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United States regulatory compliance

The Drug Supply Chain Security Act (DSCSA)

Regulation

The Drug Supply Chain Security Act (DSCSA), which is Title II of the Drug Quality and Security Act (DQSA), and which amended the Food, Drug and Cosmetics Act (FD&C) of the U.S. Code of Federal Regulations (CFR) 

Who is the Authority?​

U.S. Department of Health and Human Services (HHS), Food and Drug Administration (US FDA) 

 

What is the Status?

Industry is currently in a stabilization period

What are the Marking Requirements?

National Drug Code (through GTIN)​
Serial number​
Batch number​
Expiration date

What are the Key Dates?

11/27/2023 deadline, stabilization period 11/27/2024

Waivers beyond stabilization period

  • Manufacturers and Repackagers: May 27, 2025
  • Wholesale Distributors: August 27, 2025
  • Dispensers with 26 or more full-time employees: November 27, 2025

What are the Reporting Requirements?​

EPCIS, Tracing, ATP

What Products are in scope?​

Prescription drug in finished dosage form such as, ​capsules​, tablets​, lyophilized products before reconstitution​

Do you need help with your regulatory compliance needs?

We offer powerful serialization and traceability functionality to help you meet global pharmaceutical regulations. Schedule a consultation now!

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