Not everyone can help you with T3 documents. Here’s why

The pharmaceutical supply chain is primarily driven by data-sharing, which empowers all the stakeholders of the pharma supply chain to get the location and status of their products. In other words, product visibility increases. But that’s not all, maintaining transaction information in an organized manner can also help in audit requirements, which needs hundreds of information within a span of 24 hours, especially in the case of saleable returns.

But before exploring how T3 documentation improves drug traceability in details, it is important to understand the concept first.  

What are T3 documents?

The T3 data for most medicines must be exchanged at the change of ownership. What the T3 data requires is sending the Transaction History (TH), the Transaction Statement (TS), and the Transaction Information (TI).

Transaction History: It is a statement that provides all the information on all transactions on a product beginning from the manufacturer. It also includes information provided in the DSCSA and associated FDA documents, information on what information is being transferred and when the corresponding T3 needs to be updated to include the transaction.

Transaction Statement: This is a detailed statement about a partner in an electronic or paper format stating that the partner is an authorized entity and has received the TS and TI from the prior owner of the product and has, therefore, no information as to whether the products he shipped are counterfeit. He also mentions that he has the right systems and processes in place to comply with the verification requirements and was not responsible for providing false TI or TH. To be exact, the transaction statement must include the following information and requires that trading partners transferring ownership of the product adhere to the following information:

• Is authorized under the DSCSA
• Received the product from a trading partner that is also authorized under the DSCSA
• Received the transaction information and statement from the trading partner
• Did not knowingly ship a suspect or illegitimate product
• Has systems in place to comply with verification requirements
• Did not provide false transaction information or knowingly alter the transaction history

Transaction information: This report includes the following transaction information:

• Name of the product
• Strength and dosage
• Number of containers
• Lot number of the specific product
• Specific NDC#
• Date of transaction and shipment
• Business name and address of the trading partner sending/receiving the product

 T3 document timeline

• The T3 document record starts off with the manufacturer who has to provide all the necessary information to the next-in-line in an electronic format. Thereon, wholesalers, repackagers, distributors, and even dispensers have to transfer and maintain this document with every change of ownership. It is noteworthy here that none of the stakeholders can accept a product without the T3 documentation.
• If the product is found to be a suspect or a counterfeit, the product needs to be quarantined and investigated. It is important to ascertain that the product is not exchanged when in quarantine or under investigation.
• Dispensers need to verify the product identifier printed on at least 3 units or 10% of all units and furnish the exact information on the T3 document. If there are less than 3 packages to be sold, all of them need to be checked. By 2023, all the dispensers are required to have an interoperable system at the package level.

T3 document requirements

One thing is very clear. The DSCSA or the FDA has not outlined the format with which the information should be shared between pharma stakeholders. So, that leaves stakeholders to deal with 200 different ASN types and over 30 different exchange scenarios to consider for compliance. This only increases the capital investment in managing an IT team maintaining all the records every time a product is dispatched or received because the DSCSA mandates the usage of electronic data formats instead of manual entry so that all the information registered are accessible to every stakeholder at any given point. Also, given the variation in the format, there’s an increasing involvement of time and money to organize every differently formatted information coming from various sources.

The second challenge involved in the storage of T3 information includes addressing the DSCSA mandate of maintaining the records for 6 years at a stretch, which requires a system that has vast storage place and incredible speed, apart from navigable workflow and easy access.

The only way to streamline this cumbersome process is to find a full inventory and accounting system, which is flexible. This is because the DSCSA regulations are constantly changing and a new set of information is required every year. These details should be handy and available anytime the FDA chooses to perform an audit or sends an enquiry for a product recall.

Last word

Pre-2007 when the requirement for DQSA rules was drafted by the Obama Government, the pharmaceutical industry maintained records manually, which is still the case in some of the companies functioning in the industry. The process was long, arduous and subject to human error, which could lead to irreversible blunders down the line. Maintaining an error-free record can not only help you avoid penalties, but also ensure that you are not inadvertently participating in the counterfeit drug circulation.

Having said that, we have frequently been seen mentioning the need for a traceability suite, a software or a piece of equipment that could help maintain the records for further use. One main aim of suggesting these measures is to empower pharma participants to be able to share data seamless even between participants using different software or not having a traceability software in the first place.

Participants often ask this question: “Aren’t these investments mere add-ons to the expenses?” Well, they can to be one-time investments, which are flexible enough to adopt to the requirements of the future, require no further expenses.

How can TrackTraceRX help?

With our expert engineering and design, we have come up with state-of-the-art solutions to address all things T3. Few of the solutions that we have been proud of include the AR-enabled multiscanners and the traceability platform- the former empowering the L1 and L2 stakeholders while the latter ensuring a seamless saleable returns experience.

Imagine if you had a mobile-edge scanner screening thousands of medical consignments within hours, instead of days? How about maintaining records through virtual reality-enabled software, which in turn gets stored in a cloud repository for further use? How about a platform that manages information when you are performing a crucial process such as the saleable returns and refurbishing the same during FDA audits? As much as you find these features impossible design-wise, we have made them possible. Seamless data-sharing, T3 information online, easy traceability of drugs, everything is quick to be found on our traceability portal. But that’s not all. The FDA has set a deadline of 24 hours for warehouse owners to complete saleable returns editing, which includes filling up a 23-pager form requiring hundreds of information. Imagine repeating the process for thousands of products every day.

With our portal, this set of information is just a click away, saving you the time to manually search for them. This way, you can finish the auditing process in merely a day. DSCSA approved, we can promise you the following benefits:

• Flexibility to consolidate, store and search disparate transaction history, statement and information in a centralized repository
• Easy location of documents with a simple search on the platform
• Easy identification of exceptions where the information in T3 documents are not matching with the physical inventory.
• Security of data
• Compliance with varied data formats
• Audit-ready information to be used at any stage of the pharma supply chain

Organizing and navigating through the T3 documents need experience and in-depth industry knowledge, coupled with deep DSCSA insights. TrackTraceRX has been functioning in the traceability domain for a decade now, promising of error-free services. But that’s not what we are trying to prove here. We only wish you choose the right traceability partner who can automate your end-to-end pharmaceutical requirements.