reglab/statecodes huggingface dataset:
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-7.5 - Manner of issuance of prescriptions

Current through Register Vol. 56, No. 14, July 15, 2024
(a) All prescriptions for controlled substances shall be dated as of, and signed on, the day when issued and shall bear the full name and address of the patient, the drug name, strength, dosage form, quantity prescribed, directions for use, and the full name, address, proper academic degree or other definitive identification of the professional practice for which he or she is licensed, and registration number of the practitioner. All prescriptions for controlled substances, regardless of schedules, shall be presented to the pharmacist for filling within 30 days after the date when issued, except as provided in (a)1 below. A practitioner may sign a prescription in the same manner as he or she would sign a check or legal document (for example, J.H. Smith or John H. Smith). Where an oral order is not permitted, prescriptions shall be written in ink or indelible pencil or typewriter or printed on a computer printer and shall be manually signed by the practitioner. A computer-generated prescription that is printed out or faxed by the practitioner must be manually signed. The prescription may be prepared by a secretary or agent of the practitioner for the signature of the practitioner, but the prescribing practitioner is responsible in case the prescription does not conform in all essential respects to the law or rules. A corresponding liability rests upon the pharmacist who fills a prescription not prepared in the form prescribed by this section.
1. When up to three separate prescriptions for a total of up to a 90-day supply of a Schedule II controlled substance are issued to a patient by a physician pursuant to 45:9-22.1 9 ( P.L. 2009, c. 165 ), a pharmacist shall fill such prescriptions.
i. All three prescriptions may be accepted at one time and held pending filling as indicated below:
(1) The first prescription shall be filled no later than 30 days after the date of issuance; and
(2) The second and third prescriptions shall be filled no later than 30 days after the date indicated on the prescription as the earliest date on which the prescription may be filled.
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-7.6 - Persons entitled to fill prescriptions

Current through Register Vol. 56, No. 14, July 15, 2024
A prescription for controlled substances may only be filled by a pharmacist acting in the usual course of his professional practice and either registered individually or employed in a registered pharmacy or registered institutional practitioner.
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-7.7 - Administering or dispensing of narcotic drugs

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The administering or dispensing directly (but not prescribing) of narcotic drugs listed in any schedule to a narcotic drug dependent person for "detoxification treatment" or "maintenance treatment" as defined in 13:45H-11.1 shall be deemed to be within the meaning of the term "in the course of professional practice or research"; provided that the practitioner is separately registered with the Drug Control Unit as required by 13:45H-11.2 and then thereafter complies with the regulatory standards imposed relative to treatment qualifications, security, records and unsupervised use of drugs pursuant to the Act.
(b) Nothing in this section shall prohibit a physician who is not specifically registered to conduct a narcotic treatment program from administering (but not prescribing) narcotic drugs to a person for the purpose of relieving acute withdrawal symptoms when necessary while arrangements are being made for referral for treatment. Not more than one day's medication may be administered to the person or for the person's use at one time. Such emergency treatment may be carried out for not more than three days and may not be renewed or extended.
(c) This section is not intended to impose any limitations on a physician or authorized hospital staff to administer or dispense narcotic drugs in a hospital to maintain or detoxify a person as an incidental adjunct to medical or surgical treatment of conditions other than addiction, or to administer or dispense narcotic drugs to persons with intractable pain in which no relief or cure is possible or none has been found after reasonable efforts.
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-7.9 - Refilling prescriptions; Schedule II

Current through Register Vol. 56, No. 14, July 15, 2024
The refilling of a prescription for a controlled substance listed in Schedule II is prohibited.
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-7.11 - Labeling of substances; Schedule II

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The pharmacist filling a written or emergency oral prescription for a controlled substance listed in Schedule II shall affix to the package a label, conforming to the provisions set forth in 24:21-17.
(b) The requirements of (a) above do not apply where a controlled substance listed in Schedule II is prescribed for administration to an ultimate user who is institutionalized: provided, that:
1. Not more than a seven-day supply of the controlled substance listed in Schedule II is dispensed at one time;
2. The controlled substance listed in Schedule II is not in the possession of the ultimate user prior to the administration;
3. The institution maintains appropriate safeguards and records regarding the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule II; and
4. The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.
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-7.12 - Filing of prescriptions; Schedule II

