FD&C Act Chapter V: Drugs and Devices

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

FD&C Act Section Number Title
Sec. 501 Sec. 351 - Adulterated drugs and devices
Sec. 502 Sec. 352 - Misbranded drugs and devices
Sec. 503 Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products
Sec. 503A Sec. 353a - Pharmacy compounding
Sec. 503A-1 Sec. 353a-1 - Enhanced Communication
Sec. 503B Sec. 353b - Outsourcing facilities
Sec. 503C Sec. 353c - Prereview of television advertisements
Sec. 504 Sec. 354 - Veterinary feed directive drugs
Sec. 505 Sec. 355 - New drugs
Sec. 355-1 - Risk evaluation and mitigation strategies
Sec. 505A Sec. 355a - Pediatric studies of drugs
Sec. 355b - Adverse-event reporting
Sec. 505B Sec. 355c - Research into pediatric uses for drugs and biological products
Sec. 355c-1 - Report
Sec. 505C Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, and waivers
Sec. 505D Sec. 355e - Pharmaceutical security
Sec. 506 Sec. 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. 506A Sec. 356a - Manufacturing changes
Sec. 506B Sec. 356b - Reports of postmarketing studies
Sec. 506C Sec. 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Sec. 357 - Repealed.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. 508 Sec. 358 - Authority to designate official names
Sec. 509 Sec. 359 - Nonapplicability of subchapter to cosmetics
Sec. 510 Sec. 360 - Registration of producers of drugs or devices
Sec. 511 Sec. 360a - Clinical trial guidance for antibiotic drugs
Sec. 360a-1 - Clinical trials
Sec. 512 Sec. 360b - New animal drugs
Sec. 513 Sec. 360c - Classification of devices intended for human use
Sec. 360c-1 - Reporting
Sec. 514 Sec. 360d - Performance standards
Sec. 515 Sec. 360e - Premarket approval
Sec. 515A Sec. 360e-1 - Pediatric uses of devices
Sec. 516 Sec. 360f - Banned devices
Sec. 517 Sec. 360g - Judicial review
Sec. 360g-1. Agency documentation and review of significant decisions regarding devices
Sec. 518 Sec. 360h - Notification and other remedies
Sec. 360h-1. Program to improve the device recall system
Sec. 519 Sec. 360i - Records and reports on devices
Sec. 520 Sec. 360j - General provisions respecting control of devices intended for human use
Sec. 521 Sec. 360k - State and local requirements respecting devices
Sec. 522 Sec. 360l - Postmarket surveillance
Sec. 523 Sec. 360m - Accredited persons
Sec. 524 Sec. 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 Number Title
Sec. 525 Sec. 360aa - Recommendations for investigations of drugs for rare diseases or conditions
Sec. 526 Sec. 360bb - Designation of drugs for rare diseases or conditions
Sec. 527 Sec. 360cc - Protection for drugs for rare diseases or conditions
Sec. 528 Sec. 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 Number Title
Sec. 531 Sec. 360hh - Definitions
Sec. 532 Sec. 360ii - Program of control
Sec. 533 Sec. 360jj - Studies by Secretary
Sec. 534 Sec. 360kk - Performance standards for electronic products
Sec. 535 Sec. 360ll - Notification of defects in and repair or replacement of electronic products
Sec. 536 Sec. 360mm - Imports
Sec. 537 Sec. 360nn - Inspection, records, and reports
Sec. 538 Sec. 360oo - Prohibited acts
Sec. 539 Sec. 360pp - Enforcement
Sec. 360qq - Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
Sec. 541 Sec. 360rr - Federal-State cooperation
Sec. 542 Sec. 360ss - State standards

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

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

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

FD&C Act Section Number Title
Sec. 561 Sec. 360bbb - Expanded access to unapproved therapies and diagnostics
Sec. 652 Sec. 360bbb-1 - Dispute resolution
Sec. 563 Sec. 360bbb-2 - Classification of products
Sec. 564 Sec. 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. 565 Sec. 360bbb-4 - Countermeasure development, review, and technical assistance
Sec. 566 Sec. 360bbb-5 - Critical Path Public-Private Partnerships
Sec. 567 Sec. 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 Number Title
Sec. 571 Sec. 360ccc - Conditional approval of new animal drugs for minor use and minor species
Sec. 572 Sec. 360ccc-1 - Index of legally marketed unapproved new animal drugs for minor species
Sec. 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 Title
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 Number Title
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 Number Title
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