reglab/statecodes huggingface dataset:
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 1 - GENERAL PROVISIONS; REGISTRATION › Section 13:45H-1.7 - Changes in schedule

Current through Register Vol. 56, No. 14, July 15, 2024
Consistent with the provisions set forth in 24:21-3, regulations promulgated pursuant to the United States Comprehensive Drug Abuse Prevention and Control Act of 1970, which designate, reschedule or delete a substance as a controlled substance under Federal Law, shall be deemed to be effective under the New Jersey Controlled Dangerous Substance Act (24:21-1 et seq.) 30 days after their effective date of the Federal regulation, unless the Director, within that 30 day period, shall object to inclusion, rescheduling or deletion, which objection shall thereafter be published in the New Jersey Register.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 1 - GENERAL PROVISIONS; REGISTRATION › Section 13:45H-1.8 - Duplicate registration

Current through Register Vol. 56, No. 14, July 15, 2024
Any registrant requesting a duplicate of a certificate of registration shall apply to the Drug Control Unit in writing and pay a fee of $ 5.00 for such duplicate.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 2 - SECURITY REQUIREMENTS › Section 13:45H-2.1 - Security requirements generally

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All applicants and registrants shall provide effective controls and procedures to guard against theft and diversion of controlled substances. In order to determine whether a registrant has provided effective controls against diversion, the Division shall use the security requirements set forth in 13:45H-2.2, 2.3 and 2.5 as standards for the physical security controls and operating procedures necessary to prevent diversion. Materials and construction which will provide a structural equivalent to the physical security controls set forth in N.J.A.C. 13:45H-2.2, 2.3 and 2.5 may be used in lieu of the materials and construction described in those sections.
(b) Substantial compliance with the standards set forth in 13:45H-2.2 through 2.6 may be deemed sufficient by the Division after evaluation of the overall security system and needs of the applicant or registrant. In evaluating the overall security system of a registrant or applicant, the Division may consider any of the following factors as the Division may deem relevant to the need for strict compliance with security requirements:
1. The type of activity conducted (e.g., processing of bulk chemicals, preparing dosage forms, packaging, labeling, co-operative buying, and so forth);
2. The type and form of controlled substances handled (e.g., bulk liquids or dosage units, usable powders or nonusable powders);
3. The quantity of controlled substances handled;
4. The location of the premises and the relationship such location bears on security needs;
5. The type of building construction comprising the facility and the general characteristics of the building or buildings;
6. The type of vault, safe, and secure enclosures or other storage system (e.g., automatic storage and retrieval system) used;
7. The type of closures on vaults, safes, and secure enclosures;
8. The adequacy of key control systems and/or combination lock control systems;
9. The adequacy of electric detection and alarm systems, if any, including use of supervised transmittal lines and standby power sources;
10. The extent of unsupervised public access to the facility, including the presence and characteristics of perimeter fencing, if any;
11. The adequacy of supervision over employees having access to manufacturing and storage areas;
12. The procedures for handling business guests, visitors, maintenance personnel, and nonemployee service personnel;
13. The availability of local police protection or of the registrant's or applicant's security personnel, and;
14. The adequacy of the registrant's or applicant's system for monitoring the receipt, manufacture, distribution, and disposition of controlled substances in its operations.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 2 - SECURITY REQUIREMENTS › Section 13:45H-2.2 - Physical security controls for nonpractitioners: storage areas

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Raw materials, bulk materials awaiting further processing, and finished products which are controlled substances listed in Schedule I or II shall be stored in one of the following secure storage areas;
1. Where small quantities permit, a safe or steel cabinet:
i. Which safe or steel cabinet shall have the following specifications or the equivalent; 30 man-minutes against surreptitious entry, 10 man-minutes against forced entry, 20 man-hours against lock manipulation, and 20 man-hours against radiological techniques;
ii. Which safe or steel cabinet, if it weighs less than 750 pounds, is bolted or cemented to the floor or wall in such a way that it cannot be readily removed; and
iii. Which safe or steel cabinet, if necessary, depending upon the quantities and type of controlled substances stored, is equipped with an alarm system, which upon attempted unauthorized entry, shall transmit a signal directly to a central protection company or a local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant, or such other protection as the Division may approve.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 2 - SECURITY REQUIREMENTS › Section 13:45H-2.3 - Physical security controls for nonpractitioners; manufacturing areas

