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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

Section I - Introduction

Disclaimer

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

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

Section XII – Other Pharmacy Operations

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

Section XIII – Other Controlled Substance Regulations

Controlled Substance Distribution by a Pharmacy – “Five Percent Rule”

United States Postal Service Mailing Requirements for Controlled Substances

Section XIV – Combat Methamphetamine Epidemic Act of 2005

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

Appendix A-N

 

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U.S. DEPARTMENT OF JUSTICE  •  DRUG ENFORCEMENT ADMINISTRATION
Office of Diversion Control  •  8701 Morrissette Drive  •  Springfield, VA 22152  •  1-800-882-9539