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(DEA-DC-046)(EO-DEA154) Pharmacist Manual

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(DEA-DC-046)(EO-DEA154) Pharmacist Manual Pharmacist’s Manual An Informational Outline of the Controlled Substances Act Revised 2020 Drug Enforcement Administration Pharmacist’s Manual --------------------------------------------------------------------------------------------------------------------- Timothy J. Shea Acting Administrator Drug Enforcement Administration William T. McDermott Assistant Administrator Diversion Control Division Loren T. Miller Chief, Policy Section This Pharmacist’s Manual has been prepared by the Drug Enforcement Administration, Diversion Control Division, 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 2020 edition replaces all previous editions of the Pharmacist’s Manual issued by the Drug Enforcement Administration, both hard copy and electronic. Guidance documents, like this document, are not binding and lack the force and effect of law, unless expressly authorized by statute or expressly incorporated into a contract, grant, or cooperative agreement. Consistent with Executive Order 13891 and the Office of Management and Budget implementing memoranda, the Department will not cite, use, or rely on any guidance document that is not accessible through the Department’s guidance portal, or similar guidance portals for other Executive Branch departments and agencies, except to establish historical facts. To the extent any guidance document sets out voluntary standards (e.g., recommended practices), compliance with those standards is voluntary, and noncompliance will not result in enforcement action. Guidance documents may be rescinded or modified in the Department’s complete discretion, consistent with applicable laws. EO‐DEA154, October 8, 2020, DEA‐DC‐046 Drug Enforcement Administration Pharmacist’s Manual EO‐DEA154 --------------------------------------------------------------------------------------------------------------------- Table of Contents SECTION I – INTRODUCTION ........................................................................................ 6 Disclaimer .................................................................................................................................................. 6 Authorization for Public Dissemination ...................................................................................................... 7 Message from the Assistant Administrator ................................................................................................ 8 Preface ...................................................................................................................................................... 9 SECTION II – SCHEDULES OF CONTROLLED SUBSTANCES .................................. 11 Schedule I Controlled Substances .......................................................................................................... 11 Schedule II Controlled Substances ......................................................................................................... 11 Schedule III Controlled Substances ........................................................................................................ 12 Schedule IV Controlled Substances ........................................................................................................ 12 Schedule V Controlled Substances ......................................................................................................... 12 Scheduled Listed Chemical Products (SLCP) ......................................................................................... 13 SECTION III – REGISTRATION REQUIREMENTS ....................................................... 14 New Pharmacy Registration .................................................................................................................... 14 Renewal of Pharmacy Registration ......................................................................................................... 14 Affidavit for Renewal of Retail Chain Pharmacy Registration ................................................................. 15 Change of Business Address .................................................................................................................. 16 Termination of Registration ..................................................................................................................... 16 Transfer of Business ................................................................................................................................ 17 Denial of Registration in the Public Interest ............................................................................................ 18 Suspension or Revocation of Registration .............................................................................................. 18 Chemical Registration Requirements ...................................................................................................... 19 SECTION IV – ORDERING CONTROLLED SUBSTANCES ......................................... 20 Ordering Schedules I and II Controlled Substances ............................................................................... 20 Requesting DEA Forms 222 .................................................................................................................... 20 Completing DEA Forms 222 .................................................................................................................... 21 Power of Attorney to Sign DEA Forms 222 ............................................................................................. 23 Cancellation and Voiding DEA Forms 222 .............................................................................................. 26 Lost or Stolen DEA Forms 222 ................................................................................................................ 26 Return of Unused DEA Forms 222 .......................................................................................................... 26 Continued Use of Existing Stocks of Triplicate DEA Forms 222 ............................................................. 27 Procedure for Obtaining Triplicate DEA Forms 222 ................................................................................ 27 Completing Triplicate DEA Forms 222 .................................................................................................... 27 Unaccepted and Defective Triplicate DEA Forms 222 ............................................................................27 Cancellation and Voiding a Triplicate DEA Form 222 ............................................................................. 28 Lost or Stolen Triplicate DEA Forms 222 ................................................................................................ 28 Return of Unused Triplicate DEA Forms 222 .......................................................................................... 29 Controlled Substance Ordering System (CSOS) – Electronic Order Forms ............................................ 29 Unaccepted and Defective Electronic Orders ......................................................................................... 30 Cancellation and Voiding of Electronic Orders ........................................................................................ 30 Lost Electronic Orders ............................................................................................................................. 31 Ordering Schedules III-V Controlled Substances .................................................................................... 31 SECTION V – INVENTORY REQUIREMENTS ............................................................. 33 Initial Inventory ........................................................................................................................................ 33 Biennial Inventory .................................................................................................................................... 34 Newly Scheduled Controlled Substance Inventory ................................................................................. 34 2020 Edition Page 2 Drug Enforcement Administration Pharmacist’s Manual EO‐DEA154 --------------------------------------------------------------------------------------------------------------------- Inventory for Damaged, Defective, or Impure Substances ...................................................................... 34 SECTION VI – RECORDKEEPING REQUIREMENTS .................................................. 35 Required Records .................................................................................................................................... 35 Central Recordkeeping ............................................................................................................................ 36 Prescription Records ............................................................................................................................... 36 Electronic Prescription Records .............................................................................................................. 37 SECTION VII – VALID PRESCRIPTION REQUIREMENTS .......................................... 39 Acceptable Changes to a Prescription .................................................................................................... 39 Who May Issue .......................................................................................................................................
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