DSCSA Amendments and Requirements

Title II of the Drug Quality and Security Act

The Drug Supply Chain Security Act (DSCSA) was amended with the addition of 'Section 203 Enhanced Drug Distribution Security'. In addition to the manufacturer requirements, dispenser requirements, wholesale distributor requirements, and repackager requirements outlined in 'Section 582 Requirements' entities on the U.S. Drug Supply Chain must meet amended requirements. This DSCSA amendments and requirements reference provides all amendments and requirements from 'Section 203 Enhanced Drug Distribution Security' in an unedited form and are accurate as of 03/28/2022 10:12am EST.

All requirements, terms, and definitions are sourced directly from: Title II of the Drug Quality and Security Act.

DSCSA Amendments and Requirements Table of Contents

    Enhanced Drug Distribution Security

    Guidance Documents

    Public Meetings

    Pilot Projects


    Rule of Construction

    Requests for Information

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