Drugs

Drug Supply Chain Security Act (DSCSA) Implementation Plan – Accessible Text Version

 
Graphic representing a summary of planned implementation time frames for the Drug Supply Chain Security Act over a 10-year period, beginning in 2014. Time frames are estimates and are based on the requirements set forth in the law. This implementation plan will be updated as appropriate. The date of enactment was November 27, 2013. 
 
There are 15 key activities on the graphic, each represented as a bar graph for planned time frames for FDA implementation, and where appropriate, stakeholder implementation..
 
  1. Issue notice of public docket to collect stakeholder comments on standards for interoperable exchange of transaction information, history and statement in paper or electronic format. Planned FDA implementation period: Beginning of 2014 through early 2014. 
  2. Publish guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs. Planned FDA implementation period: Beginning of 2014 through mid-2014. 
  3. Publish draft guidance establishing standards for interoperable exchange of transaction information, history, statement in paper or electronic format. Planned FDA implementation period: Beginning of 2014 through late 2014.
  4. Establish a system for third-party logistic provider reporting to FDA. Planned FDA implementation period: Beginning of 2014 through late 2014. 
  5. Establish a system for wholesale drug distributor reporting to FDA and public database with licensing information. Planned FDA implementation period: Beginning of 2014 through the end of 2014.
  6. Develop regulations establishing standards for licensing of wholesale drug distributors. Planned FDA implementation period: Beginning of 2014 through late 2015. Planned stakeholder implementation period: Late 2015 through late 2017.
  7. Develop regulations establishing standards for licensing of third-party logistics providers. Planned FDA implementation period: Beginning of 2014 through late 2015. Planned stakeholder implementation period: Late 2015 through late 2016.
  8. Publish guidance on processes for waivers, exceptions, exemptions. Planned FDA implementation period: Beginning of 2014 through late 2015. Planned stakeholder implementation period: late 2015 through mid-2017.
  9. Publish final guidance on grandfathering product. Planned FDA implementation period: Beginning of 2014 through late 2015.
  10. Conduct at least five public meetings. Planned FDA implementation period: Beginning of 2015 through mid-2021.
  11. Establish one or more pilot projects in coordination with stakeholders to explore and evaluate methods to enhance the safety and security of supply chain. Planned FDA implementation period: Beginning of 2015 through end of 2020.
  12. Conduct and complete a technology and software assessment on feasibility of small dispensers to conduct drug tracing at the package level. Planned FDA implementation period: Beginning of 2017 through end of 2020.
  13. Publish final guidance on system attributes necessary to enable secure tracing at the package level. Planned FDA implementation period: Beginning of 2018 through late-2022. Planned stakeholder implementation period: Late 2022 through late 2023.
  14. Publish final guidance on the standards for interoperable data exchange to enhance secure tracing of product at package level. Planned FDA implementation period: Beginning of 2018 through late-2022. Planned stakeholder implementation period: Late 2022 through late 2023.
  15. Develop regulations establishing enhanced drug distribution security system for interoperable electronic tracing of product at the package level. Planned FDA implementation period: Beginning of 2017 through late-2021. Planned stakeholder implementation period: Late 2021 through late 2023.
 
 
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. FDA’s Center for Drug Evaluation and Research is the lead for the Drug Supply Chain Security Act Implementation and other agency components are actively engaged.                              
 
 
Section of DSCSADeliverable TypeDeliverable DescriptionEstimated 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
Guidance
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
Guidance
Publish guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs
5/27/2014
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

 

 

 

 

Page Last Updated: 09/17/2015
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