The Drug Supply Chain Security Act and How Rufus Can Help You Comply
Pharmaceutical manufacturers — as well as their third-party logistics providers that package and distribute products — are under growing pressure to comply with government requirements.
These manufacturers also must ensure patient safety and product quality, while balancing the implementation of important innovations. Traceability in the drug supply chain has made it difficult to make advances in these areas. But the U.S. Food and Drug Administration (FDA) outlined the Drug Supply Chain Security Act (DSCSA) to change that.
The goal of the DSCSA is to boost resiliency and accountability across the pharmaceutical industry's supply chain. Still, compliance comes with challenges. Fortunately, Rufus WorkHero's scanning, tracking and software management solutions can help bring efficiency and accuracy so you can comply with key conditions of the DSCSA.
What is the Drug Supply Chain Security Act (DSCSA)?
First, business leaders must become familiar with the law: The DSCSA outlines a series of requirements for manufacturers, repackagers, wholesale distributors, dispensers and third-party logistics providers — particularly around the identification, tracing and verification of products.
Certain requirements started in November 2014, while other key conditions were rolled out in various stages the following years. The DSCSA is expected to take full effect in November 2023.
In anticipation, companies have invested heavily in the needed technology and infrastructure — in fact, a 2017 KPMG report showed 45 percent of businesses surveyed had spent over $50 million to support compliance.
Unfortunately, the pandemic slowed — or even shut down — these advances. With November fast approaching, companies need to plan for implementation.
Why is the DSCSA Important?
The DSCSA aims to insulate the supply chain, and this could curb some of the major supply chain and operational issues businesses are currently experiencing. In addition to creating a more resilient supply chain, the end goal of the DSCSA is to ensure prescription drugs can be tracked throughout the manufacturing and distribution process.
Over its 10-year implementation, the DSCSA aims to:
Establish an end-to-end verification system to validate the legitimacy of a drug, down to the package level.
Easily detect illegitimate or counterfeit products in the pharmaceutical supply chain.
And toward the final phase, create a self-sufficient system with supply chain-wide traceability, allowing for easy identification and recall.
Essentially, the DSCSA will protect against counterfeit and unapproved medicines to protect consumers. Of course, pharmaceutical companies don't intend to distribute harmful medications, but the complexity of the global supply chain makes this difficult to regulate.
For instance, in 2012, the FDA reported the distribution of counterfeit cancer medicine in the U.S., containing no active ingredient. And in 2019, cases of drug counterfeiting reached a record high, with illegitimate pharmaceuticals causing serious health issues.
How Rufus WorkHero Can Help
For these reasons and more, it's vital that all trading partners understand their responsibilities and work together to help facilitate efficient distribution and availability of drug products in the United States.
With Rufus WorkHero's scanning, tracking and software management solutions, you can quickly and easily comply with three key areas of the DSCSA:
Product identification: Manufacturers and repackagers must put a unique product identifier on certain prescription drug packages — for example, a barcode that can be easily read electronically.
Product tracing: Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) in the pharmaceutical supply chain must provide information about a drug, and who handled it, each time it is sold in the U.S. market.
Product verification: Manufacturers, wholesaler drug distributors, repackagers and many dispensers (primarily pharmacies) must establish systems and processes to verify the product identifier on certain prescription drug packages.
With Rufus Workhero, you can track any type of warehouse or operational task imaginable, allowing you to accurately monitor products and processes. This not only lets you optimize your workflow, you can scan products accurately, all in real time, complying with the conditions of the DSCSA.
Rufus WorkHero offers a variety of wearable barcode scanners that are both effective and ergonomic. By allowing workers to operate hands-free, these scanners improve productivity and efficiency up to 50 percent.
Additionally, by connecting workers to automation, you can track the performance of your equipment and pinpoint any issues, offering you a higher level of quality control.
WorkHero also includes Rufus Intelligence, a productivity management software solution, so you can visualize each worker’s scanning activity, ensuring your products are accurately identified and handled.
Are you ready to incorporate the technology you need to comply with the DSCSA? Rufus WorkHero provides wearable barcode scanners and rugged Android devices, a robust software dashboard suite for management, and support for one monthly subscription cost. No hidden fees, starting at just $99/worker.