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Understanding Interoperability in the Context of the DSCSA

Christian Souza

Interoperability?

Organizations that make up the US drug supply chain are left with just two more weeks to meet the FDA’s extended deadline of 1stMay, 2015 for securing compliance with the transaction data exchange guidelines mentioned in the DSCSA. As part of the said act, pharmaceutical manufacturers, wholesale distributors, dispensers and re-packagers are required to generate, track and store Transaction Information (TI), Transaction History (TH) and Transaction Statements (TS) for each and every shipment – over the period of a good six years.

While expounding on the details of the transaction data exchange set to take place between various trading partners, the text of the DSCSA law refers to the term ‘interoperability’ a number of times, without explicitly defining it. This pretty much leaves the core definition of the term up to the FDA.

“the FDA is now required to hold a public meeting to collect input on the core system that will support secure, interoperable data exchange among trading partners anytime between 2014 and 2021. To seal the deal, the FDA is obligated to publish final guidance on the standards for industry-wide exchange of interoperable electronic data, no later than November, 2022.”

Before trying to making sense of the FDA’s definition of the ‘interoperability’, it’s worth revisiting the timeline of the events chalked out in the DSCSA for establishing standards around interoperable transaction data exchange – including TI, TH and TS. Back in November 2013, President Obama signed the DSCSA into law. One year down the road, the FDA published a draft that provided guidance on the initial standards proposed for the interoperable exchange of transaction data. It is this very draft that needs to be conformed to for meeting the May 2015 data exchange requirements. Moving forward, the FDA is now required to hold a public meeting to collect input on the core system that will support secure, interoperable data exchange among trading partners anytime between 2014 and 2021. To seal the deal, the FDA is obligated to publish final guidance on the standards for industry-wide exchange of interoperable electronic data, no later than November, 2022. For streamlining the standardization process, the FDA would obviously want to collect information from as many sources as possible pushing the finalization of the definition to early 2021 – around six years from today.

Let’s have a closer look at interim definition that is currently in place. As per the initial standard draft, interoperability is all about the ability to exchange product tracing information among trading partners, making sure that the said is done accurately, efficiently and consistently. For a compliance system to be interoperable, the trading partners should be empowered to successfully capture and maintain the product tracing information.

While the existing definition might be suitable for the current phase of implementation, it still does not specify the architecture of a single, standardized underlying electronic format based upon which the transaction exchange data is to be engineered. Till that is done, there are going to be inefficiencies plaguing the compliance mechanism in one form or the other, resulting in lost time and increased incurred costs. A finer definition of operability is what the FDA needs to work towards – that’s something the FDA totally understands and is already planning to do in the final guide for transaction data exchange.

The industry must meet  interoperability before 2023

For now, your goals should be to choose a DSCSA provider that can start laying down the framework of what is required to exchange data at a batch lot level and have a foundation ready for serialization. This DSCSA provider should be able to:

1. Accept T3s,

2. Provide portals for your upstream and downstream trading partners

3. Store data for up to 6 years

4. Provide an audit system to handle T3 data

5. Manage electronic communication such as EDI and handle low end T3s such as paper format

6. Integrate with your ERP/WMS

7. Provide visibility for your supply chain

Data Exchange

The United States is one of the twenty pharmaceutical markets in the world that require constituent organizations making up the respective drug supply chain to conform to serialization and data exchange requirements.

In regards to electronic product tracing, the US drug supply chain is governed by laws laid down by the Food and Drug Administration over the entire implementation period. The Drug Supply Chain Security Act, signed into law back in November 2013, is the core governing document set up by the FDA to regulate generation, serialization, tracking, exchange and storage of supply chain data at the shipment level. The FDA also enjoys full legal authority to delineate other methods of compliance with the said law.

Here’s a quick breakdown of the most important aspects of the traceability data exchange architecture and the DSCSA you need to consider while securing compliance for your organization.

Serialization:

The DSCSA puts forward stern requirements for serialization of prescription drugs that are related directly to human health. With the serial numbers assigned by the manufacturer of the drug itself, the core serialization process is to be carried out at both the item and the case level. The data bearing mechanisms for serialization, recommended by the FDA, comprise of: a two-dimensional data barcode at the item level, a one-dimensional barcode at the case level.

Furthermore, a standard numerical identifier as per law is also required to be included along with each package – comprising of a National Drug Code and the 20 digit alphanumeric serial number. The long-term objective here is to make the National Drug Code a part of the Global Grade Identification Number coupled with a 12-digit numeric serial number.

Supply Chain Data:

Documenting the 3Ts, namely the Transaction Information (TI), the Transaction History (TH) and Transaction Statements (TS), is an important requirement laid down by the FDA in the DSCSA. Beginning 1stJanuary 2015, not only should the TI, TH and TS be generated, provided and captured with each instance of ownership change, but the documentary evidence at each step should also be retained for a six years as well.

Product owners and trading partners must also verify the 3Ts and provide the same to the FDA or other relevant authorities in event of an investigation. Guidelines expounding the nitty-gritties related to unit-level tracing interoperability are in the pipeline and are expected to be out around the year 2022.

Funding:

Supply chain organizations are expected to fund compliance systems by themselves – the government is not liable for providing funds of any sort for setting up compliance systems.

Governance:

The existing implementation of any compliance system is based solely upon the understanding of the DSCSA statute by the organizations making up the drug supply chain. A specific data architecture or governance model has not been specified by the FDA just yet – the setting up the said is still in the works.

The FDA is actively seeking input from the pharmaceutical industry via workshops and respond to comments, and encourages participation of the supply chain constituent companies in pilot studies and trainings to speed up the finalization of the governance documents. The extended deadline for the enforcement of the DSCSA, 1stMay 2015, is just two weeks away. It is important that your organization start now before being put in risk of sanctions or fines.

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