cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
7 rows where part_number = 2 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:1.0.1.1.2.1.98.1 | 21 | Food and Drugs | I | A | 2 | PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | A | Subpart A—General Provisions | § 2.5 Imminent hazard to the public health. | FDA | (a) Within the meaning of the Federal Food, Drug, and Cosmetic Act an imminent hazard to the public health is considered to exist when the evidence is sufficient to show that a product or practice, posing a significant threat of danger to health, creates a public health situation (1) that should be corrected immediately to prevent injury and (2) that should not be permitted to continue while a hearing or other formal proceeding is being held. The imminent hazard may be declared at any point in the chain of events which may ultimately result in harm to the public health. The occurrence of the final anticipated injury is not essential to establish that an imminent hazard of such occurrence exists. (b) In exercising his judgment on whether an imminent hazard exists, the Commissioner will consider the number of injuries anticipated and the nature, severity, and duration of the anticipated injury. | ||||
| 21:21:1.0.1.1.2.1.98.2 | 21 | Food and Drugs | I | A | 2 | PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | A | Subpart A—General Provisions | § 2.10 Examination and investigation samples. | FDA | [42 FR 15559, Mar. 22, 1977, as amended at 63 FR 51299, Sept. 25, 1998] | (a)(1) When any officer or employee of the Department collects a sample of a food, drug, or cosmetic for analysis under the act, the sample shall be designated as an official sample if records or other evidence is obtained by him or any other officer or employee of the Department indicating that the shipment or other lot of the article from which such sample was collected was introduced or delivered for introduction into interstate commerce, or was in or was received in interstate commerce, or was manufactured within a Territory. Only samples so designated by an officer or employee of the Department shall be considered to be official samples. (2) For the purpose of determining whether or not a sample is collected for analysis, the term analysis includes examinations and tests. (3) The owner of a food, drug, or cosmetic of which an official sample is collected is the person who owns the shipment or other lot of the article from which the sample is collected. (b) When an officer or employee of the Department collects an official sample of a food, drug, or cosmetic for analysis under the act, he shall collect at least twice the quantity estimated by him to be sufficient for analysis, unless: (1) The amount of the article available and reasonably accessible for sampling is less than twice the quantity so estimated, in which case he shall collect as much as is available and reasonably accessible. (2) The cost of twice the quantity so estimated exceeds $150. (3) The sample cannot by diligent use of practicable preservation techniques available to the Food and Drug Administration be kept in a state in which it could be readily and meaningfully analyzed in the same manner and for the same purposes as the Food and Drug Administration's analysis. (4) The sample is collected from a shipment or other lot which is being imported or offered for import into the United States. (5) The sample is collected from a person named on the label of the article or his agent, and such person is also the owner of the article. (6)… | |||
| 21:21:1.0.1.1.2.1.98.3 | 21 | Food and Drugs | I | A | 2 | PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | A | Subpart A—General Provisions | § 2.19 Methods of analysis. | FDA | [42 FR 15559, Mar. 22, 1977, as amended at 47 FR 946, Jan. 8, 1982; 54 FR 9034, Mar. 3, 1989; 70 FR 40880, July 15, 2005; 70 FR 67651, Nov. 8, 2005] | Where the method of analysis is not prescribed in a regulation, it is the policy of the Food and Drug Administration in its enforcement programs to utilize the methods of analysis of the AOAC INTERNATIONAL (AOAC) as published in the latest edition (13th Ed., 1980) of their publication “Official Methods of Analysis of the Association of Official Analytical Chemists,” and the supplements thereto (“Changes in Methods” as published in the March issues of the “Journal of the Association of Official Analytical Chemists”), which are incorporated by reference, when available and applicable. Copies are available from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. In the absence of an AOAC method, the Commissioner will furnish a copy of the particular method, or a reference to the published method, that the Food and Drug Administration will use in its enforcement program. Other methods may be used for quality control, specifications, contracts, surveys, and similar nonregulatory functions, but it is expected that they will be calibrated in terms of the method which the Food and Drug Administration uses in its enforcement program. Use of an AOAC method does not relieve the practioner of the responsibility to demonstrate that he can perform the method properly through the use of positive and negative controls and recovery and reproducibility studies. | |||
| 21:21:1.0.1.1.2.2.98.1 | 21 | Food and Drugs | I | A | 2 | PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | B | Subpart B—Human and Animal Foods | § 2.25 Grain seed treated with poisonous substances; color identification to prevent adulteration of human and animal food. | FDA | (a) In recent years there has developed increasing use of poisonous treatments on seed for fungicidal and other purposes. Such treated seed, if consumed, presents a hazard to humans and livestock. It is not unusual for stocks of such treated food seeds to remain on hand after the planting season has passed. Despite the cautions required by the Federal Seed Act (53 Stat. 1275, as amended 72 Stat. 476, 7 U.S.C. 1551 et seq. ) in the labeling of the treated seed, the Food and Drug Administration has encountered many cases where such surplus stocks of treated wheat, corn, oats, rye, barley, and sorghum seed had been mixed with untreated seed and sent to market for food or feed use. This has resulted in livestock injury and in legal actions under the Federal Food, Drug, and Cosmetic Act against large quantities of food adulterated through such admixture of poisonous treated seeds with good food. Criminal cases were