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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of Dec 22, 2023.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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TITLE 21--FOOD AND DRUGS
CHAPTER II--DRUG ENFORCEMENT ADMINISTRATION
DEPARTMENT OF JUSTICE
 
PART 1305ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES
 

Subpart A - General Requirements
   § 1305.01 - Scope of part 1305.
   § 1305.02 - Definitions.
   § 1305.03 - Distributions requiring a Form 222 or a digitally signed electronic order.
   § 1305.04 - Persons entitled to order Schedule I and II controlled substances.
   § 1305.05 - Power of attorney.
   § 1305.06 - Persons entitled to fill orders for Schedule I and II controlled substances.
   § 1305.07 - Special procedure for filling certain orders.

Subpart B - DEA Form 222
   § 1305.11 - Procedure for obtaining DEA Forms 222.
   § 1305.12 - Procedure for executing DEA Forms 222.
   § 1305.13 - Procedure for filling DEA Forms 222.
   § 1305.14 - Procedure for endorsing DEA Forms 222.
   § 1305.15 - Unaccepted and defective DEA Forms 222.
   § 1305.16 - Lost and stolen DEA Forms 222.
   § 1305.17 - Preservation of DEA Forms 222.
   § 1305.18 - Return of unused DEA Forms 222.
   § 1305.19 - Cancellation and voiding of DEA Forms 222.
   § 1305.20 - Transition provisions allowing continued use of existing stocks of triplicate DEA Forms 222.

Subpart C - Electronic Orders

 General Information
   § 1306.01 - Scope of part 1306.
   § 1306.02 - Definitions.
   § 1306.03 - Persons entitled to issue prescriptions.
   § 1306.04 - Purpose of issue of prescription.
   § 1306.05 - Manner of issuance of prescriptions.
   § 1306.06 - Persons entitled to fill prescriptions.
   § 1306.07 - Administering or dispensing of narcotic drugs.
   § 1306.08 - Electronic prescriptions.
   § 1306.09 - Prescription requirements for online pharmacies.

 Controlled Substances Listed in Schedule II
   § 1306.11 - Requirement of prescription.
   § 1306.12 - Refilling prescriptions; issuance of multiple prescriptions.
   § 1306.13 - Partial filling of prescriptions.
   § 1306.14 - Labeling of substances and filling of prescriptions.
   § 1306.15 - Provision of prescription information between retail pharmacies and central fill pharmacies for prescriptions of Schedule II controlled substances.

 Controlled Substances Listed in Schedules III, IV, and V
   § 1306.21 - Requirement of prescription.
   § 1306.22 - Refilling of prescriptions.
   § 1306.23 - Partial filling of prescriptions.
   § 1306.24 - Labeling of substances and filling of prescriptions.
   § 1306.25 - Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes.
   § 1306.26 - Dispensing without prescription.
   § 1306.27 - Provision of prescription information between retail pharmacies and central fill pharmacies for initial and refill prescriptions of Schedule III, IV, or V controlled substances.

 General Information
   § 1307.01 - Definitions.
   § 1307.02 - Application of State law and other Federal law.
   § 1307.03 - Exceptions to regulations.

 Special Exceptions for Manufacture and Distribution of Controlled Substances
   § 1307.11 - Distribution by dispenser to another practitioner.
   § 1307.13 - Incidental manufacture of controlled substances.

 Disposal of Controlled Substances
   § 1307.22 - Delivery of surrendered and forfeited controlled substances.

 Special Exempt Persons
   § 1307.31 - Native American Church.

 Special Exceptions Related to Telemedicine
   § 1307.41 - Temporary extension of certain COVID-19 telemedicine flexibilities for prescription of controlled medications.

 General Information
   § 1308.01 - Scope of this part.
   § 1308.02 - Definitions.
   § 1308.03 - Administration Controlled Substances Code Number.

