New Jersey Administrative Code

Notes N.J. Admin. Code § 13:45H-5.23 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-5.24 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-5.25 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

(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 …

(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 gov…

(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 substa…

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 h…

Every two years following the date on which the initial inventory is taken by a registrant pursuant to N.J.A.C. 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 whic…

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 N.J.S.A. 24:21-3 adding a substance to any schedule of controlled substances, which substance was, immediately prior to…

Each person registered or authorized under 21 CFR 1301.13(e), 1307.11, or N.J.A.C. 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 purs…

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…

Notes N.J. Admin. Code § 13:45H-6.10 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.11 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.12 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.13 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.14 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.15 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.16 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.17 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.18 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

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. 12…

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. Notes N.J. Admin. Code § 13:45H-6.3 Adopted by 47 N.J.R…

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. Notes N.J. Admin. Code § 13:45H-6.4 Adopted by 47 N.J.R. 230…

(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 …

(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…

Notes N.J. Admin. Code § 13:45H-6.7 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.8 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-6.9 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Rules governing the issuance, filling and filing of prescriptions are set forth specifically by the sections of this subchapter. Notes N.J. Admin. Code § 13:45H-7.1

(a) The partial filling of a prescription for a controlled substance listed in Schedule II is permissible, if the pharmacist is unable to supply the full quantity called for in a written or emergency oral prescription and he or she makes a notation of the quantity supplied on the…

(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 N.J.S.A. 24:21-17. (b) The requirements of (a) above do not apply where a controlled …

All written prescriptions and written records of emergency oral prescriptions shall be kept in accordance with requirements of N.J.A.C. 13:45H-5.4. Notes N.J. Admin. Code § 13:45H-7.12 Amended by 47 N.J.R. 2300(a), effective 9/8/2015

(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…

(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 prescri…

(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 …

(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 N.J.S.A. 24:21-17. (b) The requirements of (a) above do not apply when a controlled substance listed …

All prescriptions for controlled substances listed in Schedules III, IV, and V shall be kept in accordance with N.J.A.C. 13:45H-5.4. Notes N.J. Admin. Code § 13:45H-7.17 Amended by 47 N.J.R. 2300(a), effective 9/8/2015

(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 d…

(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 r…

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 (N.J.S.A. 24:21-1 et seq.). "Federal Act" means the Controlled Substances Act (Title…

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 pre…

(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 p…

(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 substanc…

(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 acad…

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. Notes N.J. Admin. Code § 13:45H-7.…

(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 N.J.A.C. 13:45H-11.1 shall be deemed to be within the meaning of…

(a) A pharmacist may dispense directly a controlled substance listed in Schedule II, which is a prescription drug as determined under the Federal Food, Drug, and Cosmetic Act, only pursuant to a written prescription signed by the prescribing individual practitioner, except as pro…