21 U.S. Code § 371 - Regulations and hearings

prev | next
(a) Authority to promulgate regulations
The authority to promulgate regulations for the efficient enforcement of this chapter, except as otherwise provided in this section, is vested in the Secretary.
(b) Regulations for imports and exports
The Secretary of the Treasury and the Secretary of Health and Human Services shall jointly prescribe regulations for the efficient enforcement of the provisions of section 381 of this title, except as otherwise provided therein. Such regulations shall be promulgated in such manner and take effect at such time, after due notice, as the Secretary of Health and Human Services shall determine.
(c) Conduct of hearings
Hearings authorized or required by this chapter shall be conducted by the Secretary or such officer or employee as he may designate for the purpose.
(d) Effectiveness of definitions and standards of identity
The definitions and standards of identity promulgated in accordance with the provisions of this chapter shall be effective for the purposes of the enforcement of this chapter, notwithstanding such definitions and standards as may be contained in other laws of the United States and regulations promulgated thereunder.
(e) Procedure for establishment
(1) Any action for the issuance, amendment, or repeal of any regulation under section 343 (j), 344 (a), 346, 351 (b), or 352 (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) shall be begun by a proposal made
(A) by the Secretary on his own initiative, or
(B) by petition of any interested person, showing reasonable grounds therefor, filed with the Secretary. The Secretary shall publish such proposal and shall afford all interested persons an opportunity to present their views thereon, orally or in writing. As soon as practicable thereafter, the Secretary shall by order act upon such proposal and shall make such order public. Except as provided in paragraph (2), the order shall become effective at such time as may be specified therein, but not prior to the day following the last day on which objections may be filed under such paragraph.
(2) On or before the thirtieth day after the date on which an order entered under paragraph (1) is made public, any person who will be adversely affected by such order if placed in effect may file objections thereto with the Secretary, specifying with particularity the provisions of the order deemed objectionable, stating the grounds therefor, and requesting a public hearing upon such objections. Until final action upon such objections is taken by the Secretary under paragraph (3), the filing of such objections shall operate to stay the effectiveness of those provisions of the order to which the objections are made. As soon as practicable after the time for filing objections has expired the Secretary shall publish a notice in the Federal Register specifying those parts of the order which have been stayed by the filing of objections and, if no objections have been filed, stating that fact.
(3) As soon as practicable after such request for a public hearing, the Secretary, after due notice, shall hold such a public hearing for the purpose of receiving evidence relevant and material to the issues raised by such objections. At the hearing, any interested person may be heard in person or by representative. As soon as practicable after completion of the hearing, the Secretary shall by order act upon such objections and make such order public. Such order shall be based only on substantial evidence of record at such hearing and shall set forth, as part of the order, detailed findings of fact on which the order is based. The Secretary shall specify in the order the date on which it shall take effect, except that it shall not be made to take effect prior to the ninetieth day after its publication unless the Secretary finds that emergency conditions exist necessitating an earlier effective date, in which event the Secretary shall specify in the order his findings as to such conditions.
(f) Review of order
(1) In a case of actual controversy as to the validity of any order under subsection (e) of this section, any person who will be adversely affected by such order if placed in effect may at any time prior to the ninetieth day after such order is issued file a petition with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such order. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary thereupon shall file in the court the record of the proceedings on which the Secretary based his order, as provided in section 2112 of title 28.
(2) If the petitioner applies to the court for leave to adduce additional evidence, and shows to the satisfaction of the court that such additional evidence is material and that there were reasonable grounds for the failure to adduce such evidence in the proceeding before the Secretary, the court may order such additional evidence (and evidence in rebuttal thereof) to be taken before the Secretary, and to be adduced upon the hearing, in such manner and upon such terms and conditions as to the court may seem proper. The Secretary may modify his findings as to the facts, or make new findings, by reason of the additional evidence so taken, and he shall file such modified or new findings, and his recommendation, if any, for the modification or setting aside of his original order, with the return of such additional evidence.
(3) 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.
(4) The judgment of the court affirming or setting aside, in whole or in part, any such order of the Secretary shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification as provided in section 1254 of title 28.
(5) 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.
(6) The remedies provided for in this subsection shall be in addition to and not in substitution for any other remedies provided by law.
(g) 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.
(h) Guidance documents
(1)
(A) 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.
(B) 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.
(C)
(i) 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.
(ii) 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.
(D) For guidance documents that set forth existing practices or minor changes in policy, the Secretary shall provide for public comment upon implementation.
(2) 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.
(3) 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.
(4) 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.
(5) 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.

