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Recodification of N.J.A.C. 8:65 as 13:45H

Notice of Administrative Changes and Corrections
Controlled Dangerous Substances

Take notice that, pursuant to the transfer of authority under P.L. 2007, c. 244, the Division of Consumer Affairs has requested, and the Office of Administrative Law has agreed to permit, the recodification of N.J.A.C. 8:65 as 13:45H. This recodification, along with attendant technical changes to the rule text concerning cross-references and agency names, are effective March 17, 2011 and shall be manifested in the New Jersey Administrative Code in the 5-2-2011 Code update. In addition, administrative corrections are made throughout the chapter text to update the cross-reference format to the current Code standard.

Take further notice that the Division has also requested that administrative changes to the texts of New Jersey Board of Dentistry rule N.J.A.C. 13:30-8.18, Board of Medical Examiners rule N.J.A.C. 13:35-7.7, and State Board of Pharmacy rules N.J.A.C. 13:39-5.8, 6.2, 7.4, 7.8 and 7.15, be made to correct applicable cross-references in connection with the recodification of N.J.A.C. 8:65 as 13:45H.

   This notice of administrative changes and corrections is published in accordance with N.J.A.C. 1:30-2.7.

Full text of the administrative changes to the rules in N.J.A.C. 13:30, 13:35 and 13:39 referenced above follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

13:30-8.18   Issuance of prescriptions; NJPBs; controlled dangerous substances

(a) (No change.)

(b) Licensees issuing prescriptions for controlled dangerous substances shall comply with all State and Federal laws concerning the issuance of such prescriptions, including requirements set forth at N.J.A.C. [8:65] 13:45H.

13:35-7.7   Prohibitions on prescribing, administering or dispensing of controlled substances for detoxification; limited exceptions

(a) (No change.)

(b) Unless registered with the [New Jersey Department of Health and Senior Services] Division of Consumer Affairs to conduct a narcotic treatment program pursuant to N.J.S.A. 24:21-10 and N.J.A.C. [8:65]13:45H-11.2, a practitioner shall not dispense or administer a narcotic drug or a depressant drug listed in any schedule which drug is intended for the purpose of "detoxification" or "maintenance treatment," except:

1.-2. (No change.)

13:39-5.8   Minimum equipment and supplies; cleanliness

(a) All prescription areas shall contain the following minimum equipment and supplies, which shall be stored, so as to be readily accessible:

1. (No change.)

2. Over the counter Schedule V Record Book or an electronic recording system, as permitted by Federal law pursuant to 21 CFR 1306.26 and 1304.04, to maintain all required information consistent with N.J.A.C. [8:65]13:45H-7.19(a)5, if Schedule V controlled substances are sold without a prescription;

3.-13. (No change.)

(b)-(c) (No change.)

13:39-6.2   Pharmacist-in-charge

(a)-(c) (No change.)

(d) Whenever there is a change of a pharmacist-in-charge of a pharmacy, an inventory of all controlled dangerous substances as defined in N.J.A.C. [8:65]13:45H-10.1 through 10.5 shall be performed consistent with the requirements of N.J.A.C. [8:65]13:45H-5.4 and 5.5.

(e)-(f) (No change.)

13:39-7.4   Emergency dispensing

(a) (No change.)

(b) A pharmacist may dispense an emergency supply of a Schedule II controlled dangerous substance in the absence of a current, valid prescription upon receipt of oral authorization from a practitioner as provided under Federal law pursuant to 21 CFR 1306.11, consistent with the requirements of N.J.A.C. [8:65]13:45H-7.8.

13:39-7.8   Transfer of prescriptions between pharmacies

(a)-(c) (No change.)

(d) A prescription for a Schedule III, IV or V controlled substance may be transferred between pharmacies pursuant to N.J.A.C. [8:65]13:45H-7.14(h) and 7.18(d). A prescription for a Schedule III, IV or V controlled substance that has been transferred shall not be transferred a second time. This prohibition shall not apply to the transfer of such prescriptions between pharmacies engaged in central prescription handling pursuant to N.J.A.C. 13:39-4.18(e) and to pharmacies that share a real-time, on-line database consistent with the requirements of 21 CFR 1306.25.

(e) (No change.)

13:39-7.15   Restriction on sale of Schedule V over-the-counter controlled substances

(a) (No change.)

(b) The standard of professional judgment and care that attends the sale of a Schedule V over-the-counter con-trolled substance shall conform to the following:

1. All pharmacists shall comply with N.J.A.C. [8:65]13:45H-7.19, which requires that the sale of specified controlled substances be limited [page=1205] in quantity during any 48-hour period, that the purchaser be at least 18 years of age, and that the pharmacist obtain suitable identification (including proof of age where appropriate) from every purchaser not known to the pharmacist.

2. (No change.)

3. The pharmacist shall enter every sale of a Schedule V substance in the Over-the-Counter Schedule V Record Book pursuant to N.J.A.C. [8:65]13:45H-7.19. The information to be recorded shall include the purchaser's first and last name, street address, city and state, the name and quantity of the Schedule V substance sold, the date of each sale, and the name or initials of the pharmacist making the sale.

4. - 8. (No change.)

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