Title 21

PART 1301

Part 1301 - Registration Of Manufacturers, Distributors, And Dispensers Of Controlled Substances

PART 1301 - REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES Authority:21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 886a, 951, 952, 956, 957, 958, 965 unless otherwise noted. Source:36 FR 7778, Apr. 24, 1971, unless otherwise noted. Redesignated at 38 FR 26609, Sept. 24, 1973.

21:9.0.1.1.2.0.1SUBJGRP 1
   General Information
21:9.0.1.1.2.0.1.1SECTION 1301.01
   1301.01 Scope of this part 1301.
21:9.0.1.1.2.0.1.2SECTION 1301.02
   1301.02 Definitions. Link
21:9.0.1.1.2.0.1.3SECTION 1301.03
   1301.03 Information; special instructions.
21:9.0.1.1.2.0.2SUBJGRP 2
   Registration
21:9.0.1.1.2.0.2.4SECTION 1301.11
   1301.11 Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.
21:9.0.1.1.2.0.2.5SECTION 1301.12
   1301.12 Separate registrations for separate locations.
21:9.0.1.1.2.0.2.6SECTION 1301.13
   1301.13 Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.
21:9.0.1.1.2.0.2.7SECTION 1301.14
   1301.14 Filing of application; acceptance for filing; defective applications.
21:9.0.1.1.2.0.2.8SECTION 1301.15
   1301.15 Additional information.
21:9.0.1.1.2.0.2.9SECTION 1301.16
   1301.16 Amendments to and withdrawal of applications.
21:9.0.1.1.2.0.2.10SECTION 1301.17
   1301.17 Special procedures for certain applications.
21:9.0.1.1.2.0.2.11SECTION 1301.18
   1301.18 Research protocols.
21:9.0.1.1.2.0.2.12SECTION 1301.19
   1301.19 Special requirements for online pharmacies.
21:9.0.1.1.2.0.3SUBJGRP 3
   Exceptions to Registration and Fees
21:9.0.1.1.2.0.3.13SECTION 1301.21
   1301.21 Exemption from fees.
21:9.0.1.1.2.0.3.14SECTION 1301.22
   1301.22 Exemption of agents and employees; affiliated practitioners.
21:9.0.1.1.2.0.3.15SECTION 1301.23
   1301.23 Exemption of certain military and other personnel.
21:9.0.1.1.2.0.3.16SECTION 1301.24
   1301.24 Exemption of law enforcement officials.
21:9.0.1.1.2.0.3.17SECTION 1301.25
   1301.25 Registration regarding ocean vessels, aircraft, and other entities.
21:9.0.1.1.2.0.3.18SECTION 1301.26
   1301.26 Exemptions from import or export requirements for personal medical use.
21:9.0.1.1.2.0.3.19SECTION 1301.27
   1301.27 Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.
21:9.0.1.1.2.0.3.20SECTION 1301.28
   1301.28 Exemption from separate registration for practitioners dispensing or prescribing Schedule III, IV, or V narcotic controlled drugs approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment.
21:9.0.1.1.2.0.3.21SECTION 1301.29
   1301.29 [Reserved]
21:9.0.1.1.2.0.4SUBJGRP 4
   Action on Application for Registration: Revocation or Suspension of Registration
21:9.0.1.1.2.0.4.22SECTION 1301.31
   1301.31 Administrative review generally.
21:9.0.1.1.2.0.4.23SECTION 1301.32
   1301.32 Action on applications for research in Schedule I substances.
21:9.0.1.1.2.0.4.24SECTION 1301.33
   1301.33 Application for bulk manufacture of Schedule I and II substances.
21:9.0.1.1.2.0.4.25SECTION 1301.34
   1301.34 Application for importation of Schedule I and II substances.
21:9.0.1.1.2.0.4.26SECTION 1301.35
   1301.35 Certificate of registration; denial of registration.
21:9.0.1.1.2.0.4.27SECTION 1301.36
   1301.36 Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.
21:9.0.1.1.2.0.4.28SECTION 1301.37
   1301.37 Order to show cause.
21:9.0.1.1.2.0.5SUBJGRP 5
   Hearings
21:9.0.1.1.2.0.5.29SECTION 1301.41
   1301.41 Hearings generally.
21:9.0.1.1.2.0.5.30SECTION 1301.42
   1301.42 Purpose of hearing.
21:9.0.1.1.2.0.5.31SECTION 1301.43
   1301.43 Request for hearing or appearance; waiver.
21:9.0.1.1.2.0.5.32SECTION 1301.44
   1301.44 Burden of proof.
21:9.0.1.1.2.0.5.33SECTION 1301.45
   1301.45 Time and place of hearing.
21:9.0.1.1.2.0.5.34SECTION 1301.46
   1301.46 Final order.
21:9.0.1.1.2.0.6SUBJGRP 6
   Modification, Transfer and Termination of Registration
21:9.0.1.1.2.0.6.35SECTION 1301.51
   1301.51 Modification in registration.
21:9.0.1.1.2.0.6.36SECTION 1301.52
   1301.52 Termination of registration; transfer of registration; distribution upon discontinuance of business.
21:9.0.1.1.2.0.7SUBJGRP 7
   Security Requirements
21:9.0.1.1.2.0.7.37SECTION 1301.71
   1301.71 Security requirements generally.
21:9.0.1.1.2.0.7.38SECTION 1301.72
   1301.72 Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; storage areas.
21:9.0.1.1.2.0.7.39SECTION 1301.73
   1301.73 Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.
21:9.0.1.1.2.0.7.40SECTION 1301.74
   1301.74 Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs.
21:9.0.1.1.2.0.7.41SECTION 1301.75
   1301.75 Physical security controls for practitioners.
21:9.0.1.1.2.0.7.42SECTION 1301.76
   1301.76 Other security controls for practitioners.
21:9.0.1.1.2.0.7.43SECTION 1301.77
   1301.77 Security controls for freight forwarding facilities.
21:9.0.1.1.2.0.8SUBJGRP 8
   Employee Screening - Non-Practitioners
21:9.0.1.1.2.0.8.44SECTION 1301.90
   1301.90 Employee screening procedures.
21:9.0.1.1.2.0.8.45SECTION 1301.91
   1301.91 Employee responsibility to report drug diversion.
21:9.0.1.1.2.0.8.46SECTION 1301.92
   1301.92 Illicit activities by employees.
21:9.0.1.1.2.0.8.47SECTION 1301.93
   1301.93 Sources of information for employee checks.