The US Drug Supply Chain Security Act (DSCSA) is a federal regulation that aims to improve the safety and security of the pharmaceutical supply chain by implementing enhanced tracking and tracing requirements. The DSCSA is being implemented in stages, with the final stage set to take effect on November 27, 2023. In this article, we will discuss the key things that stakeholders in the pharmaceutical industry need to do to get ready for the final stage of the DSCSA regulation.
- Understand the Final Requirements of DSCSA
The final stage of the DSCSA requires manufacturers, repackagers, wholesale distributors, and dispensers to have systems in place to facilitate the identification, verification, and tracing of prescription drugs. Stakeholders must understand the final requirements of the DSCSA and how they apply them to their operations.
The four DSCSA requirements that must be in place by the November 27, 2023, deadline are:
Product Identification - A unique product identifier (UPI) must be at the package level for products entering the supply chain via a transaction. This means that a 2D barcode based upon the current requirements must be on all packaging often necessitating an update to the existing packaging artwork.
Verification - Authorized trading partners (ATP) must verify the product identifier of a product received before distributing that product in the supply chain. For returned products, it is especially important as this verification is part of the reselling of that returned product.
Traceability - Authorized trading partners must provide transaction information (TI) and a transaction statement (TS) to other authorized trading partners (ATP) within the supply chain. This traceability can be used to assist in an analysis of the transactions, details, or even the current state of the product received.
Compliance - Authorized trading partners (ATP) must have a process for both identifying suspect or illegitimate products and for alerting the appropriate parties or FDA if such products have been identified. Likewise, notifications may come from appropriate parties alerting Authorized trading partners (ATP) requesting confirmation or actions to take place within a specified timeframe.
- Develop a Serialization Plan
Stakeholders in the pharmaceutical supply chain must have systems in place to serialize products at the package level. This means that each package must have a unique product identifier and be marked with a 2D barcode. Stakeholders should develop a serialization plan to ensure that their products are properly marked and identified. Considerations should be given to the following when developing your Serialization plan:
Pre-printed model - Preprinted product labels are typically outsourced and managed by 3rd party providers. Oversight will be dependent upon documented processes established upfront to ensure the availability of serial numbers either in blocks or ranges for now and in the future.
IT-based serialization model – IT-based serialization systems allow for the ability to gather production analytics, track the manufacturing of products, and integrate with other manufacturing and warehouse systems.
Packaging changes - Will the packaging need to be updated to accommodate the serialization and will existing packaging artwork need to change?
- Establish a Verification System
The DSCSA requires stakeholders to have a system in place to verify the authenticity of prescription drugs. Verification systems must be able to confirm that the product identifier on a package matches the UPI in the national database. Stakeholders must establish a verification system that complies with DSCSA requirements. When beginning to develop a verification system it is important to keep the following in mind:
Turnaround time - DSCSA 2023 requirements are that the verification responses must be received within 24 hours. Your process should reflect that as being “no later than”. Responsiveness must be prioritized as Verification is mission-critical.
The volume of requests - Estimates are that the daily requests across the supply chain could increase exponentially over the coming months and years. It may be appropriate to identify an individual or individuals to handle all these requests. If in a decentralized operation, it may make sense to have a team whose members are located across multiple time zones.
Documentation and Compliance - A documented process is key to compliance and continuous improvement. If the process is documented as part of an SOP this will ensure that the process is being evaluated continuously for adherence and potential improvement.
- Ensure Product Tracing Capabilities
The final stage of the DSCSA requires stakeholders to have systems in place to trace prescription drugs from the manufacturer to the dispenser. This means that stakeholders must be able to identify the parties involved in the supply chain and the movement of products between those parties. Stakeholders must ensure that their tracing capabilities comply with DSCSA requirements. Those DSCSA requirements for ensuring product traceability include:
Trace - Enable Secure tracing of products at the packaging level.
Verify - Use product identifiers to verify products at the package level.
Respond - Enable prompt response to suspect and illegitimate products.
Improve - Create efficiencies of recalls.
- Prepare for Investigations and Recalls
The DSCSA requires stakeholders to be prepared to conduct investigations and recalls in the event of a suspected or confirmed counterfeit or suspect product. Stakeholders must have systems in place to identify suspect products and quickly remove them from the supply chain. Stakeholders must also be prepared to provide information to the FDA and other regulatory authorities in the event of an investigation.
Create Protocols - Establish protocols for the detailed steps on how your organization will respond to or initiate investigations and recalls.
Establish SLAs - Install Service Level Agreements (SLAs) into the documented process for handling Investigations and Recalls. Monitor and analyze if those SLAs are being met and work towards continuous improvement to minimize deviations.
- Train Staff on DSCSA Requirements
Stakeholders in the pharmaceutical industry must ensure that their staff is trained on the final requirements of the DSCSA. This includes training on serialization, verification, tracing, and investigation and recalls procedures. Training should be ongoing to ensure that staff are up to date on DSCSA requirements.
Incorporate into Training Process - By taking the time to absorb the DSCSA requirements into your organization’s training you will ensure that everyone understands the importance of the organization’s response to these DSCSA requirements and has specific instructions on how to ensure compliance.
In conclusion, stakeholders in the pharmaceutical industry must take steps to get ready for the final stage of the DSCSA regulation. This includes understanding the final requirements of the DSCSA, developing a serialization plan, establishing a verification system, ensuring product tracing capabilities, preparing for investigations and recalls, and training staff on DSCSA requirements. By taking these steps, stakeholders can ensure that their operations comply with DSCSA requirements and contribute to a safer and more secure pharmaceutical supply chain.
How can CosmoTrace help?
We provide serialization consulting, implementation & integration services to help our clients manage end-to-end serialization projects and prepare them for the existing and upcoming regulations across the globe.
We are well versed with the compliance regulations for various markets and can help you with implementing the US DSCSA serialization requirements.
Our team of experts strategizes and plans end-to-end solutions using a combination of years of knowledge in product serialization, pharmaceutical supply chains, life sciences, and brand integrity.
Disclaimer
This information is being provided ‘As Is’ with no claims of suitability for a particular purpose. It represents just one possible interpretation of information available in the public domain or through membership organizations, and that interpretation is subject to change. This information does not constitute legal advice. Users must refer to the source material for the complete requirements and form their own interpretation before making business decisions. Please use the references below to follow the updates at the source.