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All manufacturing activities (including processing, packaging and labeling) involving controlled substances listed in any schedule shall be conducted in accordance with the following:
1. All in-process substances shall be returned to the controlled substances storage area at the termination of the process. If the process is not terminated at the end of a workday (except where a continuous process or other normal manufacturing operation should not be interrupted), the processing area or tanks, vessels, bins or bulk containers containing such substances shall be securely locked, with adequate security for the area or building. If the security requires an alarm, such alarm, upon unauthorized entry, shall transmit a signal directly to a central station protection company, or local or State police agency which has a legal duty to respond, or a 24-hour control station operated by the registrant.
2. Manufacturing activities with controlled substances shall be conducted in an area or areas of clearly defined limited access which is under surveillance by an employee or employees designated in writing as responsible for the area "limited access" may be provided, in the absence of physical dividers such as walls or partitions, by traffic control lines or restricted space designation. The employee designated as responsible for the area may be engaged in the particular manufacturing operation being conducted, provided, that he is able to provide continuous surveillance of the area in order that unauthorized persons may not enter or leave the area without his knowledge.
3. During the production of controlled substances, the manufacturing areas shall be accessible to only those employees required for efficient operation. When it is necessary for employee maintenance personnel, nonemployee maintenance personnel, business guests or visitors to be present in or pass through manufacturing areas during production of controlled substances, the registrant shall provide for adequate observation of the area by an employee specifically authorized in writing.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 2 - SECURITY REQUIREMENTS › Section 13:45H-2.5 - Physical security controls for practitioners

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Controlled substances listed in Schedule I shall be stored in a securely locked, substantially constructed cabinet.
(b) Controlled substances listed in Schedules II, III, IV and V shall be stored in a securely locked, substantially constructed cabinet. However, pharmacies may disperse such substances throughout the stock of noncontrolled substances in such a manner as to obstruct the theft or diversion of the controlled substances.
(c) This section shall also apply to nonpractitioners authorized to conduct research or chemical analysis under another registration. The registrant shall not employ as an agent or employee who has access to controlled substances any person who has had an application for registration denied, or has had his registration revoked, at any time.
(d) The registrant shall notify the Drug Control Unit of the theft or loss of any controlled substances upon discovery of such loss or theft. The registrant shall also complete DDC-52 form regarding such loss or theft.
(e) Carfentanil, etorphine hydrochloride and diprenorphine shall be stored in a safe or steel cabinet equivalent to a U.S. Government Class V security container.
(f) This section shall apply to those persons or duly authorized agents registered for the purposes of purchasing and dispensing sodium pentobarbital for animal euthanasia. Safeguards and security to the sodium pentobarbital shall be in compliance with 13:45H-2.1.
(g) A person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia shall maintain records and inventories and shall file the reports required by this subchapter.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS › Section 13:45H-3.1 - Scope

