What Are the 2023 DSCSA Interoperability Requirements?

Compared to other industries, the pharmaceutical industry is still way behind in data sharing and technology adoption. In fact, there are still pharma companies in the USA that have just begun using data integration technologies that have been prevalent in many other industries since the 1990s.

Lack of data sharing within the industry has paved the way for the entry of counterfeit drugs. Many developing and developed countries are grappling with the increased presence of illegal drugs in their pharma supply chain, with the pandemic only exacerbating the issue.

The technology already exists, and we, as an industry, can make it happen. Fortunately, DSCSA has brought in its wake many mandatory data-sharing and traceability requirements, making product visibility effortless. When it’s fully effective, supply chain members will be able to track the products as they move through the chain, trace them to their origin, and even perform efficient product recalls, all the while prohibiting the entry of fake drugs.

However, a real-time, interoperable system must be established to achieve this vision, with no chinks in its armour. Luckily, DSCSA has issued many interoperability guidelines to help pharma stakeholders prepare for compliance ahead of time. Let’s take a look.

INTERRELATED STATUTORY COMPONENTS

Currently, the DSCSA is under phase one of the traceability requirements, which require products to be trackable at the lot level. From November 27, 2023, the law will enter its second phase, requiring products to be traceable through an interoperable, electronic method at the package level. There are currently few details available regarding the guidelines. However, the information that is available now lists three interrelated statutory components that will come into effect in 2023.

However, you must first be aware of Transaction statements (TS) and Transaction information (TI) to understand these statutory components.

Transaction Information (TI): TI is a document that outlines the specifics of the current transaction. It includes:

Number of containers
Dosage and strength of the product
NDC (National Drug Code)
Date of transaction
Lot number
Date of shipment
Container information

Transaction Statement (TS): The transaction statement is a declaration that confirms that the seller:

Is an authorized and registered entity
Got the product from an authorized and registered trading partner
Did not deliberately tamper with the transaction history
Did not deliberately deliver any counterfeit, suspicious, ineligible product
Has acknowledged the TI and TS from the previous entity in the supply chain

Now that you are aware of what TI and TS are, let’s look at the three interrelated statutory components:

Blog 2023 DSCSA Interoperability Requirements

INTEROPERABLE EXCHANGE

Under this statutory component, authorized trading partners must exchange required transaction information electronically and in an interoperable and secure manner through transaction information (TI) and transaction statements (TS). Moreover, the TI must also include the package-level product identifier.

INTEROPERABLE VERIFICATION

After data exchange comes data verification. To achieve effective data validation, trading partners must have the resources to verify the product identifier on a package or sealed homogenous case in a secure, electronic, interoperable manner.

INTEROPERABLE TRACING

Once data exchange and verification have been achieved, pharmaceutical stakeholders can easily track & trace products throughout the supply chain.

To ensure seamless traceability, authorized training partners must build a secure, interoperable, electronic system to provide TS and TI in response to a track & trace request. This system should also enhance data collection to produce TIs for every transaction, going all the way back to the manufacturer.

FDA GUIDANCE ON 2023 REQUIREMENTS

Not all Phase 1 requirements end on November 27, 2023. However, the requirement that each product transfer must be accompanied by a full transaction history (TH) will no longer be in effect. If you aren’t aware of TH, it’s a document that lists all the previous changes of hands a product has gone through.

This phase 2 change is consistent with DSCSA’s “one up and one back” model, where each trading entity records the details of the purchase as well as the sale. Even though TH won’t be required, FDA expects interoperable tracing processes and systems to be capable of providing information that is functionally equivalent to a unit-level TH.

Moreover, in the upcomingfda guidelines, the FDA is also expected to lay down the attributes systems will need to ensure seamless and secure tracing of products at the package level. Plus, the guidelines will also discuss the standards of interoperable data exchange to improve the security of the pharmaceutical supply chain.

The FDA has already conducted a series of assessments, pilot activities, and meetings with pharmaceutical stakeholders to develop the precise guidelines and establish the technical feasibility of the November 2023 compliance.

THE BOTTOM LINE

The DSCSA isn’t just about printing barcodes and forcing compliance. With its interoperability requirements, it envisions an end-to-end track & trace system that’ll not only bar the entry of illegal drugs into the supply chain but also make inventory management, returns and recalls, drug verification, and overall operations much more smooth and seamless.