Current through Register Vol. 56, No. 14, July 15, 2024
All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of 13:45H-5.4.
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-7.13 - Requirements of prescriptions; Schedules III, IV, and V

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, pursuant to a written prescription of a duly registered individual practitioner or a facsimile prescription as set forth in 13:39-7.10.
(b) A pharmacist may dispense directly a controlled substance listed in Schedule III, IV, or V, which is a prescription drug as determined under the Federal Food, Drug and Cosmetic Act, pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist containing all information required in 13:45H-7.5(a)  except for the signature of the prescribing individual practitioner.
(c) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule III, IV, or V in the course of his or her professional practice without a prescription, subject to 13:45H-7.7.
(d) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule III, IV, or V pursuant to an oral prescription made by a prescribing individual practitioner and promptly reduced to writing by the pharmacist (containing all information required in 13:45H-7.5(a)  except for the signature of the prescribing individual practitioner), or pursuant to an order for medication made by an individual practitioner, subject to 13:45H-7.7.
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-7.14 - Refilling of prescriptions; Schedules III, IV and V

Current through Register Vol. 56, No. 14, July 15, 2024
(a) No prescription for a controlled substance listed in Schedule III or IV shall be filled or refilled more than six months after the date on which such prescription was issued and no such prescription authorized to be refilled may be refilled more than five times.
(b) A prescription for a controlled substance listed in Schedule V may be refilled only as expressly authorized by the prescribing individual practitioner on the prescription. If no such authorization is given, the prescription may not be refilled.
(c) Each refilling of a prescription shall be entered on the back of the prescription or on the electronic prescription record (or on another appropriate uniformly maintained, readily retrievable record, such as medication records), which indicates by the number of the prescription the following information:
1. The name and dosage of the controlled substance;
2. The date of each refilling;
3. The quantity dispensed;
4. The identity or initials of the dispensing pharmacist in each refilling; and
5. The total number of refills for that prescription, initialed, and dated by the pharmacist as of the date of dispensing, and shall state the amount dispensed.
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-7.15 - Partial filling of prescriptions; Schedules III, IV, and V

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The partial filling of a prescription for a controlled substance listed in Schedule III, IV, or V is permissible, provided that:
1. Each partial filling is recorded in the same manner as a refilling;
2. The total quantity dispensed in all partial fillings does not exceed the total quantity prescribed; and
3. No dispensing occurs after six months after the date on which the prescription was issued.
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-7.16 - Labeling of substances; Schedules III, IV, and V

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The pharmacist filling a prescription for a controlled substance listed in Schedule III, IV, or V shall affix to the package a label conforming to the provisions set forth in 24:21-17.
(b) The requirements of (a) above do not apply when a controlled substance listed in Schedule III, IV, or V is prescribed for administration to an ultimate user who is institutionalized: provided, that:
1. Not more than a 34-day supply or 100 dosage units, whichever is less, of the controlled substance listed in Schedule III, IV, or V is dispensed at one time;
2. The controlled substance listed in Schedule III, IV, or V is not in the possession of the ultimate user prior to administration;
3. The institution maintains appropriate safeguards and records the proper administration, control, dispensing, and storage of the controlled substance listed in Schedule III, IV, or V; and
4. The system employed by the pharmacist in filling a prescription is adequate to identify the supplier, the product, and the patient, and to set forth the directions for use and cautionary statements, if any, contained in the prescription or required by law.
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-7.17 - Filing prescriptions; Schedules III, IV, and V

Current through Register Vol. 56, No. 14, July 15, 2024
All prescriptions for controlled substances listed in Schedules III, IV, and V shall be kept in accordance with 13:45H-5.4.
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-7.18 - Transfer between pharmacies of prescription information for Schedules III, IV, and V controlled substances for refill purposes

