Implementing DSCSA: Stabilization Period and Expectations

 

DATE: On Demand

Visit CDER Small Business and Industry Assistance Page

ABOUT THIS WEBINAR

• 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.

INTENDED AUDIENCE

• 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

TOPICS COVERED

• 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

FDA SPEAKER

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

FDA RESOURCES

• FDA/CDER’s main DSCSA webpage
• CDER Statement: DSCSA compliance policies establish 1-year stabilization period
• Enhanced Drug Distribution Security Requirements Under Section 582(g)(1) of the Federal Food, Drug, and Cosmetic 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
• Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act
• DSCSA Standards for the Interoperable Exchange of Information for Tracing of Certain Human, Finished, Prescription Drugs Guidance for Industry