Enhanced Drug Distribution Security at the Package Level

The FDA will hold a virtual public meeting on November 16, 2021, on enhanced drug distribution security at the package level.

The purpose of this public meeting is to provide members of the pharmaceutical distribution supply chain and other interested stakeholders an opportunity to provide input to FDA on the implementation of the enhanced drug distribution security provisions of the Drug Supply Chain Security Act (DSCSA) that go into effect in 2023.

FDA requests that stakeholders prepare comments responding to the following questions for one or more of the topics listed below:

1. How is implementation of the 2023 enhanced system requirements progressing for your organization?
2. What challenges is your organization facing?
3. Are the proposed recommendations in FDA’s guidance on enhanced drug distribution security at the package level helpful to achieve compliance with 2023 enhanced system requirements? If not, what additional information would be useful?
4. Are there areas in which FDA could provide more clarity?

Topics

1. Enhanced Drug Distribution Security
   • System Attributes
   • Aggregation, Inference, and Physical Security Features
2. System Structure
   • Data Architecture
   • Adoption of Data and System Security
   • Protecting Confidential Commercial Information and Trade Secrets
   • System Access and Data Retrieval
3. Enhanced Product Tracing
   • Serialized Transaction Information and Data Exchange (Incorporation of the Product Identifier into Product Tracing Information)
   • Responsibilities of the Selling and Buying Trading Partners with regard to the Product Tracing Information
   • Handling Aggregation Errors and Other Discrepancies
4. Gathering of Relevant Product Tracing Information
5. Enhanced Verification
   • Verification of Distributed Product
   • Verification of Saleable Return Product
   • Alerts for Illegitimate Product
6. Trading Partner Readiness
   • Your organization’s overall readiness for implementation
   • Components that your organization is furthest along in developing, including the components being prioritized and the components that are easier or more challenging to implement

Additional Information

• Enhanced Drug Distribution Security at the Package Level Under the Drug Supply Chain Security Act Draft Guidance for Industry
• FDA Webinar on October 5, 2021: Enhanced Drug Distribution Security in 2023 Under the DSCSA