Staying one step ahead of the DSCSA
The Drug Supply Chain Security Act, or DSCSA, establishes national standards for securing the United States prescription drug channel, from the pharmaceutical manufacturer all the way to the dispenser.
Who touches the drug before it reaches the patient?
However, it will also bring new rules and regulations to drug companies, creating an increased opportunity for potential mistakes and pitfalls. Mistakes that can cost you time and money by preventing the distribution of products and incurring fines/penalties (even jail time).
The DSCSA has several provisions, allowing the FDA the authority to draft additional requirements and enforcement criteria, which can suddenly put your drug out of compliance. We will remain vigilant, watching for any changes and adjusting plans to make sure you remain DSCSA compliant.
To remain compliant with the DSCSA, serialization is key; however, a number of new Standard Operating Procedures (SOPs) must be established, new data connections must be formed, and additional barcoding and labeling requirements must be integrated into your packaging plans.
Integrated DSCSA Consultation Services: We offer neutral, third-party education on DSCSA requirements to ensure your organization understands its regulatory obligations. Our experts stay engaged with industry trends by attending conferences and participating in DSCSA working groups, enabling us to provide insights into best practices. Additionally, we keep you informed on the latest FDA guidance and regulatory updates, ensuring your operations remain compliant with evolving standards.
Expert Advice on Data Provider Selection: Advise your organization during the selection process of serialization data providers, ensuring the solution aligns with your compliance needs and budget, preventing unnecessary overspending.
Project Management for Serialization Integration: Support the seamless integration of serialization systems with your packaging and trading partners, managing the process the from start to finish.
SOP Alignment and Quality Assurance: Offer guidance to ensure your Standard Operating Procedures (SOPs) are aligned with DSCSA requirements and your internal quality standards.
Labeling Compliance: Review and scan labels to ensure they meet HDA and GS1 guidelines, which downstream trading partners require for proper compliance.
Master Data Element Creation: Assist in the creation of required master data elements for serialization, ensuring all data is accurate and compliant.
Packager Support and Deficiency Resolution: Work closely with your packager to identify and resolve any deficiencies, ensuring your serialization process remains compliant and efficient.
Industry Monitoring and Consulting: Two Labs will provide clients with a dedicated DSCSA consultant to monitor industry updates, such as new FDA guidance and best practices. This consultant will also offer strategic advice and handle contractual obligations related to DSCSA compliance.
Serialization System Administration: Two Labs will act as the system administrator for clients' serialization software, reviewing updates and changes to ensure they align with the client's compliance needs.
Exception Handling: The service will manage both proactive and reactive exception handling within the serialization process. This includes identifying, diagnosing, and resolving data or process issues that could lead to product quarantines.
Support for Legal and Regulatory Investigations: In cases where exceptions escalate to a level that requires legal reporting to the FDA, Two Labs will assist clients' legal and regulatory teams by providing insights and guidance based on their deep knowledge of serialization systems.
We Lead Pharma Manufacturers Through the Commercial Strategy and Operations Journey
At Two Labs, we’re excited to see what new capabilities the DSCSA brings to the pharmaceutical industry, but we also realize that it will put a lot of stress on drug manufacturers. We’re here to help lighten the load, making sure your transition to DSCSA compliance is as easy as possible.
If you have any questions about Two Labs’ capabilities and how we can help with ensuring your DSCSA compliance, contact us for a consultation.
Tracing is essentially an extension of what companies should already have in place in their suspect drug investigation procedures. The tracing request should not be looked at in a vacuum but as another component of a robust suspect drug investigation.
While Tracing hasn’t gotten much airtime outside the tight circle of DSCSA experts – those of us who live and breathe this – the new Tracing requirement is a fundamental process that will become the norm in the pharmaceutical industry.
Through every step of the commercial journey, Two Labs is your partner in driving success.
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