21 CFR § 328.3 - Definitions.

---
identifier: "/us/cfr/t21/s328.3"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 328.3 - Definitions."
title_number: 21
title_name: "Food and Drugs"
section_number: "328.3"
section_name: "Definitions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "D"
subchapter_name: "DRUGS FOR HUMAN USE"
part_number: "328"
part_name: "OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331, 351, 352, 353, 355, 371."
regulatory_source: "60 FR 13595, Mar. 13, 1995, unless otherwise noted."
cfr_part: "328"
---


# 328.3 Definitions.

As used in this part:

(a) *Alcohol* means the substance known as ethanol, ethyl alcohol, or Alcohol, USP.

(b) *Inactive ingredient* means any component of a product other than an active ingredient as defined in § 210.3(b)(7) of this chapter.