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Chapter 45H Controlled Dangerous Substances

PLEASE READ Rules and regulations of the Division of Consumer Affairs, 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 the free LexisNexis Public Access Portal. LexisNexis Public Access Portal: The text of rules and regulations and notices of proposal and adoptions in PDF format provided on this website by the Division of Consumer Affairs are unofficial courtesy copies, which may differ from the official text. Though every effort is made to ensure that the text of courtesy copies is identical to the official version, if any discrepancies exist between the text on this website and the official version, the official version will govern.

PLEASE READ Rules and regulations of the Division of Consumer Affairs, the boards and committees in, and other units of, the Division are codified in Title 13 of the New Jersey Administrative Code,

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Transcription of Chapter 45H Controlled Dangerous Substances

1 PLEASE READ Rules and regulations of the Division of Consumer Affairs, 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 the free LexisNexis Public Access Portal. LexisNexis Public Access Portal: The text of rules and regulations and notices of proposal and adoptions in PDF format provided on this website by the Division of Consumer Affairs are unofficial courtesy copies, which may differ from the official text. Though every effort is made to ensure that the text of courtesy copies is identical to the official version, if any discrepancies exist between the text on this website and the official version, the official version will govern.

2 Controlled Dangerous Substances LAW AND PUBLIC SAFETY N E W J E R S E Y A D M I N I S T R AT I V E C O D E TITLE 13 LAW AND P UBLIC S AFETY Chapter 45H C O N T R O L L E D D A N G E R O U S S U B S TA N C E S Chapter 45H Page 1 of 64 Last Revision Date: 9/8/2015 Controlled Dangerous Substances LAW AND PUBLIC SAFETY C H A P T E R TA B L E O F C O N T E N T S SUBCHAPTER 1. GENERAL PROVISIONS; REGISTRATION .. 6 13:45H Registration fees .. 6 13:45H Definitions .. 7 13:45H Registration requirements .. 7 13:45H Activities requiring 9 13:45H Registration application .. 11 13:45H Action upon application .. 12 13:45H Assignment or transfer of registration .. 12 13:45H Changes in schedule .. 13 13:45H Duplicate registration .. 13 SUBCHAPTER 2. SECURITY REQUIREMENTS .. 13 13:45H Security requirements generally.

3 13 13:45H Physical security controls for nonpractitioners: storage areas .. 15 13:45H Physical security controls for nonpractitioners; manufacturing areas .. 17 13:45H Other security controls for nonpractitioners .. 18 13:45H Physical security controls for practitioners .. 19 SUBCHAPTER 3. LABELING AND PACKAGING REQUIREMENTS .. 20 13:45H Scope .. 20 13:45H Definitions .. 20 13:45H Symbol required; exceptions .. 21 13:45H Location and size of symbol on label .. 22 13:45H Location and size of symbol on labeling .. 22 13:45H Effective dates of labeling requirements .. 23 13:45H Sealing of Controlled Substances .. 23 13:45H Labeling and packaging requirements for imported and exported Substances .. 23 SUBCHAPTER 4. (RESERVED) .. 24 SUBCHAPTER 5. RECORDS AND REPORTS OF REGISTRANTS.

4 24 13:45H Scope .. 24 13:45H Definitions .. 24 13:45H Persons required to keep records and file reports .. 25 13:45H Maintenance of records and inventories .. 26 13:45H General requirements for inventories .. 27 Chapter 45H Page 2 of 64 Last Revision Date: 9/8/2015 Controlled Dangerous Substances LAW AND PUBLIC SAFETY 13:45H Initial inventory date .. 28 13:45H Biennial inventory date .. 28 13:45H Inventory date for newly Controlled Substances .. 29 13:45H Inventories of manufacturers, distributors, dispensers, researchers, reverse distributors, importers, exporters, and chemical analysts .. 29 13:45H General requirements for continuing records .. 29 13:45H Records for manufacturers, distributors, dispensers, researchers, importers, exporters, and reverse distributors .. 30 13:45H Records for chemical analysts.

