U.S. Regulations Drug Supply Chain Security Act: Opportunity for Track and Trace Solution Providers

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The U.S. Food and Drug Administration (FDA) has issued November 27th, 2023 as the deadline for the pharmaceutical industry to comply with the Drug Supply Chain Security Act (DSCSA). This regulation has opened a series of opportunities for track and trace solution providers in the U.S. market. Read on to find out more about the impact of the Act on the industry along with the latest solutions in this segment.

Under the leadership of Former U.S. President Barack Obama, the U.S. Drug Quality and Security Act (DQSA) became a law in 2013. Comprising of two parts – Title I: The Compounding Quality Act which focuses on compounded drugs and Title II: the Drug Supply Chain Security Act (DSCSA), the DQSA was passed in the background of accidental distribution of contaminated steroid injections which claimed the lives of 64 people and left 793 patients down with infection.

What is the Drug Supply Chain Security Act?

Recently, the DQSA’s Drug Supply Chain Security Act (DSCSA) has been in the news but what is the core focus of the act? According to the website of the U.S. Food and Drug Administration (FDA), Title II of the Drug Quality and Security Act, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the United States.

It further adds that this will enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements will also improve detection and removal of potentially dangerous drugs from the drug supply chain to protect U.S. consumers, shares the site.

Watershed moment for the pharma industry

This is a vital move for the pharmaceutical industry and one that cannot be ignored by the different stakeholders in the sector. “This is a watershed change for the industry because it establishes a new ‘hyper level’ of tracking that was not possible before,” mentions Herb Wong, Senior Vice President, Product and Strategy at rfxcel, a leader in digital supply chain traceability solutions acquired by the Antares Vision Group, a global provider of intelligent track and trace, inspection, and smart data management solutions for the life sciences and food and beverage sectors. He explains that generally, the first phase of the DSCSA focused on lot-level traceability and complying with requirements for exchanging information. The second phase creates full interoperable electronic unit-level traceability — or full serialization of the U.S. pharma supply chain.

This means that the industry will now have to adopt enhanced track and trace solutions in their operations and they must do it in the coming months if they haven’t already done so as the FDA has now set a deadline of November 27th, 2023 to comply with the Drug Supply Chain Security Act (DSCSA).

Federico Finotti, Sales Director from Sea Vision USA, a firm specializing in vision systems, track and trace, and 4.0 solutions for the pharmaceutical industry shares, “US pharma companies have to meet the DSCSA deadline of 2023 for the local market, and at the same time they have to keep an eye on the markets abroad where they export their goods to, and comply with all their track and trace regulations. Production lines have to be ready for the complete aggregation process to be compliant with DSCSA for the local market on both existing and new packaging lines.”

“In this regulatory landscape, solution providers can help pharma companies realize a bigger vision of ‘value beyond compliance’. For example, serialized data allows for laser-focused recalls, improved tracking, and earlier detection of diversion or fraud in the supply chain,” opines Wong.

Golden opportunity for track and trace solution providers

Now, this a golden opportunity for track and trace solution providers to significantly increase their customer base in the US and they know it well. “The DSCSA creates a window of opportunity for the track and trace providers who have a strong presence in the US market, shares Finotti. “Those companies will get a chance to propose reliable and tested solutions on a market as big as the United States, with plenty of pharmaceutical packaging lines.”

He mentions that track and trace solution providers will make sure the companies have all necessary tools to comply with this regulation. Most of them have been familiar with similar regulations for years, ever since they were introduced in China and the European Union.

With the deadline fast approaching, track and trace solution providers in the U.S. market will definitely see a spike in their sales.

Ongoing discussions with U.S. pharma companies

The competition is real and solution providers are leaving no stone unturned to impress and win the confidence of their target audience. “We are in continuous discussions with US companies,” says Wong. “As the track and trace market matures, we are seeing a consolidation of solution providers. Companies that have failed to innovate or deliver on their promise of compliance are being replaced. A sizable amount of our talks is with pharma companies that want to switch from their current providers.”

Agreeing with this, Finotti opines, “This is a moment for the pharmaceutical companies to reconsider the level of support received in the past years by their current track and trace vendors, and to evaluate potential new vendors bearing in mind their technical solutions and the level of assistance offered.”

Latest solutions in the market

Sea Vision’s latest solutions are based on the concept of improving process automation via continuous digitalization of the process. The company aims to provide an easy tool for the creation of the Electronic Batch Record combining different technologies such as digital connection to all the components of the line (machines, PLCs, checkweighers, printers) and the artificial intelligence to support the software in special critical phases.

For instance, one of its latest solutions performs production line clearance with the help of cameras distributed in different positions inside the machines and throughout the whole line in order to provide a digital proof (images) of the correct conclusion of the clearing procedure. This solution aims at improving the packaging processes with the help of continuous digitalization that allows to get feedbacks and statistics for the runtime and post-production evaluation of the efficiency and safety of the packaging line.

Rfxcel offers a digital fingerprint to be associated with its customers’ products. Like a human fingerprint, each digital fingerprint is unique. The technology endows every product with unique characteristics directly on the packaging. This is the scannable digital fingerprint, which is invisible to the naked eye and cannot be counterfeited. The solution is non-invasive and requires no additional printing or changes to the packaging. There are benefits for consumers and companies alike.

For example, patients can use a mobile app to scan products that have digital fingerprints to confirm that they are authentic. Pharma companies can use digital fingerprints for product investigations and different types of tracking.

Track and trace providers are constantly trying to upgrade their solutions with the latest features to stay ahead of their counterparts and this ensures that the pharma industry secures the best technology from time to time. Overall, a win-win situation for everyone.

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