cfr_sections

Current Code of Federal Regulations (eCFR) — the actual text of federal regulations in force. Covers 19 CFR titles with 123,000+ regulatory sections and full-text search.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

4 rows where part_number = 335 and title_number = 21 sorted by section_id

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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
21:21:5.0.1.1.15.1.1.1 21 Food and Drugs I D 335 PART 335—ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE A Subpart A—General Provisions   § 335.1 Scope. FDA       (a) An over-the-counter antidiarrheal drug product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
21:21:5.0.1.1.15.1.1.2 21 Food and Drugs I D 335 PART 335—ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE A Subpart A—General Provisions   § 335.3 Definitions. FDA     [68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004] As used in this part: (a) Antidiarrheal. A drug that can be shown by objective measurement to treat or control (stop) the symptoms of diarrhea. (b) Diarrhea. A condition characterized by increased frequency of loose, watery stools (three or more daily) during a limited period (24 to 48 hours), usually with no identifiable cause. (c) Travelers' diarrhea. A subset of diarrhea occurring in travelers that is most commonly caused by an infectious agent.
21:21:5.0.1.1.15.2.1.1 21 Food and Drugs I D 335 PART 335—ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE B Subpart B—Active Ingredients   § 335.10 Antidiarrheal active ingredients. FDA       The active ingredient of the product consists of any one of the following when used within the dosage limits established for each ingredient in § 335.50(d): (a) Bismuth subsalicylate. (b) Kaolin.
21:21:5.0.1.1.15.3.1.1 21 Food and Drugs I D 335 PART 335—ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE C Subpart C—Labeling   § 335.50 Labeling of antidiarrheal drug products. FDA     [68 FR 18881, Apr. 17, 2003, as amended at 69 FR 26302, May 12, 2004] (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product either as an “antidiarrheal” or “for diarrhea.” (b) Indications. The labeling of the product states, under the heading “Use,” one or more of the phrases listed in this paragraph (b), as appropriate. Other truthful and nonmisleading statements, describing only the indications for use that have been established and listed in this paragraph (b) may also be used, as provided in § 330.1(c)(2) of this chapter, subject to the provisions of section 502 of the Federal Food, Drug, and Cosmetic Act (the act) relating to misbranding and the prohibition in section 301(d) of the act against the introduction or delivery for introduction into interstate commerce of unapproved new drugs in violation of section 505(a) of the act. (1) For products containing bismuth subsalicylate identified in § 335.10(a). The labeling states [select one of the following: “controls” or “relieves”] [select one or both of the following: “diarrhea” or “travelers' diarrhea”]. If both “diarrhea” and “travelers' diarrhea” are selected, each shall be preceded by a bullet in accordance with § 201.66(b)(4) and (d)(4) of this chapter and the heading “Uses” shall be used. (2) For products containing kaolin identified in § 335.10(b). The labeling states “helps firm stool within 24 to 48 hours”. (3) Additional indications —(i) When any additional indications are used, the heading “Uses” shall be used and each listed use shall be preceded by a bullet in accord with § 201.66(b)(4) of this chapter. (ii) In addition to the indication in paragraph (b)(1) of this section, one or both of the following may be used for products containing bismuth subsalicylate in § 335.10(a): “[bullet] reduces number of bowel movements” “[bullet] helps firm stool”. (c) Warnings. The labeling of the product contains the following warnings under the heading “Warnings”: (1) For products containing any ingredient identified in § 335.10. (i)…

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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);