DSCSA enforcement delay: No time to take foot off the gas

Manufacturers must step up their efforts to iron out glitches and stabilize their track-and-trace systems under the Drug Supply Chain Security Act to ensure they are ready to go live next year. Failure to do so puts a trading partner at risk of US Food and Drug Administration (FDA) enforcement, according to experts who spoke to Focus on the implications of the agency’s decision to delay enforcing these requirements for one year.

Focus reached out to Matt Sample, senior vice president of manufacturer operations at Cencora, (formerly AmerisourceBergen) and Tish Pahl, an attorney with Olsson Frank Weeda Terman Matz PC, to discuss lingering challenges with track and trace, as well as the implications of the FDA’s recent announcement that it will grant trading partners one more year to comply with the law (RELATED: FDA gives firms one-year reprieve from DSCSA track and trace requirements, Regulatory Focus 25 August 2023).

These systems were supposed to be in place by 27 November 2023; in the new compliance policy, FDA states that it does not intend to take enforcement action until 27 November 2024.

These interviews have been edited for length and clarity.

Focus: In your view, was FDA’s recent action necessary? We keep hearing that trading partners were not ready and did not have these systems in place.

Sample: It was definitely necessary from a perspective of not impacting product access and patient safety. We saw that the manufacturers were not ready. These challenges would result in products showing up at my dock without data and being quarantined. Thirty-five percent of the products were showing up without data.

We have been advocating for phased implementation for 6 months. If products keep showing up without data, we would be in bad shape come November.

Focus: The August guideline calls for a one-year “stabilization period” and does not necessarily say anything about enforcement discretion. Does this mean FDA is actively looking for firms to implement these systems?

Pahl: Yes. FDA said what it means, and we find what FDA meant in two places: in the stabilization policy itself and in the presentation that FDA gave at the recent HDA [Healthcare Distribution Alliance] Traceability Seminar.

The stabilization guidance policy states, “FDA generally expects trading partners to have the systems and processes in place to meet these requirements as of November 27, 2023,” not 2024. That is a quote directly from the stabilization policy. However, [FDA] recognizes there are technical and operational issues, which may not be fully resolved by then. That is where the stabilization comes in. FDA expects trading partners generally to meet these requirements by November 2023. This is what I am telling my clients.

Sample: [FDA] actually underlines the point that industry is not supposed to stop the stabilization process. FDA had to get permission to use a special typographical font to underline in the guidance (see page 5). While that may ring hollow for people not used to reading guidance, it’s actually a pretty big deal.

Focus: What advice do you have for manufacturers in the one-year interim?

Sample: Honestly, turn [these systems] on and send as much data as possible. We have had people who were reluctant to turn it on. They were afraid it wasn’t going to work. Work with us and work out the kinks. We are not going to fix things and stabilize if you don’t turn it on.

Focus: Are you hearing about any major stumbling blocks that are impeding implementation? Are there other major issues that you are hearing about?

Sample: People who did not have product aggregated were not ready. (Aggregation allows trading partners to be able to infer the data at the smaller unit levels.) They may have changed something a year ago, but they did not know what was in the box. If you have delayed any forms of aggregation, do not stop or do not delay, these systems must be in place. The other issue is data integrity to get the right quality checks in place. When you ship something to me, are you writing reports to make sure that you have sent enough serial numbers?

Pahl: Another issue – apart from manufacturers who cannot yet send aggregated data – is the use of EPCIS [Electronic Product Code Information Services] information. Sending EPCIS and exchanging data at a package level is hard. There are some manufacturers who think they can just flip a switch and be able to send accurate and complete EPCIS files for the transaction. That is not a properly founded belief. When we first switched from paper methods to the ASN [Advanced Shipment Notice] for exchange of transaction data, that took weeks and months of work between trading partners and most trading partners were familiar with the ASN. The ASN is also a more forgiving document than EPCIS.

Focus: Do you think that FDA take enforcement action against companies that are not getting their systems ready – perhaps if they are inspecting for something else?

Pahl: I do not know if FDA would issue a warning letter for failure to make good faith efforts, but it would not be unreasonable to see that and would not be unexpected. Two things are important about the stabilization period. First, you need to be engaged in good faith efforts to comply with the 2023 requirements as soon as possible. Second, FDA states that they expect continued compliance with all current requirements, including the use of current methods to exchange and store transaction data. You have to walk and chew gum at the same time, you have to be using your current methods and getting into compliance with 2024 requirements as quickly as possible. If you are not doing both, you are at particular risk.

Focus: Is there anything else you would like to add?

Pahl: Anyone who takes their foot off the gas and decides not to reengage until next year is making a grave mistake. Don’t rely on continuing to delay getting into compliance and for FDA to look the other way. People need to stay on top of this.

DSCSA enforcement delay: No time to take foot off the gas

Related topics

Recommended content

Welcome to the new RAPS Digital Experience