21 U.S. Code Part A— Drugs and Devices

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  1. § 351. Adulterated drugs and devices
  2. § 352. Misbranded drugs and devices
  3. § 353. Exemptions and consideration for certain drugs, devices, and biological products
  4. § 353a. Pharmacy compounding
  5. § 353a–1. Enhanced communication
  6. § 353b. Outsourcing facilities
  7. § 353c. Prereview of television advertisements
  8. § 354. Veterinary feed directive drugs
  9. § 355. New drugs
  10. § 355–1. Risk evaluation and mitigation strategies
  11. § 355–2. Actions for delays of generic drugs and biosimilar biological products
  12. § 355a. Pediatric studies of drugs
  13. § 355b. Adverse-event reporting
  14. § 355c. Research into pediatric uses for drugs and biological products
  15. § 355c–1. Report
  16. § 355d. Internal committee for review of pediatric plans, assessments, deferrals, deferral extensions, and waivers
  17. § 355e. Pharmaceutical security
  18. § 355f. Extension of exclusivity period for new qualified infectious disease products
  19. § 355g. Utilizing real world evidence
  20. § 355h. Regulation of certain nonprescription drugs that are marketed without an approved drug application
  21. § 356. Expedited approval of drugs for serious or life-threatening diseases or conditions
  22. § 356–1. Accelerated approval of priority countermeasures
  23. § 356a. Manufacturing changes
  24. § 356b. Reports of postmarketing studies
  25. § 356c. Discontinuance or interruption in the production of life-saving drugs
  26. § 356c–1. Annual reporting on drug shortages
  27. § 356d. Coordination; task force and strategic plan
  28. § 356e. Drug shortage list
  29. § 356f. Hospital repackaging of drugs in shortage
  30. § 356g. Standards for regenerative medicine and regenerative advanced therapies
  31. § 356h. Competitive generic therapies
  32. § 356i. Prompt reports of marketing status
  33. § 356j. Discontinuance or interruption in the production of medical devices
  34. § 357. Qualification of drug development tools
  35. § 358. Authority to designate official names
  36. § 359. Nonapplicability of subchapter to cosmetics
  37. § 360. Registration of producers of drugs or devices
  38. § 360a. Clinical trial guidance for antibiotic drugs
  39. § 360a–1. Clinical trials
  40. § 360a–2. Susceptibility test interpretive criteria for microorganisms
  41. § 360b. New animal drugs
  42. § 360b–1. Priority zoonotic animal drugs
  43. § 360c. Classification of devices intended for human use
  44. § 360c–1. Reporting
  45. § 360d. Performance standards
  46. § 360e. Premarket approval
  47. § 360e–1. Pediatric uses of devices
  48. § 360e–3. Breakthrough devices
  49. § 360f. Banned devices
  50. § 360g. Judicial review
  51. § 360g–1. Agency documentation and review of significant decisions regarding devices
  52. § 360h. Notification and other remedies
  53. § 360h–1. Program to improve the device recall system
  54. § 360i. Records and reports on devices
  55. § 360j. General provisions respecting control of devices intended for human use
  56. § 360k. State and local requirements respecting devices
  57. § 360l. Postmarket surveillance
  58. § 360m. Accredited persons
  59. § 360n. Priority review to encourage treatments for tropical diseases
  60. § 360n–1. Priority review for qualified infectious disease products