{"database": "openregs", "table": "cfr_sections", "is_view": false, "human_description_en": "where part_number = 328 sorted by section_id", "rows": [["21:21:5.0.1.1.9.1.1.1", 21, "Food and Drugs", "I", "D", "328", "PART 328\u2014OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 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\u2014OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL", "A", "Subpart A\u2014General Provisions", "", "\u00a7 328.3 Definitions.", "FDA", "", "", "", "As used in this part:\n\n(a)  Alcohol  means the substance known as ethanol, ethyl alcohol, or Alcohol, USP.\n\n(b)  Inactive ingredient  means any component of a product other than an active ingredient as defined in \u00a7 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\u2014OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL", "B", "Subpart B\u2014Ingredients", "", "\u00a7 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.\n\n(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.\n\n(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.\n\n(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.\n\n(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 \u00a7 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.\n\n(f) Ipecac syrup is exempt from the provisions of paragraph (d) of this section.\n\n(g) The following drugs are temporarily exempt from the provisions of paragraphs (b), (c), and (d) of this section:\n\n(1) Aromatic Cascara Fluidextract.\n\n(2) Cascara Sagrada Fluidextract.\n\n(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\u2014OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL", "C", "Subpart C\u2014Labeling", "", "\u00a7 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 \u00b0F (15.56 \u00b0C) in accordance with \u00a7 201.10(d)(2) of this chapter.\n\n(b) A statement expressing the amount (percentage) of alcohol present in a product shall appear prominently and conspicuously on the \u201cprincipal display panel,\u201d as defined in \u00a7 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 \u201cprincipal display panel\u201d of the immediate container label.\n\n(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.\n\n(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.\n\n(e) For a product to state in its labeling that it is \u201calcohol free,\u201d it must contain no alcohol (0 percent).\n\n(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: \u201cConsult a physician for use in children under 12 years of age.\u201d\n\n(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 section: \u201cConsult a physician for use in children under 6 years of age.\u201d\n\n(h) When the direction regarding age in paragraph (e) or (f) of this section differs from an age-limiting direction contained in any OTC drug monograph in this chapter, the direction containing the more stringent age limitation shall be used."], ["33:33:3.0.1.1.22.0.1.1", 33, "Navigation and Navigable Waters", "II", "", "328", "PART 328\u2014DEFINITION OF WATERS OF THE UNITED STATES", "", "", "", "\u00a7 328.1 Purpose.", "USACE", "", "", "", "This section defines the term \u201cwaters of the United States\u201d 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 \u201cwaters of the United States.\u201d The terminology used by section 404 of the Clean Water Act includes \u201cnavigable waters\u201d which is defined at section 502(7) of the Act as \u201cwaters of the United States including the territorial seas.\u201d To provide clarity and to avoid confusion with other Corps of Engineer regulatory programs, the term \u201cwaters of the United States\u201d 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\u2014DEFINITION OF WATERS OF THE UNITED STATES", "", "", "", "\u00a7 328.2 General scope.", "USACE", "", "", "", "Waters of the United States include those waters listed in \u00a7 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\u2014DEFINITION OF WATERS OF THE UNITED STATES", "", "", "", "\u00a7 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:\n\n(a)  Waters of the United States  means:\n\n(1) Waters which are:\n\n(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;\n\n(ii) The territorial seas; or\n\n(iii) Interstate waters;\n\n(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;\n\n(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;\n\n(4) Wetlands adjacent to the following waters:\n\n(i) Waters identified in paragraph (a)(1) of this section; or\n\n(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;\n\n(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.\n\n(b) The following are not \u201cwaters of the United States\u201d even where they otherwise meet the terms of paragraphs (a)(2) through (5) of this section:\n\n(1) Waste treatment systems, including treatment ponds or lagoons, designed to meet the requirements of the Clean Water Act;\n\n(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;\n\n(3) Ditches (including roadside ditches) excavated wholly in and draining only dry land and that do not carry a relatively permanent flow of water;\n\n(4) Artificially irrigated areas that would revert to dry land if the irrigation ceased;\n\n(5) Artificial lakes or ponds created by excavating or diking dry land to collect and retain water and which are used exclusively for such purposes as stock watering, irrigation, settling basins, or rice growing;\n\n(6) Artificial reflecting or swimming pools or other small ornamental bodies of water created by excavating or diking dry land to retain water for primarily aesthetic reasons;\n\n(7) Waterfilled depressions created in dry land incidental to construction activity and pits excavated in dry land for the purpose of obtaining fill, sand, or gravel unless and until the construction or excavation operation is abandoned and the resulting body of water meets the definition of waters of the United States; and\n\n(8) Swales and erosional features ( e.g.,  gullies, small washes) characterized by low volume, infrequent, or short duration flow.