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Section 582(a)(2): Publish draft guidance establishing standards for interoperable exchange of transaction information, history, and statements in paper or electronic format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