Regulatory Information

FD&C Act Chapter V: Drugs and Devices

For the most current official legislative enactments, search Title 21 on the Office of Law Revision Counsel, United States Code advanced search or browse the United States Code.

Part A - Drugs and Devices (sections 351 - 360n-1)

FD&C Act Section NumberTitle
Sec. 501Sec. 351 - Adulterated drugs and devices
Sec. 502Sec. 352 - Misbranded drugs and devices
Sec. 503Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products
Sec. 503ASec. 353a - Pharmacy compounding
Sec. 503A-1Sec. 353a-1 - Enhanced Communication
Sec. 503BSec. 353b - Outsourcing facilities
Sec. 503CSec. 353c - Prereview of television advertisements
Sec. 504Sec. 354 - Veterinary feed directive drugs
Sec. 505Sec. 355 - New drugs
 Sec. 355-1 - Risk evaluation and mitigation strategies
Sec. 505ASec. 355a - Pediatric studies of drugs
 Sec. 355b - Adverse-event reporting
Sec. 505BSec. 355c - Research into pediatric uses for drugs and biological products
 Sec. 355c-1 - Report
Sec. 505CSec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers
Sec. 505DSec. 355e - Pharmaceutical security
Sec. 506Sec. 356 - Fast track products
 Sec. 355f - Extension of exclusivity period for new qualified infectious disease products
 Sec. 356. Expedited approval of drugs for serious or life-threatening diseases or conditions
 Sec. 356-1 - Accelerated approval of priority countermeasures
Sec. 506ASec. 356a - Manufacturing changes
Sec. 506BSec. 356b - Reports of postmarketing studies
Sec. 506CSec. 356c - Discontinuance or interruption in the production of life-saving drugs
 Sec. 356c-1 - Annual reporting on drug shortages
 Sec. 356d - Coordination; task force and strategic plan
 Sec. 356e - Drug shortage list
 Sec. 356f - Hospital repackaging of drugs in shortage
 Sec. 357 - Repealed. Pub. L. 105-115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325
Sec. 508Sec. 358 - Authority to designate official names
Sec. 509Sec. 359 - Nonapplicability of subchapter to cosmetics
Sec. 510Sec. 360 - Registration of producers of drugs or devices
Sec. 511Sec. 360a - Clinical trial guidance for antibiotic drugs
 Sec. 360a-1 - Clinical trials
Sec. 512Sec. 360b - New animal drugs
Sec. 513Sec. 360c - Classification of devices intended for human use
 Sec. 360c-1 - Reporting
Sec. 514Sec. 360d - Performance standards
Sec. 515Sec. 360e - Premarket approval
Sec. 515ASec. 360e-1 - Pediatric uses of devices
Sec. 516Sec. 360f - Banned devices
Sec. 517Sec. 360g - Judicial review
 Sec. 360g-1. Agency documentation and review of significant decisions regarding devices
Sec. 518Sec. 360h - Notification and other remedies
 Sec. 360h-1. Program to improve the device recall system
Sec. 519Sec. 360i - Records and reports on devices
Sec. 520Sec. 360j - General provisions respecting control of devices intended for human use
Sec. 521Sec. 360k - State and local requirements respecting devices
Sec. 522Sec. 360l - Postmarket surveillance
Sec. 523Sec. 360m - Accredited persons
Sec. 524Sec. 360n - Priority review to encourage treatments for tropical diseases
 Sec. 360n-1. Priority review for qualified infectious disease products

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

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

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

FD&C Act Section NumberTitle
Sec. 531Sec. 360hh - Definitions
Sec. 532Sec. 360ii - Program of control
Sec. 533Sec. 360jj - Studies by Secretary
Sec. 534Sec. 360kk - Performance standards for electronic products
Sec. 535Sec. 360ll - Notification of defects in and repair or replacement of electronic products
Sec. 536Sec. 360mm - Imports
Sec. 537Sec. 360nn - Inspection, records, and reports
Sec. 538Sec. 360oo - Prohibited acts
Sec. 539Sec. 360pp - Enforcement
 Sec. 360qq - Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
Sec. 541Sec. 360rr - Federal-State cooperation
Sec. 542Sec. 360ss - State standards

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

FD&C Act Section NumberTitle
 Secs. 360aaa to 360aaa-6 - Omitted

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

FD&C Act Section NumberTitle
Sec. 561Sec. 360bbb - Expanded access to unapproved therapies and diagnostics
Sec. 652Sec. 360bbb-1 - Dispute resolution
Sec. 563Sec. 360bbb-2 - Classification of products
Sec. 564Sec. 360bbb-3 - Authorization for medical products for use in emergencies
 Sec. 360bbb-3a - Emergency use of medical products
 Sec. 360bbb-3b - Products held for emergency use
Sec. 565Sec. 360bbb-4 - Countermeasure development, review, and technical assistance
Sec. 566Sec. 360bbb-5 - Critical Path Public-Private Partnerships
Sec. 567Sec. 360bbb-6 - Risk communication
 Sec. 360bbb-7 - Notification
 Sec. 360bbb-8 - Consultation with external experts on rare diseases, targeted therapies, and genetic targeting of treatments
 Sec. 360bbb-8a - Optimizing global clinical trials
 Sec. 360bbb-8b - Use of clinical investigation data from outside the United States
 Sec. 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 NumberTitle
Sec. 571Sec. 360ccc - Conditional approval of new animal drugs for minor use and minor species
Sec. 572Sec. 360ccc-1 - Index of legally marketed unapproved new animal drugs for minor species
Sec. 573Sec. 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 NumberTitle
 Sec. 360ddd - Definitions
 Sec. 360ddd-1 - Regulation of medical gases
 Sec. 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 NumberTitle
 Sec. 360eee - Definitions
 Sec. 360eee-1 - Requirements
 Sec. 360eee-2 - National standards for prescription drug wholesale distributors
 Sec. 360eee-3 - National standards for third-party logistics providers
 Sec. 360eee-4 - Uniform national policy

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

FD&C Act Section NumberTitle
 Sec. 360fff - Definitions
 Sec. 360fff-1 - Submission of requests
 Sec. 360fff-2 - Eligibility determinations; data submission; filing
 Sec. 360fff-3 - GRASE determination
 Sec. 360fff-4 - Guidance; other provisions
 Sec. 360fff-5 - Sunscreen monograph
 Sec. 360fff-6 - Non-sunscreen time and extent applications
 Sec. 360fff-7 - Report


Page Last Updated: 10/05/2015
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