| Chapter I (U.S.C. Subchapter I)-- |
|
|
| Short Title |
1 |
301 |
| Chapter II (U.S.C. Subchapter II)-- |
|
|
| Definitions |
201 |
321 |
| Chapter III (U.S.C. Subchapter III)--Prohibited Acts and Penalties |
|
|
| Prohibited Acts |
301 |
331 |
| Injunction Proceedings |
302 |
332 |
| Penalties |
303 |
333 |
| Seizure |
304 |
334 |
| Hearing Before Report of Criminal Violation |
305 |
335 |
| Debarment, Temporary Denial of Approval, and Suspension |
306 |
335a |
| Civil Penalties |
307 |
335b |
| Authority to Withdraw Approval of Abbreviated Drug Applications |
308 |
335c |
| Report of Minor Violations |
309 |
336 |
| Proceedings in Name of United States; Provision as to Subpoenas |
310 |
337 |
| Chapter IV (U.S.C. Subchapter IV)--Food |
|
|
| Definitions and Standards for Food |
401 |
341 |
| Adulterated Food |
402 |
342 |
| Misbranded Food |
403 |
343 |
| Enacted without a section heading. |
403A |
343--1 |
| Dietary Supplement Labeling Exemptions |
403B |
343--2 |
| Disclosure |
403C |
343--3 |
| Emergency Permit Control |
404 |
344 |
| Regulations Making Exemptions |
405 |
345 |
| Tolerances for Poisonous Ingredients in Food |
406 |
346 |
| Oleomargarine or Margarine |
407 |
347 |
| Tolerances and Exemptions for Pesticide Chemical Residues |
408 |
346a |
| Food Additives |
409 |
348 |
| Bottled Drinking Water Standards |
410 |
349 |
| Vitamins and Minerals |
411 |
350 |
| Requirements for Infant Formulas |
412 |
350a |
| New Dietary Ingredients |
413 |
350b |
| Maintenance and Inspection of Records |
414 |
350c |
| Registration of Food Facilities |
415 |
350d |
| Sanitary transportation practices |
416 |
350e |
| Reportable food registry |
417 |
350f |
| Chapter V (U.S.C. Subchapter V)--Drugs and Devices
Subchapter A (U.S.C. Part A)-- Drugs and Devices |
|
|
| Adulterated Drugs and Devices |
501 |
351 |
| Misbranded Drugs and Devices |
502 |
352 |
| Exemptions and Consideration for Certain Drugs, Devices, and Biological Products |
503 |
353 |
| Pharmacy Compounding |
503A |
353a |
| Veterinary Feed Directive Drugs |
504 |
354 |
| New Drugs |
505 |
355 |
| Risk Evaluation and Mitigation Strategies |
505-1 |
355-1 |
| Pediatric Studies of Drugs |
505A |
355a |
| Research Into Pediatric Uses for Drugs and Biological Products |
505B |
355c |
| Internal committee for review of pediatric plans, assessments, deferrals, and waivers |
505C |
355d |
| Pharmaceutical security |
505D |
355e |
| Fast Track Products |
506 |
356 |
| Manufacturing Changes |
506A |
356a |
| Reports of Postmarketing Studies |
506B |
356b |
| Discontinuance of a Life Saving Product |
506C |
356c |
| Repealed |
507 |
357 |
| Authority to Designate Official Names |
508 |
358 |
| Nonapplicability to Cosmetics |
509 |
359 |
| Registration of Producers of Drugs and Devices |
510 |
360 |
| Clinical trial guidance for antibiotic drugs |
511 |
360a |
| New Animal Drugs |
512 |
360b |
| Classification of Devices Intended for Human Use |
513 |
360c |
| Performance Standards |
514 |
360d |
| Premarket Approval |
515 |
360e |
| Pediatric uses of devices |
515A |
360e-1 |
| Banned Devices |
516 |
360f |
| Judicial Review |
517 |
360g |
| Notification and Other Remedies |
518 |
360h |
| Records and Reports on Devices |
519 |
360i |