\n\n(c) In this section, the following definitions apply:\n\n(1)  Wetlands  means those areas that are inundated or saturated by surface or ground water at a frequency and duration sufficient to support, and that under normal circumstances do support, a prevalence of vegetation typically adapted for life in saturated soil conditions. Wetlands generally include swamps, marshes, bogs, and similar areas.\n\n(2)  Adjacent  means having a continuous surface connection.\n\n(3)  High tide line  means the line of intersection of the land with the water's surface at the maximum height reached by a rising tide. The high tide line may be determined, in the absence of actual data, by a line of oil or scum along shore objects, a more or less continuous deposit of fine shell or debris on the foreshore or berm, other physical markings or characteristics, vegetation lines, tidal gages, or other suitable means that delineate the general height reached by a rising tide. The line encompasses spring high tides and other high tides that occur with periodic frequency but does not include storm surges in which there is a departure from the normal or predicted reach of the tide due to the piling up of water against a coast by strong winds such as those accompanying a hurricane or other intense storm.\n\n(4)  Ordinary high water mark  means that line on the shore established by the fluctuations of water and indicated by physical characteristics such as clear, natural line impressed on the bank, shelving, changes in the character of soil, destruction of terrestrial vegetation, the presence of litter and debris, or other appropriate means that consider the characteristics of the surrounding areas.\n\n(5)  Tidal waters  means those waters that rise and fall in a predictable and measurable rhythm or cycle due to the gravitational pulls of the moon and sun. Tidal waters end where the rise and fall of the water surface can no longer be practically measured in a predictable rhythm due to masking by hydrologic, wind, or other effects."], ["33:33:3.0.1.1.22.0.1.4", 33, "Navigation and Navigable Waters", "II", "", "328", "PART 328\u2014DEFINITION OF WATERS OF THE UNITED STATES", "", "", "", "\u00a7 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)\n\n(b)  Tidal waters of the United States.  The landward limits of jurisdiction in tidal waters:\n\n(1) Extends to the high tide line, or\n\n(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.\n\n(c)  Non-tidal waters of the United States.  The limits of jurisdiction in non-tidal waters:\n\n(1) In the absence of adjacent wetlands, the jurisdiction extends to the ordinary high water mark, or\n\n(2) When adjacent wetlands are present, the jurisdiction extends beyond the ordinary high water mark to the limit of the adjacent wetlands.\n\n(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\u2014DEFINITION OF WATERS OF THE UNITED STATES", "", "", "", "\u00a7 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."]], "truncated": false, "filtered_table_rows_count": 9, "expanded_columns": [], "expandable_columns": [], "columns": ["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"], "primary_keys": ["section_id"], "units": {}, "query": {"sql": "select 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 from cfr_sections where \"part_number\" = :p0 order by section_id limit 101", "params": {"p0": "328"}}, "facet_results": {"title_number": {"name": "title_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=328", "results": [{"value": 33, "label": 33, "count": 5, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&title_number=33", "selected": false}, {"value": 21, "label": 21, "count": 4, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&title_number=21", "selected": false}], "truncated": false}, "agency": {"name": "agency", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=328", "results": [{"value": "USACE", "label": "USACE", "count": 5, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&agency=USACE", "selected": false}, {"value": "FDA", "label": "FDA", "count": 4, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&agency=FDA", "selected": false}], "truncated": false}, "part_number": {"name": "part_number", "type": "column", "hideable": false, "toggle_url": "/openregs/cfr_sections.json?part_number=328", "results": [{"value": "328", "label": "328", "count": 9, "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json", "selected": true}], "truncated": false}}, "suggested_facets": [{"name": "title_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=title_name"}, {"name": "chapter", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=chapter"}, {"name": "subchapter", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=subchapter"}, {"name": "part_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=part_name"}, {"name": "subpart", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=subpart"}, {"name": "subpart_name", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=subpart_name"}, {"name": "section_heading", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=section_heading"}, {"name": "amendment_citations", "toggle_url": "https://www.pawtectors.org/openregs/cfr_sections.json?part_number=328&_facet=amendment_citations"}], "next": null, "next_url": null, "private": false, "allow_execute_sql": true, "query_ms": 2689.4649059977382, "source": "Federal Register API & Regulations.gov API", "source_url": "https://www.federalregister.gov/developers/api/v1", "license": "Public Domain (U.S. Government data)", "license_url": "https://www.regulations.gov/faq"}