The FDA has just granted the pharmaceutical industry a one-year extension on enforcing certain enhanced drug distribution security requirements. With the original compliance deadline set for November 27, 2023, the FDA’s decision comes in response to industry concerns and the need for greater clarity.
Background
In 2013, the Drug Supply Chain Security Act (DSCSA) set the stage for a more secure pharmaceutical supply chain. However, as the 2023 deadline approached, concerns arose regarding industry readiness, so, while the FDA has issued the compliance requirements, they granted this one-year extension in order to ensure the industry was prepared for compliance.
FDA’s Enforcement Delay
The FDA will not enforce specific requirements under §582(g)(1) of the Federal Food, Drug, and Cosmetic Act until November 27, 2024. Below are the specific requirements that will be subject to delayed enforcement:
- Electronic Transactions: No enforcement action will be taken against trading partners for not conducting secure, interoperable electronic transactions.
- Package-Level Tracing: Stakeholders have more time to align their systems for package-level product tracing.
- Swift Response: Systems and processes for responding to transaction information requests during recalls or investigations have an extended grace period.
- Confidentiality: More time is provided to protect commercial data and trade secrets during information gathering.
- Saleable Returns: Entities accepting saleable returns have until 2024 to comply.
FDA’s Guidance
The FDA stresses that this guidance doesn’t justify delaying implementation; rather, it aims to help stakeholders refine their processes. It is still crucial to continue working towards full compliance with §582(g)(1).
In sum, the FDA’s one-year extension offers a balance between industry concerns and the need for a secure drug supply chain. Stakeholders should use this additional time wisely to ensure compliance when the enforcement period begins.
How We Can Help
Our dedicated and experienced team of healthcare attorneys are closely monitoring the development of this guidance as the enforcement deadline approaches. In the meantime, if you are in need of expert healthcare counsel regarding the applicability of §582(g)(1) of the Federal Food, Drug, and Cosmetic Act to your practice, or have any questions, please do not hesitate to contact our knowledgeable and experienced attorneys at (212) 668-0200 or by email at info@mdrxlaw.com.