The USP Drug Classification (USP DC) is an independent drug classification system developed in response to stakeholder input that it would be helpful to have a classification system beyond the Medicare Model Guidelines (MMG), to assist with formulary support outside of Medicare Part D. The Healthcare Quality & Safety Expert Committee goal is to create a comprehensive classification system for use in drug formulary development or review in non-acute or outpatient care settings. This tool has the potential to provide guidance towards the design and comparison of balanced formularies.
- October 5 - October 30, 2020: USP DC Draft was posted for Public Comment
- Download USP DC 2021 Draft
- The proposed USP DC 2021 draft includes new FDA approved drugs from Nov 2019 to Jul 2020.
- New FDA approved drugs during the Aug 2020 to Oct 2020 time period will be considered in this publication.
- New FDA approved drugs beyond Nov 1, 2020 will be considered in the following publication.
- December 18, 2020: USP DC 2021 will be published
- If there are additional questions, please contact email@example.com.
- Download USP DC 2021 Draft
Important: The USP DC is not designed for CMS Part D Formulary Submissions. Part D Stakeholders should use the USP Medicare Model Guidelines (USP MMG)
The USP DC is intended for use by any stakeholder interested in a classification of drugs for use in formulary development or review. The classification system can have many uses for formulary support including but not limited to:
- Building and mapping formularies
- Reviewing formulary adequacy for a minimum baseline of drugs
- Identifying drugs in a particular pharmacologic grouping
- Reviewing formularies and comparing formulary design and benefits
USP DC may be helpful as part of a comprehensive formulary review process, but is not intended to replace the final review provided by the local pharmacy and therapeutics (P&T) committees. Moreover, USP DC is not intended for review of medical benefit drug coverage, since USP DC does not include all drugs administered in a clinical setting.
Origins of Development
USP has a long history of creating classification systems for the purpose of formulary review. 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). This section included a requirement that Part D plans cover at least 2 two drugs in each USP Category and Class.
The USP DC was initiated by stakeholder feedback to meet evolving public health needs. 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 an independent classification system that can provide a more comprehensive inclusion of outpatient drugs, more frequent revisions, and more detailed mapping tools for implementation.
The USP DC is a classification system separate from the MMG and is not endorsed or funded by the CMS.
A comparison of the USP DC to the MMG
|USP Medicare Model Guidelines (USP MMG)||USP Drug Classification (USP DC)|
|Developed under the Medicare Modernization Act to support Medicare Part D requirements||
Provides Drug Examples
|Part D eligible drugs only||Common US outpatient drugs|
|Developed through USP Expert Volunteers, Stakeholder Engagement, and Public Comment Processes||√||√|
Utilizes USP Guiding Principles for establishing Categories and Classes
|Implementation Tools: Mapping to RxNorm||CMS FRF- MMG Alignment File (triennial)||USP DC- RxNorm Alignment File (annual)|
|Stakeholder Focus in Public Comment||Medicare Stakeholders||All Stakeholders|
|Revision Cycle||Every 3 years*||Annual|
|Publication Version||USP MMG v9.0||USP DC 2021|
|Intended Publication Date||
February 1, 2023
December 18, 2020
*Upon request of Centers for Medicare and Medicaid Services (CMS)
The USP DC 2020 contains a listing of unique active pharmaceutical ingredients including single entity drug products, combination drug products, and vaccines. The previous 2019 version was organized into two lists: Single Entity and Combination list, and Vaccine list. To improve readability, the two lists were combined to include all the example drugs.
Below is a definition of the data elements on the USP Drug Classification.
|USP Category||A USP Category is the broadest classification of the USP Drug Classification system and provides a high level formulary structure. In USP DC 2020 there are 51 USP categories.|
|USP Class||A USP Class is a more granular classification, occurring within a specific USP Category in the USP Drug Classification system. In USP DC 2020 there are 171 USP classes.|
An attribute of a drug, providing additional informational groupings on drugs based on therapeutic use or pharmacology.
