the FDA, earlier this month, announced its intent not to take action against manufacturers, wholesale distributors and re-packagers who are still struggling to implement a robust transaction data exchange system within their respective portion of the medical supply chain.
Delay? We will take it!
Consider it a New Year gift, a modern-day miracle, or prayers being answered – the FDA, earlier this month, announced its intent not to take action against manufacturers, wholesale distributors and re-packagers who are still struggling to implement a robust transaction data exchange system within their respective portion of the medical supply chain. The grace period for achieving backward compliance now extends till the 1st of May, 2015 – a good four months beyond the original deadline the 1st of January, 2015.
So why did the FDA announce the postponement in this first place? Grave concerns about the practical consequences of incompliance – drug shortage and medical supply chain disruption – were initially expressed by the Healthcare Management Distribution Management Association. The same was echoed by a number of manufacturers, wholesale distributors and re-packagers highlighting the unforeseen complications associated with the exchange of the three T’s namely Transaction Information, Transaction History and Transaction Statements. To minimize possible disruptions in the dissemination of the prescription drugs as highlighted by the stakeholders, the FDA realized it is only logical to lend the trade partners some extra time.
And what exactly is it that makes the data exchange process so complicated? Well – just about everything. The Transaction Information component of the data, albeit the most straight-forward of the lot, consists of product name, unit numbers, strength, dosage, size, container size, lot number, transaction date, shipment date, business name from and to. The Transaction History includes the Transaction Information for each transaction going all the way back to the manufacturer. Finally, the Transaction Statement ensures that a number of exhaustive ownership transference checks are strictly followed.
“A plethora of companies are unaware that even though the FDA is not enforcing the law until May, the law is in full effect since 1st January, 2015. This means that coming May, the FDA has every right to inspect T3 data all the way from the month of January 2015 to any given point in time.”
It is, however, important to understand that the announcement by FDA is, in essence, an extension in the compliance-check deadline, and not an extension in the actual implementation of the transactional data exchange mechanism. A plethora of companies are unaware that even though the FDA is not enforcing the law until May, the law is in full effect since 1st January, 2015. This means that coming May, the FDA has every right to inspect T3 data all the way from the month of January 2015 to any given point in time. What companies ought to be doing right now is generating, accumulating and storing transactional data right away. This is bound to do away with backlog that might plague the company operations at a later stage.
At the heart of seamless transactional data exchange lies the core transport method used to relay information to corresponding trade partners. The DSCSA law is quite flexible in terms of the recommendations for the transport method and even allows for conventional methods to be used – paper, legacy invoices, pdf receipts, emails are all acceptable means of transport under the act.
There is a catch to these dated methods though – the DSCSA act required transactional data to be kept safe for a span of six years per transaction. And the said condition is set to transition from the per-lot basis of today to a per-packaging basis in the coming decade. Simply printing and storing these documents physically is bound to be a menace, especially for full six years. Let alone the timely retrieval of records if such a print based solution were to be implemented, the storage alone poses stern environmental threats and ridiculously high financial overheads. The most appropriate modern-day solution is to make the most out of secure, cloud-based web portal for transaction data exchange – a server where transaction information is secure, stored in a disaster-proof, eco-friendly manner and available for retrieval within fraction of a second, 24/7 round the year.
The extension in the deadline for DSCSA compliance is a blessing in disguise for manufacturers, wholesale distributors and re-packagers who are yet to implement transaction data exchange mechanism within their operations. Accomplishing compliance is not easy, and this is where we, at TrackTraceRx, come in. Our state-of the-art, cloud-based server meets all the transaction data exchange requirements laid down in the DSCSA act, securing compliance for your organization within merely 3 to 4 working days. TrackTraceRx serverallows for advance features including seamless partner integration and transactional, e-commerce portal setup all at an amazingly affordable price plan.
Make sure you make the most out of the awarded grace period. Rather than procrastinating the implementation till the very month of May, the best thing would be to accumulate and store transactional data right away. Feel free to drop us a line and discover how we can help you with accomplishing exactly that all within a matter of 3 to 4 days.
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