Insights for Pharmaceutical, Diagnostics, Pharmacies, Third Party Logistics (3PLS), Supply Chain, Transportation and Life Science Companies on DSCSA
Implementing the Drug Supply Chain Security Act (DSCSA) presents various challenges for stakeholders in the pharmaceutical industry, including complexity, cost, system integration, interoperability, supply chain complexity, as well as training the entire ecosystem.
- Compliance with DSCSA requirements can be complex and resource-intensive, particularly for smaller pharmaceutical companies or entities with limited technological infrastructure. Implementing serialization, track and trace systems, and data management processes often require significant investments in technology, training, and operational changes.
- Integrating new serialization and traceability systems with existing supply chain processes and technologies can be challenging. Ensuring seamless data exchange and interoperability between different entities within the supply chain, such as manufacturers, distributors, and dispensers, requires careful planning and coordination.
- Managing and exchanging vast amounts of data generated by serialization and traceability systems can be a significant challenge. Establishing standardized data formats, communication protocols, and data-sharing agreements among trading partners is essential for efficient and accurate information exchange.
- Ensuring interoperability and connectivity among various serialization and traceability systems used by different stakeholders is crucial. The ability to share and access information across the supply chain in a secure and standardized manner is essential for effective traceability and compliance.
- Properly training personnel on the new systems, processes, and compliance requirements is critical but can be a challenge. Education and awareness programs are necessary to ensure that all stakeholders understand their roles and responsibilities under the DSCSA and can effectively implement the required measures.
- The pharmaceutical supply chain is complex, involving multiple entities, transportation modes, and global distribution networks. Implementing DSCSA requirements across this complex network poses challenges in terms of ensuring consistent compliance, monitoring product movements, and maintaining data integrity throughout the supply chain.
- Achieving consensus among various stakeholders on implementation strategies, data standards, and regulatory interpretations can be challenging. Balancing the diverse perspectives and priorities of manufacturers, distributors, dispensers, and regulatory agencies requires ongoing collaboration and communication.
The DSCSA is specific to the United States, and achieving global harmonization of serialization and traceability requirements presents additional challenges for companies operating in international markets. Navigating different regulatory frameworks and ensuring compliance with country-specific regulations can be complex and time-consuming.
Addressing these challenges requires a proactive approach, effective collaboration among stakeholders, investment in technology and infrastructure, and ongoing engagement with regulatory authorities. The industry as a whole is continuously working towards finding solutions and best practices to overcome these implementation challenges and ensure successful compliance with the DSCSA.
We put together a set of key elements from various sources to help you navigate coming changes. As always, consult with your legal team as well as your compliance group to ensure adherence to the law. The content in this document is not intended to be legal or contractual advice.
The Drug Supply Chain Security Act (DSCSA) is a comprehensive piece of legislation enacted in the United States to enhance the security, traceability, and safety of prescription drugs throughout the supply chain. The DSCSA addresses the growing concern of counterfeit, adulterated, or otherwise illegitimate drugs entering the market and posing risks to patient health.
- Lot-level Traceability: Starting January 1, 2015, manufacturers, repackagers, and wholesale distributors are required to provide and capture transaction information, transaction history, and transaction statements when transferring ownership of prescription drugs at the lot level.
- Product Serialization: By November 27, 2017, manufacturers are required to serialize prescription drug packages, i.e., assign unique product identifiers (serial numbers) to individual units of the drug product. The serialized data is used for enhanced traceability.
- Verification and Saleable Returns: Beginning November 27, 2019, wholesale distributors are required to verify the product identifier and quarantine any suspect or illegitimate products. Additionally, wholesale distributors are allowed to accept saleable returns from authorized trading partners if certain conditions are met.
- Enhanced Verification Requirements: Starting November 27, 2020, wholesale distributors are required to verify the product identifier of prescription drugs in their possession before further distribution, with a few exceptions.
- Enhanced Saleable Returns Verification: From November 27, 2023, wholesale distributors are required to verify the product identifier of saleable returned drugs before they are reintroduced into the supply chain.
