USP Drug Classification System

Status Updates

The public comment period for the USP Drug Classification (USP DC) system will be extended for a second round of public comments anticipated to occur early in Fall 2017.

Comments received from the first public comment period are currently being evaluated, and a revised USP DC is anticipated during Summer 2017 prior to the Fall public comment period.

Check back to website for updates, or sign up for Healthcare Quality Updates.

USP Drug Classification System Frequently Asked Questions

The USP Drug Classification system (USP DC) is an independent drug classification system currently under development by the USP Healthcare Quality& Safety Expert Committee. The USP DC is designed to address stakeholder needs emerging from the extended use of the USP Medicare Model Guidelines (USP MMG) beyond the Medicare Part D benefit.

USP has developed and updated the USP Medicare Model Guidelines since 2004, under the Medicare Prescription Drug Improvement and Modernization Act (2003), Section 1860D-4(b)(3)(C)(ii). The Centers for Medicare & Medicaid Services (CMS) periodically request revision of the model through a Cooperative Agreement between USP and CMS. Currently, USP updates the USP MMG every three years. The USP MMG reflects a tailored approach to assist in the formulary plan development of Medicare D, specifically medication coverage relative to beneficiary therapeutic coverage. USP remains fully committed with CMS to produce the USP MMG, in response to their periodic request for revision to meet their needs in managing the Medicare Part D benefit.

Over the past ten years, the USP MMG has been adopted in other health policy settings outside of its intended Medicare utilization. Through this extension of use, public comment and stakeholder feedback has identified the need to create a an independent classification system that can provide a more comprehensive inclusion of outpatient drugs, more frequent revisions, and more detailed mapping tools for implementation.

USP DC 2017 Builds on USP MMG Utilization and Success

The USP DC is intended to be complementary to the USP MMG and is developed with similar guiding principles, taxonomy, and structure of the USP Categories and Classes. The added benefits include:

  • USP Categories and Classes will be assigned to common outpatient drugs available in the US market, extending beyond Medicare Part D eligibility
  • Non-Medicare stakeholders will be able to provide public comment on the USP Categories and Classes
  • Annual revision of mapping tools will provide more timely alignment of US drugs to USP Categories and Classes
  • Flexibility to propose additional features in the system, beyond USP Categories and Classes, to meet evolving stakeholders utilization of the classification system

Proposed USP Drug Classification System Compared to USP MMG

  USP Medicare Model Guidelines(USP MMG) USP Drug Classification System (USP DC)
Developed through USP Expert Volunteers, Stakeholder Engagement, and Public Comment Processes

Utilizes USP Guiding Principles for establishing Categories and Classes
Contains USP Categories and Classes
Provides Drug Examples Part D eligible drugs only Common US outpatient drugs
Implementation Tools: Mapping to RxNorm
CMS FRF- MMG Alignment File (triannual) USP DC- RxNorm Alignment File (annual)
Supports Medicare Part D requirements N/A
Stakeholder Focus in Public Comment Medicare Stakeholders All Stakeholders 
Revision Cycle Tri-annual* Annual
Publication Version USP MMG v7.0 Proposed first edition:
USP DC 2017
Publication Date February, 2017 November 1, 2017 (anticipated)

*Upon request of CMS

Second Public Comment Period: Fall 2017

USP will seek additional public feedback from stakeholders on the proposed USP Drug Classification system. A first round of public comments in Fall 2016 provided significant support and comments for the draft USP DC. The Healthcare Quality & Safety Expert Committee is considering additional revision, and will seeking a second round of public comments in Fall 2017.

How to Participate

  • Check back at this location in Summer 2017 for a schedule of participation opportunities for the revised USP Drug Classification system.