With UPM Pharmaceuticals, working towards pharmaceutical serialization compliance ahead of the 2024 DSCSA mandate is a collaborative effort to enhance the security, traceability and efficiency of your drug supply chain. UPM’s approach to serialization and aggregation is designed not only to meet, but surpass, regulatory mandates, ensuring a streamlined transition towards enhanced compliance and a quicker path to market for your products.
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Understanding the 2024 DSCSA Serialization and Aggregation Mandate
The Drug Supply Chain Security Act (DSCSA) outlines the steps required to build an electronic, interoperable system to identify and trace certain prescription drugs as they are distributed within the United States. This mandates pharmaceutical companies to implement serialization and aggregation processes to ensure the security and traceability of drug products.
What Is the Serialization Requirement in Pharmaceuticals?
The requirement for serialization in the pharmaceutical industry is driven by global regulatory mandates aimed at enhancing drug supply chain security. Under the 2024 DSCSA Mandate, pharmaceutical companies must assign a unique identifier to each saleable unit of a drug. This identifier should include vital information such as the product's lot number, expiration date and a serial number unique to each unit.
Furthermore, the DSCSA serialization requirements mandate that the unique identifiers be encoded in both human-readable form and machine-readable barcodes to facilitate easy scanning and verification at various points in the supply chain. Pharmaceutical serialization compliance is not merely a regulatory obligation but a significant step towards ensuring the authenticity and safety of pharmaceutical products. With UPM Pharmaceuticals as your partner, navigating regulatory intricacies and achieving compliance becomes a collaborative, well-supported process, ensuring that your products are traceable, verifiable and protected against potential threats within the supply chain.
DSCSA Serialization Requirements
Complying with the DSCSA serialization requirements is crucial for pharmaceutical companies to ensure the traceability and authenticity of their products. Here are the key requirements as outlined by the DSCSA:
- Unique Identifier Assignment: Each saleable unit and homogeneous case of a drug product must be assigned a unique identifier, which includes a National Drug Code (NDC), serial number, lot number and expiration date.
- Human and Machine Readable Format: The unique identifier should be encoded in both a human-readable format and a machine-readable 2D barcode to facilitate easy scanning and verification at various points in the supply chain.
- Data Maintenance: Manufacturers, repackagers and other stakeholders must maintain the product tracing information for at least six years.
- Product Identifier Verification: Before a product can be further distributed, the product identifier must be verified, especially in cases where the product is deemed suspect or illegitimate.
- Notification of Illegitimate Product: Stakeholders must have systems in place to respond to discovering a suspect or illegitimate product, including quarantine and timely notification to the FDA and other stakeholders.
- Interoperable Data Exchange: Stakeholders should be able to exchange transaction information, transaction history and transaction statements in a secure, interoperable, electronic manner to trace the distribution history of a product.
These requirements are geared towards enhancing the traceability, safety and security of drug products throughout the supply chain, aligning with the broader goal of ensuring public health and compliance in the pharmaceutical industry.
When Does DSCSA Aggregation and Serialization Enforcement Start?
The enforcement of the new electronic prescription tracking system has been delayed, moving from November 27, 2023, to November 27, 2024. During this extended preparation period, UPM Pharmaceuticals is your trusted partner in DSCSA compliance, aiding in seamless transition and adherence to the new electronic prescription tracking mandates.
The Importance of Compliance
Adherence to the DSCSA Serialization and Aggregation requirements is more than just a regulatory necessity; it's a significant stride towards ensuring patient safety and fortifying brand reputation. Here are some of the compelling benefits of compliance:
- Enhanced Pharmaceutical Serialization And Traceability: With serialization and aggregation, pharmaceutical companies can trace the journey of each product from the manufacturing facility to the pharmacy, ensuring authenticity and safety.
- Increased Accountability: The ability to track and trace pharmaceutical products fosters a culture of accountability within the entire supply chain.
- Brand Protection: Compliance shields brands from counterfeit drugs, which is crucial for maintaining brand reputation and consumer trust.
Why Is Serialization for Pharmaceuticals Important?
Many people are asking why serialization is important and what is the use of serialization in the pharmaceutical industry. Serialization in pharma plays a pivotal role in the industry by ensuring the traceability and authenticity of drug products. Through assigning a unique identifier to each saleable unit, serialization enables accurate tracking of drugs throughout the supply chain, from the manufacturer to the distributor, and, finally, to the pharmacy.
- Pharmaceutical serialization is instrumental in combating counterfeit drugs, ensuring that only authentic and safe products reach the consumers.
- Pharmaceutical serialization and traceability provide a robust foundation for efficient recall processes. In the event of a product recall, serialization allows for swift identification and recall, minimizing any potential risks to public health and mitigating financial losses for pharmaceutical companies.
- Serialization for pharmaceuticals supports compliance with evolving regulatory requirements, such as the 2024 DSCSA Mandate, ensuring that pharmaceutical companies adhere to industry standards, thereby fortifying their brand reputation and consumer trust.
UPM's Comprehensive Pharmaceutical Data Aggregation Solutions
Aggregation in pharmaceutical products is necessary for managing serialization data to ensure traceability and compliance in the supply chain, especially in light of regulatory mandates like the 2024 DSCSA.
Here’s a snapshot of how UPM Pharmaceuticals can help you manage DSCSA aggregation requirements:
- Data Collection and Organization: We deploy pharmaceutical data aggregation solutions to collect crucial serialization data, including unique identifiers, batch numbers and expiration dates, organizing it for streamlined access and analysis.
