FDA Releases Final Guidances on Drug Supply Chain Law, Including Interoperability Rules
FDA recently finalized three guidance documents related to the Drug Supply Chain Security Act. A final guidance titled "DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs" identifies the standards that will be…
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used beginning Nov. 27, 2023, when "electronic-based approaches are generally required to be used among all trading partners to meet the enhanced drug distribution security requirements" of DSCSA. Another final guidance focuses on “Enhanced Drug Distribution Security" at the package level under the DSCSA and clarifies the "enhanced drug distribution security requirements" listed under the new law. Finally, another final guidance recently released by the agency covers the "Wholesale Distributor Verification Requirement" for saleable returned drug products and the "Dispenser Verification Requirements" when investigating a suspect or illegitimate product. The new guidance extends the FDA's current enforcement policies by a year to Nov. 27, 2024.