Pharmacist’s Manual

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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

Last update

Feb. 15, 2013

Pharmacist’s Manual

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