the address above to get more information about that request/requirement. It is possible that other wholesale distributors have the same request pending. They can respond to this essay to register their request here if they want to.
In addition, Cardinal Health will publish any day now version 2.0 of their DSCSA Onboarding Guide, which, I’m told, is a major update to their previous version 1.2. The document is aimed at their suppliers of Rx products that fall under the DSCSA and includes information on the technical connections necessary to help them meet their DSCSA obligations. That new document should be posted in the next day or so on Cardinal’s Pharmaceutical Tracing for Manufacturers web page under the “Technical” tab. Start looking for it later today or first thing next week. Make sure you get version 2.0.
Another resource is a new webinar recording offered by Vantage Consulting, with Andrew Meyer of Mutual Drug, a top 10 wholesale distributor co-op (!) from North Carolina (register to hear the recording here). In the webinar, which has the unlikely title, “The Hitchhiker’s Guide to 2019 VRS/Data Transfer -- Don’t Panic: We’ve Got You Covered”, the main topic is the saleable returns problem and the two solutions Mutual Drug is asking manufacturers to provide. It’s very helpful to hear a smaller wholesaler saying pretty much the same thing the Big-3 wholesalers are saying about how to solve their 2019 saleable returns deadline. The Q&A at the end of the webinar is very good and even touches on aggregation in this new context (see "Aggregation: The Achilles’ Heel of Pharma Supply Chain Operation Under A Serialization Regulation"). I’ve known Andrew for a long time and he’s a great speaker.
I’ll keep looking for resources from other wholesale distributors and publish them on RxTrace. You can probably find vendor solutions for VRS from this point forward. I can’t endorse any specific solutions but just make sure you are aware of the capabilities you are investing in before you buy.
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- Posted By:
- Dirk Rodgers
- March 7, 2019
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