| General Provisions Respecting Control of Devices Intended for Human Use |
520 |
360j |
| State and Local Requirements Respecting Devices |
521 |
360k |
| Postmarket Surveillance |
522 |
360l |
| Accredited Persons |
523 |
360m |
| Subchapter B (U.S.C. Part B)--Drugs for Rare Diseases or Conditions |
|
|
| Priority review to encourage treatments for tropical diseases |
524 |
360n |
| Recommendations for Investigations of Drugs for Rare Diseases and Conditions |
525 |
360aa |
| Designation of Drugs for Rare Diseases or Conditions |
526 |
360bb |
| Protection for Drugs for Rare Diseases or Conditions |
527 |
360cc |
| Open Protocols for Investigations of Drugs for Rare Diseases or Conditions |
528 |
360dd |
| Subchapter C (U.S.C. Part C)—Electronic Product Radiation Control |
|
|
| Definitions |
531 |
360hh |
| Electronic Product Radiation Control Program |
532 |
360ii |
| Studies by the Secretary |
533 |
360jj |
| Performance Standards for Electronic Products |
534 |
360kk |
| Notification of Defects In, and Repair or Replacement Of, Electronic Products |
535 |
360ll |
| Imports |
536 |
360mm |
| Inspection and Reports |
537 |
360nn |
| Prohibited Acts |
538 |
360oo |
| Enforcement |
539 |
360pp |
| Repealed |
540 |
360qq |
| Federal-State Cooperation |
541 |
360rr |
| Effect on State Standards |
542 |
360ss |
| Subchapter D (U.S.C. Part D)—Dissemination of Treatment Information |
|
|
| Requirements for Dissemination of Treatment Information on Drugs or Devices |
551 |
360aaa |
| Information Authorized to be Disseminated |
552 |
360aaa-1 |
| Establishment of List of Articles and Publications Disseminated and List of Providers That Received Articles and Reference Publications |
553 |
360aaa-2 |
| Requirement Regarding Submission of Supplemental Application for New Use; Exemption from Requirement |
554 |
360aaa-3 |
| Corrective Actions; Cessation of Dissemination |
555 |
360aaa-4 |
| Definitions |
556 |
360aaa-5 |
| Rules of Construction |
557 |
360aaa-6 |
| Subchapter E (U.S.C. Part E)—General Provisions Relating to Drugs and Devices |
|
|
| Expanded Access to Unapproved Therapies and Diagnostics |
561 |
360bbb |
| Dispute Resolution |
562 |
360bbb-1 |
| Classification of Products |
563 |
360bbb-2 |
| Authorization for Medical Products for Use in Emergencies |
564 |
360bbb-3 |
| Technical assistance |
565 |
360bbb-4 |
| Critical Path Public-Private Partnerships |
566 |
360bbb-5 |
| Risk Communication |
567 |
360bbb-6 |
| Subchapter F (U.S.C. Part F)—New Animal Drugs for Minor Use and Minor Species |
|
|
| Conditional Approval of New Animal Drugs for Minor Use and Minor Species |
571 |
360ccc |
| Index of Legally Marketed Unapproved New Animal Drugs for Minor Species |
572 |
360ccc-1 |
| Designated New Animal Drugs for Minor Use or Minor Species |
573 |
360ccc-2 |
| Chapter VI (U.S.C. Subchapter VI)—Cosmetics |
|
|
| Adulterated Cosmetics |
601 |
361 |
| Misbranded Cosmetics |
602 |
362 |
| Regulations Making Exemptions |
603 |
363 |
Chapter VII (U.S.C. Subchapter VII)—General Authority
Subchapter A (U.S.C. Part A)—General Administrative Provisions |
|
|
| Regulations and Hearings |
701 |
371 |
| Examinations and Investigations |
702 |
372 |
| Records of Interstate Shipment |
703 |
373 |
