As the pharmaceutical industry moves towards implementing the Drug Supply Chain Security Act (DSCSA), the FDA has had an active year issuing guidelines, holding meetings, and conducting a pilot program while responding to recalls and COVID-19.

There is currently a wide range of preparations in the industry, with some trading partners already exchanging EPCIS files. Still, there is concern that some smaller players are unaware of the important DSCSA milestones ahead, and a general lack of confidence among stakeholders. distributors, manufacturers and distributors regarding the full implementation of FDA regulations by November 2023.

At HDA’s 2021 Traceability Webinar, Connie Jung, RPh, Senior Policy Advisor to the FDA, provided an update on the Agency’s activities and what the improved future state looks like. Connie Jung, RPh, Senior Policy Advisor, FDA

Improved product tracing in 2023

The FDA receives many questions about what “enhanced product tracing” means. As Jung explained, the provisions include the exchange of transaction information (TI) and transaction records (TS) in a secure and interoperable electronic manner. Some manufacturers are already doing this, but there could be slight changes when the 2023 milestone arrives.

For example, Transaction History (TH) is part of the current product tracking information. The obligation to provide this to the next trading partner ends in November 2023. There are additional requirements under the improved arrangements for collecting this information – transaction information going back to the manufacturer (which looks like transaction history). ). look like exactly what you as a trading partner are used to providing, the system as a whole should allow the FDA to be able to put this information together so that we can understand all the transactions going back to the manufacturer, “, Jung said.

Another key change in 2023 applies to the product identifier. “The Product ID began encoding on products in 2018. But it is currently not required to be part of the transaction information until 2023,” Jung said. “Because of this, there has been some confusion, but keep in mind that the Product ID must currently be encoded on products since 2018.” The new information that will be required in TI in November 2023 and on beyond are the following:

• NDC
• Batch number
• Serial number
• Expiration date

Trading partners need to think about how to integrate this additional data into IT, as well as how to deal with when the tracking information of the products and the products themselves do not arrive downstream at exactly the same time. .

Efficient data exchange is essential to meet traceability requirements.

Management of errors and deviations

Errors or discrepancies may not always reach the level of a suspect product. Jung noted that they were discussing aggregation errors and discrepancies in the EDDS guidelines, along with some examples. “I would like to stress that the product tracing information must be true, accurate and complete, but if there are any errors which could be of a somewhat administrative nature, or if there are other discrepancies, the steps Logics are: work with your business partner to determine what this error or discrepancy is and why it occurred, and try to resolve it. Do this as quickly as possible so that you know if you need to quarantine the product because it is suspicious / illegitimate or if it is really legitimate and you are able to sell the product and keep it in distribution ” , she said.

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Collection of information / response to requests

Information requests are a key part of the DSCSA requirements under sections 582 (g) (1) (D) and (E) of the FD&C Act. “Whether it’s a regulator or other authorized training partner, in the improved world there has to be a way for the applicant to submit a request and communicate it to a business partner and that the business partner is supposed to be able to respond and provide either the relevant IT or TS depending on demand, ”Jung explained.

• Section D refers to an investigation of a suspicious and illegitimate product. In the event of a recall, the FDA may request this information.
• The language of Section E is slightly different, but it’s still about providing relevant product tracing information on a request basis. This section focuses on the information needed to produce the transaction information that returns to the manufacturer.

“Both are of course very critical when investigating a suspicious or illegitimate product. We know the industry is working on how this can be done, ”Jung said. She added that the Agency is also working on this and will hopefully be able to communicate how to proceed in the near future.

Some product verification requirements went into effect as early as 2015, which includes steps to quarantine and investigate the product (and dispose of it if it is determined to be illegitimate).

Now that there are product identifiers on packaging – and in 2023 this product identifier information is part of the TI – Jung explained that the supply chain needs to think about how it can perform the verification. using the product identifier. “We know that there have been pilot projects and other activities related to product identification verification focused on NDC data elements, serial number, lot number, date of release. ‘expiration,’ Jung said.

