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
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
Section 582(a)(2): Publish draft guidance establishing standards for interoperable exchange of transaction information, history, and statements in paper or electronic format
Section 582(a)(3): Publish guidance on processes for waivers, exceptions, exemptions
Section 582(a)(5): Publish final guidance on grandfathering product
Section 582(g): Conduct and complete a technology and software assessment on feasibility of small dispensers to conduct drug tracing at the package level
Section 582(h): Publish guidance on identification of suspect product and termination of notifications of illegitimate product for finished human prescription drugs
Section 582(h): Publish final guidance on standards for interoperable data exchange to enhance secure tracing of product at the package level
Section 582(h): Publish final guidance on system attributes necessary to enable secure tracing at the package level
Section 582(i): Conduct at least five public meetings to enhance the safety and security of the pharmaceutical distribution supply chain
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
Section 503(e): Establish a system for wholesale drug distributor reporting to FDA and public database with licensing information
Sections 583 and 584: Develop regulations establishing standards for licensing of wholesale drug distributors and third-party logistics providers