This database provides information on standards that have been incorporated by reference into the US Code of Federal Regulations (CFR). To obtain copies of the standards referenced, information should be provided in the referenced CFR section about how to obtain a copy. Alternatively, individuals can check with the standards publisher, a standards resellers or for a limited number of standards used in regulations, consult the American National Standards Institute (ANSI) Incorporated by Reference (IBR) Portal. This portal provides a mechanism for limited and free access to some of the standards that have been incorporated by reference in the U.S. Code of Federal Regulations (CFR).
Incorporated by (Agency) | FR Citation | CFR Citation Sort ascending | Document Number | Document Edition / Year | Title of Standard | Standard Publishing Organization |
---|---|---|---|---|---|---|
Health and Human Services Department | 89 FR 7496 | 21 CFR 820 | ISO 9000:2015(E), Clause 3 | 2015 | Medical Devices; Quality System Regulation Amendments | International Organization for Standardization |
Health and Human Services Department | 89 FR 7496 | 21 CFR 820 | ISO 13485:2016(E) | 2016 | Medical Devices; Quality System Regulation Amendments | International Organization for Standardization |
Health and Human Services Department | 87 FR 50698 | 21 CFR 808 | ANSI/CTA-2051 | 2017 | Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | Consumer Technology Association |
Health and Human Services Department | 87 FR 50698 | 21 CFR 808 | ANSI/ASA S3.22-2014 (R2020) | 2014 | Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | American National Standards Institute |
Food and Drug Administration | 21 CFR 801.430(f)(2) | ASTM D3492 | 1997 | Standard Specification for Rubber Contraceptives (Male Condoms) | ASTM International | |
Food and Drug Administration | 21 CFR 801.420(c)(4) | ANSI S3.22 | 2003 | Specification for Hearing Aid Characteristics | American National Standards Institute | |
Food and Drug Administration | 21 CFR 801.410(d)(2) | ASTM D412 | 1968 | Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers-Tension | ASTM International | |
Food and Drug Administration | 21 CFR 801.410(d)(2) | ASTM D1415 | 1988 | Standard Test Method for Rubber Property--International Hardness | ASTM International | |
Health and Human Services Department | 87 FR 50698 | 21 CFR 801 | ANSI/CTA 2051-2017 | 2017 | Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | Consumer Technology Association |
Health and Human Services Department | 87 FR 50698 | 21 CFR 801 | ANSI ASA S3.22-2014 (R2020) | 2014 | Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | Acoustical Society of America |
Health and Human Services Department | 87 FR 50698 | 21 CFR 800 | CTA 2051-2017 | 2017 | Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | American National Standards Institute |
Health and Human Services Department | 87 FR 50698 | 21 CFR 800 | ANSI ASA S3.22-2014 (R2020) | 2014 | Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids | American National Standards Institute |
Food and Drug Administration | 21 CFR 73.585(b)(1) | LNPI S.O.P. number: Lab/119/01, Revision 01 | 2001 | Qualitative Analysis of Lycopene, Its Isomers and Other Carotenoids in Different Concentrations of Lyc-O-Mato® (Tomato Oleoresin) and in Tomato Pulp by High Performance Liquid Chromatography (HPLC) | LycoRed Natural Products Industries | |
Food and Drug Administration | 21 CFR 73.450(b) | Food Chemicals Codex | 1981 | Riboflavin | National Academy Press | |
Food and Drug Administration | 21 CFR 73.450(a)(1) | Food Chemicals Codex | 1981 | Riboflavin | National Academy Press | |
Food and Drug Administration | 21 CFR 73.165(b) | Food Chemicals Codex | 1996 | Ferrous lactate | National Academy Press | |
Food and Drug Administration | 21 CFR 73.160(b) | Food Chemicals Codex | 1981 | Ferrous Gluconate | National Academy Press | |
Food and Drug Administration | 21 CFR 73.160(a) | Food Chemicals Codex | 1981 | Ferrous Gluconate | National Academy Press | |
Health and Human Services Department | 87 FR 58445 | 21 CFR 73 | FCC 13 : limestone, ground | 2022 | Listing of Color Additives Exempt From Certification; Calcium Carbonate | Food and Drug Administration, U.S. Department of Health and Human Services |
Health and Human Services Department | 87 FR 58445 | 21 CFR 73 | CAS 471-34-1 | 2022 | Listing of Color Additives Exempt From Certification; Calcium Carbonate | U.S. Pharmacopeial Convention |
