GENERAL INFORMATION

• § 1301.01 - Scope of this part 1301.

• § 1301.02 - Definitions.Link

• § 1301.03 - Information; special instructions.

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.

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.

• § 1301.28 - 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.

• § 1301.29 - [Reserved]

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; default.

• § 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.

• § 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 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.