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        Federal Food, Drug, and Cosmetic Act (FD&C Act)

FD&C Act Chapter V: Drugs and Devices Home
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          Federal Food, Drug, and Cosmetic Act (FD&C Act)
          FD&C Act Chapter V: Drugs and DevicesFederal Food, Drug, and Cosmetic Act (FD&C Act) FD&C Act Chapter V: Drugs and Devices
  	
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    PrintTo search the FD&C Act on the Law Revision Counsel website, you may either search by U.S. code section numberor browse the Title 21 section listing.

Part A - Drugs and Devices (sections 351 - 360n-1)
	Part B - Drugs for Rare Diseases or Conditions (sections 360aa - 360ff)
	Part C - Electronic Product Radiation Control (sections 360hh - 360ss)
	Part D - Dissemination of Treatment Information (sections 360aaa - 360aaa-6)
	Part E - General Provisions Relating to Drugs and Devices (sections 360bbb - 360bbb-8c)
	Part F - New Animal Drugs for Minor Use and Minor Species (sections 360ccc - 360ccc-2)
	Part G - Medical Gases (sections 360ddd to 360ddd-2)
	Part H - Pharmaceutical Distribution Supply Chain (sections 360eee to 360eee-4)
	Part I - Nonprescription Sunscreen and Other Active Ingredients (sections 360fff to 360fff-7)Part A - Drugs and Devices (sections 351 - 360n-1)

FD&C Act Section Number
			TitleSec. 501
			Sec. 351 - Adulterated drugs and devicesSec. 502
			Sec. 352 - Misbranded drugs and devicesSec. 503
			Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological productsSec. 503A
			Sec. 353a - Pharmacy compoundingSec. 503A-1
			Sec. 353a-1 - Enhanced CommunicationSec. 503B
			Sec. 353b - Outsourcing facilitiesSec. 503C
			Sec. 353c - Prereview of television advertisementsSec. 504
			Sec. 354 - Veterinary feed directive drugsSec. 505
			Sec. 355 - New drugsSec. 355-1 - Risk evaluation and mitigation strategiesSec. 505A
			Sec. 355a - Pediatric studies of drugsSec. 355b - Adverse-event reportingSec. 505B
			Sec. 355c - Research into pediatric uses for drugs and biological productsSec. 355c-1 - ReportSec. 505C
			Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waiversSec. 505D
			Sec. 355e - Pharmaceutical securitySec. 506
			Sec. 356 - Fast track productsSec. 355f - Extension of exclusivity period for new qualified infectious disease productsSec. 356. Expedited approval of drugs for serious or life-threatening diseases or conditionsSec. 356-1 - Accelerated approval of priority countermeasuresSec. 506A
			Sec. 356a - Manufacturing changesSec. 506B
			Sec. 356b - Reports of postmarketing studiesSec. 506C
			Sec. 356c - Discontinuance or interruption in the production of life-saving drugsSec. 356c-1 - Annual reporting on drug shortagesSec. 356d - Coordination; task force and strategic planSec. 356e - Drug shortage listSec. 356f - Hospital repackaging of drugs in shortageSec. 357 - Repealed. Pub. L. 105-115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325Sec. 508
			Sec. 358 - Authority to designate official namesSec. 509
			Sec. 359 - Nonapplicability of subchapter to cosmeticsSec. 510
			Sec. 360 - Registration of producers of drugs or devicesSec. 511
			Sec. 360a - Clinical trial guidance for antibiotic drugsSec. 360a-1 - Clinical trialsSec. 512
			Sec. 360b - New animal drugsSec. 513
			Sec. 360c - Classification of devices intended for human useSec. 360c-1 - ReportingSec. 514
			Sec. 360d - Performance standardsSec. 515
			Sec. 360e - Premarket approvalSec. 515A
			Sec. 360e-1 - Pediatric uses of devicesSec. 516
			Sec. 360f - Banned devicesSec. 517
			Sec. 360g - Judicial reviewSec. 360g-1. Agency documentation and review of significant decisions regarding devicesSec. 518
			Sec. 360h - Notification and other remediesSec. 360h-1. Program to improve the device recall systemSec. 519
			Sec. 360i - Records and reports on devicesSec. 520
			Sec. 360j - General provisions respecting control of devices intended for human useSec. 521
			Sec. 360k - State and local requirements respecting devicesSec. 522
			Sec. 360l - Postmarket surveillanceSec. 523
			Sec. 360m - Accredited personsSec. 524
			Sec. 360n - Priority review to encourage treatments for tropical diseasesSec. 360n-1. Priority review for qualified infectious disease products

