42 CFR § 427.100 - Definitions.
---
identifier: "/us/cfr/t42/s427.100"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 427.100 - Definitions."
title_number: 42
title_name: "Public Health"
section_number: "427.100"
section_name: "Definitions."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "B"
subchapter_name: "MEDICARE PROGRAM"
part_number: "427"
part_name: "MEDICARE PART B DRUG INFLATION REBATE PROGRAM"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 1395w-3a(i), 1302, and 1395hh."
regulatory_source: "89 FR 98578, Dec. 9, 2024, unless otherwise noted."
cfr_part: "427"
---
# 427.100 Definitions.
As used in this subpart, the following definitions apply:
*EUA Declaration* means the March 27, 2020, Emergency Use Authorization (EUA) Declaration for Drugs and Biological Products under section 564 of the Food, Drug, and Cosmetic (FD&C) Act.
*Individual who uses such a drug or biological* means a unique Medicare Part B beneficiary who was furnished the Part B drug or biological that was covered under Part B during the applicable calendar quarter, identified using final action claims data with dates of service during the calendar year set forth in § 427.101(b)(6) and with allowed charges greater than zero.