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The transfer of original prescription information for a controlled dangerous substance listed in Schedule III, IV, or V for the purpose of refill dispensing is permissible between pharmacies on a one-time basis. However, pharmacies electronically sharing a real time, online database may transfer up to the maximum refills permitted by law and the prescriber's authorization.
(b) Transfers are subject to the following requirements:
1. The transfer is communicated directly between two licensed pharmacists and the transferring pharmacist records the following information:
i. Write the word "VOID" on the face of the invalidated prescription; for electronic prescriptions, information that the prescription has been transferred must be added to the prescription record;
ii. Record on the reverse of the invalidated prescription the name, address, and DEA registration number of the pharmacy to which it was transferred and the name of the pharmacist receiving the prescription information; for electronic prescriptions, such information must be added to the prescription record; and
iii. Record the date of the transfer and the name of the pharmacist transferring the information.
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-7.19 - Dispensing without prescription

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A controlled substance listed in schedule V, and a controlled substance listed in schedule II, III, or IV which is not a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, may be dispensed by a pharmacist without a prescription to a purchaser at retail, provided that:
1. Such dispensing is made only by a pharmacist (as defined in 13:45H-7.1 ), and not by a nonpharmacist employee even if under the supervision of a pharmacist (although after the pharmacist has fulfilled his professional and legal responsibilities set forth in this section, the actual cash, credit transaction, or delivery, may be completed by a nonpharmacist);
2. Not more than 240 cc. (eight ounces) of any such controlled substance containing opium, nor more than 120 cc. (four ounces) of any other such controlled substance nor more than 48 dosage units of any such controlled substance containing opium, nor more than 24 dosage units of any other such controlled substance may be dispensed at retail to the same purchaser in any given 48-hour period;
3. The purchaser is at least 18 years of age;
4. The pharmacist requires every purchaser of a controlled substance under this Section not known to him to furnish suitable identification (including proof of age where appropriate);
5. A bound record book for dispensing of controlled substances under this Section is maintained by the pharmacist, which book shall contain the name and address of the purchaser, the name and quantity of controlled substance purchased, the date of each purchase, and the name or initials of the pharmacist who dispensed the substance to the purchaser (the book shall be maintained in accordance with the recordkeeping requirement of 13:45H-5.4 ); and
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-7.20 - Electronic prescriptions

Current through Register Vol. 56, No. 14, July 15, 2024
An individual practitioner may issue, and a pharmacist may accept for dispensing, an electronic prescription for a controlled dangerous substance, consistent with the requirements of this chapter and Federal law. For purposes of this section, "electronic prescription" means a prescription that is transmitted by a computer device in a secure manner, including computer-to-computer and computer-to-facsimile transmissions.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.1 - 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 ). 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 301.02.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.2 - Application of State Law and other Federal Law

Current through Register Vol. 56, No. 14, July 15, 2024
Nothing in Parts 301 through 308, 311, 312, 316 of Federal Regulations shall be construed as authorizing or permitting any person to do any act which such person is not authorized or permitted to do under other Federal laws or obligations under international treaties, conventions or protocols, or under the law of the State in which he desires to do such act nor shall compliance with such Parts be construed as compliance with other Federal or State laws unless expressly provided in such other laws.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.4 - Distribution by dispenser to another practitioner or reverse distributor

Current through Register Vol. 56, No. 14, July 15, 2024
A practitioner who is registered to dispense controlled substances may distribute (without being registered to distribute) a quantity of such substance in accordance with 21 CFR 1307.11, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.5 - Manufacture and distribution of narcotic solutions and compounds by a pharmacist

Current through Register Vol. 56, No. 14, July 15, 2024
As an incident to a distribution under 13:45H-8.4 a pharmacist may manufacture (without being registered to manufacture) an aqueous or oleaginous solution or solid dosage form containing a narcotic controlled substance in a proportion not exceeding 20 percent of the completed solution, compound or mixture.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.7 - Distribution upon discontinuance or transfer of business