- Compliance Requirements
To stay compliant with the DSCSA and effectively share data, pharmaceutical companies can adopt various strategies and technologies. Here are some key considerations:
- Electronic Data Exchange: Implementing electronic data exchange systems allows companies to efficiently share information and comply with the data sharing requirements of the DSCSA. This includes sharing transaction information, transaction statements, and transaction history, as required by the Act. Electronic data exchange promotes accuracy, timeliness, and transparency in data sharing among trading partners.
- Standardized Data Formats: Adopting standardized data formats, such as the Electronic Data Interchange (EDI) standards, facilitates seamless data sharing across the supply chain. Standardized formats ensure consistency and compatibility in data exchange, reducing errors and enhancing efficiency.
- Product Serialization: Implementing product serialization involves assigning unique serial numbers to individual drug units or product packages. This enables traceability throughout the supply chain, from manufacturer to dispenser. Serialized data can be shared among trading partners to ensure product authenticity, track product movement, and facilitate recall management.
- Track and Trace Systems: Employing track and trace systems helps monitor and record the movement of prescription drugs across the supply chain. These systems enable the capture and sharing of data related to product identifiers, transaction information, and transaction history. By tracking and tracing products, companies can identify and address any instances of suspect or illegitimate products.
- Secure Data Storage and Access Controls: Ensuring secure data storage and access controls is crucial for maintaining the integrity and confidentiality of shared data. Companies should implement robust data security measures, including encryption, user authentication, and data backup protocols, to protect sensitive information from unauthorized access or breaches.
- Collaboration with Trading Partners: Collaborating with trading partners is essential for effective data sharing and compliance. Companies should establish clear communication channels and collaborative relationships with manufacturers, repackagers, wholesale distributors, and dispensers to exchange necessary data and ensure compliance with DSCSA requirements.
- Technology Solutions: Leveraging technology solutions, such as cloud-based platforms, data management systems, and track and trace software, can streamline data sharing and compliance processes. These solutions provide centralized data storage, real-time visibility, and automated workflows, facilitating efficient data exchange and compliance monitoring.
- Regulatory Compliance Audits: Conducting regular internal audits and assessments of data sharing processes and systems helps ensure ongoing compliance with DSCSA requirements. Audits can identify any gaps or areas for improvement in data sharing practices, enabling companies to take corrective actions and maintain compliance.
It is important for pharmaceutical companies to establish robust data governance policies and standard operating procedures that align with DSCSA requirements. By implementing efficient data sharing mechanisms, utilizing appropriate technologies, and fostering collaboration with trading partners, companies can meet their compliance obligations, ensure the integrity of the drug supply chain, and protect patient safety.
Tracking and Traceability Overview
DSCSA includes tracking and traceability requirements that aim to enhance the visibility and accountability of prescription drugs throughout the supply chain. These requirements enable effective tracking of product movement and facilitate the tracing of drugs in case of recalls, suspected counterfeit products, or other safety concerns. Here are the key elements of the tracking and traceability requirements under the DSCSA:
- Product Transaction Information (TI): Manufacturers, repackagers, wholesale distributors, and dispensers are required to provide and maintain accurate product transaction information for each sale, transfer, or distribution of a prescription drug. The TI includes the following details:
- The proprietary or established name of the product
- Strength and dosage form
- National Drug Code (NDC) of the product
- Container size
- Number of containers
- Lot number of the product
- Date of the transaction
- Transaction History (TH): The DSCSA mandates that a transaction history record is created and maintained for each transaction involving the sale, transfer, or distribution of a prescription drug. The transaction history captures the complete record of all transactions, from the initial sale by the manufacturer to subsequent transactions through the supply chain until the product reaches the dispenser. The TH includes information such as:
- Names and addresses of all parties involved in the transaction
- Dates of each transaction
- Quantity of product transferred
- Unique identifier of the product, including the standardized numerical identifier (SNI)
- Lot number and expiration date of the product
- Transaction Statement (TS): With each transfer of ownership or distribution, the DSCSA requires the transferor (the party transferring the product) to provide a transaction statement to the receiving entity. The transaction statement confirms compliance with the DSCSA requirements and affirms that the product being transferred is not counterfeit, stolen, or otherwise compromised. The TS states that:
- The entity transferring the product is authorized as per the DSCSA
- The product being transferred is not suspect or illegitimate
- The transferor is responsible for complying with the verification requirements of the DSCSA
- Authorized Trading Partners: The DSCSA establishes the concept of “Authorized Trading Partners” (ATPs) to ensure that all entities involved in the pharmaceutical supply chain are authorized, legitimate, and meet specific criteria. The ATPs include manufacturers, repackagers, wholesale distributors, and dispensers. The DSCSA requires verification and documentation of the ATP status for all transactions, ensuring that products are only sourced from authorized and trustworthy partners.
