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  1. News & Events for Human Drugs

Implementing DSCSA: Stabilization Period and Expectations


DATE: On Demand

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  • FDA will review the Drug Supply Chain Security Act (DSCSA) implementation and expectations for trading partners to achieve interoperable, electronic tracing of products at the package level.
  • FDA will review recent guidances for industry related to supply chain security requirements and other updates.
  • FDA will clarify the stabilization period from November 27, 2023 - November 27, 2024.


  • Trading partners — manufacturers, repackagers, wholesale distributors, dispenser (primarily pharmacies) — obligated to adhere to the DSCSA enhanced drug distribution security requirements by November 27, 2024
  • Other stakeholders – such as solution providers or consultants – that may work with trading partners to develop systems and process for the DSCSA requirements
  • State regulators


  • DSCSA implementation timeline
  • Provisions of section 582(g)(1) of the FD&C Act
  • Establishment of a stabilization period from November 2023 - November 2024 for trading partners to continue to build and validate interoperable systems and processes
  • Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the FD&C Act—Compliance Policies
  • Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification Requirements When Investigating a Suspect or Illegitimate Product—Compliance Policies
  • Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FD&C Act
  • Addition key final guidances:
  • What is next and agency expectations


Leigh Verbois, PhD
Director | Office of Drug Security, Integrity, and Response (ODSIR)
Office of Compliance (OC) | CDER | FDA


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