Chapter 45H Controlled Dangerous Substances - New Jersey Division of ...
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Rules and regulations of the New Jersey Division of Consumer Affairs (Division), the boards and committees in, and other units of, the Division are codified in Title 13 of the New Jersey Administrative Code, published by LexisNexis. Notices of proposal and notices of adoption are printed in the New Jersey Register, also published by LexisNexis. The official text of the rules and regulations and their regulatory history and notices of rule proposals and adoptions can be found through LexisNexis.
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CONTROLLED DANGEROUS SUBSTANCES
LAW AND PUBLIC SAFETY
NEW JERSEY ADMINISTRATIVE CODE TITLE 13
LAW AND PUBLIC SAFETY CHAPTER 45H
CONTROLLED DANGEROUS SUBSTANCES
Chapter 45H
Page 1 of 64
Last Revision Date: 2/19/2019
CONTROLLED DANGEROUS SUBSTANCES
LAW AND PUBLIC SAFETY
CHAPTER TABLE OF CONTENTS
SUBCHAPTER 1. GENERAL PROVISIONS; REGISTRATION .......................................................... 6
13:45H-1.1 Registration fees ........................................................................................................................ 6 13:45H-1.1A Definitions................................................................................................................................ 7 13:45H-1.2 Registration requirements ......................................................................................................... 7 13:45H-1.3 Activities requiring registration.................................................................................................. 9 13:45H-1.4 Registration application ........................................................................................................... 11 13:45H-1.5 Action upon application ........................................................................................................... 12 13:45H-1.6 Assignment or transfer of registration..................................................................................... 12 13:45H-1.7 Changes in schedule................................................................................................................. 13 13:45H-1.8 Duplicate registration............................................................................................................... 13
SUBCHAPTER 2. SECURITY REQUIREMENTS ........................................................................... 13
13:45H-2.1 Security requirements generally.............................................................................................. 13 13:45H-2.2 Physical security controls for nonpractitioners: storage areas................................................ 15 13:45H-2.3 Physical security controls for nonpractitioners; manufacturing areas .................................... 17 13:45H-2.4 Other security controls for nonpractitioners ........................................................................... 18 13:45H-2.5 Physical security controls for practitioners.............................................................................. 19
SUBCHAPTER 3. LABELING AND PACKAGING REQUIREMENTS ............................................... 20
13:45H-3.1 Scope ........................................................................................................................................ 20 13:45H-3.2 Definitions ................................................................................................................................ 20 13:45H-3.3 Symbol required; exceptions ................................................................................................... 21 13:45H-3.4 Location and size of symbol on label ....................................................................................... 22 13:45H-3.5 Location and size of symbol on labeling .................................................................................. 22 13:45H-3.6 Effective dates of labeling requirements ................................................................................. 23 13:45H-3.7 Sealing of controlled substances.............................................................................................. 23 13:45H-3.8 Labeling and packaging requirements for imported and exported substances ...................... 23
SUBCHAPTER 4. (RESERVED) .................................................................................................. 24
SUBCHAPTER 5. RECORDS AND REPORTS OF REGISTRANTS ................................................... 24
13:45H-5.1 Scope ........................................................................................................................................ 24 13:45H-5.2 Definitions ................................................................................................................................ 24 13:45H-5.3 Persons required to keep records and file reports .................................................................. 25 13:45H-5.4 Maintenance of records and inventories................................................................................. 26 13:45H-5.5 General requirements for inventories ..................................................................................... 27
Chapter 45H
Page 2 of 64
Last Revision Date: 2/19/2019
CONTROLLED DANGEROUS SUBSTANCES
LAW AND PUBLIC SAFETY
13:45H-5.6 Initial inventory date ................................................................................................................ 28 13:45H-5.7 Biennial inventory date ............................................................................................................ 28 13:45H-5.8 Inventory date for newly-controlled substances ..................................................................... 29 13:45H-5.9 Inventories of manufacturers, distributors, dispensers, researchers, reverse distributors, importers, exporters, and chemical analysts.............................................................................................. 29 13:45H-5.10 General requirements for continuing records ....................................................................... 29 13:45H-5.11 Records for manufacturers, distributors, dispensers, researchers, importers, exporters, and reverse distributors..................................................................................................................................... 30 13:45H-5.12 Records for chemical analysts................................................................................................ 30 13:45H-5.13 General requirements for reporting: manufacturers, importers, exporters, distributors, and reverse distributors..................................................................................................................................... 30 13:45H-5.14 Reports from manufacturers importing narcotic raw material ............................................. 30 13:45H-5.15 Reports of manufacturers importing coca leaves .................................................................. 31 13:45H-5.16 Inventory and record requirements for registered users of sodium pentobarbital .............. 31
SUBCHAPTER 6. ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES ....................... 31