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Any registrant desiring to discontinue or transfer business activities altogether or with respect to controlled dangerous substances shall comply with the provisions of 21 CFR 1301.52, which is incorporated herein by reference.
(b) A registrant shall notify the Drug Control Unit in writing no less than 14 days prior to the discontinuance or transfer of business activities with respect to controlled substances as set forth in (a) above, unless the Drug Control Unit waives this time limitation in individual instances, and shall return for cancellation to the Drug Control Unit, within 10 days of the discontinuance or transfer of business activities, the State Certification of Registration. Such notification shall include, but not be limited to:
1. Name, address, State CDS and Federal DEA registration numbers of the registrant discontinuing or transferring his controlled substances activities;
2. Name, address, State CDS and Federal DEA registration numbers of the registrant, or proof of application for same, of registrant to whom the controlled substances are to be transferred;
3. Name, address, State CDS and Federal DEA registration numbers, or proof of application for same of the registrant receiving the records, which include prescription files, or patient orders of practitioners of the discontinued business;
4. Name, and address of the person or firm who will maintain records, such as invoices, purchase records and executed order forms of the discontinued or transferred business for a period of not less than two years; and
5. The date on which the discontinuance or transfer of the business activity will take place.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.8 - Distribution to ocean vessels or aircraft

Current through Register Vol. 56, No. 14, July 15, 2024
If acquired by and dispensed under the general supervision of a medical officer described in 21 CFR 1301.25(b), or the master or first officer of the vessel under the circumstances described in 21 CFR 1301.25(d), controlled substances may be held for stocking, be maintained in, and dispensed from medicine chests, first aid packets, or dispensaries on board any vessel engaged in international trade or in trade between ports of the United States and any merchant vessel belonging to the U.S. Government, or on board any aircraft operated by an air carrier under a certificate of permit issued pursuant to the Federal Aviation Act of 1958 ( 49 U.S.C. §
										1301 ) as set forth in 21 CFR 1301.25, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.9 - Incidental manufacture of controlled substances

Current through Register Vol. 56, No. 14, July 15, 2024
Any registered manufacturer who, incidentally but necessarily, manufactures a controlled substance as a result of the manufacture of a controlled substance or basic class of controlled substance for which he or she is registered and has been issued an individual manufacturing quota pursuant to 21 CFR Part 1303 (if such substance or class is listed in Schedule I or II) shall be exempt from the requirement of registration pursuant to 21 CFR Part 1301 and, if such incidentally manufactured substance is listed in Schedule I or II, shall be exempt from the requirement of an individual manufacturing quota pursuant to 21 CFR Part 1303, if such substances are disposed of in accordance with 21 CFR Part 1317.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.10 - Procedure for disposing of controlled substances

Current through Register Vol. 56, No. 14, July 15, 2024
Any person in possession of any controlled substance and desiring or required to dispose of such substance shall comply with 21 CFR Part 1317, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.11 - Registrant return or recall

Current through Register Vol. 56, No. 14, July 15, 2024
Each registrant shall comply with the return or recall provisions set forth in 21 CFR 1317.10, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.12 - Reverse distributor authorized activities

Current through Register Vol. 56, No. 14, July 15, 2024
Every reverse distributor shall acquire controlled substances from a registrant as set forth in 21 CFR 1317.15, which is incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.13 - Notification from registrants authorized to collect controlled substances

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every registrant shall notify the Drug Control Unit within five days of the Drug Enforcement Administration authorizing the registrant to be an authorized collector of controlled substances as set forth in 21 CFR Part 1317 Subpart C.
(b) Every registrant shall notify the Drug Control Unit whenever there is any change to its status as an authorized collector within five days of such change.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.14 - Native American Church

Current through Register Vol. 56, No. 14, July 15, 2024
The listing of peyote as a controlled substance in schedule I does not apply to the nondrug use of peyote in bona fide religious ceremonies of the Native American Church, and members of the American Native Church so using peyote are exempt from registration. Any person who manufactures peyote for or distributes peyote to the Native American Church, however, is required to obtain registration annually and to comply with all other requirements of law.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 8 - MISCELLANEOUS PROVISIONS › Section 13:45H-8.15 - Humane societies and animal care facilities

