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Mere traceability is not enough for VRS-compliance; Here’s what you need


VRS-compliance is merely a part of DSCSA compliance. But that’s not enough because there are a number of things that need to be considered while achieving one milestone at a time. So, here’s a checklist with all the important pre-requisites for DSCSA compliance by 2023. Some of the important points of discussion would be the importance of FDA-NDC, what are FDA labelers, and how multiscanners help in streamlining VRS compliance with the help of look-up directories and FDA labelers.
Editor: Kaustav Sarkar Last Updated: 24-Nov-2020

According to WHO, one in 1 in 10 products in developing countries are found to be fake, which not only lead to fatalities but also dupes the economy of close to $200 billion annually. Each year close to 250,000 children die because of consumption of counterfeit drugs and similar effects are visible among the elderly too, which warn of worse times to come.

Reducing the scale of purview to America would have similar alarming effects. More so, because 70% of the elderly population are on prescription drugs, which are the most vulnerable to the counterfeit mafia. According to a report by the AARP, illicit drugs are most likely to target Americans of age 50 years and above. This, despite the presence of world’s most powerful health departments like the Food and Drug Association (FDA).

Things, however, are looking up for the pharmaceutical track and trace industry, especially since the phased implementation of Drug Supply Chain and Security Act (DSCSA) guidelines since 2013.

Here’s how.

Check the list- a Must

The FDA does not indiscriminately mandate pharma companies to get their approval, but imposes them to be DQSA requirements-ready by using the methods and supply chain process recommended by the health department. For instance, if you have the right equipment to check the traceability of drugs across its journey, you are more than ready to qualify the FDA’s list of labelers, who later help in identifying authentic drugs at the return saleable stage or the VRS (Verified Router Service) stage.

Having said that, traceability also requires certain amount of interoperability between stakeholders, which also defines the DQSA law-readiness of the supply chain. That is possible with the introduction of GS1 coding standards that allows entities to leverage the power of information at all levels to strengthen supply chain integrity, increase efficiency and reduce costs.

These are just few of the advantages offered by the GS1 standard of identifying drugs. They help in (but not restricted to) identifying the unique serialization of the products, logistics unit, location, assets, documents, shipments, consignments, and service relationships in the supply chain.

The GS1 barcode system is basically a combination of Linear and 2D barcodes in the form of Global Trade Item Number (GTIN), Serial Shipping Container Code (SSCC) and Global Location Number (GLN), which together help in identifying the journey of a drug from manufacturing to distribution.

But it is not as simple as it sounds.

FDA-NDC: Why is it important for pharmaceutical tracking?

There are pre-requisites pertaining to the approval of the drugs that are being manufactured and the process is directly related to the security of a drug supply chain, especially at the return saleable stage.

So, what exactly is this NDC (National Drug Code) or the Labeler Code? The Drug Listing Act of 1972, registered drug establishments have to provide FDA with a current list of drugs that are manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. The NDC is a unique 3-digit identifier that help in identifying drugs, also serving as the universal product identifiers for drugs. The FDA publishes this list in the NDC directory, which is updated on a regular basis.

The information submitted in the directory are referred by Verification Router Service providers when a request to identify a ‘suspect’ drugs is raised at the VRS level. This directory is also connected with the Look-up Directories (LDs) that help advanced multiscanners guided by DSCSA serialization requirements to retrieve the required data within seconds.

It must be remembered here that the Drug Code is issued by the FDA to a manufacturer only when the drug he is manufacturing qualifies the ‘pre-approval’ and the ‘post-approval’ stages’ that preserve the safety and effectiveness of the drug’s proposed use, appropriateness of the drug’s proposed labeling, and the adequacy of the manufacturing methods to assure the drug’s identity , purity, and quality. However, the labeler code is subject to withdrawal if the drug in question is not effective or is said to show fatal side effects.