13:45H-6.1 General requirements .............................................................................................................. 31 13:45H-6.2 Definitions ................................................................................................................................ 31 13:45H-6.3 Orders for humane society or licensed animal shelter ............................................................ 32 13:45H-6.4 Preservation of order forms..................................................................................................... 32 13:45H-6.5 Persons entitled to fill orders for Schedule I and Schedule II controlled substances .............. 32 13:45H-6.6 Lost and stolen order forms..................................................................................................... 33
SUBCHAPTER 7. PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES .............................................................................................................................................. 34
13:45H-7.1 Scope ........................................................................................................................................ 34 13:45H-7.2 Definitions ................................................................................................................................ 34 13:45H-7.3 Persons entitled to issue prescriptions .................................................................................... 35 13:45H-7.4 Purpose of issue of prescription .............................................................................................. 35 13:45H-7.5 Manner of issuance of prescriptions........................................................................................ 36 13:45H-7.6 Persons entitled to fill prescriptions ........................................................................................ 37 13:45H-7.7 Administering or dispensing of narcotic drugs ........................................................................ 38 13:45H-7.8 Requirements of prescriptions; Schedule II ............................................................................. 38 13:45H-7.9 Refilling prescriptions; Schedule II ........................................................................................... 40 13:45H-7.10 Partial filling of prescriptions; Schedule II.............................................................................. 40 13:45H-7.11 Labeling of substances; Schedule II........................................................................................ 41 13:45H-7.12 Filing of prescriptions; Schedule II ......................................................................................... 41 13:45H-7.13 Requirements of prescriptions; Schedules III, IV, and V ........................................................ 42 13:45H-7.14 Refilling of prescriptions; Schedules III, IV and V ................................................................... 42 13:45H-7.15 Partial filling of prescriptions; Schedules III, IV, and V........................................................... 45
Chapter 45H
Page 3 of 64
Last Revision Date: 2/19/2019
CONTROLLED DANGEROUS SUBSTANCES
LAW AND PUBLIC SAFETY
13:45H-7.16 Labeling of substances; Schedules III, IV, and V..................................................................... 45 13:45H-7.17 Filing prescriptions; Schedules III, IV, and V........................................................................... 45 13:45H-7.18 Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes ................................................................................................... 46 13:45H-7.19 Dispensing without prescription ............................................................................................ 47 13:45H-7.20 Electronic prescriptions .......................................................................................................... 48
SUBCHAPTER 8. MISCELLANEOUS PROVISIONS ..................................................................... 49
13:45H-8.1 Definitions ................................................................................................................................ 49 13:45H-8.2 Application of State Law and other Federal Law ..................................................................... 49 13-45H-8.3 Exceptions to regulations......................................................................................................... 49 13:45H-8.4 Distribution by dispenser to another practitioner or .............................................................. 50 reverse distributor ...................................................................................................................................... 50 13:45H-8.5 Manufacture and distribution of narcotic solutions and compounds by a pharmacist .......... 50 13:45H-8.6 Distribution to supplier ............................................................................................................ 50 13:45H-8.7 Distribution upon discontinuance or transfer of business....................................................... 50 13:45H-8.8 Distribution to ocean vessels or aircraft .................................................................................. 51 13:45H-8.9 Incidental manufacture of controlled substances ................................................................... 51 13:45H-8.10 Procedure for disposing of controlled substances................................................................. 52 13:45H-8.11 Registrant return or recall...................................................................................................... 52 13:45H-8.12 Reverse distributor authorized activities ............................................................................... 52 13:45H-8.13 Notification from registrants authorized to collect controlled substances ........................... 52 13:45H-8.14 Native American Church ........................................................................................................ 52 13:45H-8.15 Humane societies and animal care facilities .......................................................................... 52
SUBCHAPTER 9. (RESERVED) .................................................................................................. 56
SUBCHAPTER 10. CONTROLLED DANGEROUS SUBSTANCES SCHEDULES ................................ 56
13:45H-10.1 Schedules of controlled dangerous substances ..................................................................... 56 13:45H-10.2 (Reserved) .............................................................................................................................. 57 13:45H-10.3 (Reserved) .............................................................................................................................. 57 13:45H-10.4 (Reserved) .............................................................................................................................. 57 13:45H-10.5 (Reserved) .............................................................................................................................. 57 13:45H-10.6 Excluded O.T.C. substances.................................................................................................... 57 13:45H-10.7 Excepted prescription drugs .................................................................................................. 57 13:45H-10.8 Exempt chemical preparations .............................................................................................. 58
SUBCHAPTER 11. NARCOTIC TREATMENT PROGRAM ............................................................ 58
13:45H-11.1 Definitions .............................................................................................................................. 58 13:45H-11.2 Registration; fees ................................................................................................................... 59
Chapter 45H
Page 4 of 64
Last Revision Date: 2/19/2019
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