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Authorized agents of incorporated humane societies or licensed animal care facilities registered to purchase, possess, and to dispense sodium pentobarbital for animal euthanasia pursuant to 24:21-11.f shall be authorized to dispense:
1. Any commercially prepared sodium pentobarbital drug product for animal euthanasia approved for interstate sale by the United States Food and Drug Administration, provided the registrant complies with the approved recommended dosage regime in the labeling;
2. A standard compounded formula of sodium pentobarbital for animal euthanasia established by the Division as follows:
i. Sodium pentobarbital injection (for animal euthanasia), formula non-sterile solution:
U.S.P. Sodium Pentobarbital (Powder)
460 grams
Isopropyl Alcohol
250 mls.
Methyl Violet
1 drop
U.S.P. Water for injection quantity sufficient to make
1000 mls.
ii. Using the formula in (a)2i above, the strength of this mixture will provide 460 mgs of sodium pentobarbital per milliliter.
iii. Lethal dose: one milliliter per 10 pounds of body weight for small animals; horses and other large animals --one milliliter per 10 pounds of body weight subject to a maximum dose of 100 milliliters.
iv. Package and storage: Package in tight containers with rubber stoppers and store under refrigeration. Solutions decompose on standing. Heat accelerates the decomposition.
v. Expiration date: five days from date or manufacture.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 10 - CONTROLLED DANGEROUS SUBSTANCES SCHEDULES › Section 13:45H-10.6 - Excluded O.T.C. substances

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The list of non-narcotic substances that, may, under the Federal Food, Drug and Cosmetic Act ( 21 U.S.C. §
										301 ) may be lawfully sold over the counter without a prescription, are excluded from all schedules of the New Jersey Controlled Dangerous Substance Act.
(b) A complete list of non-narcotic substances is found in 21 CFR 1308.22 (38 F.R.8255, March 30, 1973, as amended 41 F.R. 16553, April 20, 1976; 41 F.R. 53477, Dec. 7, 1976). Copies of 21 CFR Part 1300, revised as of April 1, 1977, may be purchased from the U.S. Government Printing Office at
http://www.gpo.gov/fdsys/
.
(c) (No change.)
(c) A complete listing of those non-narcotic substances subject to this subchapter may be reviewed in the office of the Drug Control Unit.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 10 - CONTROLLED DANGEROUS SUBSTANCES SCHEDULES › Section 13:45H-10.7 - Excepted prescription drugs

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The list of drugs in dosage unit form, and any other drug of the quantitative composition listed for one of the listed drugs or which is the same except that it contains a lesser quantity of controlled substances, and which is restricted to dispensing by prescription, are excepted from the provisions of the New Jersey Controlled Dangerous Substances Act.
(b) A complete list of excepted prescription drugs are found in 21 CFR 1308.32. Copies of 21 CFR Part 1300, revised as of April 1, 1977, may be purchased from the U.S. Government Printing Office at
http://www.gpo.gov/fdsys/
.
(c) A complete listing of those excepted prescription drugs subject to this subchapter may be reviewed in the office of the Drug Control Unit.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 10 - CONTROLLED DANGEROUS SUBSTANCES SCHEDULES › Section 13:45H-10.8 - Exempt chemical preparations

