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Pharmacist's Manual

TABLE OF CONTENTS

An Informational Outline of the Controlled Substances Act of 1970

Message from the Administrator

Preface

• New Chemical Control Requirements

• Internet Resources

• Schedule I Substances
• Schedule II Substances
• Schedule III Substances
• Schedule IV Substances 
• Schedule V Substances 

• Chemical Registration Requirements 
• New Pharmacy Registration 
• Change of Business Address
• Affidavit for Renewal of Retail Chain Pharmacy Registration 
• Denial, Revocation or Suspension of Registration 
• Denial of Registration in the Public Interest 
• Termination of Registration 
• Transfer of Business 

• Transfer of Controlled Substances 
  • To Another Pharmacy 
  • To A Supplier or Manufacturer 
  • To a Reverse Distributor Registered to Dispose of Controlled Substances
• Destruction of Controlled Substances
  • Once-a-Year DEA Authorization for Destruction
  • Exception to DEA Authorization for Destruction 
  • Reverse Distributors Authorized to Destroy Controlled Substances 
  • "Blanket Authorization" for Destruction of Controlled Substances

• Request for Employment Waiver for Certain Pharmacy Employees 
• Controlled Substance Theft or Loss 
  • In-Transit Loss 
  • Breakage/Spillage
• Controlled Substance Registrant Protection Act of 1984
  • Federal Investigation
  • Penalties Upon Conviction

• Records that Must be Maintained 
• Central Recordkeeping 
• Prescription Records 

• Initial Inventory 
• Biennial Inventory 
• Newly Scheduled Controlled Substance Inventory
• Inventory of Drugs for Destruction or No Longer Saleable 

• Schedule II Substances (U.S. Official Order Forms - Schedule I & II)
  • Requesting Order Forms 
  • Completing Order Forms 
  • Power of Attorney to Sign an Order Form 
  • Lost or Stolen Order Forms 
• Schedule III-V Substances 

• Who May Issue 
• Verification of Practitioner Registration 
  • Construction of Valid DEA Registration Numbers for Practitioners
  • Practitioner’s Use of a Hospital’s DEA Registration Number 
  • Exception to the Registration Requirement for Public Health Service or Bureau of Prisons Personnel 
  • Registration Requirement for Military Personnel 
  • Mid-Level Practitioners 
• Purpose of Issue 
• Schedule II Substances 
  • Refills 
  • Facsimile Prescriptions for Schedule II Substances 
  • Exceptions for Schedule II Facsimile Prescriptions 
• Schedule III-V Substances 
  • Refills 
  • Computerization of Prescription Information 
  • Facsimile Prescriptions for Schedule III-V Substances 
  • Telephone Authorization for Schedule III-V Prescriptions 
  • Transfer of Prescription Information 
• Prescription Monitoring Programs 

• Required Information for Prescription Labels 
• Schedule II Controlled Substances 
  • Emergency Dispensing 
  • Partial Dispensing 
  • Exception for Schedule II Prescriptions at Long Term Care Facilities 
  • Internet Pharmacies
  • Electronic Transmission of Prescriptions
• Schedules III-V Controlled Substance Prescriptions 
  • Partial Dispensing 
  • Dispensing Without a Prescription 
  • Delivery of a Controlled Substance or Drug Product Containing Listed Chemicals to Persons in Another Country 
• Central Fill Pharmacy

• Emergency Kits in Long Term Care Facilities 

• Use of Methadone Outside a Narcotic Treatment Program

• Controlled Substances for Medical Missions and Humanitarian Charitable Solicitations
• Controlled Substance Distribution by a Pharmacy 
• U.S. Postal Service Mailing Requirements for Controlled Substances 

• Summary of MCA's Major Provisions Which Concern Pharmacists
• Regulated Chemicals 
• Recordkeeping for List I Chemicals 
• Proof of Identity Requirement for Purchasers of List I Chemicals 
• Excessive or Unusual Purchases of List I Chemicals (Suspicious Orders) 
• List I Chemical Security 

Appendix

Inside Back Cover