These tracking and traceability requirements under the DSCSA aim to establish a robust system for tracing the movement of prescription drugs throughout the supply chain. By implementing accurate record-keeping, maintaining transaction histories, and verifying the authenticity and legitimacy of products, stakeholders contribute to a secure and transparent drug supply chain that protects patient safety and prevents the distribution of counterfeit or compromised drugs.
Reporting Suspect or Illegitimate Products
Under the Drug Supply Chain Security Act (DSCSA), all entities involved in the pharmaceutical supply chain, including manufacturers, repackagers, wholesale distributors, and dispensers, are required to report suspect or illegitimate products to the Food and Drug Administration (FDA). This reporting requirement is crucial for ensuring patient safety, preventing the distribution of counterfeit or compromised drugs, and maintaining the integrity of the drug supply chain. Here are the key aspects of reporting suspect or illegitimate products under the DSCSA:
- Definition of Suspect or Illegitimate Products: The DSCSA defines suspect or illegitimate products as prescription drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise compromised in terms of their safety, efficacy, or quality. Any product that raises suspicion of being fraudulent, unauthorized, or potentially harmful is considered suspect or illegitimate.
- Reporting Obligations: All entities within the pharmaceutical supply chain have an obligation to report any suspect or illegitimate products they encounter. The reporting requirements apply to both physical products and instances where there are indications of suspect or illegitimate activities within the supply chain.
- Reporting Process: When a suspect or illegitimate product is identified, the entity that discovers or receives the product is responsible for promptly reporting it to the FDA. The reporting process involves providing detailed information about the product, the circumstances surrounding its discovery, and any supporting evidence or documentation.
- Collaboration with the FDA: Once the report is submitted, the FDA collaborates with the reporting entity to investigate the suspect or illegitimate product. This collaboration may involve sharing additional information, providing samples for analysis, and coordinating efforts to mitigate any risks to public health.
- Confidentiality and Protection from Liability: The DSCSA provides provisions to protect entities that report suspect or illegitimate products in good faith. The reporting entities are shielded from liability, ensuring that they can freely and openly cooperate with the FDA without fear of reprisal.
- Timeliness and Compliance: Reporting suspect or illegitimate products should be done in a timely manner. The DSCSA emphasizes the importance of prompt reporting to enable swift action by regulatory authorities and to mitigate potential risks to patient safety.
By requiring the reporting of suspect or illegitimate products, the DSCSA promotes transparency, collaboration, and proactive measures to identify and address potential threats to the pharmaceutical supply chain. This reporting process enhances patient safety, helps to prevent the distribution of counterfeit drugs, and strengthens the overall integrity of the drug supply chain.
Storage Conditions and the Role of USP Guidelines
Under the new Act, compliance requirements for storage conditions are essential to maintaining the safety, efficacy, and quality of prescription drugs throughout the pharmaceutical supply chain. The United States Pharmacopeia (USP) guidelines play a crucial role in establishing standards for proper storage and handling of pharmaceutical products. Here are the compliance requirements for storage conditions and the role of USP guidelines under the DSCSA:
- Storage Conditions: The DSCSA mandates that all entities involved in the pharmaceutical supply chain must ensure appropriate storage conditions for prescription drugs. Storage conditions refer to the temperature, humidity, light exposure, and other environmental factors that can impact the stability and integrity of pharmaceutical products.
- USP Guidelines: The USP is a non-profit organization that establishes standards for the quality, purity, and strength of medications. The USP publishes guidelines and chapters that provide recommended storage conditions for various pharmaceutical products. These guidelines help ensure that medications are stored in conditions that maintain their stability and prevent degradation.