5 30 13:45H General requirements for reporting: manufacturers, importers, exporters, distributors, and reverse distributors .. 30 13:45H Reports from manufacturers importing narcotic raw material .. 30 13:45H Reports of manufacturers importing coca leaves .. 31 13:45H Inventory and record requirements for registered users of sodium pentobarbital .. 31 SUBCHAPTER 6. ORDERS FOR SCHEDULE I AND II Controlled Substances .. 31 13:45H General requirements .. 31 13:45H Definitions .. 31 13:45H Orders for humane society or licensed animal shelter .. 32 13:45H Preservation of order forms .. 32 13:45H Persons entitled to fill orders for Schedule I and Schedule II Controlled Substances .. 32 13:45H Lost and stolen order forms .. 33 SUBCHAPTER 7. PRESCRIPTION REQUIREMENTS FOR Controlled Dangerous Substances .

6 34 13:45H Scope .. 34 13:45H Definitions .. 34 13:45H Persons entitled to issue prescriptions .. 35 13:45H Purpose of issue of prescription .. 35 13:45H Manner of issuance of prescriptions .. 36 13:45H Persons entitled to fill prescriptions .. 37 13:45H Administering or dispensing of narcotic drugs .. 38 13:45H Requirements of prescriptions; Schedule II .. 38 13:45H Refilling prescriptions; Schedule II .. 40 13:45H Partial filling of prescriptions; Schedule II .. 40 13:45H Labeling of Substances ; Schedule II .. 41 13:45H Filing of prescriptions; Schedule II .. 41 13:45H Requirements of prescriptions; Schedules III, IV, and V .. 42 13:45H Refilling of prescriptions; Schedules III, IV and V .. 42 13:45H Partial filling of prescriptions; Schedules III, IV, and V .. 45 Chapter 45H Page 3 of 64 Last Revision Date: 9/8/2015 Controlled Dangerous Substances LAW AND PUBLIC SAFETY 13:45H Labeling of Substances ; Schedules III, IV, and V.

7 45 13:45H Filing prescriptions; Schedules III, IV, and V .. 45 13:45H Transfer between pharmacies of prescription information for Schedules III, IV, and V Controlled Substances for refill purposes .. 46 13:45H Dispensing without prescription .. 47 13:45H Electronic prescriptions .. 48 SUBCHAPTER 8. MISCELLANEOUS PROVISIONS .. 49 13:45H Definitions .. 49 13:45H Application of State Law and other Federal Law .. 49 13 45H Exceptions to regulations .. 49 13:45H Distribution by dispenser to another practitioner or .. 50 reverse distributor .. 50 13:45H Manufacture and distribution of narcotic solutions and compounds by a pharmacist .. 50 13:45H Distribution to supplier .. 50 13:45H Distribution upon discontinuance or transfer of business .. 50 13:45H Distribution to ocean vessels or aircraft.

8 51 13:45H Incidental manufacture of Controlled Substances .. 51 13:45H Procedure for disposing of Controlled Substances .. 52 13:45H Registrant return or recall .. 52 13:45H Reverse distributor authorized activities .. 52 13:45H Notification from registrants authorized to collect Controlled Substances .. 52 13:45H Native American Church .. 52 13:45H Humane societies and animal care facilities .. 52 SUBCHAPTER 9. (RESERVED) .. 56 SUBCHAPTER 10. Controlled Dangerous Substances SCHEDULES .. 56 13:45H Schedules of Controlled Dangerous Substances .. 56 13:45H (Reserved) .. 57 13:45H (Reserved) .. 57 13:45H (Reserved) .. 57 13:45H (Reserved) .. 57 13:45H Excluded Substances .. 57 13:45H Excepted prescription drugs .. 57 13:45H Exempt chemical preparations .. 58 SUBCHAPTER 11. NARCOTIC TREATMENT PROGRAM.

9 58 13:45H Definitions .. 58 13:45H Registration; fees .. 59 Chapter 45H Page 4 of 64 Last Revision Date: 9/8/2015 Controlled Dangerous Substances LAW AND PUBLIC SAFETY 13:45H Application forms .. 59 13:45H Security requirements .. 59 13:45H Persons required to keep records .. 60 13:45H Records for treatment program which compound narcotics for treatment programs and other locations .. 61 13:45H Treatment of narcotic addicts with opioid medications .. 64 Chapter 45H Page 5 of 64 Last Revision Date: 9/8/2015 Controlled Dangerous Substances LAW AND PUBLIC SAFETY SUBCHAPTER 1. GENERAL PROVISIONS; REGISTRATION. 13 REGISTRATION FEES. a) Manufacturers of Controlled Dangerous Substances shall pay an annual fee of $ at the time of application for registration or for renewal of registration.

10 B) Distributors and reverse distributors of Controlled Dangerous Substances shall pay an annual fee of $ 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 $ 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 $ 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.


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