Simply put, drugs without NDCs do not appear in the directory, which in turn confirms its ‘unapproved’ or ‘counterfeit’ status.

This brings us to the next questions.

Why might a manufacturer give the FDA DSCSA approval a skip?

Here’s the catch. Owing to the cumbersome process of drug approval and the regular interference of FDA even when the drug is under circulation, small-scale manufacturers often give it a skip taking advantage of FDA’s phased process of document submission. For instance, manufacturers can easily submit doctored documents pertaining to the clinical trials and get themselves the labeler code. In other cases, a few manufacturers choose to reformulate the unapproved drugs, without bringing it to the compliance standards of the agency to evade action from it.

Add to it the pressure FDA faces from small-time manufacturers of drugs who are not registered in the first place and function illegally, trying to introduce their drug in the DSCSA-guided supply chain; the likes of the Villa Brothers in Cuba who infiltrated an Elli Lilly warehouse in Enfield and a GSK warehouse in Virginia, rendering both the companies poorer by millions and leaving end-users shaky.

By the time the FDA reviews the case (among the millions of cases everyday), the manufacturer may have already pumped the medicine in the market. According to a report by the FDA, US today has over several hundred thousands of drugs marketed illegally without the required FDA approval.

So, what happens to such drugs?

The FDA disqualifies the label code for that drug and removes it from the list of NDCs. Once done, a warning letter is sent to the manufacturer to show cause, which might even lead to cancelling the license or an unlimited ban from manufacturing any drugs.

But then what happens to the volume of the same pedigree being still sold to the public before the FDA stalls the lot? Threat to life still looms large.

Identifying the ‘unapproved’

Such illegally compounded or unapproved drugs are often caught at the fag end of the supply chain when the dispensers, either after being notified or guessing something amiss, send the products for verification.

And this is precisely where the detailing starts. FDA-approved RX-enabled multiscanners can easily find the missing link between the labeler code and the blank entry in the FDA’s NDC list (prior to its removal). In cases where the drugs have not been approved at all will miss the mark immediately when the scanners are unable to trace the drug back to the original manufacturers.

Needless to mention, the entire process takes place within fractions of seconds that speeds up the drug verification process by notches, in the purview of the tight audit deadline set by the FDA requiring the wholesale distributors to fill up 23-pager FDA 3911 notice for every illegal case that needs ‘destruction’. On similar lines, the FDA has to be intimated about each of the steps taken to ensure that nothing but the authentic drugs reach back to the shelves within a span of 24 hours.

For a clearer picture, read ‘Dealing with Negative Returns: How to be Responsibly VRS-compliant?’

Addressing thousands of such illegal returns could be a tedious job when it comes to identifying and then reporting them to the FDA. This is where technology improves the situation. While multiscanners can already speed up the end-to-end drug identification process, Augmented Reality (AR)-enabled vision-powered multiscanners go a step ahead in the real-time product verifications of the saleable or non-saleable returns.

Why TrackTraceRX?

We are world’s only VRS that offers AR-driven insta-verification scanners that can not just do the job, but do the job well for you to go ahead and sort the documents you need to send to FDA in minutes. Our Traceability portal helps you identify the drugs across timeline, throughout its journey in the supply chain, and also help you manage data by detailing each and every step of the verification. So, you have all the details right right in front of you when you send the audit report.

Our RX-driven multiscanners and traceability together ensure accurate verification, lesser cost of verification implementation, lesser man-hour cost required for manual verification, easy data-management, and faster traceability. Our API-first software engineering approach does not require spending extra hours or money in restructuring your operational framework to accommodate our software. A little patch that would take you minutes is enough to get connected to all the LDs related to the supply chain.

Responsiveness is a pre-requisite of VRS-compliance, but we take you a step further in making you responsibly compliant too. Just few weeks ahead of the November 27, 2020 deadline, your last chance of avoiding a penalty is here. We could partner you for VRS-readiness affordably and quickly.