Current through Register Vol. 56, No. 14, July 15, 2024
Requirements governing the labeling and packaging of controlled substances pursuant to Sections 305 and 1008(d) of the Act ( 21 U.S.C. 825 and 958(d) ) are set forth generally by those Sections and specifically by the Sections of this part.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS › Section 13:45H-3.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
"Commercial container" means any bottle, jar, tube, ampule or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert or other material kept with or within a commercial container, nor any carton, crate, drum or other package in which commercial containers are stored or used for shipment of controlled substances.
"Label" means any display of written, printed or graphic matter placed upon the commercial container of any controlled substance by any manufacturer of such substance.
"Labeling" means all labels and other written, printed or graphic matter upon any controlled substance or any of its commercial containers or wrappers, or accompanying such controlled substance.
"Manufacture" means the producing, preparation, propagation, compounding or processing of a drug or other substance or the packaging or repackaging of such substance, or the labeling or relabeling of the commercial container of such substance, but does not include the activities of a practitioner who, as an incident to his administration or dispensing such substance in the course of his professional practice, prepares, compounds, packages or labels such substance. The term "manufacture" means a person who manufactures a drug or other substance, whether under a registration or as a manufacturer or under authority of registration as a research or chemical analyst.
Any term not defined in this section shall have the definition set forth in Section 102 of the Act ( 21 U.S.C. 802 ) or 301.02 of 21 CFR.
(b) Any term not defined in this section shall have the definition set forth in Section 102 of the Act ( 21 U.S.C. §
										802 ) or 21 CFR Part 1300.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS › Section 13:45H-3.3 - Symbol required; exceptions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each commercial container of a controlled substance (except for a controlled substance excepted by the Division pursuant to N.J.S.A. 24:21-8d ) shall have printed on the label the symbol designating the schedule in which such controlled substance is listed. Each such commercial container, if it otherwise has no label, must bear a label complying with the requirement of this part.
(b) Each manufacturer shall print upon the labeling of each controlled substance distributed by him the symbol designating the schedule in which such controlled substance is listed.
(c) The following symbols shall designate the schedule corresponding thereto:
Schedule Symbol
1.
Schedule I I or C-I;
2.
Schedule II II or C-II;
3.
Schedule III III or C-III;
4.
Schedule IV IV or C-IV;
5.
Schedule V V or C-V;
6. The word "Schedule" need not be used. No distinction need be made between narcotic and nonnarcotic substances.
(d) The symbol is not required on a carton or wrapper in which a commercial container is held if the symbol is easily legible through such carton or wrapper.
(e) The symbol is not required on a commercial container too small or otherwise unable to accommodate a label, if the symbol is printed on the box or package from which the commercial container is removed upon dispensing to an ultimate user.
(f) The symbol is not required on a commercial container containing, or on the labeling of, a controlled substance being utilized in clinical research involving blind studies.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS › Section 13:45H-3.4 - Location and size of symbol on label

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The symbol shall be prominently located on the right upper corner of the principal panel of the label of the commercial container and/or the panel of the commercial container normally displayed to dispensers of any controlled substance listed in Schedules I through V. The symbol must be at least two times as large as the largest type otherwise printed on the label.
(b) In lieu of locating the symbol in the corner of the label, as prescribed in (a) above, the symbol may be overprinted on the label, in which case the symbol must be printed at least one-half the height of the label and in a contrasting color providing clear visability against the background color of the label.
(c) In all cases the symbol shall be clear and large enough to afford easy identification of the schedule of the controlled substance upon inspection without removal from the dispenser's shelf.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS › Section 13:45H-3.5 - Location and size of symbol on labeling

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The symbol shall be prominently located on all labeling other than labels covered by 13:45H-3.4.
(b) In all cases the symbol shall be clear and large enough to afford prompt identification of the controlled substance upon inspection of the labeling.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS › Section 13:45H-3.7 - Sealing of controlled substances

Current through Register Vol. 56, No. 14, July 15, 2024
On each bottle, multiple dose vial, or other commercial container of any controlled substance listed in Schedule I or II or of any narcotic controlled substance listed in Schedule III or IV, there shall be securely affixed to the stopper, cap, lid covering or wrapper of such container a seal to disclose upon inspection any tampering or opening of the container.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 3 - LABELING AND PACKAGING REQUIREMENTS › Section 13:45H-3.8 - Labeling and packaging requirements for imported and exported substances

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The symbol requirements of 13:45H-3.3 through 3.6 apply to every commercial container containing, and to all labeling of, controlled substances imported into the jurisdiction of and/or the customs territory of the United States, as defined to be the several states, the District of Columbia and Puerto Rico.
(b) The symbol requirements of 13:45H-3.3 through 3.6 do not apply to any commercial containers containing, or any labeling of, a controlled substance intended for export from the jurisdiction of the United States, as defined to be the several states, the District of Columbia and Puerto Rico.
(c) The sealing requirements of 13:45H-3.7 apply to every bottle, multiple dose vial, or other commercial container of any controlled substance listed in Schedule III or IV, imported into, exported from, or intended for export from, the jurisdiction of and/or the customs territory of the United States, as defined to be the several states, the District of Columbia, and Puerto Rico.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.1 - Scope

