US FDA Announces 1 Year Stabilization Period for Adherence to Package-level Electronic Drug Tracing

Author photo: Chantal Polsonetti
ByChantal Polsonetti
Company and Product News

The United States Food and Drug Administration (FDA) announced two compliance policy guidances establishing a 1-year stabilization period that grants additional time to trading partners in the pharmaceutical supply chain who need to adhere to the Drug Supply Chain Security Package-level Electronic Drug TracingAct (DSCSA) requirements for electronic drug tracing at the package level.

DSCSA, enacted in 2013, outlines steps to achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S. DSCSA requires trading partners, primarily manufacturers, wholesale distributors, dispensers, and repackagers, to provide, receive, and maintain documentation about prescription drugs and their chain of ownership from manufacturer to dispenser as the drugs are distributed in the U.S. supply chain. Currently, these entities can choose to provide such information either electronically or in paper format, while the new compliance regulations will include requiring trading partners to provide, receive and maintain documentation about products and ownership only electronically.

The stabilization period will accommodate an additional year, until November 27, 2024, to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems. The stabilization period is intended to avoid disruption to the supply chain, address industry concerns about supply chain readiness and interoperability, and ensure continued patient access to drug products as trading partners work to fully implement the enhanced drug security requirements.

FDA expects trading partners to use this stabilization period to build and validate interoperable systems and processes, manage products and data, and ensure continuity of the supply chain and product availability to patients. This period is not intended to provide, and should not be viewed as providing, a justification for delaying efforts to comply with the DSCSA.

The compliance policies support trading partners’ use of current methods to exchange and store documentation about products and their chain of ownership, investigate and report suspect or illegitimate product, and handle saleable returns.

The two guidances FDA issued are:


Engage with ARC Advisory Group

Representative End User Clients
Representative Automation Clients
Representative Software Clients