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The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government produced by the Office of the Federal Register (OFR) and the Government Publishing Office.

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Electronic Code of Federal Regulations

Electronic Code of Federal Regulations

e-CFR data is current as of November 25, 2015

Title 21Chapter IIPart 1301

TITLE 21—Food and Drugs




General Information

Scope of this part 1301.
Information; special instructions.


Persons required to register; requirement of modification of registration authorizing activity as an online pharmacy.
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.
Additional information.
Amendments to and withdrawal of applications.
Special procedures for certain applications.
Research protocols.
Special requirements for online pharmacies.

Exceptions to Registration and Fees

Exemption from fees.
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.
Registration waivers; exemption from practitioner registration for persons authorized by a United States Nuclear Regulatory Commission or agreement state medical use license or permit and administering the drug product DaTscan

Action on Application for Registration: Revocation or Suspension of Registration

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.
Order to show cause.


Hearings generally.
Purpose of hearing.
Request for hearing or appearance; waiver.
Burden of proof.
Time and place of hearing.
Final order.

Modification, Transfer and Termination of Registration

Modification in registration.
Termination of registration; transfer of registration; distribution upon discontinuance of business.

Security Requirements

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—Non-Practitioners

Employee screening procedures.
Employee responsibility to report drug diversion.
Illicit activities by employees.
Sources of information for employee checks.

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