21 C.F.R. PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
TITLE 21-Food and Drugs
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE
PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
|
Information; special instructions.
|
|
|
Persons required to register.
|
|
|
Separate registrations for separate locations.
|
|
|
Application for registration; time for application; expiration date; registration for independent activities; application forms, fees, contents and signature; coincident activities.
|
|
|
Filing of application; acceptance for filing; defective applications.
|
|
|
Amendments to and withdrawal of applications.
|
|
|
Special procedures for certain applications.
|
|
|
Exemption of agents and employees; affiliated practitioners.
|
|
|
Exemption of certain military and other personnel.
|
|
|
Exemption of law enforcement officials.
|
|
|
Registration regarding ocean vessels, aircraft, and other entities.
|
|
|
Exemptions from import or export requirements for personal medical use.
|
|
|
Separate registration by retail pharmacies for installation and operation of automated dispensing systems at long term care facilities.
|
|
|
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.
|
|
|
Administrative review generally.
|
|
|
Action on applications for research in Schedule I substances.
|
|
|
Application for bulk manufacture of Schedule I and II substances.
|
|
|
Application for importation of Schedule I and II substances.
|
|
|
Certificate of registration; denial of registration.
|
|
|
Suspension or revocation of registration; suspension of registration pending final order; extension of registration pending final order.
|
|
|
Request for hearing or appearance; waiver.
|
|
|
Time and place of hearing.
|
|
|
Modification in registration.
|
|
|
Termination of registration; transfer of registration; distribution upon discontinuance of business.
|
|
|
Security requirements generally.
|
|
|
Physical security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs; storage areas.
|
|
|
Physical security controls for non-practitioners; compounders for narcotic treatment programs; manufacturing and compounding areas.
|
|
|
Other security controls for non-practitioners; narcotic treatment programs and compounders for narcotic treatment programs.
|
|
|
Physical security controls for practitioners.
|
|
|
Other security controls for practitioners.
|
|
|
Security controls for freight forwarding facilities.
|
|
|
Employee screening procedures.
|
|
|
Employee responsibility to report drug diversion.
|
|
|
Illicit activities by employees.
|
|
|
Sources of information for employee checks.
|
|