- Role of USP Guidelines: The USP guidelines serve as a valuable resource for pharmaceutical companies to comply with the DSCSA storage requirements. They provide specific temperature ranges, storage instructions, and handling recommendations for different types of medications. By following the USP guidelines, companies can demonstrate their commitment to quality control and patient safety.
- Controlled Room Temperature (CRT): The USP guidelines define controlled room temperature (CRT) as a temperature maintained thermostatically between 20°C to 25°C (68°F to 77°F). Many medications can be stored at this temperature range without significant degradation. CRT is the preferred storage condition for most medications.
- Refrigerated Storage: Some medications require refrigeration to maintain their stability. The USP defines refrigerated storage as between 2°C to 8°C (36°F to 46°F). Examples of medications that need refrigeration include certain liquid antibiotics, insulin, and certain vaccines. Compliance with refrigerated storage requirements is crucial to prevent temperature-related degradation and maintain the efficacy of these products.
- Freezing and Elevated Temperatures: The USP guidelines caution against freezing temperatures, as freezing can affect the stability of many medications. Freezing temperatures, at or below 0°C (32°F), can cause physical and chemical changes in medications, leading to reduced efficacy or potential harm. Similarly, prolonged exposure to elevated temperatures above 40°C (104°F) can degrade medications and affect their potency.
- Manufacturer Instructions: It is important to note that specific medications may have unique storage requirements, and the manufacturer’s instructions should always be followed. Some medications may have more stringent temperature requirements or specific storage instructions, such as “refrigerate, do not freeze.” Compliance with the manufacturer’s instructions ensures the preservation of the product’s integrity and effectiveness.
By adhering to the USP guidelines for storage conditions, pharmaceutical companies can meet the compliance requirements of the DSCSA. Proper storage conditions help maintain the quality and potency of prescription drugs, reducing the risk of compromised products reaching patients. Compliance with the DSCSA storage requirements and adherence to the USP guidelines demonstrate a commitment to patient safety and the integrity of the pharmaceutical supply chain.
Importance of Temperature Monitoring
Temperature monitoring plays a crucial role in ensuring compliance with the Drug Supply Chain Security Act (DSCSA) and maintaining the integrity of pharmaceutical products throughout the supply chain. Here are the key reasons why temperature monitoring is important for DSCSA compliance:
- Product Quality and Efficacy: Many pharmaceutical products, especially biologics, vaccines, and certain medications, are sensitive to temperature variations. Deviations from the recommended storage conditions can compromise the quality, efficacy, and safety of these products. Temperature monitoring helps ensure that medications are stored within the appropriate temperature range, preserving their integrity and effectiveness.
- Compliance with Storage Requirements: The DSCSA requires entities within the pharmaceutical supply chain to adhere to storage and handling requirements. Temperature monitoring provides objective and quantitative data to demonstrate compliance with these requirements. It enables companies to track and record temperature conditions during storage, transportation, and distribution, providing evidence of proper temperature control.
- Risk Identification and Mitigation: Temperature monitoring allows for the identification of temperature excursions or deviations from the recommended storage conditions. Real-time monitoring and data logging help detect and alert stakeholders to potential temperature breaches. By promptly identifying such deviations, companies can take immediate corrective actions, such as reconditioning or discarding affected products, to mitigate risks to product quality and patient safety.
- Quality Control and Documentation: Accurate temperature monitoring data serves as documented evidence of adherence to temperature regulations and quality control practices. This data can be utilized to demonstrate compliance during audits, inspections, and regulatory reporting. It supports the traceability and accountability of pharmaceutical products, ensuring that they have been stored under suitable conditions throughout the supply chain.
- Enhanced Supply Chain Visibility: Temperature monitoring provides visibility into the temperature conditions experienced by pharmaceutical products at different stages of the supply chain. It helps identify potential temperature-sensitive areas and points of vulnerability, such as during transportation or warehousing. This information enables companies to implement targeted measures to optimize temperature control, reduce temperature excursions, and improve supply chain efficiency.
- Patient Safety and Product Integrity: Ensuring that pharmaceutical products are stored and transported within the appropriate temperature range is vital for patient safety. Temperature deviations can compromise the effectiveness and safety of medications, leading to reduced therapeutic outcomes or adverse effects. By implementing temperature monitoring, companies prioritize patient safety, mitigate the risk of compromised products, and maintain the integrity of the pharmaceutical supply chain.