Current through Register Vol. 56, No. 14, July 15, 2024
Inventory and other records and reports required under Section 307 or Section 1008(d) of the Act ( 21 U.S.C. 827 and 958(d) ) shall be in accordance with, and contain the information required by, those Sections and by the Sections of this part.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms, when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
"Act" means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801 ) and/or the Controlled Substances Import and Export Act (84 Stat. 1285; 21 U.S.C. 951 ).
"Commercial container" means any bottle, jar, tube, ampule, or other receptacle in which a substance is held for distribution or dispensing to an ultimate user, and in addition, any box or package in which the receptacle is held for distribution or dispensing to an ultimate user. The term "commercial container" does not include any package liner, package insert of other material kept with or within a commercial container, nor any carton, crate, drum, or other package in which commercial containers are stored or are used for shipment of controlled substances.
"Dispenser" means an individual practitioner, institutional practitioner, pharmacy or pharmacist who dispenses a controlled substance.
"Individual practitioner" means a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States or the jurisdiction in which he practices, but does not include a pharmacist, a pharmacy, or an institutional practitioner.
"Institutional practitioner" means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted by the United States or the jurisdiction in which it practices, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.
"Name" means the official name, common or usual name, chemical name, or brand name of a substance.
"Pharmacist" means any pharmacist licensed by a State to dispense controlled substances, and shall include any other person (e.g., pharmacist intern) authorized by a State to dispense controlled substances under the supervision of a pharmacist licensed by such State.
"Readily retrievable" means that certain records are kept by automatic data processing systems or other electronic or mechanized record keeping systems in such a manner that they can be separated out from all other records in a reasonable time and/or records are kept on which certain items are asterisked, redlined, or in some other manner visually identifiable apart from other items appearing on the records.
Any term not defined in this section shall have the definition set forth in Sections 102 and 1001 of the Act ( 21 U.S.C. 802 and 951 ) and in 24:21-1 et seq.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.3 - Persons required to keep records and file reports

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each registrant shall maintain the records and inventories and shall file the reports required by this part, except as exempted by this section. Any registrant who is authorized to conduct other activities without being registered to conduct those activities, either pursuant to 24:21-10 or pursuant to 13:45H-8.5 or 21 CFR 1301.22(b), 1307.11, or 1307.13, or Part 1317, shall maintain the records and inventories and shall file the reports required by this part for persons registered or authorized to conduct such activities (for example, when a registered manufacturer conducts chemical analysis, he or she shall maintain the records and inventories required of chemical analysts). All records of each activity may be maintained in one consolidated record system.
(b) A registered individual practitioner is not required to keep records with respect to narcotic controlled substances listed in Schedules II through V, which he or she prescribes in the lawful course of his or her professional practice; he or she shall keep records, however, with respect to such substances that he or she administers and dispenses.
(c) A registered individual practitioner is required to keep records with respect to nonnarcotic controlled substances listed in Schedules II through V, which he or she dispenses or administers.
(d) A registered person using any controlled substance in research conducted in conformity with an exemption granted under Section 505(i) or 512(j) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(i) or 360 b(j) ) at a registered establishment which maintains records in accordance with either of these sections is not required to keep records if he notifies the Bureau of the name, address, and registration number of the establishment maintaining such records.
(e) A registered person using any controlled substance in preclinical research or in teaching at a registered establishment which maintains records with respect to such substances is not required to keep records if he notifies the Drug Enforcement Administration and the Drug Control Unit of the name, address, and registration number of the establishment maintaining such records.
(f) Notice required by (d) and (e) above shall be given at the time the person applies for registration or reregistration and shall be made in the form of an attachment to the application, which shall be filed with the application.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.4 - Maintenance of records and inventories

