Scope.
Reference in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
Title 21 CFR reference
Explore the full hierarchy of this title across chapters, subchapters, and parts.
Select a part from the tree to begin
Browse chapters and parts on the left to load sections
United States • Title 21 CFR • Part 328
Part 328 — PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
This part establishes limits on the concentration of alcohol as an inactive ingredient in over-the-counter (OTC) drug products intended for oral ingestion. It specifies maximum allowable alcohol percentages based on the age group for which the product is labeled and requires prominent labeling of alcohol content. Exemptions and temporary exemptions are also addressed.
What this part covers
- Sets maximum alcohol concentrations for OTC oral drugs: 10% for adults/children 12+, 5% for children 6-11, and 0.5% for children under 6.
- Requires alcohol content to be stated as a percentage on the principal display panel.
- Mandates specific cautionary statements for products with higher alcohol content intended for adults/children 12+ or children 6-11.
- Allows for exemptions from alcohol concentration limits upon petition to the FDA, with documented cause.
- Provides temporary exemptions for specific products like Aromatic Cascara Fluidextract, Cascara Sagrada Fluidextract, and homeopathic products.
- Specifies that products labeled 'alcohol free' must contain 0% alcohol.
Sections in Part 328
Alcohol.
(a) Any over-the-counter (OTC) drug product intended for oral ingestion shall not contain alcohol as an inactive ingredient in concentrations that exceed those established in this part, unless a specific exemption, as provided in paragraph (e) or (f) of this section, has been approved. (b) For any OTC drug product intended for oral ingestion and labeled for use by adults and children 12 years of age and over, the amount of alcohol in the product shall not exceed 10 percent. (c) For any OTC drug product intended for oral ingestion and labeled for use by children 6 to under 12 years of age, the amount of alcohol in the product shall not exceed 5 percent. (d) For any OTC drug product intended for oral ingestion and labeled for use by children under 6 years of age, the amount of alcohol in the product shall not exceed 0.5 percent. (e) The Food and Drug Administration will grant an exemption from paragraphs (b), (c), and (d) of this section where appropriate, upon petition under the provisions of § 10.30 of this chapter. Appropriate cause, such as a specific solubility or manufacturing problem, must be adequately documented in the petition. Decisions with respect to requests for…
Definitions.
As used in this part: Alcohol(a) means the substance known as ethanol, ethyl alcohol, or Alcohol, USP. Inactive ingredient(b) means any component of a product other than an active ingredient as defined in § 210.3(b)(7) of this chapter.
Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol.
(a) The amount (percentage) of alcohol present in a product shall be stated in terms of percent volume of absolute alcohol at 60 °F (15.56 °C) in accordance with § 201.10(d)(2) of this chapter. (b) A statement expressing the amount (percentage) of alcohol present in a product shall appear prominently and conspicuously on the “principal display panel,” as defined in § 201.60 of this chapter. For products whose principal display panel is on the immediate container label and that are not marketed in another retail package (e.g., an outer box), the statement of the percentage of alcohol present in the product shall appear prominently and conspicuously on the “principal display panel” of the immediate container label. (c) For products whose principal display panel is on the retail package and the retail package is not the immediate container, the statement of the percentage of alcohol present in the product shall also appear on the immediate container label; it may appear anywhere on that label in accord with section 502(e) of the Federal Food, Drug, and Cosmetic Act. (d) The statement expressing the amount (percentage) of alcohol present in the product shall be in a size reasonably…
Regulatory Context
This document sits within United States CFR and is most useful when linked to operational submission, quality, and inspection workflows.
United StatesCFR