brought against some firms and individuals. Where the treated seeds are prominently colored, buyers and users or processors of agricultural food seed for food purposes are able to detect the admixture of the poisonous seed and thus reject the lots; but most such buyers, users, and processors do not have the facilities or scientific equipment to determine the presence of the poisonous chemical at the time crops are delivered, in cases where the treated seeds have not been so colored. A suitable color for this use is one that is in sufficient contrast to the natural color of the food seed as to make admixture of treated, denatured seeds with good food easily apparent, and is so applied that it is not readily removed. (b) On and after December 31, 1964, the Food and Drug Administration will regard as adulterated any interstate shipment of the food seeds wheat, corn, oats, rye, barley, and sorghum bearing a poisonous treatment in excess of a recognized tolerance or treatment for which no tolerance or exemption from tolerance is recognized in regulations promulgated pursuant to section 408 of the Federal Food,… | ||||
| 21:21:1.0.1.1.2.2.98.2 | 21 | Food and Drugs | I | A | 2 | PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | B | Subpart B—Human and Animal Foods | § 2.35 Use of secondhand containers for the shipment or storage of food and animal feed. | FDA | (a) Investigations by the Food and Drug Administration, the National Communicable Disease Center of the U.S. Public Health Service, the Consumer and Marketing Service of the U.S. Department of Agriculture, and by various State public health agencies have revealed practices whereby food and animal feed stored or shipped in secondhand containers have been rendered dangerous to health. Such contamination has been the result of the original use of these containers for the storage and shipment of articles containing or bearing disease organisms or poisonous or deleterious substances. (b) The Commissioner concludes that such dangerous or potentially dangerous practices include, but are not limited to, the following: (1) Some vegetable growers and packers employ used poultry crates for shipment of fresh vegetables, including cabbage and celery. Salmonella organisms are commonly present on dressed poultry and in excreta and fluid exudates from dressed birds. Thus wooden crates in which dressed poultry has been iced and packed are potential sources of Salmonella or other enteropathogenic microorganisms that may contaminate fresh vegetables which are frequently consumed without heat treatment. (2) Some potato growers and producers of animal feeds use secondhand bags for shipment of these articles. Such bags may have originally been used for shipping or storing pesticide-treated seed or other articles bearing or containing poisonous substances. Thus these secondhand bags are potential sources of contamination of the food or animal feed stored or shipped therein. (c) In a policy statement issued April 11, 1968, the Food and Drug Administration declared adulterated within the meaning of section 402(a) of the Federal Food, Drug, and Cosmetic Act shipments of vegetables or other edible food in used crates or containers that may render the contents injurious to health. This policy statement is extended so that the Food and Drug Administration will regard as adulterated within the meaning of section 402(a) of the act shipment… | ||||
| 21:21:1.0.1.1.2.4.98.1 | 21 | Food and Drugs | I | A | 2 | PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | F | Subpart F—Caustic Poisons | § 2.110 Definition of ammonia under Federal Caustic Poison Act. | FDA | For the purpose of determining whether an article containing ammonia is subject to the Federal Caustic Poison Act, the ammonia content is to be calculated as NH 3 . | ||||
| 21:21:1.0.1.1.2.5.98.1 | 21 | Food and Drugs | I | A | 2 | PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS | G | Subpart G—Provisions Applicable to Specific Products Subject to the Federal Food, Drug, and Cosmetic Act | § 2.125 Use of ozone-depleting substances in foods, drugs, devices, or cosmetics. | FDA | [67 FR 48384, July 24, 2002, as amended at 71 FR 70873, Dec. 7, 2006; 70 FR 17192, Apr. 4, 2005; 75 FR 19241, Apr. 14, 2010; 73 FR 69552, Nov. 19, 2008; 75 FR 19241, Apr. 14, 2010; 81 FR 74302, Oct. 26, 2016] | (a) As used in this section, ozone-depleting substance (ODS) means any class I substance as defined in 40 CFR part 82, appendix A to subpart A, or class II substance as defined in 40 CFR part 82, appendix B to subpart A. (b) Except as provided in paragraph (c) of this section, any food, drug, device, or cosmetic that is, consists in part of, or is contained in an aerosol product or other pressurized dispenser that releases an ODS is not an essential use of the ODS under the Clean Air Act. (c) A food, drug, device, or cosmetic that is, consists in part of, or is contained in an aerosol product or other pressurized dispenser that releases an ODS is an essential use of the ODS under the Clean Air Act if paragraph (e) of this section specifies the use of that product as essential. For drugs, including biologics and animal drugs, and for devices, an investigational application or an approved marketing application must be in effect, as applicable. (d) [Reserved] (e) The use of ODSs in the following products is essential: (1) Metered-dose corticosteroid human drugs for oral inhalation. Oral pressurized metered-dose inhalers containing the following active moieties: (i)-(v) [Reserved] (2) Metered-dose short-acting adrenergic bronchodilator human drugs for oral inhalation. Oral pressurized metered-dose inhalers containing the following active moieties: (i)-(v) [Reserved] (3) [Reserved] (4) Other essential uses. (i)-(ii) [Reserved] (iii) Anesthetic drugs for topical use on accessible mucous membranes of humans where a cannula is used for application. (iv)-(ix) [Reserved] (f) Any person may file a petition under part 10 of this chapter to request that FDA initiate rulemaking to amend paragraph (e) of this section to add an essential use. FDA may initiate notice-and-comment rulemaking to add an essential use on its own initiative or in response to a petition, if granted. (1) If the petition is to add use of a noninvestigational product, the petitioner must submit compelling evidence that: (i) Substanti… |
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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);