Predictably after the Nov 2018 DSCSA serialization milestone passed serialization vendors needed to find their next marketable offering. Enter VRS.
The result has been a flood of marketing materials highlighting the advantages and/or readiness of one VRS service over another. In turn this has resulted in pharma manufacturers raising questions to me about how best to approach their "VRS requirements".
My immediate response to that question is- "Are you sure you need a VRS?"
The purpose of this post is to clarify what is required under DSCSA as it relates to verifications and the role VRS plays in meeting those requirements in certain scenarios. My hope is to help some manufacturers avoid being 'sold' a new solution feature by their provider when its actually not necessary to meet their requirements. Moreover, I hope to make clear that by simply signing up for a VRS a manufacturer doesn't magically meet all the verification/suspect/illegitimate product handling requirements under DSCSA.
First let's define what DSCSA says about verifications and the upcoming milestone in the regulation that is making this such a hot topic.
Come November of this year wholesalers will be required to perform a verification of any returned items which they hope to resell. (e.g. saleable returns). To meet this requirement wholesalers will be reliant on manufacturers to provide the data necessary to decide if the item is 'verified'. There are generally two ways to achieve this: Either the manufacturers share their serialization/traceability data (e.g. EPCIS) downstream with the wholesalers or the manufacturers respond to a verification request.
Since many manufacturers are far away from being able to provide serialized/aggregated data to their downstream partners, the focus has largely turned to responding to verification requests.
For manufacturers, the ability to respond to verification requests is nothing new- in fact- the ability to respond to certain verification requests for non-serialized items has been in place since the first milestones of DSCSA went live. And as of last November, manufacturers are required to respond to verification requests for serialized items.
Most importantly, nowhere in DSCSA does it state that in order to meet the verification requirements one must leverage VRS. While DSCSA does define the timelines for when each segment of the supply chain must be able to respond to verification requests, it does not define how those verification requests may be made nor does it define how the responses must be provided.
Point being, the industry could meet DSCSA verification requirements by leveraging phone calls, emails and carrier pigeons if it wanted to.
But alas, the industry, largely driven by the big wholesalers, recognized the absolute efficiency nightmare such non-automated approaches would have on their operations. In response VRS was born- a way to systematically submit verification requests to a manufacturer and rapidly receive a response. VRS meets DSCSA requirements for saleable returns verifications and saves big wholesaler's operational efficiency- happy days.
But what happens if I'm a small manufacturer who only sells to small specialty wholesalers or skips wholesalers altogether and sells direct to pharmacies... do I need VRS? The answer is possibly (and probably) no you don't. It all comes down to your customers because VRS is not a DSCSA requirement, it's a US pharma industry requirement if you do business with customers who require you have a VRS capability in order to ship product to them.
So, if you are unsure the next step is to talk to your customers. Ask them their plans for meeting the Nov 2019 wholesaler salable returns requirements. Ask them if they will be requiring their suppliers (i.e. you) to leverage VRS. You might find many of your customers are not even planning to use VRS. You might find instead they prefer to receive the EPCIS data for the items you ship them (which means aggregation and ensuring your L4/5 system can adequately handle such downstream exchange becomes your top priority). Or you might find they are perfectly fine relying on emails/phone calls/carrier pigeons as the volumes of saleable returns verifications is anticipated to be quite low.
If none of your customers say they will require VRS then, for the present time, you are safe not having a VRS capability. What you must do however, no matter what your customers say, is ensure you have the proper processes in place to respond to verification requests and further have the processes to handle suspect/illegitimate product. (See https://www.jennason.com/dvm)
But if you do have customers that expect/require you to have a VRS capability then shop around. The very nature of VRS requires it be inter-operable- meaning it doesn't matter who your customer's VRS provider is or your neighbors VRS provider- you can choose whomever you like. Go with your current provider's VRS feature if you don't want the headache of introducing a new vendor. Or if you think your vendor is charging an astronomical amount for the service there are plenty of offerings out there that will layer on top of your existing providers system. (but be prepared its not a 'flip of the switch' if you go that route)
As always my message to manufacturers is- maintain oversight of your serialization program, and in the case of VRS-
A) Don't let your vendor simply sell you on a feature that may not be needed
B) Recognize that VRS covers the ability to respond to saleable returns verification requests - it does not satisfy your legal requirements of having processes and systems in place to respond to all types of verification requests and, moreover, it does not satisfy your legal requirements of having the processes and systems in place for handling suspect and illegitimate products.
You’ll likely find serialization ranked near the top of the ‘Most annoying/frustrating/irritating/just plain bad things to ask a Pharmaceu...
Up until recently GS1 US (and likely other GS1 organizations) offered a 'One-Off' GLN Subscription service to help organizations obt...
In general I try to stay out of the political on-goings at the Federal, State, and international level in regards to pharma serialization an...
Needing to comply with EU FMD? Don't miss this critical GS1 Guidance on the proper use of NTINs in EPCISRecently I highlighted an important GS1 guidance which aimed to correct a common misuse of GLN/SGLNs in EPCIS events. Next in our serie...
Traceability Tip of The Day: Determine Proper Ownership of Data in Your Serialization and Traceability SolutionLeverage best practices from Enterprise Integration to retain proper data ownership in your global serialization and traceability solution...
Important Public Service Announcement from GS1 and what it means for your Serialization ImplementationGS1 recently released a PSA (Public Service Announcement) noting a specific practice which is currently widespread in pharma serialization...
In the early days of enterprise pharma serialization solutions the Serial Number Manager (SNM) component was somewhat of an after-thought. ...
I considered a number of angles for how to approach this post on blockchain and what I realized is that my thoughts on blockchain are confli...
A lesson that stuck with me from my consulting days is the importance of setting expectations- never surprise a client with negative news. ...
A constant battle which has waged since the beginning of serialization regulations in pharma is the notion of “Spirit of the Law” vs “Lett...
- ▼ 2019 (8)
- ► 2018 (10)