Expert: Manufacturers making ‘great progress’ towards DSCSA compliance
Editor's Note: This article was updated 13 June to clarify Gorniak's responses on the company's outreach efforts.Most drugmakers are actively transmitting serialized data under the Drug Supply Chain Security Act (DSCSA) and will be in compliance with the law when it takes effect this November; however, much work still lies ahead in getting those companies who are not sending serialized data up to speed, Gregg Gorniak, vice president of manufacturer operations and data services at drug wholesaler Cencora, told Focus.
Cencora is one of the three largest drug distributors in the US; the other two are Cardinal Health and McKesson.
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. In August 2023, FDA announced it would be giving firms a one-year reprieve or “stabilization period” to give companies more time to prepare their systems. (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023)
On Tuesday, FDA announced a re-opening of the public docket on the stabilization period to allow for additional time to comment and to accommodate the feedback FDA receives from an upcoming public meeting on 17-18 June on DSCSA implementation. The workshop, organized by FDA and Partnership for DSCSA Governance (PDG), will focus on the stabilization period midway checkpoint.
This interview has been edited for clarity.
Focus: What are you seeing in terms of DSCSA implementation?
Gorniak: Since the stabilization announcement in August 2023, we did see two periods of a nice ramping up from the manufacturers and more DSCSA data flowing through to us between August and November of 2023. December is always slow for every industry because of Christmas and New Year’s, and we had another good ramp up from January to mid-March but there has been a trail off between March and the end of April. We are seeing anywhere between 80 to 95% of our purchase orders have the data. Fifteen to 20% of data is missing or coming in late. Between 40 to 50 manufacturers are in that bucket. Overall, there has been great momentum and progress, but there is still a lot that has to be done.
Focus: Are you reaching out to manufacturers and working through this?
Gorniak: We reach out to them daily, if not more. We are trying to work with them and partner with them [through the process of onboarding]. We understand it is a partnership and not just us telling them what to do. We are trying to make them understand this is for the greater good of industry.
Right before the stabilization announcement last year, we had a bucket of manufacturers that had no plan, they were not responding to us, and we could not get a hold of them. That number was 54 manufacturers.We've had that number drop to 2. That is fantastic, to now say we are down to 2, that's great.
Focus: Are you seeing many problems with exceptions or sending you the wrong data?
Gorniak: I would not say it is not a problem… Really what you’re seeing is as an industry trying to figure out what are the exceptions are. We’ve met with industry workshops such as HDA [Healthcare Distribution Alliance] and the PDSA [Pharmaceutical Distribution Security Alliance] to document the exceptions we’re running into, and then we try to develop a plan for these exceptions and correcting that.
Focus: Are there different types of exceptions?
Gorniak: There are different types of exceptions ... The truck backs up and there is a product but no data. This is the biggest exception and the easiest one [to resolve]. Or there can be data but no product. Then there are data errors within the data file.
Focus: Do you see a lot of products going into quarantine come November because of either missing data or wrong data?
Gorniak: That is a loaded question but unfortunately, yes, I do. To be a realist I think we are going to see that. This is what stabilization was supposed to work out. We should be doing [testing] now while we are in stabilization. We are working to not see large numbers [of product] go into quarantine. Come November, I don’t want to see large numbers of product in quarantine.
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