[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2005]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR1301.01]

[Page 13-14]
 
                         TITLE 21-FOOD AND DRUGS
 
   CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
 
PART 1301_REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS 
OF CONTROLLED SUBSTANCES--Table of Contents
 
Sec. 1301.01  Scope of this part 1301.




                           General Information

Sec.
1301.01 Scope of this part 1301.
1301.02 Definitions.
1301.03 Information; special instructions.

                              Registration

1301.11 Persons required to register.
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.

                   Exceptions to Registration and Fees

1301.21 Exception 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.

  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.

                                Hearings

1301.41 Hearings generally.
1301.42 Purpose of hearing.
1301.43 Request for hearing or appearance; waiver.
1301.44 Burden of proof.
1301.45 Time and place of hearing.
1301.46 Final order.

         Modification, Transfer, and Termination of Registration

1301.51 Modification in registration.

[[Page 14]]

1301.52 Termination of registration; transfer of registration; 
          distribution upon discontinuance of business.

                          Security Requirements

1301.71 Security requirements generally.
1301.72 Physical security controls for nonpractitioners; narcotic 
          treatment programs and compounders for narcotic treatment 
          programs; storage areas.
1301.73 Physical security controls for nonpractitioners; compounders for 
          narcotic treatment programs; manufacturing and compounding 
          areas.
1301.74 Other security controls for nonpractitioners; narcotic treatment 
          programs and compounders for 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.

    Authority: 21 U.S.C. 821, 822, 823, 824, 871(b), 875, 877, 951, 952, 
953, 956, 957.

    Source: 36 FR 7778, Apr. 24, 1971, unless otherwise noted. 
Redesignated at 38 FR 26609, Sept. 24, 1973.

                           General Information


    Procedures governing the registration of manufacturers, 
distributors, dispensers, importers, and exporters of controlled 
substances pursuant to sections 301-304 and 1007-1008 of the Act (21 
U.S.C. 821-824 and 957-958) are set forth generally by those sections 
and specifically by the sections of this part.

[62 FR 13945, Mar. 24, 1997]