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FD&C Act Chapter V: Drugs and Devices

 

 

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

FD&C Act Section number

Title

Reference

Sec. 501

Sec. 351 - Adulterated drugs and devices

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Sec. 502

Sec. 352 - Misbranded drugs and devices

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Sec. 503

Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products

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Sec. 503A

Sec. 353a - Pharmacy compounding

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Sec. 503B

Sec. 353b - Prereview of television advertisements

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Sec. 504

Sec. 354 - Veterinary feed directive drugs

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Sec. 505

Sec. 355 - New drugs

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Sec. 355-1 - Risk evaluation and mitigation strategies

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Sec. 505A

Sec. 355a - Pediatric studies of drugs

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Sec. 355b - Adverse-event reporting

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Sec. 505B

Sec. 355c - Research into pediatric uses for drugs and biological products

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Sec. 505C

Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers

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Sec. 505D

Sec. 355e - Pharmaceutical security

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Sec. 506

Sec. 356 - Fast track products

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Sec. 356-1 - Accelerated approval of priority countermeasures

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Sec. 506A

Sec. 356a - Manufacturing changes

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Sec. 506B

Sec. 356b - Reports of postmarketing studies

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Sec. 506C

Sec. 356c - Discontinuance of life saving product

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Sec. 357 - Repealed. Pub. L. 105-115, title I, §125(b)(1), Nov. 21, 1997, 111 Stat. 2325

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Sec. 508

Sec. 358 - Authority to designate official names

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Sec. 509

Sec. 359 - Nonapplicability of subchapter to cosmetics

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Sec. 510

Sec. 360 - Registration of producers of drugs or devices

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Sec. 511

Sec. 360a - Clinical trial guidance for antibiotic drugs

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Sec. 512

Sec. 360b - New animal drugs

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Sec. 513

Sec. 360c - Classification of devices intended for human use

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Sec. 514

Sec. 360d - Performance standards

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Sec. 515

Sec. 360e - Premarket approval

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Sec. 515A

Sec. 360e-1 - Pediatric uses of devices

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Sec. 516

Sec. 360f - Banned devices

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Sec. 517

Sec. 360g - Judicial review 

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Sec. 518

Sec. 360h - Notification and other remedies 

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Sec. 519

Sec. 360i - Records and reports on devices 

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Sec. 520

Sec. 360j - General provisions respecting control of devices intended for human use 

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Sec. 521

Sec. 360k - State and local requirements respecting devices 

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Sec. 522

Sec. 360l - Postmarket surveillance 

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Sec. 523

Sec. 360m - Accredited persons 

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Sec. 524

Sec. 360n - Priority review to encourage treatments for tropical diseases 

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

FD&C Act Section number

Title

Reference

Sec. 525

Sec. 360aa - Recommendations for investigations of drugs for rare diseases or conditions 

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Sec. 526

Sec. 360bb - Designation of drugs for rare diseases or conditions 

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Sec. 527

Sec. 360cc - Protection for drugs for rare diseases or conditions 

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Sec. 528

Sec. 360dd - Open protocols for investigations of drugs for rare diseases or conditions 

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Sec. 360ee - Grants and contracts for development of drugs for rare diseases and conditions 

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

FD&C Act Section number

Title

Reference

Sec. 531

Sec. 360hh - Definitions 

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Sec. 532

Sec. 360ii - Program of control 

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Sec. 533

Sec. 360jj - Studies by Secretary 

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Sec. 534

Sec. 360kk - Performance standards for electronic products 

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Sec. 535

Sec. 360ll - Notification of defects in and repair or replacement of electronic products 

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Sec. 536

Sec. 360mm - Imports 

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Sec. 537

Sec. 360nn - Inspection, records, and reports 

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Sec. 538

Sec. 360oo - Prohibited acts 

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Sec. 539

Sec. 360pp - Enforcement 

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Sec. 360qq - Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285 

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Sec. 541

Sec. 360rr - Federal-State cooperation 

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Sec. 542

Sec. 360ss - State standards 

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

FD&C Act Section number

Title

Reference

 

Secs. 360aaa to 360aaa-6 - Omitted 

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Part E - General Provisions Relating to Drugs and Devices (sections 360bbb - 360bbb-6)
 

FD&C Act Section number

Title

Reference

Sec. 561

Sec. 360bbb - Expanded access to unapproved therapies and diagnostics 

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Sec. 652

Sec. 360bbb-1 - Dispute resolution 

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Sec. 563

Sec. 360bbb-2 - Classification of products 

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Sec. 564

Sec. 360bbb-3 - Authorization for medical products for use in emergencies 

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Sec. 565

Sec. 360bbb-4 - Technical assistance 

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Sec. 566

Sec. 360bbb-5 - Critical Path Public-Private Partnerships 

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Sec. 567

Sec. 360bbb-6 - Risk communication 

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

FD&C Act Section number

Title

Reference

Sec. 571

Sec. 360ccc - Conditional approval of new animal drugs for minor use and minor species 

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Sec. 572

Sec. 360ccc-1 - Index of legally marketed unapproved new animal drugs for minor species 

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Sec. 573

Sec. 360ccc-2 - Designated new animal drugs for minor use or minor species 

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