| Factory Inspection |
704 |
374 |
| Publicity |
705 |
375 |
| Seafood Inspection |
706 |
376 |
| Advertising of Certain Foods |
707 |
378 |
| Confidential Information |
708 |
379 |
| Presumption |
709 |
379a |
| Consolidated Administrative and Laboratory Facility |
710 |
379b |
| Automation of Food and Drug Administration |
711 |
379d |
| Conflicts of interest |
712 |
379d-1 |
| Policy on the review and clearance of scientific articles published by FDA employees |
713 |
379d-2 |
| Subchapter B (U.S.C. Part B)—Colors |
|
|
| Listing and Certification of Color Additives for Foods, Drugs, and Cosmetics |
721 |
379e |
Subchapter C (U.S.C. Part C)—Fees
Part 1 (U.S.C. Subpart 1)—Freedom of Information Fees |
|
|
| Recovery and Retention of Fees for Freedom of Information Requests |
731 |
379f |
| Part 2 (U.S.C. Subpart 2)—Fees Relating to Drugs |
|
|
| Definitions |
735 |
379g |
| Authority to Assess and Use Drug Fees |
736 |
379h |
| Fees relating to advisory review of prescription-drug television advertising |
736a |
379h-1 |
| Reauthorization; reporting requirements |
736b |
79h-2 |
| Part 3 (U.S.C. Subpart 3)—Fees Relating to Devices |
|
|
| Definitions |
737 |
379i |
| Authority to Assess and Use Device Fees |
738 |
379j |
| Reauthorization; reporting requirements |
738a |
379j-1 |
| Part 4 (U.S.C. Subpart 4)—Fees Relating to Animal Drugs |
|
|
| Definitions |
739 |
379j-11 |
| Authority to Assess and Use Animal Drug Fees |
740 |
379j-12 |
| Subchapter D (Part D)—Information and Education |
|
|
| Information System |
741 |
379k |
| Education |
742 |
379l |
| Subchapter E (U.S.C. Part E)—Environmental Impact Review |
|
|
| Environmental Impact |
746 |
379o |
| Subchapter F (U.S.C. Part F)—National Uniformity for Nonprescription Drugs and Preemption for Labeling or Packaging of Cosmetics |
|
|
| National Uniformity for Nonprescription Drugs |
751 |
379r |
| Preemption for Labeling or Packaging of Cosmetics |
752 |
379s |
| Subchapter G (U.S.C. Part G)—Safety Reports |
|
|
| Safety Report Disclaimers |
756 |
379v |
| Subchapter H—Serious Adverse Event Reports |
|
|
| Serious adverse event reporting for nonprescription drugs |
760 |
379aa |
| Serious adverse event reporting for dietary supplements |
761 |
379aa-1 |
| Subchapter I—Reagan-Udall Foundation for the Food and Drug Administration |
|
|
| Establishment and functions of the Foundation |
770 |
379dd |
| Location of Foundation |
771 |
379dd-1 |
| Activities of the Food and Drug Administration |
772 |
379dd-2 |
| Chapter VIII (U.S.C. Subchapter VIII)—Imports and Exports |
|
|
| Imports and Exports |
801 |
381 |
| Exports of Certain Unapproved Products |
802 |
382 |
| Office of International Relations |
803 |
383 |
| Importation of Prescription Drugs |
804 |
384 |
| Chapter IX (U.S.C. Subchapter IX)—Miscellaneous |
|
|
| Separability Clause |
901 |
391 |
| Effective Date and Repeals |
902 |
392 |
| Food and Drug Administration |
903 |
393 |
| Scientific Review Groups |
904 |
394 |
| Loan Repayment Program |
905 |
395 |
| Practice of Medicine |
906 |
396 |
| Contracts for Expert Review |
907 |
396 |
| Notices to States Regarding Imported Food |
908 |
398 |
| Grants to States for Inspections |
909 |
399 |
| Office of the Chief Scientist |
910 |
399a |
