Source: http://www.law.cornell.edu/uscode/text/21/371?qt-us_code_tabs=3
Timestamp: 2014-10-26 05:57:25
Document Index: 34981529

Matched Legal Cases: ['§ 371', '§ 371', '§ 371', '§ 701', '§ 32', '§ 2', '§ 2', '§ 21', '§ 103', '§ 8', '§ 6', '§ 3', '§ 3', '§ 405', '§ 619', '§ 3', '§ 4', '§ 8', '§ 3', '§ 3', '§ 8', '§ 4', 'arts 131', '§ 21', '§ 21', '§ 1143', '§ 403', 'art 1502', 'art 1507', 'art 1701', 'art 1702', 'art 1', 'art 2', 'art 3', 'art 4', 'art 5', 'art 7', 'art 10', 'art 11', 'art 12', 'art 13', 'art 14', 'art 15', 'art 16', 'art 17', 'art 19', 'art 20', 'art 21', 'art 25', 'art 26', 'art 50', 'art 54', 'art 56', 'art 58', 'art 60', 'art 70', 'art 71', 'art 73', 'art 74', 'art 80', 'art 81', 'art 82', 'art 99', 'art 100', 'art 101', 'art 102', 'art 104', 'art 105', 'art 106', 'art 107', 'art 108', 'art 109', 'art 110', 'art 111', 'art 113', 'art 114', 'art 115', 'art 118', 'art 119', 'art 120', 'art 123', 'art 129', 'art 130', 'art 131', 'art 133', 'art 135', 'art 136', 'art 137', 'art 139', 'art 145', 'art 146', 'art 150', 'art 152', 'art 155', 'art 156', 'art 158', 'art 160', 'art 161', 'art 163', 'art 164', 'art 165', 'art 166', 'art 168', 'art 169', 'art 170', 'art 171', 'art 172', 'art 174', 'art 180', 'art 181', 'art 182', 'art 184', 'art 186', 'art 189', 'art 190', 'art 200', 'art 201', 'art 202', 'art 203', 'art 205', 'art 206', 'art 207', 'art 208', 'art 209', 'art 210', 'art 211', 'art 212', 'art 216', 'art 225', 'art 226', 'art 250', 'art 290', 'art 299', 'art 300', 'art 310', 'art 312', 'art 314', 'art 315', 'art 316', 'art 320', 'art 328', 'art 330', 'art 331', 'art 332', 'art 333', 'art 335', 'art 336', 'art 338', 'art 340', 'art 341', 'art 343', 'art 344', 'art 346', 'art 347', 'art 348', 'art 349', 'art 350', 'art 352', 'art 355', 'art 357', 'art 358', 'art 361', 'art 369', 'art 500', 'art 501', 'art 502', 'art 509', 'art 510', 'art 511', 'art 514', 'art 515', 'art 516', 'art 530', 'art 556', 'art 558', 'art 570', 'art 571', 'art 579', 'art 582', 'art 584', 'art 589', 'art 600', 'art 606', 'art 607', 'art 610', 'art 630', 'art 640', 'art 660', 'art 680', 'art 700', 'art 701', 'art 710', 'art 720', 'art 73021', 'art 740', 'art 800', 'art 801', 'art 803', 'art 806', 'art 807', 'art 808', 'art 809', 'art 810', 'art 812', 'art 814', 'art 820', 'art 821', 'art 822', 'art 83021', 'art 860', 'art 861', 'art 862', 'art 864', 'art 866', 'art 868', 'art 870', 'art 872', 'art 874', 'art 876', 'art 878', 'art 880', 'art 882', 'art 884', 'art 886', 'art 888', 'art 890', 'art 892', 'art 895', 'art 89721', 'art 898', 'art 1002', 'art 1010', 'art 1020', 'art 1030', 'art 1040', 'art 1050', 'art 1141', 'art 1240', 'art 1250', 'art 23', 'art 160', 'art 174', 'art 179', 'art 180', 'art 186', 'art 10']

21 U.S. Code § 371 - Regulations and hearings | LII / Legal Information Institute
U.S. Code › Title 21 › Chapter 9 › Subchapter VII › Part A › § 371 21 U.S. Code § 371 - Regulations and hearings
Upon the filing of the petition referred to in paragraph (1) of this subsection, the court shall have jurisdiction to affirm the order, or to set it aside in whole or in part, temporarily or permanently. If the order of the Secretary refuses to issue, amend, or repeal a regulation and such order is not in accordance with law the court shall by its judgment order the Secretary to take action, with respect to such regulation, in accordance with law. The findings of the Secretary as to the facts, if supported by substantial evidence, shall be conclusive.
