{"data":{"id":"us/42-cfr-427.100","jurisdiction":"us","citation":"42 CFR 427.100","heading":"Definitions.","body":"As used in this subpart, the following definitions apply:\nEUA 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\u0026C) Act.\nIndividual 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.","path":["Title 42—Public Health","CHAPTER IV—CENTERS FOR MEDICARE \u0026 MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER B—MEDICARE PROGRAM","PART 427—MEDICARE PART B DRUG INFLATION REBATE PROGRAM","Subpart B—Determination of Part B Rebatable Drugs"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"6453f55fc1398dd6f9760a6238f0bfbd41e3b964410258162d8559919901f549","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-427.20","next":"us/42-cfr-427.101"},"notice":"GroundRules: Original legal text. Not legal advice."}