cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
1 row where part_number = 361 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:5.0.1.1.31.0.1.1 | 21 | Food and Drugs | I | D | 361 | PART 361—PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH | § 361.1 Radioactive drugs for certain research uses. | FDA | [40 FR 31308, July 25, 1975, as amended at 40 FR 44543, Sept. 29, 1975; 42 FR 15674, Mar. 22, 1977; 43 FR 14646, Apr. 7, 1978; 46 FR 8955, Jan. 27, 1981; 49 FR 44460, Nov. 7, 1984; 50 FR 8996, Mar. 6, 1985; 55 FR 11582, Mar. 29, 1990; 56 FR 10806, Mar. 14, 1991; 67 FR 4907, Feb. 1, 2002] | (a) Radioactive drugs (as defined in § 310.3(n) of this chapter) are generally recognized as safe and effective when administered, under the conditions set forth in paragraph (b) of this section, to human research subjects during the course of a research project intended to obtain basic information regarding the metabolism (including kinetics, distribution, and localization) of a radioactively labeled drug or regarding human physiology, pathophysiology, or biochemistry, but not intended for immediate therapeutic, diagnostic, or similar purposes or to determine the safety and effectiveness of the drug in humans for such purposes ( i.e. , to carry out a clinical trial). Certain basic research studies, e.g., studies to determine whether a drug localizes in a particular organ or fluid space and to describe the kinetics of that localization, may have eventual therapeutic or diagnostic implications, but the initial studies are considered to be basic research within the meaning of this section. (b) The conditions under which use of radioactive drugs for research are considered safe and effective are: (1) Approval by Radioactive Drug Research Committee. A Radioactive Drug Research Committee, composed and approved by the Food and Drug Administration in accordance with paragraph (c) of this section, has determined, in accordance with the standards set forth in paragraph (d) of this section, that: (i) The pharmacological dose is within the limits set forth in paragraph (b)(2) of this section; (ii) The radiation dose is within the limits set forth in paragraph (b)(3) of this section; (iii) The radiation exposure is justified by the quality of the study being undertaken and the importance of the information it seeks to obtain; (iv) The study meets the other requirements set forth in paragraph (d) of this section regarding qualifications of the investigator, proper licensure for handling radioactive materials, selection and consent of research subjects, quality of radioactive drugs used, research protocol design, repor… |
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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);