Current through Register Vol. 56, No. 14, July 15, 2024
A list of exempt preparations and mixtures as shown in 21 C.F.R. 1308.24, as amended by a final order published in the Federal Register on February 18, 1992 (see 57 F.R. 5818) which in the form and quantity listed in the application (indicated as the "date of application") are designated exempt chemical preparations and are not subject to the provisions of the New Jersey Controlled Dangerous Substances Act.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 11 - NARCOTIC TREATMENT PROGRAM › Section 13:45H-11.1 - 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.
"Compounder" means any person engaging in maintenance or detoxification treatment who also mixes, prepares, packages or changes the dosage form of a narcotic drug listed in Schedules II, III, IV or V for use in maintenance or detoxification treatment by another narcotic treatment program.
"Detoxification treatment" means the administration or dispensing for a period not in excess of 21 days, of a narcotic drug or narcotic drugs in decreasing doses to an individual in order to alleviate adverse physiological or psychological effects incident to withdrawal from the continuous or sustained use of a narcotic drug and as a method of bringing the individual to a narcotic drug-free state within such period of time.
"Maintenance treatment" means the dispensing for a period in excess of 21 days, of a narcotic drug or narcotic drugs in the treatment of an individual for dependence upon heroin or other morphine-like drug.
"Narcotic treatment program" means a program engaged in maintenance or detoxification treatment with narcotic drugs.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 11 - NARCOTIC TREATMENT PROGRAM › Section 13:45H-11.2 - Registration; fees

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Every person who engages in a narcotic treatment program, including a compounder, shall obtain a registration and shall obtain a renewal of the registration each year thereafter.
(b) In conducting a narcotic treatment program using any narcotic drug listed in Schedules II, III, IV and V, employees, agents, or affiliated practitioners in programs, need not register separately.
(c) Each program site located away from the principal location and at which place narcotic drugs are stored or dispensed must be separately registered and obtain narcotic drugs by use of order forms pursuant to 13:45H-5.6.
(d) For each registration or reregistration to engage in a narcotic treatment program, including a compounder, the applicant shall pay an annual fee of $ 20.00 at the time of application for registration or for renewal of registration.
(e) The payment of fees as required by (d) above shall be subject to the exemptions provided in 13:45H-1.1.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 11 - NARCOTIC TREATMENT PROGRAM › Section 13:45H-11.3 - Application forms

Current through Register Vol. 56, No. 14, July 15, 2024
Application to conduct a narcotic treatment program, including a compounder, shall be made in accordance with the provisions of 13:45H-1.4.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 11 - NARCOTIC TREATMENT PROGRAM › Section 13:45H-11.4 - Security requirements

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Applicants to conduct a narcotic treatment program shall comply with the general security requirements as provided in 13:45H-2.1.
(b) In addition to the security requirements required in (a) above, all manufacturing activities (including processing, packaging and labeling) involving controlled substances listed in any schedule and all activities of compounders shall be conducted in accordance with the following:
1. The acceptance of delivery of narcotic substances by a narcotic treatment program shall be made only by a licensed practitioner employed at the facility or other authorized individuals designated in writing. At the time of delivery, the licensed practitioner or other authorized individual in writing (excluding persons currently or previously dependent on narcotic drugs), shall sign for the narcotics and place his specific title (if any) on any invoice. Copies of these signed invoices shall be kept by the distributor.
2. Narcotics dispensed or administered at a narcotic treatment program will be dispensed or administered directly to the patient by either the licensed practitioner or a registered nurse under direction of the licensed practitioner, a licensed practical nurse under the direction of the licensed practitioner, or a pharmacist under the direction of the licensed practitioner.
3. Persons enrolled in a narcotic treatment program will be required to wait in an area physically separated from the narcotic storage and dispensing area.
4. All narcotic treatment programs must comply with the provisions of 26:2G-21 through 30; and with standards established by the Secretary of the Federal Department of Health and Human Services (after consultation with the Drug Enforcement Administration) respecting the quantities of narcotic drugs which may be provided to persons enrolled in a narcotic treatment program for unsupervised use.
5. The Division may exercise discretion regarding the degree of security required in narcotic treatment programs based on such factors as the location of a program, the number of physicians, staff members and security guards. Similarly, such factors will be taken into consideration when evaluating existing security at a narcotic treatment program.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 11 - NARCOTIC TREATMENT PROGRAM › Section 13:45H-11.5 - Persons required to keep records