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every inventory and other record required to be kept under this subchapter shall be kept by the registrant and be available, for at least two years from the date of such inventory of records or pursuant to recordkeeping provisions of the State professional licensing board governing the registrant, whichever is longer, for inspecting and copying by authorized employees of the Drug Enforcement Administration and the Drug Control Unit, except that financial and shipping records (such as invoices and packing slips but not executed order forms subject to 21 CFR 1305.17 ) may be kept at a central location, rather than at the registered location in accordance with 21 CFR 1304.04, which is incorporated herein by reference.
(b) Each registered manufacturer, distributor, reverse distributor, importer, and exporter shall maintain inventories and records and controlled substances as follows:
1. Inventories and records of controlled substances listed in schedules I and II shall be maintained separately from all of the records of the registrant; and
2. Inventories and records of controlled substances listed in schedules III, IV, and V shall be maintained either separately from all other records of the registrant or in such form that the information required is readily retrievable from the ordinary business records of the registrant.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.5 - General requirements for inventories

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each inventory shall contain a complete and accurate record of all controlled substances on hand on the date the inventory is taken. Controlled substances shall be deemed to be "on hand" if they are in the possession of or under the control of the registrant, including substances returned by a customer, substances ordered by a customer but not yet invoiced, substances stored in a warehouse on behalf of the registrant, and substances in the possession of employees of the registrant and intended for distribution as complimentary samples.
(b) A separate inventory shall be made by a registrant for each registered location. In the event controlled substances in the possession or under the control of the registrant at a location for which he is not registered, the substances shall be included in the inventory of the registered location to which they are subject to control or to which the person possessing the substance is responsible. Each inventory for a registered location shall be kept at the registered location.
(c) A separate inventory shall be made by a registrant for each independent activity for which he is registered, except as provided in 13:45H-5.12.
(d) A registrant may take an inventory on a date that is within four days of the registrant's biennial inventory date pursuant to 13:45H-5.7 if, as part of the registrant's CDS registration renewal, the registrant provides the Drug Control Unit with the date the inventory was taken. A registrant may take an inventory either as of the opening of business or as of the close of business on the inventory date. The registrant shall indicate on the inventory records whether the inventory is taken as of the opening or as of the close of business and the date the inventory was taken.
(e) An inventory must be maintained in a written, typewritten or printed form. An inventory taken by use of an oral recording device must be promptly transcribed.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.6 - Initial inventory date

Current through Register Vol. 56, No. 14, July 15, 2024
Every person required to keep records shall take an inventory of all stocks of controlled substances on hand on the date he or she first engages in the manufacture, distribution, or dispensing of controlled substances, in accordance with 21 CFR 1304.11(b), which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.7 - Biennial inventory date

Current through Register Vol. 56, No. 14, July 15, 2024
Every two years following the date on which the initial inventory is taken by a registrant pursuant to 13:45H-5.6, the registrant shall take a new inventory of all stocks of controlled substances on hand. The biennial inventory may be taken on the day of the year on which the initial inventory was taken or on the registrant's regular general physical inventory date, if any, which is nearest to and does not vary by more than six months from the biennial date that would otherwise apply. If the registrant elects to take the biennial inventory on his regular general physical inventory date or another fixed date, he shall notify the Drug Enforcement Administration and the Drug Control Unit of this election and of the date on which the biennial inventory will be taken.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.8 - Inventory date for newly-controlled substances

Current through Register Vol. 56, No. 14, July 15, 2024
On the effective date of a rule by the Drug Enforcement Administration Administrator pursuant to 308.48, 308.49 or 308.50 of the Act or the Division pursuant to 24:21-3 adding a substance to any schedule of controlled substances, which substance was, immediately prior to that date, not listed on any such schedule, every registrant required to keep records who possesses that substance shall take an inventory of all stocks of the substance on hand. Thereafter such substances shall be included in each inventory made by the registrant pursuant to 13:45H-5.7.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.9 - Inventories of manufacturers, distributors, dispensers, researchers, reverse distributors, importers, exporters, and chemical analysts

