GroundRules
21 CFR 328.3: Definitions.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER D—DRUGS FOR HUMAN USE
- PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
- Subpart A—General Provisions
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.
Collected 2026-08-27T02:24:47Z. Source file · JSON