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Applicants to conduct a narcotic treatment program shall comply with the provisions of 24:21-1 et seq. and the regulatory provisions of 13:45H-8.4 to 8.8.
(b) In addition to the record keeping requirements required in (a) above, each person registered or authorized to maintain/or detoxify controlled substance users in a narcotic treatment program shall maintain records with the following information for each controlled substance:
1. Name of substance;
2. Strength of substance;
3. Dosage form;
4. Date dispensed;
5. Adequate identification of patient (consumer);
6. Amount consumed;
7. Amount and dosage form taken home by patient;
8. Dispenser's initials.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 11 - NARCOTIC TREATMENT PROGRAM › Section 13:45H-11.6 - Records for treatment program which compound narcotics for treatment programs and other locations

Current through Register Vol. 56, No. 14, July 15, 2024
(a) Each person registered or authorized to compound narcotic drugs for off-site use in a narcotic treatment program shall maintain records which include the following information for each narcotic drug:
1. For each narcotic controlled substance in bulk form to be used in, or capable of use in, or being used in, the compounding of the same or other noncontrolled substances in finished form:
i. The name of the substance;
ii. The quantity compounded in bulk form by the registrant, including the date, quantity and batch or other identifying number of each batch compounded;
iii. The quantity received from other persons including the date and quantity of each receipt and the name, address and registration number of the other person from whom the substance was received;
iv. The quantity imported directly by the registrant (under a registration as an importer) for use in compounding by him, including the date, quantity and import permit or declaration number of each importation;
v. The quantity used to compound the same substance in finished form, including:
(1) The date and batch or other identifying number of each compounding;
(2) The quantity used in the compound;
(3) The finished form (for example, ten milligram tablets or ten milligram concentration per fluid ounce or milliliter);
(4) The number of units of finished form compounded;
(5) The quantity used in quality control;
(6) The quantity lost during compounding and the causes therefore, if known;
(7) The total quantity of the substances contained in the finished form;
(8) The theoretical and actual yields; and
(9) Such other information as is necessary to account for all controlled substances used in the compounding process.
vi. The quantity used to manufacture other controlled and non-controlled substances; including the name of each substance manufactured and the information required in subparagraph v of this paragraph;
vii. The quantity distributed in bulk form to other programs, including the date and quantity of each distribution and the name, address and registration number of each program to whom a distribution was made;
viii. The quantity exported directly by the registrant (under a registration as an exporter) including the date, quantity, and export permit or declaration number of each exportation; and
ix. The quantity disposed of by destruction, including the reason, date, and manner of destruction. All other destruction of narcotic controlled substances will comply with 13:45H-8.9.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45H - CONTROLLED DANGEROUS SUBSTANCES › Subchapter 11 - NARCOTIC TREATMENT PROGRAM › Section 13:45H-11.7 - Treatment of narcotic addicts with opioid medications

Current through Register Vol. 56, No. 14, July 15, 2024
The United States Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA), Center for Substance Abuse Treatment (CSAT) regulations at 42 CFR Part 8, Treatment of opioid dependence with opioid medications, are incorporated herein by reference. All addiction treatment programs in New Jersey providing drugs used for treatment of narcotic addicts shall comply with these regulations and all the supplements and amendments thereto incorporated herein by reference.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45I - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Subchapter 1 - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Section 13:45I-1.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The purpose of the rules in this subchapter is to establish, pursuant to 56:16-1 et seq., a bill of rights to protect the health, safety, and welfare of passengers of certain privately-owned autobuses operating over the public highways of the State for intrastate and interstate travel, and to establish a procedure for reporting and investigating passenger complaints.
(b) This subchapter shall apply to owners and operators of autobuses.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45I - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Subchapter 1 - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Section 13:45I-1.3 - Autobus passenger bill of rights

Current through Register Vol. 56, No. 14, July 15, 2024
(a) An owner of an autobus shall take the following actions to protect the health, safety, and welfare of its passengers:
1. Ensure that all operators are well-trained;
2. Provide clear and conspicuous notice of customer complaint contact information as set forth in N.J.A.C. 13:45I-1.4; and
3. Respond to all complaints in a timely fashion and work to resolve any problems customers encounter regarding unsafe, poor, or inadequate service.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45I - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Subchapter 1 - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Section 13:45I-1.4 - Notice of complaint telephone number