Current through Register Vol. 56, No. 14, July 15, 2024
Each person registered or authorized under 21 CFR 1301.13(e), 1307.11, or 1307.13 or 13:45H-1.3 to manufacture, distribute, reverse distribute, dispense, import, export, or conduct research or chemical analysis with controlled substances and required to keep records pursuant to 13:45H-5.3 shall include in the inventory the information required in 21 CFR 1304.11(e), which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.10 - General requirements for continuing records

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every registrant required to keep records pursuant to 13:45H-5.3 shall maintain on a current basis a complete and accurate record of each substance manufactured, imported, received, sold, delivered, exported, or otherwise disposed of by him or her, except that no registrant shall be required to maintain a perpetual inventory.
(b) Separate records shall be maintained by a registrant for each registered location except as provided in N.J.A.C. 13:45H-5.4(a). In the event controlled substances are in the possession or under the control of a registrant at a location for which he is not registered, the substance shall be included in the records of the registered location to which they are subject to control or to which the person possessing the substance is responsible.
(c) Separate records shall be maintained by a registrant for each independent activity for which he is registered, except as provided in N.J.A.C. 13:45H-5.18 and 5.19.
(d) In recording dates of receipt, importation, distribution, exportation, or other transfers, the date on which the controlled substances are actually received, imported, distributed, exported, or otherwise transferred shall be used as the date of receipt or distribution of any documents of transfer (e.g., invoices or packing slips).
(e) In addition to any other recordkeeping requirements, any registrant that destroys a controlled substance pursuant to 21 CFR 1317.95(d), or causes the destruction of a controlled substance pursuant to 21 CFR 1317.95(c), shall maintain a record of destruction in accordance with 21 CFR 1304.21(e), which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.11 - Records for manufacturers, distributors, dispensers, researchers, importers, exporters, and reverse distributors

Current through Register Vol. 56, No. 14, July 15, 2024
Each person registered or authorized under 21 CFR 1301.13(e), 1307.11, or 1307.13 or 13:45H-1.3 to manufacture, distribute, reverse distribute, dispense, import, export, or conduct research with controlled substances shall maintain records with the information listed in 21 CFR 1304.22, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.12 - Records for chemical analysts

Current through Register Vol. 56, No. 14, July 15, 2024
Each person registered or authorized by 21 CFR 1301.13(e) or 13:45H-1.3 to conduct chemical analysis with controlled substances shall maintain records in accordance with 21 CFR 1304.23, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.13 - General requirements for reporting: manufacturers, importers, exporters, distributors, and reverse distributors

Current through Register Vol. 56, No. 14, July 15, 2024
Every registered manufacturer, registered importer, registered exporter, registered distributor, and reverse distributor, except any officer or agency of the Veteran's Administration or who or which is exempted from registration pursuant to 21 U.S.C. §
										822(c) and 13:45H-1.3 shall file reports in accordance with 21 CFR 1304.33, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.14 - Reports from manufacturers importing narcotic raw material

Current through Register Vol. 56, No. 14, July 15, 2024
Every manufacturer which imports or manufactures from narcotic raw material (opium, poppy straw, and concentrate of poppy straw) shall submit information pursuant to 21 CFR 1304.31, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.15 - Reports of manufacturers importing coca leaves

Current through Register Vol. 56, No. 14, July 15, 2024
Every manufacturer importing or manufacturing from raw coca leaves shall submit information pursuant to 21 CFR 1304.32, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 5 - RECORDS AND REPORTS OF REGISTRANTS › Section 13:45H-5.16 - Inventory and record requirements for registered users of sodium pentobarbital

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia and required to keep records shall maintain a quarterly inventory (last day of March, June, September, and December) on forms provided by the Drug Control Unit in the manner prescribed in 13:45H-5.9. A copy of such inventory shall be received in the Drug Control Unit within seven days after such required report is completed.
(b) Each person or duly authorized agent registered to use sodium pentobarbital for purposes of animal euthanasia shall make, keep, and maintain records of the use of sodium pentobarbital on forms provided by the Drug Control Unit.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 6 - ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES › Section 13:45H-6.1 - General requirements