Source

(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.)
Amendments

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”.
1992—Subsec. (b). Pub. L. 102–300, which directed the substitution of “Health and Human Services” for “Health, Education, and Welfare”, could not be executed because such words did not appear in the original statutory text. See 1993 Amendment note above and Transfer of Functions note below.
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 (j), 344 (a), 346, 351 (b), or 352 (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 (j), 344 (a), 346, 351 (b), or 352 (d) or (h) of this title”.
1960—Subsec. (e). Pub. L. 86–618substituted “section 341, 343 (j), 344 (a), 346, 351 (b), or 352 (d) or (h), of this title” for “section 341, 343 (j), 344 (a), 346 (a) or (b), 351 (b), 352 (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”.
1956—Subsec. (e). Act Aug. 1, 1956, simplified procedures governing prescribing of regulations under certain provisions of this chapter.
1954—Subsec. (e). Act Apr. 15, 1954, struck out reference to section 341 of this title, before “343(j)”, such section 341 now containing its own provisions with respect to hearings regarding the establishment of food standards.
Change of Name

Circuit Court of Appeals of the United States changed to United States court of appeals by act June 25, 1948, eff. Sept. 1, 1948.
Effective Date of 1997 Amendment

Amendment by Pub. L. 105–115effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 ofPub. L. 105–115, set out as a note under section 321 of this title.
Effective Date of 1960 Amendment

Amendment by Pub. L. 86–618effective July 12, 1960, subject to the provisions of section 203 ofPub. L. 86–618, see section 202 ofPub. L. 86–618, set out as a note under section 379e of this title.
Construction of Amendments by Pub. L. 101–535

Amendments by Pub. L. 101–535not to be construed to alter the authority of the Secretary of Health and Human Services and the Secretary of Agriculture under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.), the Federal Meat Inspection Act (21 U.S.C. 601 et seq.), the Poultry Products Inspection Act (21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (21 U.S.C. 1031 et seq.), see section 9 ofPub. L. 101–535, set out as a note under section 343 of this title.
Savings Provision

Savings clause of act Aug. 1, 1956, see note set out under section 341 of this title.
Transfer of Functions

Secretary and Department of Health, Education, and Welfare redesignated Secretary and Department of Health and Human Services by Pub. L. 96–88, title V, § 509(b),Oct. 17, 1979, 93 Stat. 695, which is classified to section 3508 (b) of Title 20, Education.
For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.
Notification of FDA Intent To Regulate Laboratory-Developed Tests

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].”
Approval of Supplemental Applications for Approved Products

Pub. L. 105–115, title IV, § 403,Nov. 21, 1997, 111 Stat. 2367, provided that:
“(a) Standards.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall publish in the Federal Register standards for the prompt review of supplemental applications submitted for approved articles under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) or section 351 of the Public Health Service Act (42 U.S.C. 262).
“(b) Guidance to Industry.—Not later than 180 days after the date of enactment of this Act [Nov. 21, 1997], the Secretary shall issue final guidances to clarify the requirements for, and facilitate the submission of data to support, the approval of supplemental applications for the approved articles described in subsection (a). The guidances shall—
“(1) clarify circumstances in which published matter may be the basis for approval of a supplemental application;
“(2) specify data requirements that will avoid duplication of previously submitted data by recognizing the availability of data previously submitted in support of an original application; and
“(3) define supplemental applications that are eligible for priority review.
“(c) Responsibilities of Centers.—The Secretary shall designate an individual in each center within the Food and Drug Administration (except the Center for Food Safety and Applied Nutrition) to be responsible for—
“(1) encouraging the prompt review of supplemental applications for approved articles; and
“(2) working with sponsors to facilitate the development and submission of data to support supplemental applications.
“(d) Collaboration.—The Secretary shall implement programs and policies that will foster collaboration between the Food and Drug Administration, the National Institutes of Health, professional medical and scientific societies, and other persons, to identify published and unpublished studies that may support a supplemental application, and to encourage sponsors to make supplemental applications or conduct further research in support of a supplemental application based, in whole or in part, on such studies.”
Hearings Pending on April 15, 1954, With Respect to Food Standards

