U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Drug Safety and Availability
  4. Drug Supply Chain Integrity
  5. Drug Supply Chain Security Act (DSCSA)
  6. Drug Supply Chain Security Act (DSCSA) Implementation Plan
  1. Drug Supply Chain Security Act (DSCSA)

Drug Supply Chain Security Act (DSCSA) Implementation Plan

The following table highlights certain deliverables described in the law.  As FDA works with stakeholders to implement the provisions of the law, additional deliverables may be identified. See DSCSA Guidances for more information.

Section of DSCSA Deliverable Type Deliverable Description
202
Issue notice of public docket to collect stakeholder comments on standards for interoperable exchange of transaction information/history/statement in paper or electronic format
202
Publish draft guidance establishing standards for interoperable exchange of transaction information/history/statement in paper or electronic format
202
Guidance
Publish guidance on processes for waivers, exceptions, exemptions
202
Guidance
Publish final guidance on grandfathering product
203
Assessment
Conduct and complete a technology and software assessment on feasibility of small dispensers to conduct drug tracing at the package level
203
Publish guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs
203
Public Meeting
Conduct at least 5 public meetings
203
Pilot Project
Establish 1 or more pilot projects in coordination with stakeholders to explore and evaluate methods to enhance the safety and security of supply chain
203
Guidance
Publish final guidance on system attributes necessary to enable secure tracing at the package level
203
Guidance
Publish final guidance on standards for interoperable data exchange to enhance secure tracing of product at the package level
204
Database
Establish a system for wholesale drug distributor reporting to FDA and public database with licensing information
204
Regulation
Develop regulations establishing standards for licensing of wholesale drug distributors
205
Database
Establish a system for third-party logistic provider reporting to FDA
205
Regulation
Develop regulations establishing standards for licensing of third-party logistic providers
 

 

Back to Top