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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

3 rows where part_number = 299 and title_number = 21 sorted by section_id

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  • 21 · 3 ✖

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  • 299 · 3 ✖

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  • FDA 3
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
21:21:4.0.1.1.21.1.1.1 21 Food and Drugs I C 299 PART 299—DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES A Subpart A—General Provisions   § 299.3 Definitions and interpretations. FDA       (a) As used in this part 299, act means the Federal Food, Drug, and Cosmetic Act, sections 201-902, 52 Stat. 1040 (21 U.S.C. 321-392), with all amendments thereto. (b) The definitions and interpretations contained in section 201 of the act shall be applicable to such terms when used in this part 299. (c) The term official name means, with respect to a drug or ingredient thereof, the name designated in this part 299 under section 508 of the act as the official name.
21:21:4.0.1.1.21.1.1.2 21 Food and Drugs I C 299 PART 299—DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES A Subpart A—General Provisions   § 299.4 Established names for drugs. FDA     [40 FR 14041, Mar. 27, 1975, as amended at 49 FR 37575, Sept. 25, 1984; 53 FR 5369, Feb. 24, 1988; 55 FR 11577, Mar. 29, 1990; 64 FR 401, Jan. 5, 1999; 69 FR 18803, Apr. 9, 2004] (a) Section 508 of the Federal Food, Drug, and Cosmetic Act (added by the Kefauver-Harris Drug Amendments of 1962; Pub. L. 87-781) authorizes the Commissioner of Food and Drugs to designate an official name for any drug if he determines that such action is necessary or desirable in the interest of usefulness and simplicity. Section 502(e) of the act (as amended by said Drug Amendments) prescribes that the labeling of a drug must bear its established name, if there is one, to the exclusion of any other nonproprietary name (except the applicable systematic chemical name or the chemical formula) and, if the drug is fabricated from two or more ingredients, the established name of each active ingredient. (b) The term established name is defined in section 502(e)(3) of the act as (1) an official name designated pursuant to section 508 of the act; (2) if no such official name has been designated for the drug and the drug is an article recognized in an official compendium, then the official title thereof in such compendium; and (3) if neither paragraphs (b) (1) or (2) of this section applies, then the common or usual name of the drug. (c) The Food and Drug Administration recognizes the skill and experience of the U.S. Adopted Names Council (USAN) in deriving names for drugs. The U.S. Adopted Names Council is a private organization sponsored by the American Medical Association, the United States Pharmacopeia, and the American Pharmaceutical Association, and has been engaged in the assignment of names to drugs since January 1964. The Council negotiates with manufacturing firms in the selection of nonproprietary names for drugs. (d) The Food and Drug Administration cooperates with and is represented on the USAN Council. In addition, the Food and Drug Administration agrees with “Guiding Principles for Coining U.S. Adopted Names for Drugs,” published in USAN and the USP Dictionary of Drug Names (USAN 1985 ed., 1961-1984 cumulative list), which is incorporated by reference. Copies are available from: U.S. Pharmacopeial …
21:21:4.0.1.1.21.1.1.3 21 Food and Drugs I C 299 PART 299—DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES A Subpart A—General Provisions   § 299.5 Drugs; compendial name. FDA       (a) The name by which a drug is designated shall be clearly distinguishing and differentiating from any name recognized in an official compendium unless such drug complies in identity with the identity prescribed in an official compendium under such recognized name. (b) The term drug defined in an official compendium means a drug having the identity prescribed for a drug in an official compendium. (c) A statement that a drug defined in an official compendium differs in strength, quality, or purity from the standard of strength, quality, or purity set forth for such drug in an official compendium shall show all the respects in which such drug so differs, and the extent of each such difference.

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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);
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