Provisions of this chapter in effect prior to Apr. 15, 1954, as applicable with respect to hearings begun prior to such date under subsection (e) of this section, regarding food standards, see Savings Provisions note set out under section 341 of this title.

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 Practices

16 CFR Part 1502 - PROCEDURES FOR FORMAL EVIDENTIARY PUBLIC HEARING

16 CFR Part 1507 - FIREWORKS DEVICES

16 CFR Part 1701 - STATEMENTS OF POLICY AND INTERPRETATION

16 CFR Part 1702 - PETITIONS FOR EXEMPTIONS FROM POISON PREVENTION PACKAGING ACT REQUIREMENTS; PETITION PROCEDURES AND REQUIREMENTS

19 CFR - Customs Duties

19 CFR Part 12 - SPECIAL CLASSES OF MERCHANDISE

21 CFR - Food and Drugs

21 CFR Part 1 - GENERAL ENFORCEMENT REGULATIONS

21 CFR Part 2 - GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

21 CFR Part 3 - PRODUCT JURISDICTION

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 17 - CIVIL MONEY PENALTIES HEARINGS

21 CFR Part 19 - STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 21 - PROTECTION OF PRIVACY

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 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 COMMUNITY

21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS

21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS

21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

21 CFR Part 60 - PATENT TERM RESTORATION

21 CFR Part 70 - COLOR ADDITIVES

21 CFR Part 71 - COLOR ADDITIVE PETITIONS

21 CFR Part 73 - LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

21 CFR Part 74 - LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

21 CFR Part 80 - COLOR ADDITIVE CERTIFICATION

21 CFR Part 81 - GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

21 CFR Part 82 - LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS

21 CFR Part 99 - DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

21 CFR Part 100 - GENERAL

21 CFR Part 101 - FOOD LABELING

21 CFR Part 102 - COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS

21 CFR Part 104 - NUTRITIONAL QUALITY GUIDELINES FOR FOODS

21 CFR Part 105 - FOODS FOR SPECIAL DIETARY USE

21 CFR Part 106 - INFANT FORMULA QUALITY CONTROL PROCEDURES

21 CFR Part 107 - INFANT FORMULA

21 CFR Part 108 - EMERGENCY PERMIT CONTROL

21 CFR Part 109 - UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL

21 CFR Part 110 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

21 CFR Part 111 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS

21 CFR Part 113 - THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS

21 CFR Part 114 - ACIDIFIED FOODS

21 CFR Part 115 - SHELL EGGS

21 CFR Part 118 - PRODUCTION, STORAGE, AND TRANSPORTATION OF SHELL EGGS

21 CFR Part 119 - DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK

21 CFR Part 120 - HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

21 CFR Part 123 - FISH AND FISHERY PRODUCTS

21 CFR Part 129 - PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

21 CFR Part 130 - FOOD STANDARDS: GENERAL

21 CFR Part 131 - MILK AND CREAM

21 CFR Part 133 - CHEESES AND RELATED CHEESE PRODUCTS

21 CFR Part 135 - FROZEN DESSERTS

21 CFR Part 136 - BAKERY PRODUCTS

21 CFR Part 137 - CEREAL FLOURS AND RELATED PRODUCTS

21 CFR Part 139 - MACARONI AND NOODLE PRODUCTS

21 CFR Part 145 - CANNED FRUITS

21 CFR Part 146 - CANNED FRUIT JUICES

21 CFR Part 150 - FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS

21 CFR Part 152 - FRUIT PIES

21 CFR Part 155 - CANNED VEGETABLES

21 CFR Part 156 - VEGETABLE JUICES

21 CFR Part 158 - FROZEN VEGETABLES

21 CFR Part 160 - EGGS AND EGG PRODUCTS

21 CFR Part 161 - FISH AND SHELLFISH

21 CFR Part 163 - CACAO PRODUCTS

