Pharmacist’s Manual An Informational Outline of the Controlled Substances Act
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Table of Contents
Section I - Introduction
Authorization for Public Dissemination
Message from the Administrator
Preface
Section II – Schedules of Controlled Substances
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)
Section III – Registration Requirements
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
Section IV – Transfer or Disposal of Controlled Substances
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
Section V – Security Requirements
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
Section VI – Recordkeeping Requirements
Required Records
Central Recordkeeping
Prescription Records
Section VII – Inventory Requirements
Initial Inventory
Biennial Inventory
Newly Scheduled Controlled Substance Inventory
Section VIII – Ordering Controlled Substances
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
Section IX – Valid Prescription Requirements
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
Section IX – Valid Prescription Requirements (continued)
Transfer of Schedules III-V Prescription Information
Prescription Monitoring Programs
Section X – Dispensing Requirements
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
Section XI – Ryan Haight Online Pharmacy Consumer Protection
Act of 2008
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
