Pharma supply chain companies face November 2023 deadline for traceability compliance
Author: Lucy Smith
The pharmaceutical industry is one of the most heavily regulated industries, and ensuring the safety and integrity of the drug supply chain is critical. The Drug Supply Chain Security Act (DSCSA) is a significant piece of US legislation designed to enhance the security and traceability of pharmaceutical products as they move through the supply chain. One crucial aspect of DSCSA compliance is the use of Electronic Product Code Information Services (EPCIS).
Compliance with the traceability requirements is required by November 2023.
Understanding the DSCSA
The Drug Supply Chain Security Act, enacted in 2013, sets forth a series of regulations to secure the pharmaceutical supply chain from manufacturing to dispensing. Its primary goal is to trace and track prescription drug products, making it easier to detect and prevent the distribution of counterfeit or substandard drugs. To achieve this, DSCSA establishes a series of key milestones and requirements for pharmaceutical companies.
DSCSA Requirements
Compliance with the DCSCA controls have five key elements:
- Product Serialization: Pharmaceutical manufacturers must serialize individual drug product units by assigning unique product identifiers, such as serial numbers and barcodes, to each unit. This enables accurate tracking throughout the supply chain.
- Data Exchange: The Act requires the exchange of transaction information, transaction history, and transaction statements (T3 information) between trading partners. This information includes details about the product’s movement and history.
- Verification: Wholesale distributors must verify the product identifier of the drugs they receive. This ensures that they are handling legitimate products.
- Product Identification and Verification: Dispensers (e.g., pharmacies) must verify the product identifier before dispensing prescription drugs to patients.
- Auditability: Should an issue arise, the FDA may request an audit trail, and the pharma company must be able to produce requested data on movement of specific serialized lots (or containers) within 48 hours. And the data must be retained for a minimum of six (6) years.
The Role of EPCIS
EPCIS, or Electronic Product Code Information Services, plays a crucial role in helping pharmaceutical companies meet the DSCSA requirements. EPCIS is a standardized protocol for sharing and managing supply chain data related to product identifiers. Here’s how EPCIS helps:
- Data Standardization: EPCIS standardizes the way information about products is captured and shared. This ensures that all stakeholders in the supply chain speak the same language, making data exchange more efficient and accurate.
- Serialization: EPCIS facilitates the serialization of products by providing a framework for assigning unique identifiers and capturing related data. This helps pharmaceutical companies meet the serialization requirement.
- Traceability: EPCIS allows for real-time tracking of pharmaceutical products as they move through the supply chain. This traceability ensures that the product’s history can be easily accessed and verified by authorized personnel.
- Data Sharing: EPCIS enables the sharing of T3 information as required by the DSCSA. It allows for secure, electronic data exchange between trading partners, promoting transparency and accuracy.
- Verification: EPCIS supports the verification process by providing a standardized method for checking the product identifier. Dispensers can use EPCIS to ensure that the products they receive are genuine and have not been tampered with.
- Reporting: EPCIS can generate reports and alerts in the event of suspicious or unauthorized product movements. This helps in the early detection of counterfeit or substandard drugs.
Time to comply
While the requirements have been finalized since early in 2022, companies in the pharma supply chain now face a November 2023 deadline for compliance with DSCSA compliance and EPCIS integration. In some cases the data required to satisfy the requirements are in existing commerce documents, such as the X12 856 ASN. Even so, it’s challenging—because Enterprise Resource Planning (ERP) and Warehouse Management Systems (WMS) and even legacy or home-grown systems each are based on slightly different data specifications.
Kleinschmidt can help
Kleinschmidt will perform a thorough analysis of the data output from your software and that of the EPCIS as well as the B2B messaging you already use with your trading partners. We will look at your unique data situation and get your connection created, tested and in production quickly.
