Understanding the Drug Supply Chain Security Act (DSCSA) – Updates of 2023

Compliance insights for pharmaceutical, diagnostics, pharmacies, third-party logistics (3PLs), supply chain, transportation, and life science companies.

Key Takeaways:

  • A new requirement for tracking at the package levels was due for implementation on November 27, 2023, but was extended to November 27, 2024.
  • Until then, the FDA is soliciting comments and information.
  • A webinar by the FDA was released to review the DSCSA implementation and expectations for all trading partners to achieve interoperable, electronic tracing of products at the package level, review recent guidance, and clarify the stabilization period extension.
  • The enforcement deadline for reporting suspicious or illegitimate products to the FDA was also extended to November 27, 2024. However, the policies outlined in 2020 still apply.
  • Temperature indicators and electronic data loggers are essential in documenting and monitoring, providing visual proof and information about cumulative exposure.

Table of Contents

As part of the U.S. Drug Quality and Security Act, the Drug Supply Chain Security Act (DSCSA) outlines the approach to achieving, at the package level, interoperable electronic tracing of products. This enables identifying and tracking certain prescription drugs distributed throughout the country.

DSCSA is meant to enhance the Food and Drug Administration’s (FDA’s) ability to protect consumers from drugs that could be counterfeit, stolen, contaminated, or could otherwise cause harm. The requirements also improve the detection and removal of dangerous drugs from the supply chain. 

The DSCSA also directs the FDA to establish licensure standards for wholesale distributors and third-party logistics providers, who must report licensing and other information annually to the FDA.

While enacted in 2013, key deadlines were established starting in 2015 with lot-level traceability. 2023 the requirement is for package-level tracking, although the FDA has enacted a one-year stabilization period for compliance until November 27, 2024. Other changes to policies and deadlines have taken place in 2023.

Latest Activity and Changes Concerning the DSCSA

  • Request for comment: Development of Small Dispensers Assessment. The FDA solicited stakeholders’ comments concerning developing a technology and software assessment that looks at the feasibility of dispensers in companies with 25 full-time or fewer employees who conduct interoperable, electronic tracing of products at the package level. This began on August 10, 2023, and the comment period closed on September 13, 2023.
  • Enhanced drug distribution security requirements beginning August 30, 2023 – this is one of two compliance policy guidelines and establishes a 1-year stabilization period allowing trading partners to meet the criteria for drug tracing at the package level. This extends the stabilization period until November 27, 2024.
  • Enhanced drug distribution security at the package level – guidance document – August 30, 2023. This guidance assists supply chain stakeholders – trading partners – striving to meet the criteria for enhanced drug distribution at the package level
  • Revision to the wholesale distributor verification requirement for saleable returned drug product and dispenser verification when investigating a suspect or illegitimate product: compliance policies – August 30, 2023. This is a revision to the original policy published on October 23, 2020. The document explains that enforcement policy compliance has been extended from November 27, 2023, to November 27, 2024.
  • Final standards for interoperable exchange of information for tracing certain human, finished, prescription drugs guidance for industry – September 5, 2023. This final guidance offers the necessary standards to facilitate the adoption of secure, interoperable electronic data exchange across the pharmaceutical distribution supply chain. It clarifies which trading partners, products, and transactions are subject to these standards. This finalizes a draft from July 2022.
  • Webinar: Implementing the DSCSA: Stabilization Period and Expectations – November 2, 2023. This webinar reviews the DSCSA implementation and expectations for all trading partners to achieve interoperable, electronic tracing of products at the package level, reviews recent guidance, and clarifies the stabilization period extension. This webinar is available on demand.
  • Request comments on implementing interoperability systems and processes for enhanced drug distribution security – November 20, 2023. Information and comments are sought to give the FDA a better understanding of the status of trading partner interoperability systems and processes for enhanced drug distribution security. 

Compliance Strategies

Pharmaceutical companies must have a robust strategy and the right technology to stay compliant. To facilitate this, consider:

  • 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, statements, and history, as required. 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, 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 product identifiers, transaction information, and transaction history data. 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 integrity and confidentiality. 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, repackages, 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 tracking software, can streamline data sharing and compliance processes. These solutions provide centralized data storage, real-time visibility, and automated workflows.
  • Regulatory compliance audits: Conducting internal audits and assessments of data-sharing processes and systems helps ensure ongoing compliance with DSCSA. Audits can identify gaps or areas for improvement in data-sharing practices, enabling companies to take corrective actions and maintain compliance.

