A supply chain expert manufacturers an essential part of the DSCSA relay race

Editor's note: a paragraph was revised to clarify potential causes of DSCSA implementation delays.

While most manufacturers will have their systems up and running and will be able to transmit pharmaceutical tracking data in compliance with the Drug Supply Chain Security Act (DCSCA) when it takes effect in November, some will not have these systems ready in time. This poses a problem for trading partners and ultimately patients, asserted Gregg Gorniak, senior director for manufacturing operations for AmerisourceBergen, in an interview with Focus.

Gorniak’s message to manufacturers is that “we can’t do this without you,” and he asserted that each trading partner, including manufacturers, distributors and dispensers, has a vital role to play in moving products though the supply chain. He also said that manufacturers that are not sending serialized data to wholesalers at this time are “already behind.”

Beginning on 27 November 2023, DSCSA requires manufacturers, wholesalers, distributors and dispensers to exchange serialized product information; the culmination of the law’s phased implementation.

Gorniak said that “poor planning” is the reason why these systems will not be ready. Some manufacturers delayed making the necessary—and expensive investments—in hardware and software packaging systems without understanding the lead time necessary to manufacture and install them. During the pandemic, the US Food and Drug Administration (FDA) granted enforcement discretion on various provisions of the law, which exacerbated the situation.

Prior to joining AmerisourceBergen, Gorniak was the DSCSA lead at GlaxoSmithKline.

The interview has been edited for clarity.

Focus: The million-dollar question is whether manufacturers will have the necessary systems in place for DSCSA compliance by 23 November. Are manufacturers sending you serialized packaging?

Gorniak: We believe a majority of manufacturers will be ready. However, the caveat is that they’re probably not going to be 100% ready. What I mean by 100% ready is that when manufacturers start to send us this aggregated and serialized data, it’s done at the production line at the manufacturer’s facilities. They can have multiple production lines at multiple facilities. Most of them are going to be connected and will start to send us data, yet will they send it for 100% of their products? That is where we will find the issue where we will get most of them but not all.

What we have seen so far is that probably around 15% either they do not have a projected date when they will go live, or the date is somewhere around November or after November. So that is a problem as well, in that they will not meet the November deadline. We have to see what we are going to do on that front.

Focus: Are these 15% small or large manufacturers? Can you classify which types of companies will not have these systems ready?

Gorniak: It really is everyone. We have large and small—branded and generic—companies. I can probably tell you one in each [category] that will be ready or will not be 100% ready. It is really all over the place.

Focus: What happens if these manufacturers don’t apply to FDA for waivers or exceptions to temporarily exempt these products from tracking requirements?

The worst-case scenario is that we can’t move their product. They would ship their products to us but if I don’t have the serialized data behind it, I am not allowed to touch it. So, if I can’t move it downstream that means I can’t get it to the dispensers who can’t get it to the patients, which leads to stock-outs and shortages in the industry. It’s a huge concern for patients. This is what we are trying to avoid.

Focus: Are you working with manufacturers to see that these tracking systems work?

Gorniak: We have been tracking everything just in case we need to ask if this is an exception so we can flag it and log it and to get some data around it, so it won’t be quarantined. We work with manufacturers and say, ‘This is what we’re seeing.’ We are doing the same thing with barcode issues and labeling. You only have five months to get this under control and fixed.

Focus: What specifically do manufacturers have to have on their packages by this November?

Gorniak: It’s all that data in the 2D-barcode. It all starts with the manufacturers. This is the largest piece that we have. The struggle that we have are that we are the downstream partners to the manufacturers. I’m talking about wholesalers like us, Cardinal and McKesson, and the dispensers. Yet the manufacturer starts this whole thing. I will give you a funny example [of how this works]. My boss, Matt Sample, coined what I call the ‘Sample Example.’ Think about DSCSA as a relay race in track and field. The manufacturer is the first runner that is holding the baton, the baton is the actual physical product as well as the serialized data. We, as wholesalers, are the second runners in the race, so I have my hand out waiting for the baton, so I need that relay runner to come to me and hand me the data and the physical product. We do the same thing, we take it and run our piece of the race to the dispenser. The fourth and the final runner, the anchor leg, is the patients. It is a partnership through this whole landscape. We cannot do it without the manufacturers.

Focus: What are the biggest barriers to getting these systems ready?

Gorniak: I will be honest. The first major barrier to this implementation is just poor planning. I am not throwing anyone under the bus, but a lot of manufacturers decided to delay the initial financial outlay of buying or purchasing hardware or software updates. A lot of this equipment such as a giant case packaging machine that is going to aggregate correctly is a couple of million dollars. They decided years ago that 2023 seems far away, and to delay those outlays. ‘We don’t want to put it in this year’s budget, we will put it in next year’s budget,’ not understanding that these hardware manufacturers have a 12-to-18-month lead time.

Then the pandemic happened. Everybody took their foot off the gas. The second piece of this was that people said, ‘We were granted enforcement discretion on saleable returns, now I have three years to get this done.’ Every milestone throughout the DSCSA’s life has been granted enforcement discretion.

Focus: Are you doing any outreach or meeting with manufacturers on DSCSA requirements?

Gorniak: That is what my team does, we are onboarding all the manufacturers. We talk to them every day. We have been auditing their barcodes. We audit our distribution centers every year. We go out there and scan as many products as we can. We produce score cards for all our manufacturers on how their barcode did on the package level and the case level. We have multiple scores as to why it either passed or failed, and whether it was a DSCSA-relevant error or a nice to have fix. This is where we have seen a significant decrease year over year in terms of where we started with bar codes issues and errors, as opposed to where we are now.

Focus: Any last-minute advice to manufacturers who don’t have these systems ready?

Gorniak: It would be to pay attention to any audit report that AmerisourceBergen sends to you and get yourself ready, look at any hardware or software requirement that you have to update. If you are not sending the serialized data right now you are already behind, you are going to need to start sending it now. That EPCIS [Electronic Product Code Information Services] data that you send, as good as you think you are with your data, it never goes right the first time. EPCIS is an extremely exact data message, it will take time to get that right and it does not have a warning, if part of it fails the whole message fails. The other thing is that [contract manufacturing organizations] CMOs are starting to play a bigger part of manufacturing. If you have not reached out to your CMO, reach out to them now to get it right. The data and these labels are vital to be compliant with DSCSA. I am not going to move a non-compliant item to the dispenser.

A supply chain expert manufacturers an essential part of the DSCSA relay race

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