As we discussed last September, counterfeit drugs are not only big business, but they also pose a significant risk to consumer safety. Safeguarding the supply chain is of paramount concern. The Drug Quality and Security Act (DSCSA) Track & Trace initiative is designed specifically to address supply chain security.
Enacted in 2013, over the years this mandate has slowly moved the pharmaceutical industry forward towards the ultimate requirement of establishing product traceability to the unit level come this November. Drug manufacturers, repackagers, wholesale distributors, and pharmacies are all required to comply.
With the deadline set for November 27th, 2023, pharmaceutical entities within the United States are mandated to comply with the DSCSA’s final requirements. In this post, we’ll highlight the electronic track and trace responsibilities that organizations in the pharma supply chain are expected to implement by November 27th.
What is DSCSA Track & Trace?
The Drug Supply Chain Security Act Track & Trace refers to a law enacted in the U.S. that focuses on ensuring the safety of prescription drugs and eliminating unapproved or illegitimate medicines from the market.
It requires pharmaceutical companies and others involved in drug distribution to create a system where each drug package is assigned a unique product identifier number. This data helps track the movement of drugs from the manufacturer to the pharmacy, ensuring that counterfeit or unsafe drugs don’t reach the hands of patients. This system also enhances transparency and safety in the pharmaceutical supply chain.
While drug manufacturers have included serial numbers on product packaging for years, there has not been a requirement to track a package-level serial number. However, the November deadline for lot level track and trace is fast approaching.
What does the November DSCSA Deadline Mandate?
The final requirements of the DSCA Track & Trace initiative, which must be implemented by November 27th, consist of the following:
- Individual package tracking transition
From November 27th, 2023, the new protocol takes effect, prioritizing technology within an interoperable system to trace each package. This transformation holds significant implications for pharmaceutical companies, necessitating the inclusion of unit-level serial numbers within prescription drug transaction history. This exchange of transaction data is necessary for your organization to uphold DSCSA compliance.
- Integration of serial numbers for comprehensive records
Organizations will need to keep an electronic record showing the serial numbers in the package. Each drug package gets unique product identifier data, often known as a global trade item number. These records help track how drugs move from manufacturer to the pharmacy.
- Third party system checks
Next comes a real check by partners like third-party logistics providers (3PLs) or distributors. They need to make sure that the physical contents of shipments, which might have thousands of products, match the electronic records. This check is done again as products go from distributor to dispenser.
- Entity registration
The DSCSA mandates the registration of every entity in the pharmaceutical supply chain engaged in production and sales.
- Rapid response for enhanced security
The DSCSA necessitates that each trading partner be able to verify potentially dubious or unauthorized products. If such products are detected, trading partners are required to initiate verification requests within a 24-hour period. These verification requests from trading partners or regulatory bodies must receive responses within the same 24-hour window. This swift response mechanism contributes to heightened security measures.
Implementing Track & Trace Changes
Implementing DSCSA Track & Trace within your organization involves several steps to ensure compliance with the law:
- Learn the rules: Understand the DSCSA rules for tracking and tracing prescription drugs.
- Choose technology: Pick the right tools to create a system for tracking drugs. This might involve using special codes, like barcodes, and software to manage the information.
- Give each drug a code: Make sure each medicine package has its special code. This code helps keep track of where the medicine goes.
- Collect information: Create a way to gather details about the medicine, like where it came from and where it’s going.
- Share data safely: Set up a secure way to share tracking data with others who can see it, like other companies involved.
- Teach your team: Train your staff to use the new system properly.
- Test the system: Before using it, test the tracking system to ensure it works correctly.
- Integration: Integrate the new system into your existing processes, like managing inventory and distributing medicine.
- Regular checks: Regularly check the tracking data to ensure everything is accurate. Do internal reviews to catch any mistakes.
- Work together: Talk to the other companies you work with to ensure everyone understands and follows the same tracking rules.
- Keep records: Keep good records of what you’ve done, the data you’ve collected, and how you’ve followed the rules.
Is your organization ready?
As a US-based CDMO, our commitment to quality drove us to meet the DSCSA requirements well before the deadline. We’ve been in compliance with the full scope of the DSCSA since November of 2018. Moreover, though the Act didn’t demand it, we voluntarily adopted the practice of grouping unit packages into cases and pallets to ease receipt of product by our customers.
Partnering with a CDMO with longstanding familiarity with supply chain security and culture of quality can ensure your organization remains in compliance with all the requirements of the DSCSA. From concept to commercialization, LGM Pharma’s full-service CDMO streamlines your ability to get your product to market faster, regardless of your dosage form.