Any action instituted under this subsection shall survive notwithstanding any change in the person occupying the office of Secretary or any vacancy in such office.
Copies of records of hearings A certified copy of the transcript of the record and proceedings under subsection (e) of this section shall be furnished by the Secretary to any interested party at his request, and payment of the costs thereof, and shall be admissible in any criminal, libel for condemnation, exclusion of imports, or other proceeding arising under or in respect to this chapter, irrespective of whether proceedings with respect to the order have previously been instituted or become final under subsection (f) of this section.
The Secretary shall develop guidance documents with public participation and ensure that information identifying the existence of such documents and the documents themselves are made available to the public both in written form and, as feasible, through electronic means. Such documents shall not create or confer any rights for or on any person, although they present the views of the Secretary on matters under the jurisdiction of the Food and Drug Administration.
Although guidance documents shall not be binding on the Secretary, the Secretary shall ensure that employees of the Food and Drug Administration do not deviate from such guidances without appropriate justification and supervisory concurrence. The Secretary shall provide training to employees in how to develop and use guidance documents and shall monitor the development and issuance of such documents.
For guidance documents that set forth initial interpretations of a statute or regulation, changes in interpretation or policy that are of more than a minor nature, complex scientific issues, or highly controversial issues, the Secretary shall ensure public participation prior to implementation of guidance documents, unless the Secretary determines that such prior public participation is not feasible or appropriate. In such cases, the Secretary shall provide for public comment upon implementation and take such comment into account.
With respect to devices, if a notice to industry guidance letter, a notice to industry advisory letter, or any similar notice sets forth initial interpretations of a regulation or policy or sets forth changes in interpretation or policy, such notice shall be treated as a guidance document for purposes of this subparagraph.
For guidance documents that set forth existing practices or minor changes in policy, the Secretary shall provide for public comment upon implementation.
In developing guidance documents, the Secretary shall ensure uniform nomenclature for such documents and uniform internal procedures for approval of such documents. The Secretary shall ensure that guidance documents and revisions of such documents are properly dated and indicate the nonbinding nature of the documents. The Secretary shall periodically review all guidance documents and, where appropriate, revise such documents.
The Secretary, acting through the Commissioner, shall maintain electronically and update and publish periodically in the Federal Register a list of guidance documents. All such documents shall be made available to the public.
The Secretary shall ensure that an effective appeals mechanism is in place to address complaints that the Food and Drug Administration is not developing and using guidance documents in accordance with this subsection.
Not later than July 1, 2000, the Secretary after evaluating the effectiveness of the Good Guidance Practices document, published in the Federal Register at 62 Fed. Reg. 8961, shall promulgate a regulation consistent with this subsection specifying the policies and procedures of the Food and Drug Administration for the development, issuance, and use of guidance documents.
(June 25, 1938, ch. 675, § 701,52 Stat. 1055; June 25, 1948, ch. 646, § 32,62 Stat. 991; Apr. 15, 1954, ch. 143, § 2,68 Stat. 55; Aug. 1, 1956, ch. 861, § 2,70 Stat. 919; Pub. L. 85–791, § 21,Aug. 28, 1958, 72 Stat. 948; Pub. L. 86–618, title I, § 103(a)(4),July 12, 1960, 74 Stat. 398; Pub. L. 101–535, § 8,Nov. 8, 1990, 104 Stat. 2365; Pub. L. 102–300, § 6(b)(1),June 16, 1992, 106 Stat. 240; Pub. L. 103–80, §§ 3(y), (dd)(1), 4
(c),Aug. 13, 1993, 107 Stat. 778, 779; Pub. L. 103–396, § 3(b),Oct. 22, 1994, 108 Stat. 4155; Pub. L. 105–115, title IV, § 405,Nov. 21, 1997, 111 Stat. 2368; Pub. L. 112–144, title VI, § 619,July 9, 2012, 126 Stat. 1063.)