Establishing robust data governance policies and standard operating procedures that align with DSCSA requirements is a must. By implementing efficient data-sharing mechanisms, utilizing appropriate technologies, and fostering collaboration with trading partners, companies meet compliance obligations, ensure the integrity of the drug supply chain, and protect sensitive data.

Tracking and Traceability

The DSCSA includes tracking and traceability requirements aiming to enhance the safety of prescription drugs throughout the supply chain. These requirements enable effective tracking of product movement and facilitate tracing in case of recalls, suspected counterfeit products, or other safety concerns. 

A new requirement for tracking the package level was due for implementation on November 27, 2023, but was extended to November 27, 2024. In the meantime, the FDA is soliciting information and comments that give the FDA a better understanding of what’s involved.

For now, here are the key elements of the tracking and traceability requirements under the DSCSA:

  • Product Transaction Information (TI): Manufacturers, repackages, wholesale distributors, and dispensers must provide and maintain accurate product transaction information for each sale, transfer, or distribution of a prescription drug. The TI includes the following details: 
      1. The proprietary or established name of the product.
      2. Strength and dosage form.
      3. National Drug Code (NDC) of the product.
      4. Container size.
      5. Number of containers.
      6. A lot number of the product.
      7. 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: 
      1. Names and addresses of all parties involved in the transaction.
      2. Dates of each transaction.
      3. Quantity of product transferred.
      4. Unique identifier of the product, including the standardized numerical identifier (SNI).
      5. The 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. This will confirm compliance with the DSCSA and affirms that the product is not counterfeit, stolen, or otherwise compromised. The TS states that: 
      1. The entity transferring the product is authorized as per the DSCSA.
      2. The product transferred is not suspect or illegitimate.
      3. The transferor is responsible for complying with the verification requirements of the DSCSA.
  • Authorized Trading Partners (ATPs): The DSCSA establishes the concept of ATPs to ensure that all entities involved in the pharmaceutical supply chain are authorized, legitimate, and meet specific criteria. The ATPs include manufacturers, repackages, 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 DSCSA requirements 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 DSCSA, all entities involved in the pharmaceutical supply chain, including manufacturers, repackages, wholesale distributors, and dispensers, must report suspect or illegitimate products to the 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. 

The compliance policies from 2020 have not changed, but the deadline for enforcement has changed from November 27, 2023, to November 27, 2024. 

Here are 6 key aspects of reporting suspect or illegitimate products under the DSCSA:

  1. Definition of suspect or illegitimate products: The DSCSA defines these as prescription drugs that may be counterfeit, diverted, stolen, intentionally adulterated, or otherwise compromised regarding their safety, efficacy, or quality. Any product that raises suspicion of being fraudulent, unauthorized, or potentially harmful is considered suspect or illegitimate.
  2. Reporting obligations: All entities within the pharmaceutical supply chain are obligated to report any suspect or illegitimate products they encounter. The reporting requirements apply to physical products and instances with indications of suspect or illegitimate activities within the supply chain.
  3. 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.
  4. 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.
  5. Liability confidentiality and protection: The DSCSA provides provisions to protect entities that report suspect or illegitimate products in good faith. The reporting entities are shielded from liability, ensuring they can freely and openly cooperate with the FDA without fear of reprisal.
  6. Timeliness and compliance: Reporting suspect or illegitimate products should be done promptly. The DSCSA emphasizes the importance of prompt reporting to enable swift action by regulatory authorities and mitigate potential patient safety risks.

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 prevent the distribution of counterfeit drugs, and strengthens the drug supply chain integrity.

Temperature Guidelines

The DSCSA does not provide specific guidelines for medication storage temperatures. Instead, it references the United States Pharmacopeia (USP) guidelines for storing and handling pharmaceutical products, including temperature controls. The USP provides general temperature guidelines for medications based on different storage conditions. 

Storage Conditions and the Role of USP Guidelines

Under the DSCSA, compliance requirements for storage conditions are essential to maintaining prescription drug safety, efficacy, and quality throughout the pharmaceutical supply chain. The United States Pharmacopeia (USP) guidelines are crucial in establishing standards for storing and handling pharmaceutical products. 

The USP is a non-profit organization that establishes medication quality, purity, and strength standards. 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.

USP guidelines serve as a valuable resource for pharmaceutical companies to comply with DSCSA storage requirements, providing specific temperature ranges, storage instructions, and handling recommendations for different types of medications.

