cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
9 rows where part_number = 328 sorted by section_id
This data as json, CSV (advanced)
Suggested facets: title_name, chapter, subchapter, part_name, subpart, subpart_name, section_heading, amendment_citations
| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:5.0.1.1.9.1.1.1 | 21 | Food and Drugs | I | D | 328 | PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL | A | Subpart A—General Provisions | § 328.1 Scope. | FDA | Reference in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted. | ||||
| 21:21:5.0.1.1.9.1.1.2 | 21 | Food and Drugs | I | D | 328 | PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL | A | Subpart A—General Provisions | § 328.3 Definitions. | FDA | 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. | ||||
| 21:21:5.0.1.1.9.2.1.1 | 21 | Food and Drugs | I | D | 328 | PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL | B | Subpart B—Ingredients | § 328.10 Alcohol. | FDA | [60 FR 13595, Mar. 13, 1995, as amended at 61 FR 58630, Nov. 18, 1996; 68 FR 24879, May 9, 2003; 88 FR 45066, July 14, 2023] | (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 exemption shall be maintained in a permanent file for public review by the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. (f) Ipecac syrup is exempt from the provisions of paragraph (d) of this section. (g) The following drugs are temporarily exempt from the provisions of paragraphs (b), (c), and (d) of this section: (1) Aromatic Cascara Fluidextract. (2) Cascara Sagrada Fluidextract. (3) Orally ingested homeopathic drug products. | |||
| 21:21:5.0.1.1.9.3.1.1 | 21 | Food and Drugs | I | D | 328 | PART 328—OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL | C | Subpart C—Labeling | § 328.50 Principal display panel of all OTC drug products intended for oral ingestion that contain alcohol. | FDA | (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 related to the most prominent printed matter on the panel or label on which it appears, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. (e) For a product to state in its labeling that it is “alcohol free,” it must contain no alcohol (0 percent). (f) For any OTC drug product intended for oral ingestion containing over 5 percent alcohol and labeled for use by adults and children 12 years of age and over, the labeling shall contain the following statement in the directions section: “Consult a physician for use in children under 12 years of age.” (g) For any OTC drug product intended for oral ingestion containing over 0.5 percent alcohol and labeled for use by children ages 6 to under 12 years of age, the labeling shall contain the following statement in the directions se… | ||||
| 33:33:3.0.1.1.22.0.1.1 | 33 | Navigation and Navigable Waters | II | 328 | PART 328—DEFINITION OF WATERS OF THE UNITED STATES | § 328.1 Purpose. | USACE | This section defines the term “waters of the United States” as it applies to the jurisdictional limits of the authority of the Corps of Engineers under the Clean Water Act. It prescribes the policy, practice, and procedures to be used in determining the extent of jurisdiction of the Corps of Engineers concerning “waters of the United States.” The terminology used by section 404 of the Clean Water Act includes “navigable waters” which is defined at section 502(7) of the Act as “waters of the United States including the territorial seas.” To provide clarity and to avoid confusion with other Corps of Engineer regulatory programs, the term “waters of the United States” is used throughout 33 CFR parts 320 through 330. This section does not apply to authorities under the Rivers and Harbors Act of 1899 except that some of the same waters may be regulated under both statutes (see 33 CFR parts 322 and 329). | |||||||
| 33:33:3.0.1.1.22.0.1.2 | 33 | Navigation and Navigable Waters | II | 328 | PART 328—DEFINITION OF WATERS OF THE UNITED STATES | § 328.2 General scope. | USACE | Waters of the United States include those waters listed in § 328.3(a). The lateral limits of jurisdiction in those waters may be divided into three categories. The categories include the territorial seas, tidal waters, and non-tidal waters (see 33 CFR 328.4 (a), (b), and (c), respectively). | |||||||
