The US Food and Drug Administration (FDA) published two additional guidances with immediate effect that provide more details for trading partners on the one-year extension from enforcement of requirements for tracking products electronically under the Drug Supply Chain Security Act (DSCSA).
A final guidance concerning the agency’s compliance policies of enhanced drug distribution security requirements was also recently published and intended for trading partners such as manufacturers, wholesale distributors, dispensers, repackagers and other stakeholders who are subject to DSCSA.
Together, the guidances comprise FDA’s plan so far for extending the deadline established by DSCSA, which requires trading partners to “achieve interoperable, electronic tracing of products to identify and trace certain prescription drugs as they are distributed throughout the U.S.” DSCSA’s requirements were set to go into effect by 27 November 2023, with the guidances extending that period by another year “to allow trading partners to implement, troubleshoot and mature their electronic interoperable systems,” FDA said in an statement announcing the guidances…
