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RULE PROPOSALS
VOLUME 42, ISSUE 21
ISSUE DATE: NOVEMBER 1, 2010
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
CONTROLLED DANGEROUS SUBSTANCES

Proposed Amendment: N.J.A.C. 8:65-7.5

Manner of Issuance of Prescriptions

Authorized By: Thomas R. Calcagni, Acting Director, Division of Consumer Affairs. Authority: N.J.S.A. 24:21-9 (P.L. 2007, c. 244) and 45:9-22.19 (P.L. 2009, c. 165).

Calendar Reference: See Summary below for explanation of exception to calendar requirement.

Proposal Number: PRN 2010-265.

Submit comments by December 31, 2010 to:

Thomas R. Calcagni, Acting Director
New Jersey Division of Consumer Affairs
124 Halsey Street
P.O. Box 45027
Newark , New Jersey 07101

The agency proposal follows:

Summary

The authority to administer the New Jersey Controlled Dangerous Substances Act (the Act), N.J.S.A. 24:21-1 et seq., was transferred from the Department of Health and Senior Services to the Division of Consumer Affairs (the Division) pursuant to P.L. 2007, c. 244. Consistent with this authority, the Division is proposing an amendment to N.J.A.C. 8:65-7.5 of the State controlled substances rules in order to ensure consistency with the provisions of P.L. 2009, c. 165, codified at N.J.S.A. 45:9-22.19, which became effective on March 1, 2010.

Under N.J.S.A. 45:9-22.19, physicians are permitted to issue multiple prescriptions authorizing a patient to receive a total of up to a 90-day supply of a Schedule II controlled dangerous substance provided: (1) each separate prescription is issued for a legitimate medical purpose by the physician acting in the usual course of professional practice; (2) the physician provides written instructions on each prescription, other than the first prescription if it is to be filled immediately, indicating the earliest date on which a pharmacy may fill each prescription; (3) the physician determines that providing the patient with multiple prescriptions in this manner does not create an undue risk of diversion or abuse; and (4) the physician complies with all other applicable State and Federal laws, rules and regulations.

The Board of Medical Examiners recently proposed an amendment to its rule at N.J.A.C. 13:35-7.6(c), which currently imposes a 30-day limitation on prescriptions for Schedule II controlled substances, to permit a physician to issue multiple prescriptions for a total of a 90-day supply of a Schedule II controlled dangerous substance, provided the requirements of the new law are satisfied. The notice of proposal appeared in the New Jersey Register on July 6, 2010 at 42 N.J.R. 1310(a).

Similarly, the Division is proposing an amendment to N.J.A.C. 8:65-7.5(a), which currently provides that all prescriptions for controlled substances, regardless of schedule, must be presented to the pharmacist for filling within 30 days after the date of issuance. The proposed amendment provides that when 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 under N.J.S.A. 45:9-22.19, the first prescription must be filled within 30 days of the date of issuance. The second and third prescriptions must be filled within 30 days of the date indicated on the prescriptions as the earliest date on which the prescriptions may be filled. In addition, all three prescriptions may be accepted by the pharmacist for filling at one time and may be held until the date indicated on the prescriptions as the earliest date for filling. A pharmacist, however, may not provide a patient with more than a 30-day supply of a Schedule II medication at one time.

The Division has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Division believes that the proposed amendment will have a positive impact upon members of the general public and upon pharmacists and pharmacies by eliminating any confusion that may exist with respect to filling prescriptions for Schedule II controlled substances issued by physicians under the new requirements of N.J.S.A. 45:9-22.19.

Economic Impact

The Division does not believe that the proposed amendment will have any economic impact upon members of the general public, pharmacists or pharmacies.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendment is governed by N.J.S.A. 24:21-9 (P.L. 2007, c. 244) and 45:9-22.19 (P.L. 2009, c. 165). The Division notes, however, that the proposed amendment is consistent with Federal Drug Enforcement Administration requirements set forth at 21 CFR 1306.12, which authorize the issuance of multiple prescriptions for a total of up to a 90-day supply of Schedule II controlled substances.

Jobs Impact

The Division does not believe that the proposed amendment will result in the creation or the loss of jobs in the State.

Agriculture Industry Impact

The Division does not believe that the proposed amendment will have any impact on the agriculture industry of the State.

Regulatory Flexibility Analysis

Currently, the Division licenses 12,741 pharmacists and permits 1,984 pharmacies. If these pharmacists and pharmacies are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies.

The proposed amendment will not impose any reporting or recordkeeping requirements upon pharmacists or pharmacies. The proposed amendment will, however, impose compliance requirements to the extent that pharmacists and pharmacies will be required to accept for filling prescriptions for Schedule II controlled substances more than 30 days after they were written, if the prescriptions were issued by the physician pursuant to N.J.S.A. 45:9-22.19. Those requirements are detailed in the Summary above.

No additional professional services will be needed to comply with the proposed amendment. The Division does not anticipate that pharmacies and pharmacists will incur any economic costs to comply with the proposed amendment, as noted in the Economic Impact statement above. The Division believes that the proposed amendment must be uniformly applied to all pharmacists and pharmacies filling prescriptions for Schedule II controlled substances issued by a physician under N.J.S.A. 45:9-22.19 in order to effectuate the purposes of the new law. Therefore, no differing compliance requirements for any pharmacy or pharmacist is provided based upon the size of the business.

Smart Growth Impact

The Division does not believe that the proposed amendment will have any impact upon the achievement of smart growth or upon the implementation of the State Development and Redevelopment Plan.

Housing Affordability Impact

The proposed amendment will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rule would evoke a change in the average costs associated with housing because the proposed amendment concerns the filling of prescriptions for controlled substances.

[page=2569] Smart Growth Development Impact

The proposed amendment will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rule would evoke a change in housing production in Planning Areas 1 or 2 or within designated centers under the State Development and Redevelopment Plan in New Jersey because the proposed amendment concerns the filling of prescriptions for controlled substances.

Full text of the proposal follows (additions indicated in boldface thus ):

SUBCHAPTER 7. PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES

8:65-7.5 Manner of issuance of prescriptions

(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 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 and shall be manually signed by the practitioner. 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 these rules.

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 N.J.S.A. 45:9-22.19 (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.

ii. Prescriptions presented individually shall be filled as indicated below:

(1) The first prescription shall be filled no later than 30 days after the date of issuance;

(2) The second and third prescriptions shall be presented to the pharmacy and filled no later than 30 days after the date indicated on the prescription as the earliest date on which the prescription may be filled.

iii. A patient shall not be provided with more than a 30-day supply of a Schedule II medication at one time.

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

   
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