The Drug Supply Chain Security Act (DSCSA) instituted sweeping changes to how prescription drugs are shipped, distributed, traced, and verified.
The U.S. Food and Drug Administration (FDA) began rolling out the requirements a decade ago. And though the Agency announced that an “extended stabilization period” would be in effect until November 27, 2024, all stakeholders should continue preparing for the full serialization of the supply chain.
If your organization is a part of the pharmaceutical supply chain, you need to familiarize yourself with DSCSA regulations, especially those that come into force in 2024.
This guide will provide a high-level overview of the provisions of DSCSA, including technological solutions that can support your compliance and prospective challenges you may encounter along the way.
Understanding DSCSA: A Quick Review
The DSCSA is part of the Drug Quality and Security Act (DQSA), which Congress enacted in November 2013. The DSCSA outlines steps to achieve pharmaceutical product tracing by creating an interoperable system between pharmaceutical supply chain members, including:
- Manufacturers
- Wholesale distributors
- Dispensers
- Repackagers
- Healthcare organizations
The purpose of the DSCSA is to limit the spread of illegitimate products and protect consumers. These requirements will also help regulators detect and remove potentially dangerous drugs from the supply chain.
DSCSA standards began taking effect as early as 2015. However, the more significant changes, such as unit-level tracing requirements, didn’t go into effect until several years later.
Key Components of DSCSA Compliance
To achieve compliance with DSCA regulations, members of the pharmaceutical supply chain must take the following steps:
- Facilitate product identification (serialization) at the package level
- Provide transaction statements for product tracing
- Verify product identifiers for certain prescription drugs
- Become authorized trading partners (ATPs) and electronically verify that their trading partners are also ATPs
DSCSA Compliance Timeline
The FDA has been rolling ou the DSCSA requirements in phases over the last decade. Notable milestones of the DSCSA include the following:
- On January 1, 2015, the DSCSA required all pharmaceutical manufacturers to print lot numbers on prescription drug packaging.
- On November 27, 2018, the DSCSA required repackagers and manufacturers to include expiration dates and serial numbers on packaging.
- On November 27, 2019, the DSCSA required wholesalers to verify prescription drugs before reselling them; they can only buy and sell products with the appropriate barcodes and serial numbers and must capture serialized product data for tracing purposes.
- On November 27, 2020, dispensers had to enact authentication policies to verify all medicines before purchasing them or selling them to consumers; they’re also required to store all transaction data.
Under the original timeline for DSCSA compliance, November 27, 2023, was the deadline for full compliance. However, as we said above, the FDA postponed enforcement by one year, to November 27, 2024.
Compliance Requirements for Different Stakeholders
DSCSA compliance requirements vary for each stakeholder.
Pharmaceutical Manufacturers
- Product tracing
- Serialization
Wholesale Distributors
- Verification of product authenticity
- Investigation of suspicious products
- Notification of any suspect products
Dispensers
- Verification of product authenticity
- Maintaining transaction information
Repackagers
- Repackaging and relabeling pharmaceuticals in accordance with DSCSA guidelines
Understanding the unique requirements your organization must meet is key to achieving and maintaining DSCSA compliance.
Technological Solutions for DSCSA Compliance
DSCSA compliance software is the key to gathering product transaction information and relaying data to trading partners. Examples of DSCSA compliance software include:
- Serialization tools
- Internet of Things (IoT) and RFID technology for real-time tracking and monitoring
- Compliance management systems for recordkeeping
To achieve compliance, your organization must leverage several complementary technologies. For instance, serialization tools will allow you to assign a standardized numerical identifier to each product, and IoT technology will support real-time package tracking as drugs travel through the supply chain.
Data Management and Integration
To manage the large volume of serialized products and associated data, you and your trading partners must collaborate in an interoperable manner. Data interoperability means your systems can exchange, share, and consume data with one another — all in compliance with DSCSA regulations.
While achieving interoperability is essential for DSCSA compliance, you must also be conscious of data security and privacy considerations. This is especially important for dispensers, which deal directly with HIPAA-protected patient data.
Regardless of what role your organization plays in the supply chain, it’s important to do your part to protect sensitive data and keep it out of the wrong hands.
Training and Education for DSCSA Compliance
Keeping your personnel up to speed on evolving regulations is vital to compliance success. To do this, you must design and implement a comprehensive training and education program. Additionally, you must ensure that your trading partners are also educating their staff on DSCSA compliance requirements.
When designing education programs, strive to deliver information and guidance in a digestible way. Instead of inundating your team with massive amounts of information, host a series of sessions to maximize retention. As new regulations are announced, modify your training content to keep staff apprised of the latest requirements.
Auditing and Validation
You can never assume compliance when dealing with complex regulatory frameworks like the DSCSA. To protect business continuity and avoid penalties, it’s imperative to engage in regular self-auditing. You should also consider partnering with a third-party provider to obtain an objective perspective on your state of DSCSA compliance.
Audits will help you validate compliance systems and identify potential weaknesses in your operations and strategy. You can use these insights to make improvements, maximize efficiency, and be prepared in case of a regulatory inspection.
Common Challenges
A variety of potential obstacles lie on the road to DSCSA compliance, including:
- Difficulties associated with identifying compliance risks
- Dealing with non-compliance issues
- Balancing compliance costs with the benefits of maintaining ATP status
- Staying ahead of regulatory changes
Despite these challenges, you can maintain compliance by combining robust data management technologies with a proactive approach. Working with the right solution provider will help ensure you’re always compliant.
Looking Beyond Compliance
Try not to view DSCSA compliance as another administrative hoop to jump through; instead, consider it a competitive advantage. Adapting to the evolving regulatory landscape can future-proof your organization and grant you full access to emerging business opportunities.
No matter how you look at it, DSCSA compliance is an investment in the longevity and success of your business and your partners’ businesses, and securing the safety of pharmaceutical supply chain.
Final Thoughts
If you haven’t achieved full DSCSA compliance, there is still time to be ready. The good news is you don’t have to tackle things on your own. Finding a trusted solution provider is the best way to fuel your compliance journey and be sure you’re ready by November 2024.
Not sure where to begin? rfxcel can help you meet the DSCSA requirements. Our powerful, user-friendly serialization, traceability, and verification technologies can be customized to meet your unique needs.
Contact us today to see how it works. One of our DSCSA experts can show you a demo, answer your questions, and explain how we can collaborate as partners to ensure your organization is prepared.