2012—Subsec. (h)(1)(C). Pub. L. 112–144designated existing provisions as cl. (i) and added cl. (ii).
1997—Subsec. (h). Pub. L. 105–115added subsec. (h).
1994—Subsec. (e)(1). Pub. L. 103–396which directed the amendment of par. (1) by striking out “or maple syrup (regulated under section 168.140 of title 21, Code of Federal Regulations).”, was executed by striking out “or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)” before “shall be begun by a proposal”, to reflect the probable intent of Congress.
1993—Subsec. (b). Pub. L. 103–80, § 3(dd)(1), substituted “Health and Human Services” for “Agriculture” in two places.
Subsec. (e)(1). Pub. L. 103–80, § 4(c), made technical correction to directory language of Pub. L. 101–535, § 8. See 1990 Amendment note below.
Pub. L. 103–80, § 3(y)(1), struck out period after second reference to “Regulations)”.
Subsec. (f)(4). Pub. L. 103–80, § 3(y)(2), substituted reference to section 1254 of title 28 for “sections 239 and 240 of the Judicial Code, as amended”.
1990—Subsec. (e)(1). Pub. L. 101–535, § 8, as amended by Pub. L. 103–80, § 4(c), substituted “Any action for the issuance, amendment, or repeal of any regulation under section 343
(d) or (h) of this title, and any action for the amendment or repeal of any definition and standard of identity under section 341 of this title for any dairy product (including products regulated under parts 131, 133 and 135 of title 21, Code of Federal Regulations) or maple sirup (regulated under section 168.140 of title 21, Code of Federal Regulations)” for “Any action for the issuance, amendment, or repeal of any regulation under section 341, 343
(d) or (h) of this title”.
1960—Subsec. (e). Pub. L. 86–618substituted “section 341, 343
(d) or (h), of this title” for “section 341, 343
(d) or (h), 354 or 364 of this title”.
1958—Subsec. (f)(1). Pub. L. 85–791, § 21(a), substituted provisions requiring transmission of a copy of the petition by clerk to Secretary, and filing of the record by Secretary, for provisions which permitted service of summons and petition any place in United States and required Secretary to certify and file transcript of the proceedings and record upon service.
Subsec. (f)(3). Pub. L. 85–791, § 21(b), inserted “Upon the filing of the petition referred to in paragraph (1) of this subsection”.
Pub. L. 112–144, title XI, § 1143,July 9, 2012, 126 Stat. 1130, provided that:
“(a) In General.—The Food and Drug Administration may not issue any draft or final guidance on the regulation of laboratory-developed tests under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) without, at least 60 days prior to such issuance—
“(1) notifying the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor, and Pensions of the Senate of the Administration’s intent to take such action; and
“(2) including in such notification the anticipated details of such action.
“(b) Sunset.—Subsection (a) shall cease to have force or effect on the date that is 5 years after the date of enactment of this Act [July 9, 2012].”