Current through Register Vol. 56, No. 14, July 15, 2024
Procedures governing the issuance, use, and preservation of orders for Schedules I and II controlled substances are set forth generally by section 308 of the Act ( 21 U.S.C. §
										828 ) and specifically by 21 CFR Part 1305, which is incorporated herein by reference, and this subchapter.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 6 - ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES › Section 13:45H-6.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms, when used in this subchapter, shall have the following meanings, unless the contents clearly indicate otherwise:
"Act" means the Controlled Substances Act (84 Stat. 1242; 21 U.S.C. 801 ) and the Controlled Substance Import and Export Act (84 Stat. 1285; 21 U.S.C. 951 ).
"D.E.A." means the Drug Enforcement Administration.
"Digital signature" means a digital signature as defined in 21 CFR 1311.02 and which is issued by the D.E.A. or the D.E.A. certification authority.
"Electronic order" means an order signed with a digital signature and which complies with the requirements of Subpart C of 21 CFR Part 1305 ( 21 CFR 1305.21 through 1305.29 ) and Subparts A and B of 21 CFR Part 1311 ( 21 CFR 1311.01 through 1311.08 and 1311.10 through 1311.65 ), which are incorporated herein by reference as amended and supplemented.
"Purchaser" means any registered person entitled to obtain and execute order forms pursuant to 21 CFR Part 1305.
"Supplier" means any registered person entitled to fill order forms pursuant to 21 CFR Part 1305.
Any term not defined in this section shall have the definition set forth in section 102 of the Act ( 21 U.S.C. 802 ) and 301.02 and 302.02 of the Act, or 24:21-1 et seq.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 6 - ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES › Section 13:45H-6.3 - Orders for humane society or licensed animal shelter

Current through Register Vol. 56, No. 14, July 15, 2024
The registered agent of a humane society or licensed animal shelter may apply for Federal purchase order forms as described in 21 CFR 1305.04 and 1305.11. Execution of the order forms shall be as specified in 21 CFR 1305.12.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 6 - ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES › Section 13:45H-6.4 - Preservation of order forms

Current through Register Vol. 56, No. 14, July 15, 2024
Order forms are required to be kept available for inspection for a period of two years or pursuant to the recordkeeping provisions of the State professional licensing board governing the registrant, whichever is longer.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 6 - ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES › Section 13:45H-6.5 - Persons entitled to fill orders for Schedule I and Schedule II controlled substances

Current through Register Vol. 56, No. 14, July 15, 2024
(a) An order for Schedules I and II controlled substances, whether on a DEA Form 222 or an electronic order, may be filled only by a person registered with DEA as a manufacturer or distributor of controlled substances listed in Schedule I or II pursuant to section 303 of the Act ( 21 U.S.C. §
										823 ) or as an importer of such substances pursuant to section 1008 of the Act ( 21 U.S.C. §
										958 ), except for the following:
1. A person registered with DEA to dispense the substances, or to export the substances, if he or she is discontinuing business or if his or her registration is expiring without reregistration, may dispose of any Schedule I or II controlled substances in his or her possession with a DEA Form 222 or an electronic order in accordance with 13:45H-8.10;
2. A purchaser who has obtained any Schedule I or II controlled substance by either a DEA Form 222 or an electronic order may return the substance to the supplier of the substance with either a DEA Form 222 or an electronic order from the supplier;
3. A person registered to dispense Schedule II substances may distribute the substances to another dispenser with either a DEA Form 222 or an electronic order only in the circumstances described in 21 CFR 1307.11;
4. A person registered or authorized to conduct chemical analysis or research with controlled substances may distribute a Schedule I or II controlled substance to another person registered or authorized to conduct chemical analysis, instructional activities, or research with the substances with either a DEA Form 222 or an electronic order, if the distribution is for the purpose of furthering the chemical analysis, instructional activities, or research; and
5. A person registered as a compounder of narcotic substances for use at off-site locations in conjunction with a narcotic treatment program at the compounding location, who is authorized to handle Schedule II narcotics, is authorized to fill either a DEA Form 222 or an electronic order for distribution of narcotic drugs to off-site narcotic treatment programs only.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 6 - ORDERS FOR SCHEDULE I AND II CONTROLLED SUBSTANCES › Section 13:45H-6.6 - Lost and stolen order forms

