What is DSCSA?

The Drug Supply Chain Security Act (DSCSA) is an important regulation aimed at enhancing the security of the pharmaceutical supply chain in the US. Enacted in 2013, the DSCSA mandates the implementation of an interoperable electronic system to trace prescription drugs from manufacturers to dispensers. The primary goal is to protect consumers from counterfeit, stolen, contaminated, or otherwise harmful drugs by ensuring the integrity of the drug supply chain.

Key points of the DSCSA include:

1. Electronic Tracking: By November 27, 2024, all entities in the pharmaceutical supply chain, including manufacturers, wholesale distributors, repackagers, and dispensers (primarily pharmacies), must use an electronic system for tracking prescription drugs. This system will replace previous paper-based methods, enhancing accuracy and efficiency in tracing drug packages.
2. Unique Product Identifiers: Each drug package must be labeled with specific identifiers, including the National Drug Code (NDC), lot number, expiration date, and a unique serial number. These identifiers help verify the authenticity of each drug package throughout the supply chain.
3. Stabilization Period: The FDA has established a one-year stabilization period from November 2023 to November 2024 to allow trading partners to fully implement and troubleshoot their electronic systems without disrupting the supply chain. During this period, the FDA will not enforce certain DSCSA requirements to help ensure a smooth transition.
4. Impact on Trading Partners: The DSCSA impacts all authorized trading partners, including manufacturers, repackagers, wholesale distributors, and dispensers. While the act does not apply to over-the-counter products and certain other medical items, it requires stringent tracking and verification for prescription drugs to ensure they are legitimate and safe for consumers.

Pharmacies and other stakeholders need to upgrade their systems to comply with the new electronic tracking requirements and collaborate with their trading partners to ensure the entire supply chain adheres to the DSCSA standards. This comprehensive approach aims to significantly reduce the risks associated with counterfeit drugs and improve overall drug safety.

What are Authorized Trading Partners?

An “authorized trading partner” under the Drug Supply Chain Security Act (DSCSA) refers to specific entities within the pharmaceutical supply chain that are legally permitted to engage in transactions involving prescription drugs. These entities must meet certain qualifications and adhere to regulatory standards to ensure the integrity and security of the drug supply chain.

Types of Authorized Trading Partners

1. 1. Manufacturers: Companies that produce prescription drugs.
   2. Repackagers: Entities that package finished drugs from manufacturers into new packaging, often for distribution to pharmacies or other entities.
   3. Wholesale Distributors: Businesses that distribute prescription drugs to various entities, including pharmacies, hospitals, and other healthcare providers.
   4. Dispensers: Primarily pharmacies, but can also include hospitals or other entities that dispense prescription drugs directly to patients.

Each of these Authorized Trading Partners has a specific role in the supply chain and responsibility for patient safety. Without the proper compliance processes, risk for the patient and organization is added to the ecosystem. DSCSA has clear requirements for Authorized Trading Partners.

Requirements for Authorized Trading Partners

1. 1. Licensing: Each trading partner must be appropriately licensed or registered with the relevant federal and state authorities. For instance, wholesale distributors and third-party logistics providers must be licensed by the state in which they operate or by the FDA if the state does not require licensing.
   2. Compliance with DSCSA Standards: Authorized trading partners must adhere to the DSCSA requirements, which include maintaining and providing transaction information, history, and statements for each transaction involving prescription drugs. This ensures that each step in the supply chain can be verified and traced back to the source.

These requirements help to minimize the potential for harmful drugs entering the supply chain and make it easier to track harmful drugs if they do enter the supply chain. Without centralized licensing and DSCSA standards, bad actors can easily put patient safety at risk.

Purpose and Importance of being an Authorized Partner

The designation of authorized trading partners is crucial for maintaining the integrity of the drug supply chain. By ensuring that only licensed and regulated entities handle prescription drugs, the DSCSA aims to prevent the introduction of counterfeit, stolen, contaminated, or otherwise harmful drugs into the market. This system enhances the safety and reliability of the pharmaceutical supply chain, ultimately protecting consumers.

