The Drug Supply Chain Security Act (DSCSA) is a federal law that was enacted in 2013 to improve the security and traceability of prescription drugs in the United States. The DSCSA has a number of requirements that are being phased in over time.
Some of the requirements that will come into effect from November 2023 include:
- Interoperable electronic tracing of prescription drugs at the package level: This requirement will require all trading partners in the drug supply chain to be able to electronically trace prescription drugs at the package level. This will allow for the tracking of prescription drugs through the supply chain and will help to identify and investigate suspect or illegitimate drugs.
- Electronic submission of transaction information (TI) and transaction statements (TS): This requirement will require all trading partners in the drug supply chain to electronically submit transaction information and transaction statements to each other. This information will be used to track the movement of prescription drugs through the supply chain and will help to identify and investigate suspect or illegitimate drugs.
- Systems and processes to promptly respond to requests for transaction information (TI) and transaction statements (TS): This requirement will require all trading partners in the drug supply chain to have systems and processes in place to promptly respond to requests for transaction information and transaction statements from the FDA or other appropriate Federal or State official. This will allow the FDA to quickly investigate and respond to reports of suspect or illegitimate drugs.
These are some of the DSCSA guidelines that will come into effect from November 2023. Pharmaceutical companies and other trading partners in the drug supply chain should be prepared to comply with these requirements.
Here are some specific aspects of how serialization and aggregation can be used to achieve the goals of the DSCSA:
- Improving the security of the drug supply chain: Serialization and aggregation can make it more difficult for counterfeiters to introduce fake or adulterated drugs into the supply chain. For example, suppose a counterfeit drug is detected at a wholesale distributor. In that case, the distributor can use the serialization information to track down the source of the drug and take action to prevent it from reaching patients.
- Increasing the traceability of prescription drugs: It can allow for the tracking of prescription drugs through the supply chain. This can help to identify and investigate suspect or illegitimate drugs. For example, suppose a patient experiences a medication error. In that case, the pharmacist can use the serialization information to track down the source of the drug and to take action to prevent it from happening again.
- Enhancing patient safety: It helps to ensure that patients receive the correct medication. For example, if a patient is dispensed the wrong medication, the pharmacist can use the serialization information to identify the mistake and correct it.
- Reducing costs: Reduction of cost is associated with drug recalls and other supply chain disruptions. For example, if a drug recall is necessary, serialization and aggregation can help to identify the affected products and to track down the source of the problem.
- Improving compliance: By meeting the requirements of the DSCSA, pharmaceutical companies can demonstrate their commitment to the security and traceability of prescription drugs. This can help to improve their reputation with regulators and customers.
Some of the key steps that companies can take include:
- Evaluate their current supply chain: Before implementing any new technologies or processes, pharma companies should first evaluate their current supply chain to identify any gaps or areas that need improvement. This will help them to develop a more comprehensive and effective implementation plan. At Jekson Vision, we do exactly the same! We offer detailed consultation based on a detailed study that our subject matter experts do while interacting with your teams.
- Select the right solutions: There are a number of different solutions that Jekson has to offer to implement the DSCSA guidelines. Pharma companies should select the system & solutions that best meet their specific needs and requirements.
- System-Driven tracking and tracing drugs: Pharma companies need to develop a system for tracking and tracing drugs throughout the supply chain. This system should be able to capture and store all relevant data, such as the product identifier, lot number, and expiration date. Jekson Vision has a proven track record of offering Track & Trace Solutions across the globe for more than a decade. With a global level of exposure, we are sure to give you the right, customized, and robust solution.
- Implement appropriate security measures: Pharma companies need to implement appropriate security measures to protect the data that is used to track and trace drugs. This includes measures such as encryption and access control. With Jekson’s proprietary solutions, which are developed at its own dedicated development center, system security is easily implemented.
- Train staff: Pharma companies need to train their staff on how to use the new system. This training should cover all aspects of the system, including how to track and trace drugs, how to generate and submit reports, and how to respond to requests for information from the FDA. Once our solutions are implemented, we ensure that detailed staff training is done at your site.
- Monitor and update the system: Pharma companies need to monitor the system on an ongoing basis to ensure that it is working properly. They should also update the system as needed to reflect changes in the law or regulations. For this, Jekson’s renowned & cost-effective SLA comes into play, which keeps you secured and free of any tension.
By following the above steps, pharma companies can implement the DSCSA guidelines that will come into effect from November 2023. This will help them to improve the security and traceability of prescription drugs in the United States.
Contact us on mobile or WhatsApp at +919328233954 or write to us at marketing@jeksonvision.com to get customized solutions for your brand and book a demo to see how it works.