Current through Register Vol. 56, No. 14, July 15, 2024
(a) If a purchaser ascertains that an unfilled order form has been lost, the purchaser shall comply with the provisions of 21 CFR 1305.16, which is incorporated herein by reference, and (b) and (c) below.
(b) Whenever any used or unused forms are stolen or lost (other than in the course of transmission) by any purchaser or supplier, the purchaser or supplier shall comply with the provisions of 21 CFR 1305.16 and immediately upon discovery of the theft or loss, report the theft or loss to the Drug Control Unit.
(c) If any unused order form reported stolen or lost is subsequently recovered or found, the Drug Control Unit shall be notified immediately.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 7 - PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES › Section 13:45H-7.1 - Scope

Current through Register Vol. 56, No. 14, July 15, 2024
Rules governing the issuance, filling and filing of prescriptions are set forth specifically by the sections of this subchapter.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 7 - PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES › Section 13:45H-7.2 - Definitions

Current through Register Vol. 56, No. 14, July 15, 2024
The following words and terms when used in this subchapter, shall have the following meanings, unless the context clearly indicates otherwise.
"Act" means the New Jersey Controlled Substances Act (24:21-1 et seq.).
"Federal Act" means the Controlled Substances Act (Title 21, United States Code 801: 84 Stat. 1242).
"Individual practitioner" means a physician, dentist, veterinarian, or other individual licensed, registered, or otherwise permitted, by the United States, the jurisdiction in which he practices, or in New Jersey, to dispense a controlled substance in the course of professional practice, but does not include a pharmacist, a pharmacy, or an institutional practitioner.
"Institutional Practitioner" means a hospital or other person (other than an individual) licensed, registered, or otherwise permitted, by the United States, the jurisdiction in which it practices, or in New Jersey, to dispense a controlled substance in the course of professional practice, but does not include a pharmacy.
"Pharmacist" means any pharmacist licensed by the State of New Jersey to dispense controlled substances and shall include any other person (for example, a pharmacist intern authorized by the State to dispense controlled substances under the supervision of a pharmacist licensed by the State).
"Prescription" means an order for medication which is dispensed to or for an ultimate user but does not include an order for medication which is dispensed for immediate administration to the ultimate user (e.g., an order to dispense a drug to a bed patient for immediate administration in a hospital is not a prescription).
"Register" and "registered" refer to registration required and permitted by Section 10 of the New Jersey Controlled Dangerous Substances Act (24:21-10 ).
Any term not defined in this section shall have the definition set forth in the New Jersey Controlled Dangerous Substances Act (24:21-1 et seq.).
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 7 - PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES › Section 13:45H-7.3 - Persons entitled to issue prescriptions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A prescription for a controlled substance may be issued only by an individual practitioner who is:
1. Authorized to prescribe controlled substances by the jurisdiction in which he is licensed to practice his profession; and
2. Either registered or exempted from registration pursuant to 21 CFR 1301.22(c) or 1301.23.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 7 - PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES › Section 13:45H-7.4 - Purpose of issue of prescription

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of Law relating to controlled substances.
(b) A prescription may not be issued in order for an individual practitioner to obtain controlled substances for supplying the individual practitioner for the purpose of general dispensing to patients.
(c) A prescription may not be issued for the dispensing of narcotic drugs listed in any schedule for "detoxification" or "maintenance treatment" as defined in 13:45H-11.1, unless the prescription is for a Schedule III, IV, or V narcotic drug approved by the Food and Drug Administration specifically for use in maintenance or detoxification treatment and the practitioner is in compliance with 21 CFR 1301.28.