Achieving Compliance with DSCSA

Achieving compliance with the Drug Supply Chain Security Act (DSCSA) involves several key steps that trading partners in the pharmaceutical supply chain must follow. Here are the primary actions needed to comply with DSCSA requirements:

1. 1.  Understand DSCSA Requirements
      • Familiarize with Regulations: Thoroughly understand the requirements outlined in the DSCSA, including the need for electronic, interoperable systems to trace prescription drugs.
      • Educational Resources: Utilize resources from the FDA and industry organizations to stay informed about updates and compliance guideline
   2.  Implement Electronic Systems
      • Adopt Interoperable Systems: Implement systems capable of electronic tracking of drug packages from the manufacturer to the dispenser. This includes using serialized identifiers for each package.
      • Technology Integration: Ensure that existing IT infrastructure is compatible with DSCSA requirements. This might involve upgrading software or acquiring new systems designed for drug tracing and verification.
   3. Labeling and Serialization
      • Unique Product Identifiers: Ensure that all drug packages are labeled with specific identifiers, including the National Drug Code (NDC), lot number, expiration date, and a unique serial number. This labeling is crucial for tracking and verifying the authenticity of the drug
   4. Maintain and Exchange Transaction Data
      • Transaction Documentation: Maintain and provide transaction information, history, and statements for each drug transaction. This includes ensuring that all data is electronically documented and accessible throughout the supply chain.
      • Compliance Documentation: Verify that transaction data includes the necessary details such as product identifier, lot number, transaction dates, and previous ownership information.
   5. Verify Trading Partners
      • Authorized Trading Partners: Engage only with authorized trading partners who are compliant with DSCSA regulations. Ensure that these partners are licensed and meet all regulatory standards.
      • Regular Audits: Conduct regular audits to verify that trading partners continue to comply with DSCSA requirements and maintain the integrity of the drug supply chain.
   6. Training and Collaboration
      • Staff Training: Provide comprehensive training to staff on DSCSA requirements, including how to use electronic systems for tracking and verifying drugs.
      • Collaboration: Work closely with other trading partners, including wholesalers, repackagers, and dispensers, to ensure seamless compliance across the supply chain.
   7.  Utilize FDA Resources
      • Guidance and Support: Leverage guidance documents, webinars, and other resources provided by the FDA to stay updated on compliance strategies and requirements.
      • Compliance Assistance: Participate in FDA-led programs and initiatives designed to assist trading partners in achieving compliance with DSCSA.

How Verisys Keeps Organizations DSCSA Compliant

Verisys can assist pharmaceutical companies in achieving DSCSA compliance through various services and solutions. Here are some ways Verisys helps with DSCSA compliance:

1. 1. 1.  Verification of Trading Partners
         • Credentialing and Licensing Verification: Verisys ensures that all trading partners, including manufacturers, wholesale distributors, repackagers, and dispensers, are properly credentialed and licensed. This is crucial as the DSCSA requires trading partners to engage only with authorized entities.
         • Continuous Monitoring: Verisys provides ongoing monitoring of trading partners to ensure they remain compliant with regulatory requirements, which helps companies maintain an up-to-date and compliant supply chain.
      2.  Data Management and Integration
         • Interoperable Systems: Verisys offers solutions that integrate with existing systems to manage and track the necessary data for DSCSA compliance.
         • Data Accuracy: Ensuring the accuracy and completeness of transaction data is critical for compliance. Verisys helps companies manage large volumes of data effectively, ensuring that all information meets DSCSA standards.
      3. Compliance Support and Training
         • Compliance Expertise: Verisys’ team of experts can provide expertise and guidance on DSCSA regulations, helping companies understand and implement the necessary compliance measures.

By leveraging Verisys’s comprehensive services, companies can ensure they meet all DSCSA requirements, thereby enhancing the security and integrity of their pharmaceutical supply chain.

Contact a Verisys DSCSA expert, to confirm your compliance with DSCSA today!