eCFR Reference Browser

---

title: "21 CFR §328.3"

source: "https://www.ecfr.gov/current/title-21/section-328.3"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "328"

part_subject: "OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "328.3"

section_subject: "Definitions."

cfr_reference: "21 CFR 328.3"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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.

§328.3 - Definitions.