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  5. Drug Supply Chain Security Act (DSCSA)
  6. FDA’s Implementation of Drug Supply Chain Security Act (DSCSA) Requirements
  1. Drug Supply Chain Security Act (DSCSA)

FDA’s Implementation of Drug Supply Chain Security Act (DSCSA) Requirements

 

Since enactment of the Drug Supply Chain Security Act (DSCSA) in 2013, FDA has implemented numerous requirements of the law to help trading partners build a more secure and transparent drug supply chain. The following table highlights progress on specific sections of the Federal Food, Drug and Cosmetic Act (FD&C Act), as amended or added by the DSCSA. See DSCSA Law and Policies for more information.

FD&C Act Requirement

Completion of Requirement

Section 582(a)(2): Issue notice of public docket to collect stakeholder comments on standards for interoperable exchange of transaction information, history, and statements in paper or electronic format

Federal Register Notice

Section 582(a)(2): Publish draft guidance establishing standards for interoperable exchange of transaction information, history, and statements in paper or electronic format

Guidance

Section 582(a)(3): Publish guidance on processes for waivers, exceptions, exemptions

Guidance

Section 582(a)(5): Publish final guidance on grandfathering product

Guidance

Section 582(g): Conduct and complete a technology and software assessment on feasibility of small dispensers to conduct drug tracing at the package level

Assessment

Section 582(h): Publish guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs

Guidance

Section 582(h): Publish final guidance on standards for interoperable data exchange to enhance secure tracing of product at the package level

Guidance

Section 582(h): Publish final guidance on system attributes necessary to enable secure tracing at the package level

Guidance

Section 582(i): Conduct at least five public meetings to enhance the safety and security of the pharmaceutical distribution supply chain

Public Meetings

Section 582(j): Establish one or more pilot projects in coordination with stakeholders to explore and evaluate methods to enhance the safety and security of supply chain

Pilot Project

Section 503(e): Establish a system for wholesale drug distributor reporting to FDA and public database with licensing information

Guidance

Database

Sections 583 and 584: Develop regulations establishing standards for licensing of wholesale drug distributors and third-party logistics providers

Proposed Rule

 

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