Drug Supply Chain Security Act (DSCSA) Implementation Plan
The following graphic represents a summary of planned implementation timeframes for the Drug Supply Chain Security Act over a 10-year period. Timeframes are estimates and are based on the requirements set forth in the law. This implementation plan will be updated as appropriate.
The following table highlights certain deliverables described in the law. Estimated target dates are based on applicable statutory deadlines and may be listed as "TBD" (to be determined) when dependent on completion of other deliverables or activities. As FDA works with stakeholders to implement the provisions of the law, additional deliverables may be identified. See DSCSA Guidances and DSCSA Overview and Implementation Plan Webinar for more information.
Section of DSCSA | Deliverable Type | Deliverable Description | Estimated Target Date |
---|---|---|---|
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
|
2/20/2014
|
|
202
|
Publish draft guidance establishing standards for interoperable exchange of transaction information/history/statement in paper or electronic format
|
11/27/2014
|
|
202
|
Guidance
|
Publish guidance on processes for waivers, exceptions, exemptions
|
11/27/2015
|
202
|
Guidance
|
Publish final guidance on grandfathering product
|
11/27/2015
|
203
|
Assessment
|
Conduct and complete a technology and software assessment on feasibility of small dispensers to conduct drug tracing at the package level
|
TBD
|
203
|
Publish guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs
|
12/09/2016
|
|
203
|
Public Meeting
|
Conduct at least 5 public meetings
|
TBD
|
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
|
TBD
|
203
|
Guidance
|
Publish final guidance on system attributes necessary to enable secure tracing at the package level
|
11/27/2022
|
203
|
Guidance
|
Publish final guidance on standards for interoperable data exchange to enhance secure tracing of product at the package level
|
11/27/2022
|
203
|
Regulation
|
Develop regulations establishing enhanced drug distribution security system for interoperable electronic tracing of product at the package level
|
11/27/2021
|
204
|
Database
|
Establish a system for wholesale drug distributor reporting to FDA and public database with licensing information
|
1/1/2015
|
204
|
Regulation
|
Develop regulations establishing standards for licensing of wholesale drug distributors
|
11/27/2015
|
205
|
Database
|
Establish a system for third-party logistic provider reporting to FDA
|
11/27/2014
|
205
|
Regulation
|
Develop regulations establishing standards for licensing of third-party logistic providers
|
11/27/2015
|