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

1 row where agency = "FDA" and part_number = 329 sorted by section_id

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title_number 1

part_number 1

agency 1

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
21:21:5.0.1.1.10.0.1.1 21 Food and Drugs I D 329 PART 329—NONPRESCRIPTION HUMAN DRUG PRODUCTS SUBJECT TO SECTION 760 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT       § 329.100 Postmarketing reporting of adverse drug events under section 760 of the Federal Food, Drug, and Cosmetic Act. FDA       (a) Reporting requirements. Reports of serious adverse events required by section 760 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) must include the information specified in this section, as applicable. Except as provided in paragraph (c)(2) of this section, these reports must be submitted to the Agency in electronic format as described in paragraph (c)(1) of this section. (b) Contents of reports. For purposes of reporting serious adverse events under section 760 of the FD&C Act, an individual case safety report (ICSR) constitutes the MedWatch form required to be submitted by section 760(d) of the FD&C Act. ICSRs include the following information: (1) Patient information. (i) Patient identification code; (ii) Patient age at the time of adverse drug experience, or date of birth; (iii) Patient gender; and (iv) Patient weight. (2) Adverse event. (i) Outcome attributed to adverse drug event; (ii) Date of adverse drug event; (iii) Date of ICSR submission; (iv) Description of adverse drug event (including a concise medical narrative); (v) Adverse drug event term(s); (vi) Description of relevant tests, including dates and laboratory data; and (vii) Other relevant patient history, including preexisting medical conditions. (3) Suspect medical product(s). (i) Name; (ii) Dose, frequency, and route of administration used; (iii) Therapy dates; (iv) Diagnosis for use (indication); (v) Whether the product is a combination product as defined in § 3.2(e) of this chapter; (vi) Whether the product is a prescription or nonprescription product; (vii) Whether adverse drug event abated after drug use stopped or dose reduced; (viii) Whether adverse drug event reappeared after reintroduction of drug; (ix) Lot number; (x) Expiration date; (xi) National Drug Code (NDC) number; and (xii) Concomitant medical products and therapy dates. (4) Initial reporter information. (i) Name, address, and telephone number; (ii) Whether the initial reporter is a health care professional; and (iii) Occupation,…

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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);