21 CFR Part 164 - TREE NUT AND PEANUT PRODUCTS

21 CFR Part 165 - BEVERAGES

21 CFR Part 166 - MARGARINE

21 CFR Part 168 - SWEETENERS AND TABLE SIRUPS

21 CFR Part 169 - FOOD DRESSINGS AND FLAVORINGS

21 CFR Part 170 - FOOD ADDITIVES

21 CFR Part 171 - FOOD ADDITIVE PETITIONS

21 CFR Part 172 - FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

21 CFR Part 174 - INDIRECT FOOD ADDITIVES: GENERAL

21 CFR Part 180 - FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

21 CFR Part 181 - PRIOR-SANCTIONED FOOD INGREDIENTS

21 CFR Part 182 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE

21 CFR Part 184 - DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

21 CFR Part 186 - INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

21 CFR Part 189 - SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

21 CFR Part 190 - DIETARY SUPPLEMENTS

21 CFR Part 200 - GENERAL

21 CFR Part 201 - LABELING

21 CFR Part 202 - PRESCRIPTION DRUG ADVERTISING

21 CFR Part 203 - PRESCRIPTION DRUG MARKETING

21 CFR Part 205 - GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS

21 CFR Part 206 - IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE

21 CFR Part 207 - REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION

21 CFR Part 208 - MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS

21 CFR Part 209 - REQUIREMENT FOR AUTHORIZED DISPENSERS AND PHARMACIES TO DISTRIBUTE A SIDE EFFECTS STATEMENT

21 CFR Part 210 - CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

21 CFR Part 211 - CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

21 CFR Part 212 - CURRENT GOOD MANUFACTURING PRACTICE FOR POSITRON EMISSION TOMOGRAPHY DRUGS

21 CFR Part 216 - PHARMACY COMPOUNDING

21 CFR Part 225 - CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

21 CFR Part 226 - CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES

21 CFR Part 250 - SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS

21 CFR Part 290 - CONTROLLED DRUGS

21 CFR Part 299 - DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES

21 CFR Part 300 - GENERAL

21 CFR Part 310 - NEW DRUGS

21 CFR Part 312 - INVESTIGATIONAL NEW DRUG APPLICATION

21 CFR Part 314 - APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG

21 CFR Part 315 - DIAGNOSTIC RADIOPHARMACEUTICALS

21 CFR Part 316 - ORPHAN DRUGS

21 CFR Part 320 - BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS

21 CFR Part 328 - OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL

21 CFR Part 330 - OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

21 CFR Part 331 - ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE

21 CFR Part 332 - ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 333 - TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 335 - ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 336 - ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 338 - NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 340 - STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 341 - COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 343 - INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 344 - TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 346 - ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 347 - SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 348 - EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 349 - OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 350 - ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 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 USE

21 CFR Part 357 - MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 358 - MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