Temperature monitoring is of paramount importance for DSCSA compliance. It enables pharmaceutical companies to uphold the quality, efficacy, and safety of medications by ensuring adherence to proper storage conditions. By monitoring and documenting temperature data, stakeholders can demonstrate compliance, identify and mitigate risks, enhance supply chain visibility, and safeguard patient health and product integrity.
DSCSA does not provide specific guidelines for medication storage temperatures. Instead, it references the United States Pharmacopeia (USP) guidelines for the proper storage and handling of pharmaceutical products, including temperature controls. The USP provides general temperature guidelines for medications based on different storage conditions. Here are the commonly recognized guidelines:
- Controlled Room Temperature (CRT): This refers to a temperature maintained thermostatically between 20°C to 25°C (68°F to 77°F). Many medications can be stored at this temperature range without significant degradation. This is the preferred storage condition for most medications.
- Refrigerated: Some medications require refrigeration to maintain their stability. The USP defines refrigerated storage as between 2°C to 8°C (36°F to 46°F). Examples of medications that need refrigeration include certain liquid antibiotics, insulin, and certain vaccines.
- Freezing: Freezing temperatures, at or below 0°C (32°F), can affect the stability of many medications and should be avoided unless explicitly stated otherwise in the product labeling. Freezing can cause physical and chemical changes in medications, leading to reduced efficacy or potential harm.
- Elevated Temperatures: Medications are typically sensitive to high temperatures. The USP generally recommends avoiding exposure to temperatures above 40°C (104°F). Prolonged exposure to elevated temperatures can degrade the medication and affect its potency.
Solutions to Monitor Temperature and Maintain Compliance
Temperature indicators play a vital role in monitoring and documenting temperature conditions during the transportation and storage of pharmaceutical products, thus aiding in compliance with DSCSA). Here are the types and applications of temperature indicators commonly used for compliance, including products like WarmMark and ColdChain Complete XS from SpotSee:
- WarmMark temperature indicators are irreversible indicators that provide a visual indication when a specified temperature threshold has been exceeded. These indicators are typically used to monitor temperature excursions above a specific threshold, such as when a product has been exposed to excessive heat. Once activated, the indicator will change color, indicating a potential temperature breach. WarmMark indicators are valuable for identifying temperature abuse during transit or storage.
- ColdChain Complete XS: ColdChain Complete XS is a irreversible temperature indicator specifically designed for monitoring temperature-sensitive products during transportation. It consists of a combined set of visual indicators to monitor lower and higher temperature thresholds in a small formcactor. The visual indicator provides a clear visual indication if the temperature exceeds the specified threshold during the monitored period. ColdChain Complete XS offers real-time temperature monitoring, allowing for immediate action in case of temperature excursions.
- Time-Temperature Indicators: Time-temperature indicators are designed to provide information about the cumulative exposure of a product to temperature conditions over time. These indicators are often used for monitoring temperature-sensitive products with strict temperature requirements. They work by gradually changing color or indicating a visual change based on the duration and intensity of temperature exposure. Time-temperature indicators are useful for evaluating whether a product has been subjected to extended periods of unfavorable temperature conditions.
- Electronic Data Loggers: Electronic data loggers are electronic devices that measure and record temperature at regular intervals. They offer advanced features such as real-time monitoring, wireless connectivity, and data storage. These loggers can transmit temperature data wirelessly or store it for later analysis. Electronic data loggers are versatile and can be used for a wide range of temperature-sensitive products, providing detailed temperature history and facilitating compliance documentation.
The applications of temperature indicators for DSCSA compliance include:
- Monitoring Temperature Excursions: Temperature indicators help identify instances of temperature deviations beyond acceptable limits, enabling prompt actions to be taken to mitigate risks and prevent damage to temperature-sensitive products.
- Compliance Documentation: Temperature indicators provide visual evidence of temperature excursions, which can be documented as part of regulatory compliance reporting. They demonstrate the steps taken to comply with temperature requirements and ensure the integrity of the pharmaceutical supply chain.
