2014 U.S. Code
Title 21 - Food and Drugs (Sections 1 - 2252)
Chapter 9 - Federal Food, Drug, and Cosmetic Act (Sections 301 - 399f)
Subchapter V - Drugs and Devices (Sections 351 - 360fff-7)

• Part A - Drugs and Devices (Sections 351 - 360n-1)
  • Sec. 351 - Adulterated drugs and devices
  • Sec. 352 - Misbranded drugs and devices
  • Sec. 353 - Exemptions and consideration for certain drugs, devices, and biological products
  • Sec. 353a - Pharmacy compounding
  • Sec. 353a-1 - Enhanced communication
  • Sec. 353b - Outsourcing facilities
  • Sec. 353c - Prereview of television advertisements
  • Sec. 354 - Veterinary feed directive drugs
  • Sec. 355 - New drugs
  • Sec. 355-1 - Risk evaluation and mitigation strategies
  • Sec. 355a - Pediatric studies of drugs
  • Sec. 355b - Adverse-event reporting
  • Sec. 355c - Research into pediatric uses for drugs and biological products
  • Sec. 355c-1 - Report
  • Sec. 355d - Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
  • Sec. 355e - Pharmaceutical security
  • 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. 356a - Manufacturing changes
  • Sec. 356b - Reports of postmarketing studies
  • 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  • Sec. 357 - Repealed.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. 358 - Authority to designate official names
  • Sec. 359 - Nonapplicability of subchapter to cosmetics
  • Sec. 360 - Registration of producers of drugs or devices
  • Sec. 360a - Clinical trial guidance for antibiotic drugs
  • Sec. 360a-1 - Clinical trials
  • Sec. 360b - New animal drugs
  • Sec. 360c - Classification of devices intended for human use
  • Sec. 360c-1 - Reporting
  • Sec. 360d - Performance standards
  • Sec. 360e - Premarket approval
  • Sec. 360e-1 - Pediatric uses of devices
  • Sec. 360f - Banned devices
  • Sec. 360g - Judicial review
  • Sec. 360g-1 - Agency documentation and review of significant decisions regarding devices
  • Sec. 360h - Notification and other remedies
  • Sec. 360h-1 - Program to improve the device recall system
  • Sec. 360i - Records and reports on devices
  • Sec. 360j - General provisions respecting control of devices intended for human use
  • Sec. 360k - State and local requirements respecting devices
  • Sec. 360l - Postmarket surveillance
  • Sec. 360m - Accredited persons
  • 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)
  • Sec. 360aa - Recommendations for investigations of drugs for rare diseases or conditions
  • Sec. 360bb - Designation of drugs for rare diseases or conditions
  • Sec. 360cc - Protection for drugs for rare diseases or conditions
  • 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)
  • Sec. 360hh - Definitions
  • Sec. 360ii - Program of control
  • Sec. 360jj - Studies by Secretary
  • Sec. 360kk - Performance standards for electronic products
  • Sec. 360ll - Notification of defects in and repair or replacement of electronic products
  • Sec. 360mm - Imports
  • Sec. 360nn - Inspection, records, and reports
  • Sec. 360oo - Prohibited acts
  • Sec. 360pp - Enforcement
  • Sec. 360qq - Repealed. Pub. L. 105-362, title VI, §601(a)(2)(A), Nov. 10, 1998, 112 Stat. 3285
  • Sec. 360rr - Federal-State cooperation
  • Sec. 360ss - State standards
• Part D - Dissemination of Treatment Information (Sections 360aaa - 360aaa-6)
  • Secs. 360aaa to 360aaa-6 - Omitted
• Part E - General Provisions Relating to Drugs and Devices (Sections 360bbb - 360bbb-8c)
  • Sec. 360bbb - Expanded access to unapproved therapies and diagnostics
  • Sec. 360bbb-1 - Dispute resolution
  • Sec. 360bbb-2 - Classification of products
  • 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. 360bbb-4 - Countermeasure development, review, and technical assistance
  • Sec. 360bbb-5 - Critical Path Public-Private Partnerships
  • 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)
  • Sec. 360ccc - Conditional approval of new animal drugs for minor use and minor species
  • Sec. 360ccc-1 - Index of legally marketed unapproved new animal drugs for minor species
  • Sec. 360ccc-2 - Designated new animal drugs for minor use or minor species
• Part G - Medical Gases (Sections 360ddd - 360ddd-2)
  • 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 - 360eee-4)
  • 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 - 360fff-7)
  • 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