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 impacting the stability and integrity of products.
  • 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). Medications requiring 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 affects the stability of many medications. Freezing temperatures, at or below 0°C (32°F), 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: 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 preserving the product’s integrity and effectiveness.

Pharmaceutical companies can meet the compliance requirements of the DSCSA by following USP guidelines for storage conditions. 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.

The Importance of Temperature Monitoring

Temperature monitoring is paramount to meet DSCSA requirements. It enables pharmaceutical companies to uphold medication quality, efficacy, and safety 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.

Here are the 6 key reasons why temperature monitoring is important for DSCSA compliance:

  1. 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 these products’ quality, efficacy, and safety. Temperature monitoring helps ensure that medications are stored within the appropriate temperature range, preserving their integrity and effectiveness.
  2. 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.
  3. Risk identification and mitigation: Temperature monitoring allows identifying 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.
  4. Quality control and documentation: Accurate temperature monitoring data is documented evidence of adherence to temperature regulations and quality control practices. This data demonstrates compliance during audits, inspections, and regulatory reporting. It supports the traceability and accountability of pharmaceutical products, ensuring storage under suitable conditions throughout the supply chain.
  5. Enhanced supply chain visibility: Temperature monitoring provides visibility into the temperature conditions and/or excursions experienced by pharmaceutical products at different supply chain stages. 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.
  6. Patient safety and product integrity: Ensuring that pharmaceutical products are stored and transported within the appropriate temperature range is vital for patient safety. Temperature excursions can compromise the effectiveness and safety of medications, leading to reduced therapeutic outcomes or adverse effects. 

Temperature monitoring is crucial in ensuring compliance with DSCSA and maintaining the integrity of pharmaceutical products throughout the supply chain.

Solutions to Monitor Temperature and Maintain Compliance

Temperature indicators play a vital role in monitoring and documenting temperature conditions and excursions 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: It’s an irreversible temperature indicator that provides visual proof when a specified temperature threshold has been exceeded. They monitor temperature excursions above a specific threshold over a specified period, such as products exposed to excessive heat. Once activated, the indicator will change color, once a temperature breach has been reached. WarmMark indicators are valuable for identifying temperature excursions during transit or storage.
  • ColdChain Complete XS: ColdChain Complete XS is an irreversible temperature indicator that monitors temperature-sensitive products during transportation. It consists of a combined set of visual indicators to monitor lower and higher temperature thresholds in a small form factor. The visual indicator provides a clear visual if the temperature exceeds the specified threshold during the monitored period. ColdChain Complete XS offers real-time temperature monitoring, allowing 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. They 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 periods of unfavorable temperature conditions.
  • Electronic Data Loggers: Electronic data loggers are electronic devices that measure and record temperature regularly. 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.
  • FreezeSafe Temperature Indicators: FreezeSafe temperature indicators provide accurate, irreversible evidence of a below-threshold temperature excursion. It’s a cost-effective solution that adds an indicator to every shipment and can be mounted directly to the product. A quick visual check of the indicator shows if the temperature has been unacceptably cold to inform quick decision-making.

The Applications of Temperature Indicators for DSCSA Compliance 

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 the implementation of corrective actions to ensure the integrity of temperature-sensitive pharmaceutical products throughout the supply chain.

  1. Monitoring temperature excursions: Temperature indicators help identify temperature deviations beyond acceptable limits, enabling prompt actions to mitigate risks and prevent damage to temperature-sensitive products.
  2. Compliance documentation: Temperature indicators provide visual evidence of temperature excursions, which can be documented in regulatory compliance reporting. They demonstrate the steps taken to comply with temperature requirements and ensure the integrity of the pharmaceutical supply chain.
  3. 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.
  4. 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.
  5. 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.

Create and Augment Your Compliance Plan

SpotSee offers various products and solutions that can assist in creating and augmenting compliance plans with the DSCSA. Here’s how you can leverage SpotSee’s offerings:

  • Temperature indicators: SpotSee offers temperature indicators like 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 identify potential supply chain issues and enables the shipper to take 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 products and supply chain processes that need monitoring and data collection.
  • Select appropriate products: Determine which SpotSee temperature indicators, impact indicators, or track and trace solutions align with your compliance needs. Consider the temperature range, impact sensitivity, and connectivity features required for your specific use cases.
  • Implement 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. 

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