- Quality Assurance: By utilizing temperature indicators, pharmaceutical companies can ensure that products have been stored and transported within the required temperature range, thereby maintaining product quality, efficacy, and patient safety.
- Risk Mitigation and Corrective Actions: Temperature indicators assist in identifying potential risks in the supply chain. If temperature excursions are detected, pharmaceutical companies can investigate the cause, assess the impact on product quality, and take appropriate corrective actions to prevent future deviations.
- Supply Chain Optimization: Temperature indicators provide valuable insights into the temperature conditions experienced by pharmaceutical products throughout the supply chain. This information helps optimize temperature control measures, reduce temperature excursions, and improve overall supply chain efficiency.
Temperature indicators such as WarmMark, ColdChain Complete XS, time-temperature indicators, and electronic data loggers are essential tools for DSCSA compliance. They enable the monitoring and documentation of temperature conditions, identification of temperature excursions, and implementation of corrective actions to ensure the integrity of temperature-sensitive pharmaceutical products throughout the supply chain.
Create and Augment Your Compliance Plan
SpotSee offers various products and solutions that can assist in creating and augmenting compliance plans with the Drug Supply Chain Security Act (DSCSA). Here’s how you can leverage SpotSee’s offerings:
- Temperature Indicators: SpotSee offers temperature indicators like, SpotBot 4G Plus, FreezeSafe WarmMark, ColdChain Complete and temperature data loggers . These indicators are adhesive labels that change color when exposed to specific temperature thresholds. By affixing these indicators to pharmaceutical shipments or storage areas, you can monitor temperature excursions and ensure compliance with DSCSA storage requirements. If the indicators indicate a temperature breach, you can take appropriate actions to mitigate potential risks and protect the integrity of the medications.
- Impact Indicators: SpotSee provides impact indicators such as ShockWatch and ShockLog that detect and record any impacts or mishandling during transportation or storage. By attaching these indicators to packages or containers, you can monitor if the medications have been subjected to excessive impact forces, which could potentially compromise their quality and efficacy. This helps in identifying potential issues in the supply chain and taking corrective actions to prevent further damage.
- Track and Trace Solutions: SpotSee’s track and trace solutions, such as the SpotSee Cloud enable real-time monitoring, data collection, and analytics for supply chain visibility. This solution can help you track the movement of pharmaceutical products, capture critical data, and generate reports for compliance with DSCSA requirements. By leveraging these solutions, you can enhance traceability, monitor product integrity, and facilitate regulatory compliance.
Data Management and Reporting: SpotSee’s cloud-based platforms provide centralized data storage, analytics, and reporting capabilities. These features allow you to collect and manage critical compliance data, including temperature records, impact events, and other relevant information. You can generate reports, analyze trends, and maintain documentation required for DSCSA compliance audits and regulatory reporting.
To incorporate SpotSee’s solutions into your compliance plan, consider the following steps:
- Assess Compliance Needs: Evaluate your specific compliance requirements under the DSCSA, particularly in areas like temperature monitoring, impact detection, and traceability. Identify the types of products and supply chain processes that need monitoring and data collection.
- Select Appropriate SpotSee Products: Determine which SpotSee temperature indicators, impact indicators, or track and trace solutions align with your compliance needs. Consider factors such as the temperature range, impact sensitivity, and connectivity features required for your specific use cases.
- Implement SpotSee Solutions: Integrate the selected SpotSee products into your existing supply chain processes. This may involve affixing temperature indicators to shipments, attaching impact indicators to packages, or integrating track and trace solutions into your data management systems.
- Train Personnel: Ensure that relevant personnel are trained on the proper use of SpotSee products, including application instructions, data collection procedures, and interpretation of indicator results. This will help maximize the effectiveness of the solutions and ensure consistent compliance practices.
- Monitor and Review: Continuously monitor the performance of SpotSee products and regularly review the collected data. Promptly address any identified issues or deviations from compliance requirements and take appropriate corrective actions as necessary.
By leveraging SpotSee’s products and solutions, you can enhance your compliance efforts by monitoring temperature conditions, detecting potential impacts, improving traceability, and maintaining accurate documentation required by the DSCSA.Contact Us