cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
2 rows where part_number = 216 and title_number = 21 sorted by section_id
This data as json, CSV (advanced)
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:4.0.1.1.14.2.1.1 | 21 | Food and Drugs | I | C | 216 | PART 216—HUMAN DRUG COMPOUNDING | B | Subpart B—Compounded Drug Products | § 216.23 Bulk drug substances that can be used to compound drug products in accordance with section 503A of the Federal Food, Drug, and Cosmetic Act. | FDA | [84 FR 4710, Feb. 19, 2019] | (a) The following bulk drug substances can be used in compounding under section 503A(b)(1)(A)(i)(III) of the Federal Food, Drug, and Cosmetic Act. (1) Brilliant Blue G, also known as Coomassie Brilliant Blue G-250. (2) Cantharidin (for topical use only). (3) Diphenylcyclopropenone (for topical use only). (4) N-acetyl-D-glucosamine (for topical use only). (5) Squaric acid dibutyl ester (for topical use only). (6) Thymol iodide (for topical use only). (b) After balancing the criteria set forth in paragraph (c) of this section, FDA has determined that the following bulk drug substances will not be included on the list of substances that can be used in compounding set forth in paragraph (a) of this section: (1) Oxitriptan. (2) Piracetam. (3) Silver Protein Mild. (4) Tranilast. (c) FDA will use the following criteria in evaluating substances considered for inclusion on the list set forth in paragraph (a) of this section: (1) The physical and chemical characterization of the substance; (2) Any safety issues raised by the use of the substance in compounded drug products; (3) The available evidence of the effectiveness or lack of effectiveness of a drug product compounded with the substance, if any such evidence exists; and (4) Historical use of the substance in compounded drug products, including information about the medical condition(s) the substance has been used to treat and any references in peer-reviewed medical literature. (d) Based on evidence currently available, there are inadequate data to demonstrate the safety or efficacy of any drug product compounded using any of the drug substances listed in paragraph (a) of this section, or to establish general recognition of the safety or effectiveness of any such drug product. Any person who represents that a compounded drug made with a bulk drug substance that appears on this list is FDA approved, or otherwise endorsed by FDA generally or for a particular indication, will cause the drug to be misbranded under section 502(a) and/or 502(bb) of the Fede… | |||
| 21:21:4.0.1.1.14.2.1.2 | 21 | Food and Drugs | I | C | 216 | PART 216—HUMAN DRUG COMPOUNDING | B | Subpart B—Compounded Drug Products | § 216.24 Drug products withdrawn or removed from the market for reasons of safety or effectiveness. | FDA | [81 FR 69676, Oct. 7, 2016, as amended at 83 FR 63573, Dec. 11, 2018] | The following drug products were withdrawn or removed from the market because such drug products or components of such drug products have been found to be unsafe or not effective. The following drug products may not be compounded under the exemptions provided by section 503A(a) or section 503B(a) of the Federal Food, Drug, and Cosmetic Act: Adenosine phosphate: All drug products containing adenosine phosphate. Adrenal cortex: All drug products containing adrenal cortex. Alatrofloxacin mesylate: All drug products containing alatrofloxacin mesylate. Aminopyrine: All drug products containing aminopyrine. Astemizole: All drug products containing astemizole. Azaribine: All drug products containing azaribine. Benoxaprofen: All drug products containing benoxaprofen. Bithionol: All drug products containing bithionol. Bromfenac sodium: All drug products containing bromfenac sodium (except ophthalmic solutions). Bromocriptine mesylate: All drug products containing bromocriptine mesylate for prevention of physiological lactation. Butamben: All parenteral drug products containing butamben. Camphorated oil: All drug products containing camphorated oil. Carbetapentane citrate: All oral gel drug products containing carbetapentane citrate. Casein, iodinated: All drug products containing iodinated casein. Cerivastatin sodium: All drug products containing cerivastatin sodium. Chloramphenicol: All oral drug products containing chloramphenicol. Chlorhexidine gluconate: All tinctures of chlorhexidine gluconate formulated for use as a patient preoperative skin preparation. Chlormadinone acetate: All drug products containing chlormadinone acetate. Chloroform: All drug products containing chloroform. Cisapride: All drug products containing cisapride. Cobalt: All drug products containing cobalt salts (except radioactive forms of cobalt and its salts and cobalamin and its derivatives). Dexfenfluramine hydrochloride: All drug products containing d… |
Advanced export
JSON shape: default, array, newline-delimited, object
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);