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The owner of an autobus shall display on the interior and exterior of the autobus, the customer complaint telephone number established by the Division for reporting violations of the autobus passenger bill of rights, using the following form of notice:
FOR COMPLAINTS ABOUT THE CONDITION OR OPERATION OF THIS VEHICLE CALL THE N.J. DIVISION OF CONSUMER AFFAIRS AT (973) 504-6200.
(b) The form of notice set forth in (a) above shall be displayed on the exterior back of the autobus in boldface type of at least one inch in height.
(c) The form of notice set forth in (a) above shall also be displayed on the front interior of the autobus on a sign not smaller than nine inches by 11 inches in boldface type of not less than 36 point font.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45I - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Subchapter 1 - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Section 13:45I-1.5 - Complaints; investigations

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The Division shall maintain a telephone number specified in N.J.A.C. 13:45I-1.4(a), where customers may communicate complaints regarding the service provided by owners and operators of autobuses.
(b) Upon receipt of a customer complaint, the director of the Division shall initiate, investigate, attempt to resolve, and if necessary, refer the complaint to the Attorney General for further action.
(c) If the Division requests the production of documents and records, and the documents and records requested by the Division are not produced within 30 days of the request, the Division may issue and serve subpoenas to compel the production of the documents and records. The Division may petition the Superior Court to enforce any such subpoena.
(d) Upon completion of its investigation, the Division shall:
1. Dismiss the complaint following a determination that no violation has occurred; or
2. Determine that a violation has likely occurred and:
i. Attempt to resolve the matter by settlement, which may include a monetary settlement to cover, among other things, any costs incurred by the Division; or
ii. If a settlement cannot be reached under (d)2i above, take further action, including a referral to the Attorney General for further action.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45I - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Subchapter 1 - BILL OF RIGHTS FOR CUSTOMERS OF CERTAIN AUTOBUSES › Section 13:45I-1.6 - Violations; penalties

Current through Register Vol. 56, No. 14, July 15, 2024
(a) A person who is determined to have violated the provisions of this subchapter shall be subject to a civil penalty of $ 1,000 for the first violation, $ 2,000 for the second violation, and $ 5,000 for third and subsequent violations.
(b) Each day during which a violation occurs shall constitute a separate offense.
(c) Any penalty shall be collected in a civil action by a summary proceeding pursuant to the Penalty Enforcement Law of 1999, 2A:58-10 et seq., and process shall be in the form of a summons or warrant issued upon the complaint of the Attorney General or any other person.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45J - LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS › Subchapter 1 - LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS › Section 13:45J-1.1 - Purpose and scope

Current through Register Vol. 56, No. 14, July 15, 2024
(a) The rules in this chapter regulate the receipt and acceptance by prescribers of anything of value from pharmaceutical manufacturers to ensure that such relationships do not interfere with prescribers' independent professional judgment. The rules in this chapter do not apply to prescribers' interactions with pharmaceutical manufacturers to the extent that such pharmaceutical manufacturers also manufacture medical devices and that such interactions are directed solely to medical devices.
(b) The rules in this chapter shall apply to a prescriber who holds an active New Jersey license and who:
1. Practices in New Jersey; or
2. Has New Jersey patients regardless of the prescriber's practice site.
New Jersey Administrative Code › Title 13 - LAW AND PUBLIC SAFETY › Chapter 45J - LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS › Subchapter 1 - LIMITATIONS ON AND OBLIGATIONS ASSOCIATED WITH PRESCRIBER ACCEPTANCE OF COMPENSATION FROM PHARMACEUTICAL MANUFACTURERS › Section 13:45J-1.1A - Pre-existing contracts

Current through Register Vol. 56, No. 14, July 15, 2024
The provisions of this chapter shall not apply to contracts entered into on or before January 15, 2018.