21 CFR Part 361 - PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH

21 CFR Part 369 - INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE

21 CFR Part 500 - GENERAL

21 CFR Part 501 - ANIMAL FOOD LABELING

21 CFR Part 502 - COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS

21 CFR Part 509 - UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL

21 CFR Part 510 - NEW ANIMAL DRUGS

21 CFR Part 511 - NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE

21 CFR Part 514 - NEW ANIMAL DRUG APPLICATIONS

21 CFR Part 515 - MEDICATED FEED MILL LICENSE

21 CFR Part 516 - NEW ANIMAL DRUGS FOR MINOR USE AND MINOR SPECIES

21 CFR Part 530 - EXTRALABEL DRUG USE IN ANIMALS

21 CFR Part 556 - TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

21 CFR Part 558 - NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

21 CFR Part 570 - FOOD ADDITIVES

21 CFR Part 571 - FOOD ADDITIVE PETITIONS

21 CFR Part 579 - IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD

21 CFR Part 582 - SUBSTANCES GENERALLY RECOGNIZED AS SAFE

21 CFR Part 584 - FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS

21 CFR Part 589 - SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED

21 CFR Part 600 - BIOLOGICAL PRODUCTS: GENERAL

21 CFR Part 606 - CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS

21 CFR Part 607 - ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS

21 CFR Part 610 - GENERAL BIOLOGICAL PRODUCTS STANDARDS

21 CFR Part 630 - GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES

21 CFR Part 640 - ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS

21 CFR Part 660 - ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS

21 CFR Part 680 - ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS

21 CFR Part 700 - GENERAL

21 CFR Part 701 - COSMETIC LABELING

21 CFR Part 710 - VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS

21 CFR Part 720 - VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS

21 CFR Part 730

21 CFR Part 740 - COSMETIC PRODUCT WARNING STATEMENTS

21 CFR Part 800 - GENERAL

21 CFR Part 801 - LABELING

21 CFR Part 803 - MEDICAL DEVICE REPORTING

21 CFR Part 806 - MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS

21 CFR Part 807 - ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

21 CFR Part 808 - EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS

21 CFR Part 809 - IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE

21 CFR Part 810 - MEDICAL DEVICE RECALL AUTHORITY

21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

21 CFR Part 820 - QUALITY SYSTEM REGULATION

21 CFR Part 821 - MEDICAL DEVICE TRACKING REQUIREMENTS

21 CFR Part 822 - POSTMARKET SURVEILLANCE

21 CFR Part 830 - UNIQUE DEVICE IDENTIFICATION

21 CFR Part 860 - MEDICAL DEVICE CLASSIFICATION PROCEDURES

21 CFR Part 861 - PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT

21 CFR Part 862 - CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

21 CFR Part 864 - HEMATOLOGY AND PATHOLOGY DEVICES

21 CFR Part 866 - IMMUNOLOGY AND MICROBIOLOGY DEVICES

21 CFR Part 868 - ANESTHESIOLOGY DEVICES

21 CFR Part 870 - CARDIOVASCULAR DEVICES

21 CFR Part 872 - DENTAL DEVICES

21 CFR Part 874 - EAR, NOSE, AND THROAT DEVICES

21 CFR Part 876 - GASTROENTEROLOGY-UROLOGY DEVICES

21 CFR Part 878 - GENERAL AND PLASTIC SURGERY DEVICES

21 CFR Part 880 - GENERAL HOSPITAL AND PERSONAL USE DEVICES

21 CFR Part 882 - NEUROLOGICAL DEVICES

21 CFR Part 884 - OBSTETRICAL AND GYNECOLOGICAL DEVICES

21 CFR Part 886 - OPHTHALMIC DEVICES

21 CFR Part 888 - ORTHOPEDIC DEVICES

21 CFR Part 890 - PHYSICAL MEDICINE DEVICES

21 CFR Part 892 - RADIOLOGY DEVICES

21 CFR Part 895 - BANNED DEVICES

21 CFR Part 897

21 CFR Part 898 - PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES

21 CFR Part 1002 - RECORDS AND REPORTS

21 CFR Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

21 CFR Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

21 CFR Part 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS

21 CFR Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

21 CFR Part 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS

21 CFR Part 1141 - CIGARETTE PACKAGE AND ADVERTISING WARNINGS

21 CFR Part 1240 - CONTROL OF COMMUNICABLE DISEASES

21 CFR Part 1250 - INTERSTATE CONVEYANCE SANITATION

40 CFR - Protection of Environment

40 CFR Part 23 - JUDICIAL REVIEW UNDER EPA-ADMINISTERED STATUTES

40 CFR Part 160 - GOOD LABORATORY PRACTICE STANDARDS

40 CFR Part 174 - PROCEDURES AND REQUIREMENTS FOR PLANT-INCORPORATED PROTECTANTS

40 CFR Part 179 - FORMAL EVIDENTIARY PUBLIC HEARING

40 CFR Part 180 - TOLERANCES AND EXEMPTIONS FOR PESTICIDE CHEMICAL RESIDUES IN FOOD

40 CFR Part 186

42 CFR - Public Health

42 CFR Part 10 - 340B DRUG PRICING PROGRAM

 

LII has no control over and does not endorse any external Internet site that contains links to or references LII.