Pub. L. 105–115, title IV, § 403,Nov. 21, 1997, 111 Stat. 2367, provided that:
This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.16 CFR - Commercial Practices16 CFR Part 1502 - PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING16 CFR Part 1507 - FIREWORKS DEVICES16 CFR Part 1701 - STATEMENTS OF POLICY AND INTERPRETATION16 CFR Part 1702 - PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS
21 CFR - Food and Drugs21 CFR Part 1 - GENERAL ENFORCEMENT REGULATIONS21 CFR Part 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS21 CFR Part 3 - PRODUCT JURISDICTION21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS21 CFR Part 5 - ORGANIZATION21 CFR Part 7 - ENFORCEMENT POLICY21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION21 CFR Part 17 - CIVIL MONEY PENALTIES HEARINGS21 CFR Part 19 - STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST21 CFR Part 20 - PUBLIC INFORMATION21 CFR Part 21 - PROTECTION OF PRIVACY21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS21 CFR Part 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES21 CFR Part 60 - PATENT TERM RESTORATION21 CFR Part 70 - COLOR ADDITIVES21 CFR Part 71 - COLOR ADDITIVE PETITIONS21 CFR Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION21 CFR Part 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION21 CFR Part 80 - COLOR ADDITIVE CERTIFICATION21 CFR Part 81 - GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS21 CFR Part 82 - LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS21 CFR Part 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES21 CFR Part 100 - GENERAL21 CFR Part 101 - FOOD LABELING21 CFR Part 102 - COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS21 CFR Part 104 - NUTRITIONAL QUALITY GUIDELINES FOR FOODS21 CFR Part 105 - FOODS FOR SPECIAL DIETARY USE21 CFR Part 106 - INFANT FORMULA QUALITY CONTROL PROCEDURES21 CFR Part 107 - INFANT FORMULA21 CFR Part 108 - EMERGENCY PERMIT CONTROL21 CFR Part 109 - UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL21 CFR Part 110 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD21 CFR Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS21 CFR Part 113 - THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS21 CFR Part 114 - ACIDIFIED FOODS21 CFR Part 115 - SHELL EGGS21 CFR Part 118 - PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS21 CFR Part 119 - DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK21 CFR Part 120 - HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS21 CFR Part 123 - FISH AND FISHERY PRODUCTS21 CFR Part 129 - PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER21 CFR Part 130 - FOOD STANDARDS: GENERAL21 CFR Part 131 - MILK AND CREAM21 CFR Part 133 - CHEESES AND RELATED CHEESE PRODUCTS21 CFR Part 135 - FROZEN DESSERTS21 CFR Part 136 - BAKERY PRODUCTS21 CFR Part 137 - CEREAL FLOURS AND RELATED PRODUCTS21 CFR Part 139 - MACARONI AND NOODLE PRODUCTS21 CFR Part 145 - CANNED FRUITS21 CFR Part 146 - CANNED FRUIT JUICES21 CFR Part 150 - FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS21 CFR Part 152 - FRUIT PIES21 CFR Part 155 - CANNED VEGETABLES21 CFR Part 156 - VEGETABLE JUICES21 CFR Part 158 - FROZEN VEGETABLES21 CFR Part 160 - EGGS AND EGG PRODUCTS21 CFR Part 161 - FISH AND SHELLFISH21 CFR Part 163 - CACAO PRODUCTS21 CFR Part 164 - TREE NUT AND PEANUT PRODUCTS21 CFR Part 165 - BEVERAGES21 CFR Part 166 - MARGARINE21 CFR Part 168 - SWEETENERS AND TABLE SIRUPS21 CFR Part 169 - FOOD DRESSINGS AND FLAVORINGS21 CFR Part 170 - FOOD ADDITIVES21 CFR Part 171 - FOOD ADDITIVE PETITIONS21 CFR Part 172 - FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION21 CFR Part 174 - INDIRECT FOOD ADDITIVES: GENERAL21 CFR Part 180 - FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY21 CFR Part 181 - PRIOR-SANCTIONED FOOD INGREDIENTS21 CFR Part 182 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE21 CFR Part 184 - DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE21 CFR Part 186 - INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE21 CFR Part 189 - SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD21 CFR Part 190 - DIETARY SUPPLEMENTS21 CFR Part 200 - GENERAL21 CFR Part 201 - LABELING21 CFR Part 202 - PRESCRIPTION DRUG ADVERTISING21 CFR Part 203 - PRESCRIPTION DRUG MARKETING21 CFR Part 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS21 CFR Part 206 - IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE21 CFR Part 207 - REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION21 CFR Part 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS21 CFR Part 209 - REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT21 CFR Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS21 CFR Part 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS21 CFR Part 216 - PHARMACY COMPOUNDING21 CFR Part 225 - CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS21 CFR Part 226 - CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES21 CFR Part 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS21 CFR Part 290 - CONTROLLED DRUGS21 CFR Part 299 - DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES21 CFR Part 300 - GENERAL21 CFR Part 310 - NEW DRUGS21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG21 CFR Part 315 - DIAGNOSTIC RADIOPHARMACEUTICALS21 CFR Part 