Countdown to DSCSA compliance—biopharmas, are you ready?

The clock is ticking for biopharmaceutical companies and others in the life sciences sector. The compliance deadline for the Drug Supply Chain Security Act is Nov. 27, 2023. Here’s what companies need to know.

What is it?

The Drug Supply Chain Security Act, or DSCSA, was enacted by Congress 10 years ago with several implementation phases throughout this time period, including manufacturers and repackagers serial product requirements, distributor and dispenser traceability measures, and now finally, mandatory electronic traceability at the unit level, or product packaging phase, by the end of November 2023.

According to a notice from the U.S. Food and Drug Administration posted in the Federal Register, “The DSCSA outlines critical steps to achieve electronic, interoperable tracing at the package level by 2023 to identify and trace certain prescription drugs as they are distributed within the United States. DSCSA requirements enhance FDA's ability to protect U.S. consumers from exposure to drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise harmful by improving the detection and removal of potentially dangerous drugs from the drug supply chain.”

Under this final phase of the regulation, companies must do the following:

• Verify and track products at a serialized level with electronic data
• Find solutions that support unit-level electronic product code information services, or EPCIS, event data
• Implement a secure data exchange network between trading partners and third parties
• Ensure trading partners are adhering to DSCSA standards and establish a quality process for resolving discrepancies

The DSCSA applies to biopharmas, pharmacies, hospital dispensers, manufacturers, repackagers and third-party logistics companies.

Failure to comply could mean business operation disruption for biopharma companies and others in the life sciences sector, or possible fines and penalties.

Challenges to address

Some companies may be behind schedule in implementing the latest traceability requirements due to a lack of fully understanding DSCSA requirements and the impact on the business, challenges with integrating organizational and third-party systems, or deficient or decreased resources. Qualified consultants can help organizations with assessment, tracking and tracing needs. However, biopharma companies should work with professionals experienced in the life sciences industry as they will understand specific product, supply chain and security issues, and ways to anticipate and address typical trouble spots within the sector.

Companies should consider:

• Data strategy: Does the organization want to own their DSCSA data as an asset or rely on a trading partner?
• Integration strategy: Leveraging key systems and creating a robust stack can turn this regulation into digital visibility across the supply chain.
• Trading partner evaluation: Companies will need to ensure they are able to transact data with their trading partners and conduct audits for compliance.
• Quality testing: Many companies own a compliant track and trace system. Equally, many have not tested their system with real data or worked to resolve quality issues with trading partners.

Computer system validation, computer system assurance and compliance with the ruling on electronic records and signatures (21 CFR Part 11): Since DSCSA-enabling technologies produce “official records” electronically that may utilize an electronic signature, these systems must comply with the requirements noted in 21 CFR Part 11.

Actions needed

If not completed already, biopharma companies should conduct a readiness assessment and gap analysis immediately to understand supply chain security deficits. Following that, companies should implement a DSCSA strategy including package selection, validation solution and remediation management.

While DSCSA compliance is the priority in implementing these required tracking and tracing improvements, the organization will also see other benefits from these digital and operational enhancements, like:

• GxP validation gaps and considerations
• Overall supply chain and inventory efficiencies as well as improved cost containment
• Elimination of duplicate data and improved summary reporting
• Improved integration and security with partners
• Decision making on future supply chain tracking enhancements
• System improvements to aid in commercial launch and growth efforts

The takeaway

Biopharmas and others in the life sciences sector must not delay DSCSA compliance. System and operational improvements can address regulatory needs and enhance overall supply chain functionality.