Pharmacist's Manual
An Informational Outline of the Controlled Substances Act
Revised 2010
Michele M. Leonhart
Administrator
Drug Enforcement Administration
Joseph T. Rannazzisi
Deputy Assistant Administrator/
Deputy Chief of Operations
Office of Diversion Control
Mark W. Caverly
Chief, Liaison and Policy Section
This manual has been prepared by the Drug Enforcement Administration, Office of Diversion Control, as a guide to assist pharmacists in their understanding of the Federal Controlled Substances Act and its implementing regulations as they pertain to the pharmacy profession.
The 2010 edition replaces all previous editions of the Pharmacist’s Manual issued by the Drug Enforcement Administration, both hard copy and electronic.
TABLE OF CONTENTS
Disclaimer
Authorization for Public Dissemination
Message from the Administrator
Preface
Schedule I Controlled Substances
Schedule II Controlled Substances
Schedule III Controlled Substances
Schedule IV Controlled Substances
Schedule V Controlled Substances
Scheduled Listed Chemical Products (SLCP)
New Pharmacy Registration
Renewal of Pharmacy Registration
Affidavit for Renewal of Retail Chain Pharmacy Registration
Change of Business Address
Termination of Registration
Transfer of Business
Denial, Suspension, or Revocation of Registration
Denial of Registration in the Public Interest
Chemical Registration Requirements
Transfer of Controlled Substances
Transfer to a Pharmacy
Transfer to the Original Supplier or Original Manufacturer
Disposal of Controlled Substances
Reverse Distributors Authorized to Dispose Controlled Substances
Disposal of Controlled Substances by Persons Not Registered with DEA
Requests for Employment Waivers for Certain Pharmacy Employees
Controlled Substance Theft or Significant Loss
In-Transit Loss
In-Transit Loss from Central Fill Pharmacy
Breakage and Spillage
Robberies and Burglaries Involving Controlled Substances
Required Records
Central Recordkeeping
Prescription Records
Initial Inventory
Biennial Inventory
Newly Scheduled Controlled Substance Inventory
Ordering Schedule II Controlled Substances
Requesting Official Order Forms
Completing Official Order Forms
Cancellation and Voiding an Official Order Form
Power of Attorney to Sign an Official Order Form
Lost or Stolen Order Forms
Controlled Substance Ordering System (CSOS) – Electronic Order Forms
Unaccepted and Defective Electronic Orders
Cancellation and Voiding of Electronic Orders
Lost Electronic Orders
Ordering Schedules III-V Controlled Substances
Who May Issue
Purpose of Issue
Corresponding Responsibility
Electronic Prescriptions
Verification of Practitioner Registration
Construction of Valid DEA Registration Number for Practitioners
Practitioner’s Use of a Hospital’s DEA Registration Number
Exemption of Federal Government Practitioners from Registration
Registration Requirements for Mid-Level Practitioners
Schedule II Controlled Substances
Refills
Issuance of Multiple Prescriptions for Schedule II Controlled Substances
Facsimile Prescriptions for Schedule II Controlled Substances
Exceptions for Schedule II Facsimile Prescriptions
Schedules III-V Controlled Substances
Refills
Electronic Recordkeeping of Schedules III-IV Prescription Information
Facsimile Prescriptions for Schedules III-V Controlled Substances
Telephone Authorization for Schedules III-V Prescriptions
Transfer of Schedules III-V Prescription Information
Prescription Monitoring Programs
Required Information for Prescription Labels
Schedule II Controlled Substance Prescriptions
Emergency Dispensing
Partial Dispensing
Partial Filling of Schedule II Prescriptions for Terminally Ill or Long Term Care Facility Patients
Schedules III-V Controlled Substance Prescriptions
Partial Dispensing
Dispensing Without a Prescription
Delivery of a Controlled Substance to Persons in Other Countries
Summary of the Act’s Major Provisions
Definition of an Online Pharmacy
Online Pharmacy Registration Exemptions
Notification Requirements
How to Register as an Online Pharmacy
State Licensure Requirements
Online Pharmacy Website Requirements
Reporting Requirements
Prescription Requirements
Definition of Prescriptions Terms
Filling New Prescriptions for Controlled Substances in Schedules III-V
Refilling Prescriptions for Controlled Substances in Schedules III-V
Central Fill Pharmacy
Long Term Care Facilities
Use of Automated Dispensing Systems by Retail Pharmacies at Long Term Care Facilities
Emergency Kits for Long Term Care Facilities
Opioid (Narcotic) Addiction Treatment Programs
Dispensing Controlled Substances for the Treatment of Pain
Controlled Substance Distribution by a Pharmacy – “Five Percent Rule”
United States Postal Service Mailing Requirements for Controlled Substances
Summary of the Act’s Major Provisions
Scheduled Listed Chemical Products
Recordkeeping Requirements
Loss or Theft of Scheduled Listed Chemical Products
Proof of Identity Requirements
Product Placement
Self-Certification
Required Training
Training Records
Self-Certification Fee
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