Part B - Drugs for Rare Diseases or Conditions (sections 360aa - 360ff)

FD&C Act Section Number
			TitleSec. 525
			Sec. 360aa - Recommendations for investigations of drugs for rare diseases or conditionsSec. 526
			Sec. 360bb - Designation of drugs for rare diseases or conditionsSec. 527
			Sec. 360cc - Protection for drugs for rare diseases or conditionsSec. 528
			Sec. 360dd - Open protocols for investigations of drugs for rare diseases or conditionsSec. 360ee - Grants and contracts for development of drugs for rare diseases and conditionsSec. 360ff - Priority review to encourage treatments for rare pediatric diseases

Part C - Electronic Product Radiation Control (sections 360hh - 360ss)

FD&C Act Section Number
			TitleSec. 531
			Sec. 360hh - DefinitionsSec. 532
			Sec. 360ii - Program of controlSec. 533
			Sec. 360jj - Studies by SecretarySec. 534
			Sec. 360kk - Performance standards for electronic productsSec. 535
			Sec. 360ll - Notification of defects in and repair or replacement of electronic productsSec. 536
			Sec. 360mm - ImportsSec. 537
			Sec. 360nn - Inspection, records, and reportsSec. 538
			Sec. 360oo - Prohibited actsSec. 539
			Sec. 360pp - EnforcementSec. 360qq - Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285Sec. 541
			Sec. 360rr - Federal-State cooperationSec. 542
			Sec. 360ss - State standards

Part D - Dissemination of Treatment Information (sections 360aaa - 360aaa-6)

FD&C Act Section Number
			TitleSecs. 360aaa to 360aaa-6 - Omitted

Part E - General Provisions Relating to Drugs and Devices (sections 360bbb - 360bbb-8c)

FD&C Act Section Number
			TitleSec. 561
			Sec. 360bbb - Expanded access to unapproved therapies and diagnosticsSec. 652
			Sec. 360bbb-1 - Dispute resolutionSec. 563
			Sec. 360bbb-2 - Classification of productsSec. 564
			Sec. 360bbb-3 - Authorization for medical products for use in emergenciesSec. 360bbb-3a - Emergency use of medical productsSec. 360bbb-3b - Products held for emergency useSec. 565
			Sec. 360bbb-4 - Countermeasure development, review, and technical assistanceSec. 566
			Sec. 360bbb-5 - Critical Path Public-Private PartnershipsSec. 567
			Sec. 360bbb-6 - Risk communicationSec. 360bbb-7 - NotificationSec. 360bbb-8 - Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatmentsSec. 360bbb-8a - Optimizing global clinical trialsSec. 360bbb-8b - Use of clinical investigation data from outside the United StatesSec. 360bbb-8c - Patient participation in medical product discussion

Part F - New Animal Drugs for Minor Use and Minor Species (sections 360ccc - 360ccc-2)

FD&C Act Section Number
			TitleSec. 571
			Sec. 360ccc - Conditional approval of new animal drugs for minor use and minor speciesSec. 572
			Sec. 360ccc-1 - Index of legally marketed unapproved new animal drugs for minor speciesSec. 573
			Sec. 360ccc-2 - Designated new animal drugs for minor use or minor species

Part G - Medical Gases (sections 360ddd to 360ddd-2)

FD&C Act Section Number
			TitleSec. 360ddd - DefinitionsSec. 360ddd-1 - Regulation of medical gasesSec. 360ddd-2 - Inapplicability of drug fees to designated medical gases

Part H - Pharmaceutical Distribution Supply Chain (sections 360eee to 360eee-4)

FD&C Act Section Number
			TitleSec. 360eee - DefinitionsSec. 360eee-1 - RequirementsSec. 360eee-2 - National standards for prescription drug wholesale distributorsSec. 360eee-3 - National standards for third-party logistics providersSec. 360eee-4 - Uniform national policy

Part I—Nonprescription Sunscreen and Other Active Ingredients (sections 360fff to 360fff-7)

FD&C Act Section Number
			TitleSec. 360fff - DefinitionsSec. 360fff-1 - Submission of requestsSec. 360fff-2 - Eligibility determinations; data submission; filingSec. 360fff-3 - GRASE determinationSec. 360fff-4 - Guidance; other provisionsSec. 360fff-5 - Sunscreen monographSec. 360fff-6 - Non-sunscreen time and extent applicationsSec. 360fff-7 - Report

                                                                                  Content current as of:
      03/28/2018FD&C Act Chapter V: Drugs and Devices
 
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