
Q&A: Pharmacies Should Use VRS Tools, Document DSCSA Compliance Processes
Matt Sample, senior vice president of manufacturer, quality, and replenishment operations at Cencora, discusses DSCSA compliance hurdles, VRS tools, and a new push toward 12-digit NDCs.
As pharmacies navigate an increasingly complex drug supply chain landscape, compliance with the Drug Supply Chain Security Act (DSCSA) has never been more urgent and consequential. With penalties for noncompliance reaching up to $500,000 and the threat of license revocation, pharmacy owners and dispensers are under growing pressure to get their systems, documentation, and verification processes right.
We sat down with Matt Sample, senior vice president of manufacturer, quality, and replenishment operations at Cencora, to cut through the complexity and offer practical guidance for pharmacists on the front lines.
Sample highlights the verification router service (VRS) as the most powerful tool available to pharmacists when a barcode fails to scan correctly. The free-to-access system, supported by the majority of drug manufacturers, allows pharmacy staff to instantly ping a manufacturer and confirm whether a product is legitimate.
“That's one of the most powerful tools that we've seen deployed,” he told Drug Topics. “Some of the counterfeit investigations over the last year were identified because of this ability to do this verification.”
Furthermore, he explored some of the more intricate, but necessary, processes for ensuring DSCSA compliance, while also teasing the upcoming push from 10- to 12-digit National Drug Codes (NDCs).
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Drug Topics: When a barcode fails to verify, what specific investigator tools or portals are available to help pharmacists quickly distinguish between a manufacturer's clerical error and a genuine counterfeit threat?
Matt Sample: I think the biggest thing is what we call VRS, which the majority of the manufacturers have signed up for. They can get it from their own third-party solution provider. You can just type in the serial number and the information about the product, and it'll ping the manufacturer and say, ‘Hey, is this good?’ That's one of the most powerful tools that we've seen deployed. Some of the counterfeit investigations over the last year were identified because of this ability to do this verification. That's the biggest tool.
The other thing: They can always default to calling their customer service reps for their wholesalers. We're here to help them too through that. But yeah, the VRS—as an artifact of DSCSA—it's the most powerful tool that there is out there.
Drug Topics: Given that noncompliance can result in fines up to $500,000 and license revocation, what are the most critical steps a pharmacy can take to ensure their data storage processes meet FDA standards?
Matt Sample: We’ve always talked about this. It's going to be the state boards of pharmacies that get out there to the individual dispensers. The FDA doesn't have capacity—especially most recently—they definitely [don’t have] bandwidth to go touch dispensers. But from what we've been seeing, working with the National Association of Boards of Pharmacy (NABP), and even the individual states, they're going to be auditing very similar to the FDA. If the FDA licensure ever comes up, they’ll have a standard on what those requirements are. But it goes back to the dispensers just need to focus on do you have your minimal set of SOPs and documents? Do you know how to get to your DSCSA data?
Very simply, when asked the question, if you don't get data, what do you do? Have an answer. That's probably a blind spot from a lot of these dispensers. Like, ‘Well, I know how to get my data.’ Yeah, but what if you have a product, Cencora didn't give you the data, and you dispensed it? That's a conversation you don't want to find yourself in without having a document that says why you did what you did. That's still the same theme.
There are some things there too. If you are using a third-party, document. Just say, ‘Hey, I, I'm using so and so third party, I've sorted data for 6 years.’ That checks all the compliance boxes for you. But again, it's all about documenting what you're doing and then making sure you follow what you documented.
Drug Topics: Can you explain the upcoming transition to 12-digit NDCs and what pharmacists should look for in their software to prepare?
Matt Sample: We've actually started looking at this—we being a handful of us in industry—just starting to peel the onion on this. NDC is everywhere, from labeling to DEA records to the entire backbone of the financial pharmaceutical system. Specific to that question, all of these point-of-sale or point-of-dispense systems are going to have to know how to read a different barcode. The current barcode on the drug today, you cannot fit a 12-digit NDC in there. You’re going to have to go to what will most likely be a 2D, since they're on there already, or a different type of barcode.
All of these systems and software vendors are going to have to change their software to read a different barcode, read a 2D, know what that NDC 12 is, and then, as we get into the complicated nature of this, what was that NDC 12 before it became a 12? Lots of work to do there. We’re just starting to scratch the surface. NDC 12 is like Y2K. The only difference is we have to do this together versus in an individual company vacuum. It's going to be huge.
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