New Jersey Administrative Code

(a) Every person who manufactures or proposes to manufacture a controlled dangerous substance or substances, unless specifically exempted by statute or specifically waived by the Director, shall obtain a registration and shall obtain a renewal of the registration every year there…

(a) Registration under N.J.A.C. 13:45H-1.2(a) or (b) shall be issued to authorize the registrant to manufacture, distribute or act as a reverse distributor of, respectively, specific controlled dangerous substances included in Schedule I or Schedule II, or to authorize the regist…

(a) All applications for registration shall be made on forms provided by the Executive Officer and shall be filed with the Drug Control Unit at PO Box 45045, Newark, NJ 07101. (b) Applications shall contain all information called for on the forms provided, except where such infor…

(a) After an application for registration has been filed, the Drug Control Unit shall make such inspection of the place of business or professional practice described in the application and such investigation of the applicant as may be necessary to determine that the applicant me…

(a) No registration nor any right granted thereunder shall be assigned or otherwise transferred to any person not named as the registrant therein nor to any place of business or professional practice not stated therein, except as provided by statute or regulations. (b) A registra…

Consistent with the provisions set forth in N.J.S.A. 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…

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. Notes N.J. Admin. Code § 13:45H-1.8 Amended by R.2002 d.276, effective 8/19/2002. See: 33 N.J.R. 2754(a), 34 N.J.R. 3…

(a) The Federal controlled dangerous substance Schedules I, II, III, IV and V at 21 CFR 1308.11 through 1308.15, as amended and supplemented, promulgated by the United States Attorney General pursuant to 21 U.S.C. §§ 811 and 812, are incorporated herein by reference. (b) Any refe…

Notes N.J. Admin. Code § 13:45H-10.2 Amended by R.1973, d.23, effective 1/17/1973. See: 5 N.J.R. 42(b). Naloxone decontrolled (Fed. Reg: V.36, 19116, September 29, 1971; V.39, 44392, December 24, 1974). Amphetamine rescheduled from schedule III to II (Fed. Reg. V.36, 12734, July …

Notes N.J. Admin. Code § 13:45H-10.3 As amended, R.1973 d.23, effective 1/17/1983. See: 5 N.J.R. 42(b). Amphetamine rescheduled from schedule III to II (Fed. Reg. V.36, 12734, July 7, 1974). Methamphetamine rescheduled from schedule III to II (Fed. Reg. V.36, 12734, July 7, 1974)…

Notes N.J. Admin. Code § 13:45H-10.4 As amended, R.1974 d.2, effective 1/2/1974. See: 6 N.J.R. 63(a). Diethylpropion controlled (Fed. Reg. V.38, 18013, July 6, 1973). Phentermine controlled (Fed. Reg. V.38, 18013, July 6, 1973). Fenfluramine controlled (Fed. Reg. V.38, 15719, Jun…

Notes N.J. Admin. Code § 13:45H-10.5 As amended, R.1977 d.440, effective 11/4/1977. See: 9 N.J.R. 465(c), 9 N.J.R. 567(a). Loperamide controlled (Fed. Reg. V.42, 54547, October 8, 1977). As amended, R.1978 d.426, effective 12/12/1978. See: 10 N.J.R. 482(b), 11 N.J.R. 16(a). Difen…

(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 li…

(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 exc…

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 de…

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 dosa…

(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, II…

Application to conduct a narcotic treatment program, including a compounder, shall be made in accordance with the provisions of N.J.A.C. 13:45H-1.4. Notes N.J. Admin. Code § 13:45H-11.3

(a) Applicants to conduct a narcotic treatment program shall comply with the general security requirements as provided in N.J.A.C. 13:45H-2.1. (b) In addition to the security requirements required in (a) above, all manufacturing activities (including processing, packaging and lab…

(a) Applicants to conduct a narcotic treatment program shall comply with the provisions of N.J.S.A. 24:21-1 et seq. and the regulatory provisions of N.J.A.C. 13:45H-8.4 to 8.8. (b) In addition to the record keeping requirements required in (a) above, each person registered or aut…

(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 cap…

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…

(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 requ…

(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 o…

(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 t…

(a) Before distributing a controlled substance to any person who the registrant does not know to be registered to possess the controlled substance, the registrant shall make a good faith inquiry with the Drug Control Unit to determine that the person is registered to possess the …

(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…

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. Notes N.J. Admin. Code § 13:45H-3.1…

(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 disp…

(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 commercia…

(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 sym…

(a) The symbol shall be prominently located on all labeling other than labels covered by N.J.A.C. 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. Notes N.J. Admin.…

Notes N.J. Admin. Code § 13:45H-3.6 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

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 cont…

(a) The symbol requirements of N.J.A.C. 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, t…

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. Notes N.J. Admin. Code § 13:45H-5.1…

(a) Every registrant required to keep records pursuant to N.J.A.C. 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 reg…

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 with controlled substances shall maintain records with the information listed in …

Each person registered or authorized by 21 CFR 1301.13(e) or N.J.A.C. 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. Notes N.J. Admin. Code § 13:45H-5.12 Adopt…

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 N.J.A.C. 13:45H-…

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. Notes N.J. Admin. Code § 13:45H-5.14 Adopted by 47 N.J.…

Every manufacturer importing or manufacturing from raw coca leaves shall submit information pursuant to 21 CFR 1304.32, which is incorporated herein by reference. Notes N.J. Admin. Code § 13:45H-5.15 Adopted by 47 N.J.R. 2300(a), effective 9/8/2015

(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 ma…

Notes N.J. Admin. Code § 13:45H-5.17 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-5.18 Repealed by 47 N.J.R. 2300(a), effective 9/8/2015

Notes N.J. Admin. Code § 13:45H-5.19 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 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…