---
kind: "section"
citation: "42 C.F.R. § 427.100"
title: "42"
number: "427.100"
heading: "Definitions."
url: "https://uscodex.org/cfr/42/427.100"
---

# §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](/cfr/42/564.md) 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)](/cfr/42/427.101.md?p=b-6) and with allowed charges greater than zero.


## Notes

### Authority

Authority: 42 U.S.C. 1395w-3a(i), 1302, and 1395hh.

### Source

Source: 89 FR 98578, Dec. 9, 2024, unless otherwise noted.