FDA published guidance to comply with the requirements of the enhanced drug distribution security, under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) which will go into effect on 27 November 2023. All trading partners (referring to manufacturers, wholesale distributors, dispensers, and repackagers) are required to implement secure, interoperable, and electronic-based approaches for transaction information exchanges including package-level product identifiers included in the transaction. Besides, trading partners are also required to establish a system and processes:
To verify products at the package level
To promptly respond with the transaction information and statement for the product upon request by the authority
To facilitate the information gathering needed for the transaction process for the product going back to the manufacturer (as per event of authority request, recalls, or suspected illegal investigations)
To accept saleable returns under appropriate conditions
Previously in November 2017, manufacturers were required to apply the electronic-based approaches for transaction history, transaction statements, and transaction information to subsequent purchasing trading partners, except when the subsequent purchaser is a state-licensed health care practitioner or licensed individual who dispenses products under the supervision of a licensed practitioners.
However, the wholesale distributors, dispensers, and repackagers may choose to use paper-based or electronic-based methods until 27 November 2023 to provide transaction information, transaction history, and transaction statements to the subsequent purchasing trading partners, as long as comply with section 582(c)(1), (d)(1), and (e)(1) of FD&C Act.
As much as the FDA expects trading partners to be fully prepared on the system and processes by 27 November 2023, the FDA also expects possible technical issues, operational issues, or alignment issues among the trading partners to happen. The guidance published is to provide clarity and flexibility for trading partners to ensure continuous drug access for the patient while transitioning into the interoperable and electronic product tracing at the package level under the DSCSA.
Hence, all the requirements regulated under Section 582 of the FD&C Act will be fully enforced on 28 November 2024. By that time, all the systems and processes should be fully implemented by the trading partners without any major issues and the FDA will take action for any activity that does not comply with the requirements.