 Schedules
   § 1308.11 - Schedule I.
   § 1308.12 - Schedule II.
   § 1308.13 - Schedule III.
   § 1308.14 - Schedule IV.
   § 1308.15 - Schedule V.

 Excluded Nonnarcotic Substances
   § 1308.21 - Application for exclusion of a nonnarcotic substance.
   § 1308.22 - Excluded substances.

 Exempt Chemical Preparations
   § 1308.23 - Exemption of certain chemical preparations; application.
   § 1308.24 - Exempt chemical preparations.

 Excluded Veterinary Anabolic Steroid Implant Products
   § 1308.25 - Exclusion of a veterinary anabolic steroid implant product; application.
   § 1308.26 - Excluded veterinary anabolic steroid implant products.

 Exempted Prescription Products
   § 1308.31 - Application for exemption of a nonnarcotic prescription product.
   § 1308.32 - Exempted prescription products.

 Exempt Anabolic Steroid Products
   § 1308.33 - Exemption of certain anabolic steroid products; application.
   § 1308.34 - Exempt anabolic steroid products.

 Exempt Cannabis Plant Material, and Products Made Therefrom, that Contain Tetrahydrocannabinols
   § 1308.35 - Exemption of certain cannabis plant material, and products made therefrom, that contain tetrahydrocannabinols.

 Hearings
   § 1308.41 - Hearings generally.
   § 1308.42 - Purpose of hearing.
   § 1308.43 - Initiation of proceedings for rulemaking.
   § 1308.44 - Request for hearing or appearance; waiver.
   § 1308.45 - Final order.
   § 1308.46 - Control required under international treaty.
   § 1308.47 - Control of immediate precursors.
   § 1308.49 - Temporary scheduling.
   § 1308.50 - Temporary and permanent scheduling of recently emerged anabolic steroids.

 General Information
   § 1309.01 - Scope of part 1309.
   § 1309.02 - Definitions.
   § 1309.03 - Information; special instructions.

 Fees for Registration and Reregistration
   § 1309.11 - Fee Amounts.
   § 1309.12 - Time and method of payment; refund.

 Requirements for Registration
   § 1309.21 - Persons required to register.
   § 1309.22 - Separate registration for independent activities.
   § 1309.23 - Separate registration for separate locations.
   § 1309.24 - Waiver of registration requirement for certain activities.
   § 1309.25 - Temporary exemption from registration for chemical registration applicants.
   § 1309.26 - Exemption of law enforcement officials.

 Application for Registration
   § 1309.31 - Time for application for registration; expiration date.
   § 1309.32 - Application forms; contents; signature.
   § 1309.33 - Filing of application; joint filings.
   § 1309.34 - Acceptance for filing; defective applications.
   § 1309.35 - Additional information.
   § 1309.36 - Amendments to and withdrawals of applications.

 Action on Applications for Registration: Revocation or Suspension of Registration
   § 1309.41 - Administrative review generally.
   § 1309.42 - Certificate of registration; denial of registration.
   § 1309.43 - Suspension or revocation of registration.
   § 1309.44 - Suspension of registration pending final order.
   § 1309.45 - Extension of registration pending final order.
   § 1309.46 - Order to show cause.

 Hearings
   § 1309.51 - Hearings generally.
   § 1309.52 - Purpose of hearing.
   § 1309.53 - Request for hearing or appearance; waiver; default.
   § 1309.54 - Burden of proof.
   § 1309.55 - Time and place of hearing.

 Modification, Transfer and Termination of Registration
   § 1309.61 - Modification in registration.
   § 1309.62 - Termination of registration.
   § 1309.63 - Transfer of registration.

 Security Requirements
   § 1309.71 - General security requirements.
   § 1309.72 - Felony conviction; employer responsibilities.
   § 1309.73 - Employee responsibility to report diversion.

Authority: 21 U.S.C. 821, 828, 871(b), unless otherwise noted.
Source: 70 FR 16911, Apr. 1, 2005, unless otherwise noted.

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