This work will have to continue. There are different methods to perform this verification, currently worked and tested by the actors of the supply chain. She added, “In this case, the applicant could be the FDA, it could also be another trading partner who could request product verification at the packaging level. So we’ve released a few guidelines and hopefully there will be some updates to some of them, in addition to the guidelines on the improved safety of drug distribution, which will also help clarify a bit more how it can happen.

Summary November 2023

Jung proposed a summary of the EDDS effective November 27, 2023, where the following activities / protocols should exist:

• TI and TS will be exchanged in a secure, interoperable electronic manner.
• TI will include the product identifier at the package level for each package included in the transaction.
• Package-level product verification systems and processes, including the standardized numeric identifier… while also being able to include the use of aggregation and inference as required.
• Systems and processes necessary to promptly respond with the TI and TS for a product to a request from the FDA (or other appropriate federal or state official) in the event of a recall or to investigate a suspicious or illegitimate product.
• Systems and processes necessary to quickly facilitate the collection of the information necessary to produce the IT for each transaction due to the manufacturer, if applicable (at the request of the FDA… or an authorized trading partner…)
• Systems and processes in place to allow acceptance of salable returns and only if that person can relate the salable return product to the IT and TS associated with that product.

“Industry needs to be able to exchange IT and TS and not just electronically, but in a secure and interoperable manner. This interoperability is essential – it means that the systems are able to communicate with each other, in different ways, whether it is requesting information or responding to those requests for information ”, linked to points three to six below. above.

“We can’t say enough that we know it’s going to be tough. We know there is a lot of work to be done, but we are optimistic that we will have improved the security of drug distribution from November 2023. This will be done across the entire supply chain. distribution, ”she added. Jung urged stakeholders to prepare, and while HDA event attendees are engaged and actively working, the recent HDA survey reveals that there are manufacturers yet to get involved.

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And after?

In collaboration with industry, the FDA will continue to develop the interoperable electronic system. Jung noted that more guidance will come with some drafts to be finalized. “We managed to release those four this summer, but there are more to come. In particular, the guidelines on standards will be updated, ”she said. “Standardization is obviously so important at all levels here, whether it’s product identification, but also in terms of master data or product traceability information data. Please watch out for these updates. We also have guidelines for our business partners that we plan to update. ”

Regulations for the proposed rule for licensing standards for wholesale / 3PL distributors are coming soon, and Jung has expressed optimism about receiving feedback from the industry.

The Agency will also pursue various collaborations and partnerships, including the PDG public-private partnership and other conferences and workshops.

Public meeting: concerns expressed

In addition to numerous webinars to stimulate stakeholder engagement and increase visibility of enhanced drug distribution requirements, the FDA hosted a public meeting on November 16, where industry partners raised concerns. for compliance in 2023.

In a statement, Anita Ducca, senior vice president of regulatory affairs at HDA, explained: “We are concerned that the draft EDDS directive, rather than facilitating implementation efforts, may actually hinder them. Today myself and some of the other speakers will explain how inconsistencies between the draft guidance and the industry’s well-described compliance efforts will hamper our shared goal of meeting the 2023 deadlines. details of the draft guidance, I cannot stress enough the importance of achieving alignment between the FDA articulation and what the industry has collectively built over the past eight years to meet the 2023 requirements.

Ducca went on to explain that the EDDS project appears to require business partners and all regulators to be connected to each other through a “communication hub,” but the DSCSA does not require these repositories, connections or functionality. “A ‘communication hub’ poses other big hurdles because we understand the intention,” she said. “For example, we believe that a single entity should build and operate this hub and require every partner in the supply chain to participate in it. But this communications center is not required by law, does not exist, is not under construction, and cannot be built and operationalized by 2023.

“Even if an entity claims to have such a system, we see huge antitrust risks if every business partner was supposed to participate. As a result, HDA could not support the industry-wide adoption of a single, proprietary offering.