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Code of Federal Regulations (Last Updated: November 8, 2024) |
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Title 21 - Food and Drugs |
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Chapter II - Drug Enforcement Administration, Department of Justice |
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Part 1301 - Registration of Manufacturers, Distributors, and Dispensers of Controlled Substances |
| General Information |
| § 1301.01 - Scope of this part 1301. |
| § 1301.02 - Definitions. Link |
| § 1301.03 - Information; special instructions. |
| Security Requirements |
| § 1301.71 - Security requirements generally. |
| § 1301.72 - Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs; storage areas. |
| § 1301.73 - Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas. |
| § 1301.74 - Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; mobile narcotic treatment programs. |
| § 1301.75 - Physical security controls for practitioners. |
| § 1301.76 - Other security controls for practitioners. |
| § 1301.77 - Security controls for freight forwarding facilities. |
| Employee Screening - Non-Practitioners |
| § 1301.90 - Employee screening procedures. |
| § 1301.91 - Employee responsibility to report drug diversion. |
| § 1301.92 - Illicit activities by employees. |
| § 1301.93 - Sources of information for employee checks. |
| Exceptions to Registration and Fees |
| § 1301.21 - Exemption from fees. |
| § 1301.22 - Exemption of agents and employees; affiliated practitioners. |
| § 1301.23 - Exemption of certain military and other personnel. |
| § 1301.24 - Exemption of law enforcement officials. |
| § 1301.25 - Registration regarding ocean vessels, aircraft, and other entities. |
| § 1301.26 - Exemptions from import or export requirements for personal medical use. |
| § 1301.27 - Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities. |
| § 1301.29 - [Reserved] |
| Registration |
| § 1301.11 - Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy. |
| § 1301.12 - Separate registrations for separate locations. |
| § 1301.13 - Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities. |
| § 1301.14 - Filing of application; acceptance for filing; defective applications. |
| § 1301.15 - Additional information. |
| § 1301.16 - Amendments to and withdrawal of applications. |
| § 1301.17 - Special procedures for certain applications. |
| § 1301.18 - Research protocols. |
| § 1301.19 - Special requirements for online pharmacies. |
| Modification, Transfer and Termination of Registration |
| § 1301.51 - Modification in registration. |
| § 1301.52 - Termination of registration; transfer of registration; distribution upon discontinuance of business. |
| Employee Screening—Non- Practitioners |
| Hearings |
| § 1301.41 - Hearings generally. |
| § 1301.42 - Purpose of hearing. |
| § 1301.43 - Request for hearing or appearance; waiver; default. |
| § 1301.44 - Burden of proof. |
| § 1301.45 - Time and place of hearing. |
| § 1301.46 - Final order. |
| Employee Screening—Non-Practitioners |
| Action on Application for Registration: Revocation or Suspension of Registration |
| § 1301.31 - Administrative review generally. |
| § 1301.32 - Action on applications for research in Schedule I substances. |
| § 1301.33 - Application for bulk manufacture of Schedule I and II substances. |
| § 1301.34 - Application for importation of Schedule I and II substances. |
| § 1301.35 - Certificate of registration; denial of registration. |
| § 1301.36 - Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order. |
| § 1301.37 - Order to show cause. |