316 - ORPHAN DRUGS21 CFR Part 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS21 CFR Part 328 - OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL21 CFR Part 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED21 CFR Part 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE21 CFR Part 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 335 - ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 340 - STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 343 - INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 344 - TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 347 - SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 349 - OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 350 - ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 352 - SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]21 CFR Part 355 - ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 357 - MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 358 - MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE21 CFR Part 361 - PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH21 CFR Part 369 - INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE21 CFR Part 500 - GENERAL21 CFR Part 501 - ANIMAL FOOD LABELING21 CFR Part 502 - COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS21 CFR Part 509 - UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL21 CFR Part 510 - NEW ANIMAL DRUGS21 CFR Part 511 - NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE21 CFR Part 514 - NEW ANIMAL DRUG APPLICATIONS21 CFR Part 515 - MEDICATED FEED MILL LICENSE21 CFR Part 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES21 CFR Part 530 - EXTRALABEL DRUG USE IN ANIMALS21 CFR Part 556 - TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD21 CFR Part 558 - NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS21 CFR Part 570 - FOOD ADDITIVES21 CFR Part 571 - FOOD ADDITIVE PETITIONS21 CFR Part 579 - IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD21 CFR Part 582 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE21 CFR Part 584 - FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS21 CFR Part 589 - SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS21 CFR Part 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS21 CFR Part 630 - GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES21 CFR Part 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS21 CFR Part 700 - GENERAL21 CFR Part 701 - COSMETIC LABELING21 CFR Part 710 - VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS21 CFR Part 720 - VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS21 CFR Part 73021 CFR Part 740 - COSMETIC PRODUCT WARNING STATEMENTS21 CFR Part 800 - GENERAL21 CFR Part 801 - LABELING21 CFR Part 803 - MEDICAL DEVICE REPORTING21 CFR Part 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS21 CFR Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES21 CFR Part 808 - EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS21 CFR Part 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE21 CFR Part 810 - MEDICAL DEVICE RECALL AUTHORITY21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES21 CFR Part 820 - QUALITY SYSTEM REGULATION21 CFR Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS21 CFR Part 822 - POSTMARKET SURVEILLANCE21 CFR Part 83021 CFR Part 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES21 CFR Part 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT21 CFR Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES21 CFR Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES21 CFR Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES21 CFR Part 868 - ANESTHESIOLOGY DEVICES21 CFR Part 870 - CARDIOVASCULAR DEVICES21 CFR Part 872 - DENTAL DEVICES21 CFR Part 874 - EAR, NOSE, AND THROAT DEVICES21 CFR Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES21 CFR Part 878 - GENERAL AND PLASTIC SURGERY DEVICES21 CFR Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES21 CFR Part 882 - NEUROLOGICAL DEVICES21 CFR Part 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES21 CFR Part 886 - OPHTHALMIC DEVICES21 CFR Part 888 - ORTHOPEDIC DEVICES21 CFR Part 890 - PHYSICAL MEDICINE DEVICES21 CFR Part 892 - RADIOLOGY DEVICES21 CFR Part 895 - BANNED DEVICES21 CFR Part 89721 CFR Part 898 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES21 CFR Part 1002 - RECORDS AND REPORTS21 CFR Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL21 CFR Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS21 CFR Part 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS21 CFR Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS21 CFR Part 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS21 CFR Part 1141 - CIGARETTE PACKAGE AND ADVERTISING WARNINGS21 CFR Part 1240 - CONTROL OF COMMUNICABLE DISEASES21 CFR Part 1250 - INTERSTATE CONVEYANCE SANITATION
40 CFR - Protection of Environment40 CFR Part 23 - JUDICIAL REVIEW UNDER EPA-ADMINISTERED STATUTES40 CFR Part 160 - GOOD LABORATORY PRACTICE STANDARDS40 CFR Part 174 - PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS40 CFR Part 179 - FORMAL EVIDENTIARY PUBLIC HEARING40 CFR Part 180 - TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD40 CFR Part 186
42 CFR - Public Health42 CFR Part 10 - 340B DRUG PRICING PROGRAM