On September 1, 2023, U.S. Pharmacopeia (USP) Healthcare Quality and Safety Expert Committee announced the release of the Draft USP Drug Classification 2024 (USP DC 2024) which was open for public comment from September 1 to September 29, 2023. The anticipated publication date for USP DC 2024 is December 15, 2023.[1] A full copy of the USP DC with proposed changed may be obtained at www.usp.org/health-quality-safety/usp-drug-classification-system.

Background
The USP is responsible for the USP Drug Classification (USP DC), an independent drug classification system, and the Medicare Part D Medicare Model Guidelines (MMG). The USP classification system is designed to assist with formulary support outside of Medicare Part D. The goal of the Healthcare Safety & Quality Expert Committee is the creation of a comprehensive classification system for use in drug formulary development or review in non-acute or outpatient care settings with the intent of providing guidance toward the design and comparison of balanced formularies. Per the USP, “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.”[1] In contrast to the USP Medicare Model Guidelines, the USP Drug Classification is not part of regulatory governance of Medicare or Medicaid.

The 2024 DC proposal includes new FDA approved drugs from November 2022-July 2023. Drugs approved from August 2023 through September 2023 will be considered for inclusion in the final version issued in December 2023. Drug products approved by the FDA after September 30, 2023, will be considered in the following publication. In general, the Subcommittee excludes most medications used in hospital-only settings, over the counter (OTC) drugs, and medications that are not FDA approved.

USP Drug Classification Hierarchy
The Drug Classification structure is a hierarchical therapeutic classification system with five levels moving from broad therapeutic category to example drug entities. Combination products are identified within the structure.

• USP Category
  • USP Class
    • Example Drugs
      • Pharmacotherapeutic Group (information-in development)
        • Combination Drug Product Identification (yes/no)

2024 Example

• Antibacterials (USP Category)
  • Beta-lactam, Penicillin (USP Class)
    • Amoxicillin/Clavulanate Potassium (Example Drugs)
      • Null value (Pharmacotherapeutic Group [information])
        • Yes (Combination Drug Product)

Proposed 2024 Changes
USP Categories, the highest level of the hierarchy, remain unchanged. Two (2) new USP Classes were added to address the first FDA approved therapies to treat COVID-19 and ALS with accompanying drug examples as shown below. The majority of the 2024 changes are forty-three (43) new Example Drugs approved between September 2022 and July 2023, which are available on the USP Drug Classification 2024 Draft.[2] One drug entity, hydroxyprogesterone caproate, was removed because the FDA approval was withdrawn for the product, and one drug entity was edited, methamphetamine hydrochloride, as the indication for obesity was removed.

2024 Draft New USP Classes

PHSL anticipates further changes may occur between now and the final 2024 DC, including September 2023 FDA approvals, new USP classes for first-in-therapy approval, or example drug removals if FDA withdraws the product’s approval.

What impact may the 2024 DC have on your business, your formulary design, or customer expectations? PHSL can provide analysis and assessment of your current and future formularies considering the 2024 USP DC and prepare communications to USP addressing your concerns and recommendations. Please contact us to discuss your needs.

[1]https://www.usp.org/health-quality/usp-drug-classification-system

[2] https://www.usp.org/health-quality/usp-drug-classification-system

Posted November 2023