cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
3 rows where part_number = 680 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:7.0.1.1.9.0.1.1 | 21 | Food and Drugs | I | F | 680 | PART 680—ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS | § 680.1 Allergenic Products. | FDA | [38 FR 32100, Nov. 20, 1973, as amended at 49 FR 25432, June 21, 1984; 49 FR 31395, Aug. 7, 1984; 55 FR 11014, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 70 FR 14986, Mar. 24, 2005; 80 FR 18093, Apr. 3, 2015] | (a) Definition. Allergenic Products are products that are administered to man for the diagnosis, prevention or treatment of allergies. (b) Source materials —(1) Criteria for source material. Only specifically identified allergenic source materials that contain no more than a total of 1.0 percent of detectable foreign materials shall be used in the manufacture of Allergenic Products, except that this requirement shall not apply to molds and animals described under paragraphs (b) (2) and (3) of this section, respectively. Source materials such as pelts, feathers, hairs, and danders shall be collected in a manner that will minimize contamination of the source material. (2) Molds. (i) Molds (excluding rusts and smuts) used as source material in the manufacture of Allergenic Products shall meet the requirements of § 610.18 of this chapter and § 680.2 (a) and (b). (ii) Mold cultures shall be free of contaminating materials (including microorganisms) prior to harvest, and care shall be taken to minimize contamination during harvest and subsequent processing. (iii) Mold manufacturers shall maintain written standard operating procedures, developed by a qualified individual, that will ensure the identity of the seed culture, prescribe adequate processing of the mold, and specify the acceptable limits and kinds of contamination. These limits shall be based on results of appropriate tests performed by the manufacturer on at least three consecutive lots of a mold that is a representative species of mold subject to the standard operating procedures. The tests shall be performed at each manufacturing step during and subsequent to harvest, as specified in the standard operating procedures. Before use of the mold as a source material for Allergenic Products, in accordance with 21 CFR 601.2, the standard operating procedures and test data from the three representative lots described above shall be submitted to and approved by the Director, Center for Biologics Evaluation and Research (see mailing address in § 600.2(a) o… | |||||
| 21:21:7.0.1.1.9.0.1.2 | 21 | Food and Drugs | I | F | 680 | PART 680—ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS | § 680.2 Manufacture of Allergenic Products. | FDA | [38 FR 32100, Nov. 20, 1973, as amended at 49 FR 25433, June 21, 1984; 67 FR 9587, Mar. 4, 2002] | (a) Extraneous allergenic substances. All manufacturing steps shall be performed so as to insure that the product will contain only the allergenic and other substances intended to be included in the final product. (b) Cultures derived from microorganisms. Culture media into which organisms are inoculated for the manufacture of Allergenic Products shall contain no allergenic substances other than those necessary as a growth requirement. Neither horse protein nor any allergenic derivative of horse protein shall be used in culture media. (c) Liquid products for oral administration. Liquid products intended for oral administration that are filled in multiple dose final containers shall contain a preservative in a concentration adequate to inhibit microbial growth. (d) Residual pyridine. Products for which pyridine is used in manufacturing shall have no more residual pyridine in the final product than 25 micrograms per milliliter. (e) [Reserved] (f) Records. A record of the history of the manufacture or propagation of each lot of source material intended for manufacture of final Allergenic Products shall be available at the establishment of the manufacturer of the source material, as required by § 211.188 of this chapter. A summary of the history of the manufacture or propagation of the source material shall be available at the establishment of the manufacturer of the final product. | |||||
| 21:21:7.0.1.1.9.0.1.3 | 21 | Food and Drugs | I | F | 680 | PART 680—ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS | § 680.3 Tests. | FDA | [38 FR 32100, Nov. 20, 1973, as amended at 39 FR 19777, June 6, 1974; 41 FR 4015, Jan. 28, 1976; 52 FR 37607, Oct. 8, 1987; 55 FR 11013, Mar. 26, 1990; 67 FR 9587, Mar. 4, 2002; 77 FR 26175, May 3, 2012; 77 FR 30884, May 24, 2012; 80 FR 37974, July 2, 2015] | (a) Identity. When a specific identity test meeting the provisions of § 610.14 of this chapter cannot be performed, the manufacture of each lot shall be separated from the manufacture of other products in a manner that will preclude adulteration, and records made in the course of manufacture shall be in sufficient detail to verify the identity of the product. (b) [Reserved] (c) Sterility. A sterility test shall be performed on each lot of each Allergenic Product as required by § 610.12 of this chapter. (d) [Reserved] (e) Potency. The potency of each lot of each Allergenic Product shall be determined as prescribed in § 610.10 of this chapter. Except as provided in this section, the potency test methods shall measure the allergenic activity of the product. Until manufacturers are notified by the Director, Center for Biologics Evaluation and Research, of the existence of a potency test that measures the allergenic activity of an allergenic product, manufacturers may continue to use unstandardized potency designations. (f) Records. The records related to the testing requirements of this section shall be prepared and maintained as required by §§ 211.165, 211.167, 211.188, and 211.194 of this chapter. |
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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);