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

6 rows where part_number = 332 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
21:21:5.0.1.1.13.1.1.1 21 Food and Drugs I D 332 PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE A Subpart A—General Provisions   § 332.1 Scope. FDA       An over-the-counter antiflatulent product in a form suitable for oral administration is generally recognized as safe and effective and is not misbranded if it meets each of the following conditions and each of the general conditions established in § 330.1 of this chapter.
21:21:5.0.1.1.13.1.1.2 21 Food and Drugs I D 332 PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE A Subpart A—General Provisions   § 332.3 Definitions. FDA     [61 FR 8838, Mar. 5, 1996] As used in this part: Antigas. A term that may be used interchangeably with the term antiflatulent. Neither term should be considered as describing the mechanism of action of the active ingredient contained in the product.
21:21:5.0.1.1.13.2.1.1 21 Food and Drugs I D 332 PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE B Subpart B—Active Ingredients   § 332.10 Antiflatulent active ingredients. FDA       Simethicone; maximum daily dose 500 mg. There is no dosage limitation at this time for professional labeling.
21:21:5.0.1.1.13.2.1.2 21 Food and Drugs I D 332 PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE B Subpart B—Active Ingredients   § 332.15 Combination with non-antiflatulent active ingredients. FDA       An antiflatulent may contain any generally recognized as safe and effective antacid ingredient(s) if it is indicated for use solely for the concurrent symptoms of gas associated with heartburn, sour stomach or acid indigestion.
21:21:5.0.1.1.13.3.1.1 21 Food and Drugs I D 332 PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE C Subpart C—Labeling   § 332.30 Labeling of antiflatulent drug products. FDA     [39 FR 19877, June 4, 1974, as amended at 40 FR 11719, Mar. 13, 1975; 51 FR 16266, May 1, 1986; 51 FR 27763, Aug. 1, 1986; 52 FR 7830, Mar. 13, 1987; 61 FR 8838, Mar. 5, 1996] (a) Statement of identity. The labeling of the product contains the established name of the drug, if any, and identifies the product as an “antiflatulent,” “antigas,” or “antiflatulent (antigas).” (b) Indications. The labeling of the product states, under the heading “Indications,” 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) (Select one of the following: “Alleviates or Relieves”) “the symptoms referred to as gas.” (2) (Select one of the following: “Alleviates” or “Relieves”) (select one or more of the following: “bloating,” “pressure,” “fullness,” or “stuffed feeling”) “commonly referred to as gas.” (c) Exemption from the general accidental overdose warning. The labeling for antiflatulent drug products containing simethicone identified in § 332.10 and antacid/antiflatulent combination drug products provided for in § 332.15, containing the active ingredients identified in § 331.11(a), (b), and (d) through (m) of this chapter are exempt from the requirement in § 330.1(g) of this chapter that the labeling bear the general warning statement “In case of accidental overdose, seek professional assistance or contact a poison control center immediately.” The labeling must continue to bear the first part of the general warning in § 330.1(g) of this chapter, which states, “Keep this and all drugs out of the reach of children.”
21:21:5.0.1.1.13.3.1.2 21 Food and Drugs I D 332 PART 332—ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE C Subpart C—Labeling   § 332.31 Professional labeling. FDA       (a) The labeling of the product provided to health professionals (but not to the general public) may contain as additional indications postoperative gas pain or for use in endoscopic examination. (b) Professional labeling for an antiflatulent-antacid combination may contain information allowed for health professionals for antacids and antiflatulents.

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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);