- Hierarchy Establishment: UPM creates a hierarchical structure among the unique identifiers of individual units, cases and pallets, ensuring clear traceability from manufacturer to retailer.
- Regulatory Compliance: We facilitate adherence to pharma regulatory requirements by maintaining accurate product movement records, which are crucial for reporting and auditing.
- Enhanced Traceability: Through data aggregation, issues like counterfeit products or recalls are quickly identified and resolved.
- Interoperability: We design solutions to interact seamlessly with other systems within the supply chain, facilitating smooth data exchange and communication among different stakeholders.
- Real-Time Monitoring: UPM offers real-time monitoring capabilities, providing instant insights into product movement and status throughout the supply chain.
- Decision Support: We provide a basis for informed decision-making to improve supply chain efficiency and ensure product authenticity.
UPM Pharmaceuticals offers robust pharmaceutical data aggregation solutions, ensuring your compliance with the 2024 DSCSA mandate is seamless and effective. Our solutions are geared towards meeting and exceeding regulatory requirements, providing a streamlined approach to managing serialization data, enhancing traceability and ensuring the overall safety and efficiency of your pharmaceutical supply chain.
Frequently Asked Questions About Serialization and Aggregation
Explore some of the common questions regarding pharma serialization and aggregation.
What is Serialization for Pharmaceuticals?
Serialization in pharma refers to the assignment of a unique identifier (a serial number) to each saleable unit of a drug. This unique identifier comprises crucial information about the drug, including its origin, batch number and expiration date.
What is Aggregation in Pharmaceutical Products?
On the other hand, pharmaceutical aggregation creates a hierarchical relationship between these unique identifiers, facilitating seamless tracking and tracing of products throughout the supply chain.
Why Is Serialization in Pharma Necessary?
The necessity for pharma serialization has been propelled by the global surge in counterfeit drugs, which pose serious health risks and financial implications. Regulatory authorities have, therefore, mandated serialization for pharmaceuticals to enhance drug supply chain security, ensure product authenticity and safeguard public health. Compliance with pharmaceutical serialization regulations and mandates like the 2024 DSCSA also fosters a culture of accountability and transparency within the industry, making it an indispensable requirement for pharmaceutical manufacturers and distributors.
What Is the Difference Between Pharmaceutical Aggregation Using RFID and Aggregation Using 2D Barcodes?
Both RFID (Radio Frequency Identification) and 2D barcodes are viable technologies for aggregation in pharma packaging, both with distinct advantages and considerations. RFID enables data to be read wirelessly, allowing for faster data capture and reading multiple tags simultaneously. This can be particularly beneficial in high-volume or fast-paced environments. On the other hand, 2D barcodes are cost-effective, well-established in the industry and can store a significant amount of data. However, they require line-of-sight to be read, which can be a limitation in certain scenarios. The choice between RFID and 2D barcodes for aggregation will largely depend on the specific needs of a project, including budget, operational constraints and the level of data granularity required.
What Is Aggregation in Pharma Packaging?
Aggregation in pharmaceutical products builds a hierarchical relationship by grouping serialized units into higher packaging levels like cases, pallets or batches, each with unique identifiers. This structure enhances tracking and tracing across the supply chain.
Through pharmaceutical data aggregation, tracing a saleable unit back to its original batch or manufacturing facility becomes straightforward, adding a layer of transparency and accountability. Aggregation simplifies managing pharmaceutical serialization and traceability.
By integrating serialization and aggregation, CDMOs like UPM Pharmaceuticals align with regulatory mandates, bolstering the security, efficiency and transparency of their supply chain operations. With our packaging and warehousing services, this integration is further optimized, ensuring a well-coordinated, compliant and efficient supply chain.
Why Choose UPM Pharmaceuticals for Serialization and Aggregation?
In the face of stringent regulatory mandates such as the 2024 DSCSA serialization and aggregation requirement, partnering with a seasoned CDMO is paramount. UPM Pharmaceuticals is your partner of choice because of our rich legacy, cutting-edge technology and personalized approach toward client projects.
Operating from a sprawling 475,000-square-foot facility in Bristol, Tennessee, UPM Pharmaceuticals melds the robust capabilities of a large pharma supplier with the personalized touch and agility of a family-owned, US-based CDMO. This unique blend of large-scale capacity and individualized service translates to exceptional quality, reliability, and a seamless journey toward market readiness.
UPM’s strength lies not just in its advanced technology but in its commitment to understanding your project’s trajectory, aligning with your commercial goals, and collaborating to get your product to market. The facility, having successfully scaled up over 80 products to commercialization, demonstrates UPM's ability to navigate the complex realm of pharmaceutical serialization regulations and DSCSA aggregation requirements.
UPM’s extensive experience in technology transfer and scale-up positions it well for creating custom pharma serialization and aggregation in pharmaceutical products solutions that not only meet the DSCSA serialization requirements but also cater to your project’s specific needs.
UPM’s Serialization and Aggregation Capabilities: Simplifying Compliance and Enhancing Traceability
Entrust your serialization and aggregation needs to a partner who not only understands the pharma regulatory landscape but also values your project’s unique demands. UPM's state-of-the-art facility and team of professionals are ready to provide tailored solutions that will align with the 2024 DSCSA Serialization and Aggregation Mandate, ensuring a smooth transition toward compliance while keeping your project on track. Discover the UPM difference and how we can expedite your journey to market. Contact us to learn more about our pharmaceutical data aggregation solutions or take a virtual tour of our facility.
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