Chapter 45H Controlled Dangerous Substances - Rutgers University

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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

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Last Revision Date: 2/19/2019

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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

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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

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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

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13:45H-11.3 Application forms................................................................................................................... 59 13:45H-11.4 Security requirements............................................................................................................ 59 13:45H-11.5 Persons required to keep records.......................................................................................... 60 13:45H-11.6 Records for treatment program which compound narcotics for treatment programs and other locations ............................................................................................................................................ 61 13:45H-11.7 Treatment of narcotic addicts with opioid medications ........................................................ 64

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SUBCHAPTER 1. GENERAL PROVISIONS; REGISTRATION

13:45H-1.1 REGISTRATION FEES a) Manufacturers of controlled dangerous substances shall pay an annual fee of $400.00 at the

time of application for registration or for renewal of registration.

b) Distributors and reverse distributors of controlled dangerous substances shall pay an annual fee of $200.00 at the time of application for registration or for renewal of registration.

c) Dispensers of controlled dangerous substances or practitioners registered to conduct research with controlled dangerous substances shall pay an annual fee of $40.00 at the time of application for registration or for renewal of registration.

d) Incorporated humane societies or licensed animal control facilities registered to purchase and administer sodium pentobarbital for the purpose of animal euthanasia shall pay an annual fee of $40.00 for registration or renewal of registration as a Dispenser in the category of hospital/clinic.

e) A separate fee shall be paid for each separate place of business or professional practice for which registration is required.

f) The following persons shall be exempt from payment of a fee for registration or renewal of registration:

1) Any hospital, clinic, institution, or other facility operated by any department of the State of New Jersey;

2) Any other agency, excluding individual State employees, for which the State of New Jersey would be responsible for payment of the fee, provided that such exemption is approved by the Director of the Division of Consumer Affairs in the Department of Law and Public Safety; and

3) Hospitals and other facilities operated by any department of the United States of America.

g) Exemption from payment of a fee for registration or renewal of registration does not relieve the person of the requirement to obtain a registration or of any other requirements or duties prescribed by law.

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Last Revision Date: 2/19/2019

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13:45H-1.1A DEFINITIONS The following words and terms, when used in this chapter, shall have the following meanings

unless, the context clearly indicates otherwise:

"Controlled dangerous substance" or "controlled substance" means a controlled dangerous substance as defined in N.J.S.A. 24:21-2.

"Days" means calendar days.

"Director" means the Director of the Division of Consumer Affairs in the Department of Law and Public Safety.

"Division" means the Division of Consumer Affairs in the Department of Law and Public Safety.

"Drug Control Unit" means the administrative unit within the Department of Law and Public Safety, Division of Consumer Affairs located at PO Box 45045, Newark, NJ 07101.

"Drug Enforcement Administration" or "DEA" means the United States Department of Justice, Drug Enforcement Administration.

"Executive Officer" means the administrator of the Drug Control Unit who may be contacted at (973) 504-6351.

"Reverse distributor" means a person who receives controlled dangerous substances acquired from another person registered under this chapter for the purpose of:

1) Returning unwanted, unusable, or outdated controlled substances to the manufacturer or the manufacturer's agent; or

2) Where necessary, processing such substances or arranging for processing such substances for disposal.

13:45H-1.2 REGISTRATION REQUIREMENTS a) Every person who manufactures or proposes to manufacture a controlled dangerous substance or substances, unless specifically exempted by statute or specifically waived by the

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