---
kind: "unit"
title: "21"
title_heading: "Food and Drugs"
key: "chII/part1301"
level: "part"
label: "Part 1301"
heading: "Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances"
release: "ecfr-current"
date: "2026-08-27"
url: "https://uscodex.org/cfr/21/chII-part1301"
sections_count: 49
---

# Part 1301 — Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances

Title 21 C.F.R. — Food and Drugs › Chapter II — Drug Enforcement Administration, Department of Justice

## Sections

- [§1301.01. Scope of this part 1301.](/cfr/21/1301.01.md)
- [§1301.02. Definitions. Link](/cfr/21/1301.02.md)
- [§1301.03. Information; special instructions.](/cfr/21/1301.03.md)
- [§1301.11. Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.](/cfr/21/1301.11.md)
- [§1301.12. Separate registrations for separate locations.](/cfr/21/1301.12.md)
- [§1301.13. Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.](/cfr/21/1301.13.md)
- [§1301.14. Filing of application; acceptance for filing; defective applications.](/cfr/21/1301.14.md)
- [§1301.15. Additional information.](/cfr/21/1301.15.md)
- [§1301.16. Amendments to and withdrawal of applications.](/cfr/21/1301.16.md)
- [§1301.17. Special procedures for certain applications.](/cfr/21/1301.17.md)
- [§1301.18. Research protocols.](/cfr/21/1301.18.md)
- [§1301.19. Special requirements for online pharmacies.](/cfr/21/1301.19.md)
- [§1301.20. Registration for emergency medical services agencies.](/cfr/21/1301.20.md)
- [§1301.21. Exemption from fees.](/cfr/21/1301.21.md)
- [§1301.22. Exemption of agents and employees; affiliated practitioners.](/cfr/21/1301.22.md)
- [§1301.23. Exemption of certain military and other personnel.](/cfr/21/1301.23.md)
- [§1301.24. Exemption of law enforcement officials.](/cfr/21/1301.24.md)
- [§1301.25. Registration regarding ocean vessels, aircraft, and other entities.](/cfr/21/1301.25.md)
- [§1301.26. Exemptions from import or export requirements for personal medical use.](/cfr/21/1301.26.md)
- [§1301.27. Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.](/cfr/21/1301.27.md)
- [§1301.28-1301.29. Reserved](/cfr/21/1301.28-1301.29.md)
- [§1301.31. Administrative review generally.](/cfr/21/1301.31.md)
- [§1301.32. Action on applications for research in Schedule I substances.](/cfr/21/1301.32.md)
- [§1301.33. Application for bulk manufacture of Schedule I and II substances.](/cfr/21/1301.33.md)
- [§1301.34. Application for importation of Schedule I and II substances.](/cfr/21/1301.34.md)
- [§1301.35. Certificate of registration; denial of registration.](/cfr/21/1301.35.md)
- [§1301.36. Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.](/cfr/21/1301.36.md)
- [§1301.37. Order to show cause.](/cfr/21/1301.37.md)
- [§1301.41. Hearings generally.](/cfr/21/1301.41.md)
- [§1301.42. Purpose of hearing.](/cfr/21/1301.42.md)
- [§1301.43. Request for hearing or appearance; waiver; default.](/cfr/21/1301.43.md)
- [§1301.44. Burden of proof.](/cfr/21/1301.44.md)
- [§1301.45. Time and place of hearing.](/cfr/21/1301.45.md)
- [§1301.46. Final order.](/cfr/21/1301.46.md)
- [§1301.51. Modification in registration.](/cfr/21/1301.51.md)
- [§1301.52. Termination of registration; transfer of registration; distribution upon discontinuance of business.](/cfr/21/1301.52.md)
- [§1301.71. Security requirements generally.](/cfr/21/1301.71.md)
- [§1301.72. Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas.](/cfr/21/1301.72.md)
- [§1301.73. Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.](/cfr/21/1301.73.md)
- [§1301.74. Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs.](/cfr/21/1301.74.md)
- [§1301.75. Physical security controls for practitioners.](/cfr/21/1301.75.md)
- [§1301.76. Other security controls for practitioners.](/cfr/21/1301.76.md)
- [§1301.77. Security controls for freight forwarding facilities.](/cfr/21/1301.77.md)
- [§1301.78-1301.79. Reserved](/cfr/21/1301.78-1301.79.md)
- [§1301.80. Security controls for emergency medical services agencies.](/cfr/21/1301.80.md)
- [§1301.90. Employee screening procedures.](/cfr/21/1301.90.md)
- [§1301.91. Employee responsibility to report drug diversion.](/cfr/21/1301.91.md)
- [§1301.92. Illicit activities by employees.](/cfr/21/1301.92.md)
- [§1301.93. Sources of information for employee checks.](/cfr/21/1301.93.md)