44 N.J.R. 2101(b)
Proposed Amendment: N.J.A.C. 13:45H-7.8
Proposed New Rule: N.J.A.C. 13:45H-7.20
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Requirements of Prescriptions; Electronic Prescriptions
Authorized By: Eric T. Kanefsky, Acting Director, Division of Consumer Affairs.
Authority: N.J.S.A. 24:21-9 (P.L. 2007, c. 244).
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2012-112.
Submit comments by October 19, 2012 to:
Eric T. Kanefsky, Acting Director
New Jersey Division of Consumer Affairs
124 Halsey Street
P.O. Box 45027
Newark, New Jersey 07101
The agency proposal follows:
The rules of the Board of Medical Examiners, at N.J.A.C. 13:35-7.4A, permit a practitioner to transmit prescriptions for controlled dangerous substances (CDS) electronically if permitted by Federal law. The Board of Pharmacy, at N.J.A.C. 13:39-7.11, permits a pharmacist to accept an electronic prescription for dispensing CDS if permitted by Federal law.
On March 31, 2010, the Drug Enforcement Agency issued an interim final rule providing prescribers with the option of writing prescriptions for CDS electronically and permitting pharmacies to receive, dispense, and archive electronic prescriptions.
The Controlled Dangerous Substances rules have not been updated to allow for electronic prescriptions for CDS and are inconsistent with the rules of the Board of Medical Examiners and the Board of Pharmacy that permit practitioners to transmit, and pharmacists to fill, prescriptions for CDS. The Acting Director of the Division of Consumer Affairs is proposing an amendment to N.J.A.C. 13:45H-7.8 and a new rule at N.J.A.C. 13:45H-7.20 authorizing prescribers to transmit, and pharmacists to fill, electronic prescriptions for CDS.
Because the Acting Director has provided a 60-day comment period on this notice of proposal, this notice is excepted from the rulemaking calendar requirements pursuant to N.J.A.C. 1:30-3.3(a)5.
The Division believes that the proposed amendment and new rule will have a positive impact upon members of the general public, prescribers, pharmacists, and pharmacies by eliminating any confusion that may exist with respect to filling electronic prescriptions for controlled dangerous substances. Electronic prescriptions are more efficient and less susceptible to errors.
The Division believes that the proposed amendment and new rule will have a positive economic impact upon members of the general public, prescribers, pharmacists, and pharmacies. Electronic prescribing is more efficient and more accurate.
Federal Standards Statement
A Federal standards analysis is not required because the proposed amendment and new rule are 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 and new rule are subject to the Federal Drug Enforcement Administration Interim Final Rule set forth at 21 CFR 1300, 1304, 1306, and 1311. The DEA rules provide pharmacies, hospitals, and practitioners with the ability to use modern technology for controlled substance prescriptions while maintaining the closed system of controls on controlled substances dispensing. That the technology meets strict DEA security standards must be verified by a third-party audit of the application by a DEA-approved certification organization.
The Division does not believe that the proposed amendment and new rule 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 and new rule will have any impact on the agriculture industry of the State.
Regulatory Flexibility Statement
Because practitioners and pharmacists are individually licensed, they may be considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq. The Division issues permits to 1,984 pharmacies, some of which are "small businesses" within the meaning of the Regulatory Flexibility Act. The proposed amendment and new rule permit electronic prescribing that complies with Federal law, but they themselves do not impose any reporting, recordkeeping, or compliance requirements. Therefore, no regulatory flexibility analysis is required.
Housing Affordability Impact Analysis
The proposed amendment and new rule will have an insignificant impact on affordable housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendment and new rule concern the filling of prescriptions for controlled substances.
Smart Growth Development Impact Analysis
The proposed amendment and new rule will have an insignificant impact on smart growth and there is an extreme unlikelihood that the rules 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.
[page=2102] Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):
SUBCHAPTER 7. PRESCRIPTION REQUIREMENTS FOR CONTROLLED DANGEROUS SUBSTANCES
13:45H-7.8 Requirements of prescriptions; schedule II
(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 provided in (d) and (e) below.
(b)-(d) (No change.)
(e) If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription.
[(e)] (f) (No change in text.)
13:45H-7.20 Electronic prescriptions
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.
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