The pharmacotherapeutic groups are currently under development and not intended to be used for review of formulary adequacy for a minimum baseline of drugs. In USP DC 2020 there are 121 pharmacotherapeutic groups.
|Example Drug||An example drug is the active ingredient in a drug product (not an inactive ingredient, such as an excipient). An example drug includes the active ingredient of a drug product but not its strength or dosage form. In USP DC 2020, there are 1737 example drug placements.|
|Combination Drug Product||
A combination drug product is one that contains multiple active ingredients. The USP DC contains a column to indicate if a drug product is a combination drug product (yes/no) or if a row contains a USP Category or USP Class name (Category/Class). Users can filter this column to choose to select/view any of the following data elements: USP Category, USP Class, combination drug product, or single entity drug product.
The USP DC is developed through USP’s independent, science-based, expert-led process that relies on stakeholder input, including formal public comment periods.
USP Drug Classification Expert Panel
The USP Drug Classification Expert Panel was created for the 2015-2020 cycle under the Healthcare Quality & Safety Expert Committee. This Expert Panel of academicians, practitioners, formulary experts, patient advocates, and clinicians began their work on developing the USP DC in March of 2016. The Expert Panel advises the Healthcare Quality & Safety Expert Committee on issues discovered during the annual revision processes that are relevant to developing, implementing, and revising the USP DC.
Drug Identification and Drug Summary Files
Drugs included in the USP DC 2020 are identified through various sources, including Drugs@FDA, RxNorm Current Prescribable Content, Purple book: Lists of Licensed Biological Products, stakeholder feedback, and publicly available prescription formularies.
The Drug Summary Files were developed with key drug information that would inform placement of drugs in USP categories and classes. The Drug Summary Files include FDA regulatory information, FDA-approved labeling, and FDA Established Pharmacologic Class. When applicable, primary peer-reviewed scientific articles and treatment guidelines were also included in the Drug Summary Files.
Public Comment Process
The USP DC 2020 Proposed Draft was made available via the USP.org website for public comment from October 14th until November 15th, 2019. Stakeholders had the opportunity to provide comments via email, public comment form, stakeholder 1:1 consultations, and open microphone web meetings.
Fifteen stakeholders provided comments and over 40 requests were evaluated for incorporation in the draft. Commenters include drug manufacturers, regulators, health plans/PBMs, academia, and patient advocacy groups. The Expert Panel considered all public comments for incorporation into USP DC 2020. The Healthcare Quality & Safety Expert Committee approved USP DC 2020 in December of 2019.
Similar to the 2019 version, the Expert Panel used the following guiding principles to inform their development of the USP DC 2020.
Types of Example Drugs Listed
The Expert Panel’s goal was to include a comprehensive list of drugs used in non-acute and outpatient care settings. This includes prescription medications patients receive from community pharmacies, specialty pharmacies, skilled nursing facilities, and infusion centers. At this time, the Expert Panel has excluded from the USP DC 2020 most hospital-only, over-the-counter, and medications that are not FDA-approved. Some listed drugs may have over-the-counter products as well as prescription-only dosage forms. For example, diphenhydramine is available as an over-the-counter product for oral dosage forms and prescription-only for injectable dosage forms.
Approach to creating Categories and Classes
The USP Drug Classification retains the guiding principle of the Medicare Model Guidelines (MMG), to strike a balance of assuring patient access to the drugs that patients need with the flexibility that health plans require in offering an affordable and effective benefit.
In creating the categories and classes, there are careful considerations to minimize the creation of categories or classes with less than three example drugs. There was consideration in naming the category and class to be broad enough to encompass future mechanism of actions.
Approach to Placement of Example Drugs
The USP DC utilizes pharmacotherapeutic evidence within the context of FDA-approved indications for placing example drugs. Many of these example drugs may have established indications and uses outside of the United States and qualities of other drug classes (pharmacology). A drug in the associated list may appear in more than one USP Category or USP Class if there is a scientifically valid and clinically meaningful patient care use.
Combination products are placed in USP groupings distinguished by "Combinations" or "Other" under the respective USP Category. If the combination product includes an active ingredient that improves absorption or efficacy of another active ingredient, the placement will be based on the active ingredient that contributes to therapy and not the augmenting agent. For example, Amoxicillin/Clavulanate Potassium is placed in USP Class "Beta-lactam, Penicillins" based on amoxicillin and not clavulanate potassium, an augmenting agent that enhances the spectrum of activity of amoxicillin by inhibiting beta-lactamases that inactivate amoxicillin.
Specific dosage forms/formulations/delivery systems are generally not listed but may be included in the associated list if there is a valid and clinically meaningful patient care issue addressed by these more specific factors.