Food and Drug Administration | 21 CFR 701.3(c)(2)(iv) | Food Chemicals Codex | 1972 | Food Chemicals Codex, 2nd Edition | National Academy Press | |
Food and Drug Administration | 21 CFR 701.3(c)(2)(iv) | Food Chemicals Codex | 1974 | Food Chemicals Codex, First Supplement | National Academy Press | |
Food and Drug Administration | 21 CFR 701.3(c)(2)(iv) | Food Chemicals Codex | 1975 | Food Chemicals Codex, Second Supplement | National Academy Press | |
Food and Drug Administration | 21 CFR 701.3(c)(2)(i) | CTFA Publication | 1977 | Cosmetic Ingredient Dictionary | Cosmetic, Toiletry, and Fragrance Association, Inc. | |
Food and Drug Administration | 21 CFR 700.27(a)(6) | AOAC Method Ca 3a-46 | 1997 | Insoluble Impurities | AOAC International | |
Food and Drug Administration | 21 CFR 610.12(f) | The United States Pharmacopeia | 1995 | United States Pharmacopeia | U.S. Pharmacopeial Convention | |
Food and Drug Administration | 21 CFR 573.640(b)(4)(ii) | AOAC Official Methods | 1975 | Official Methods of Analysis | AOAC International | |
Food and Drug Administration | 21 CFR 573.640(b)(4)(ii) | AOAC Journal | 1961 | Oils, Fats, and Waxes, Vol. 44, Page 146 | AOAC International | |
Food and Drug Administration | 21 CFR 573.640(b)(4)(i) | AOAC Official Methods | 1980 | Official Methods of Analysis | AOAC International | |
Food and Drug Administration | 21 CFR 573.460(a)(2)(i) | AAFCO Publication | 2003 | Official Publication | Association of American Feed Control Officials, Inc. | |
Food and Drug Administration | 21 CFR 573.460(a)(1)(i) | AAFCO Publication | 2003 | Official Publication | Association of American Feed Control Officials, Inc. | |
Food and Drug Administration | 21 CFR 522.2640(a) | FDA Publication | 2012 | Determination of Factor Content in Tylosin by High Performance Liquid Chromatography | Food and Drug Administration, U.S. Department of Health and Human Services | |
Food and Drug Administration | 21 CFR 522.2640(a) | FDA Publication | 2001 | Determination of Factor Content in Tylosin by High Performance Liquid Chromatography | Food and Drug Administration, U.S. Department of Health and Human Services | |
Health and Human Services Department | 89 FR 51738 | 21 CFR 514 | ISO 9000 | 2015 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 514 | ISO 13485 | 2016 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 4 | ISO 9000 | 2015 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 7496 | 21 CFR 4 | ISO 13485:2016(E) | 2016 | Medical Devices; Quality System Regulation Amendments | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 4 | ISO 13485 | 2016 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 7496 | 21 CFR 4 | ISO 9000:2015(E), Clause 3 | 2015 | Medical Devices; Quality System Regulation Amendments | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 314 | ISO 9000 | 2015 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 314 | ISO 13485 | 2016 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Food and Drug Administration | 21 CFR 299.4(d) | USAN and the USP Dictionary of Drug Names | 1985 | Guiding Principles for Coining U.S. Adopted Names for Drugs | U.S. Pharmacopeial Convention | |
Food and Drug Administration | 21 CFR 26.60(b) | ISO Guide 2 | 1996 | Standardization and Related Activities-General Vocabulary of the ISO and IEC | International Organization for Standardization | |
Health and Human Services Department | 89 FR 51738 | 21 CFR 230 | ISO 9000 | 2015 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 230 | ISO 13485 | 2016 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 213 | ISO 9000 | 2015 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Food and Drug Administration | 21 CFR 211.176 | FDA Publication | 2012 | Procedures for Detecting and Measuring Penicillin Contamination in Drugs | Food and Drug Administration, U.S. Department of Health and Human Services | |
Food and Drug Administration | 21 CFR 211.176 | FDA Publication | 1989 | Procedures for Detecting and Measuring Penicillin Contamination in Drugs | Food and Drug Administration, U.S. Department of Health and Human Services | |
Health and Human Services Department | 89 FR 51738 | 21 CFR 211 | ISO 9000 | 2015 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |
Health and Human Services Department | 89 FR 51738 | 21 CFR 211 | ISO 13485 | 2016 | Current Good Manufacturing Practice, Certification, Postmarketing Safety Reporting, and Labeling Requirements for Certain Medical Gases | International Organization for Standardization |