| 33:33:3.0.1.1.22.0.1.3 | 33 | Navigation and Navigable Waters | II | 328 | PART 328—DEFINITION OF WATERS OF THE UNITED STATES | § 328.3 Definitions. | USACE | [88 FR 3142, Jan. 18, 2023, as amended at 88 FR 61968, Sept. 8, 2023] | For the purpose of this regulation these terms are defined as follows: (a) Waters of the United States means: (1) Waters which are: (i) Currently used, or were used in the past, or may be susceptible to use in interstate or foreign commerce, including all waters which are subject to the ebb and flow of the tide; (ii) The territorial seas; or (iii) Interstate waters; (2) Impoundments of waters otherwise defined as waters of the United States under this definition, other than impoundments of waters identified under paragraph (a)(5) of this section; (3) Tributaries of waters identified in paragraph (a)(1) or (2) of this section that are relatively permanent, standing or continuously flowing bodies of water; (4) Wetlands adjacent to the following waters: (i) Waters identified in paragraph (a)(1) of this section; or (ii) Relatively permanent, standing or continuously flowing bodies of water identified in paragraph (a)(2) or (a)(3) of this section and with a continuous surface connection to those waters; (5) Intrastate lakes and ponds not identified in paragraphs (a)(1) through (4) of this section that are relatively permanent, standing or continuously flowing bodies of water with a continuous surface connection to the waters identified in paragraph (a)(1) or (a)(3) of this section. (b) The following are not “waters of the United States” even where they otherwise meet the terms of paragraphs (a)(2) through (5) of this section: (1) Waste treatment systems, including treatment ponds or lagoons, designed to meet the requirements of the Clean Water Act; (2) Prior converted cropland designated by the Secretary of Agriculture. The exclusion would cease upon a change of use, which means that the area is no longer available for the production of agricultural commodities. Notwithstanding the determination of an area's status as prior converted cropland by any other Federal agency, for the purposes of the Clean Water Act, the final authority regarding Clean Water Act jurisdiction remains with EPA; (3) Ditches (i… | ||||||
| 33:33:3.0.1.1.22.0.1.4 | 33 | Navigation and Navigable Waters | II | 328 | PART 328—DEFINITION OF WATERS OF THE UNITED STATES | § 328.4 Limits of jurisdiction. | USACE | (a) Territorial Seas. The limit of jurisdiction in the territorial seas is measured from the baseline in a seaward direction a distance of three nautical miles. (See 33 CFR 329.12) (b) Tidal waters of the United States. The landward limits of jurisdiction in tidal waters: (1) Extends to the high tide line, or (2) When adjacent non-tidal waters of the United States are present, the jurisdiction extends to the limits identified in paragraph (c) of this section. (c) Non-tidal waters of the United States. The limits of jurisdiction in non-tidal waters: (1) In the absence of adjacent wetlands, the jurisdiction extends to the ordinary high water mark, or (2) When adjacent wetlands are present, the jurisdiction extends beyond the ordinary high water mark to the limit of the adjacent wetlands. (3) When the water of the United States consists only of wetlands the jurisdiction extends to the limit of the wetland. | |||||||
| 33:33:3.0.1.1.22.0.1.5 | 33 | Navigation and Navigable Waters | II | 328 | PART 328—DEFINITION OF WATERS OF THE UNITED STATES | § 328.5 Changes in limits of waters of the United States. | USACE | Permanent changes of the shoreline configuration result in similar alterations of the boundaries of waters of the United States. Gradual changes which are due to natural causes and are perceptible only over some period of time constitute changes in the bed of a waterway which also change the boundaries of the waters of the United States. For example, changing sea levels or subsidence of land may cause some areas to become waters of the United States while siltation or a change in drainage may remove an area from waters of the United States. Man-made changes may affect the limits of waters of the United States; however, permanent changes should not be presumed until the particular circumstances have been examined and verified by the district engineer. Verification of changes to the lateral limits of jurisdiction may be obtained from the district engineer. |
Advanced export
JSON shape: default, array, newline-delimited, object
CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);