NEW JERSEY REGISTER
VOLUME 35, NUMBER 18
MONDAY, SEPTEMBER 15, 2003
RULE ADOPTION

LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF PHARMACY
PRESCRIPTIONS AND MEDICATION ORDERS TRANSMITTED BY TECHNOLOGICAL DEVICE IN AN
INSTITUTION; PRESCRIPTIONS TRANSMITTED BY FACSIMILE; ELECTRONICALLY TRANSMITTED
PRESCRIPTIONS


Adopted Amendment: N.J.A.C. 13:39-5.8

Adopted New Rules: N.J.A.C. 13:39-5.8A and 5.8B

Proposed: September 3, 2002 at 34 N.J.R. 3064(a).

Adopted: December 11, 2002 by the State Board of Pharmacy, Anthony Alexander, R.Ph., President.

Filed: August 22, 2003 as R.2003 d.373, with substantive and technical changes not requiring additional public notice and comment (see N.J.A.C 1:30-6.3).

Authority: N.J.S.A. 45:14-1 et seq. and 45:1-15.1.

Effective Date: September 15, 2003.
Expiration Date: June 16, 2004.

 

Summary of Agency-Initiated Changes:

Federal Drug Enforcement Administration regulations set forth at 21 C.F.R. ß 1306.11(e) and (g), provide that a pharmacist may fill a facsimile prescription, without obtaining an original written prescription prior to dispensing, for a Schedule II narcotic substance for direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion, or for a patient enrolled in a hospice care program. In light of these Federal requirements, the Board has determined that N.J.A.C. 13:39- 5.8A(h)1 and 3 should be amended on adoption, to refer to Schedule II narcotic substances, as opposed to Schedule II substances. The Board notes, however, that N.J.A.C. 13:39-5.8A(h)2, as proposed, is consistent with Federal standards and does not require amendment. 21 C.F.R. ß 1306.11(f) provides that a pharmacist may fill a facsimile prescription, without obtaining an original written prescription prior to dispensing, for a Schedule II substance for a resident of a long term care facility.

Federal Standards Statement

A Federal standards analysis is not required because the adopted new rules and amendment are governed by N.J.S.A. 45:14-1 et seq., and are not subject to any Federal standards or requirements. The Board notes, however, that the requirements for the facsimile and electronic transmission of prescriptions for controlled substances set forth at N.J.A.C. 13:39-5.8A(h) and (i) and 5.8B(g) and (h) are consistent with the Federal DEA standards articulated at 21 C.F.R. ß ß 1306.11 and 1306.21.

Full text of the adoption follows:

<< NJ ADC 13:39-5.8 >>

13:39-5.8 Prescriptions and medication orders transmitted by technological devices in an institution

(a) (No change.)

(b) A registered pharmacist filling prescriptions under an institutional permit for employees of the institution and their dependents and for out- patients who are treated by staff members of the institution in their respective clinics, as permitted pursuant to N.J.S.A. 45:14-32, may accept for dispensing prescriptions for all substances other than Schedule II controlled dangerous substances which have been transmitted by technological device, under the following conditions only:

1.-2. (No change.)

(c)-(g) (No change.)

<< NJ ADC 13:39-5.8A >>

13:39-5.8A Prescriptions transmitted by facsimile

(a) A pharmacist may accept for dispensing a facsimile prescription, consistent with the requirements of this section. For purposes of this section, "facsimile prescription" means a prescription which is transmitted by a device which sends an exact image to the receiver.

(b) A pharmacist shall not fill a facsimile prescription transmitted by anyone other than a practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-14, or the prescribing practitioner's authorized agent.

(c) The facsimile machine used to receive prescriptions shall be located within the pharmacy prescription area.

(d) A facsimile prescription shall contain <<-the following:->>

<<-1. The prescribing practitioner's full name, address, telephone number, license number, proper academic degree or identification of professional practice for which licensed, and handwritten original signature;->>

<<-2. The full name, age, and address of the patient;->>

<<-3. The date of issuance;->>

<<-4. The name, strength and quantity of the drug prescribed;->>

<<-5. The number of refills permitted or time limit for refills, or both; and->>

<<-6. The prescribing practitioner's D.E.A. number, if the drug prescribed is a controlled substance.->> <<+all information required to be included on a written prescription pursuant to New Jersey State Board of Medical Examiners rule N.J.A.C. 13:35-7.2(d), except that an NJPB shall not be required for the prescription.+>>

(e) The facsimile transmission of the prescription shall contain the following:

1. The identification number of the facsimile machine which is used to transmit the prescription;

2. The date and time of the prescription transmission;

3. The name, address, telephone number and facsimile number of the pharmacy; and

4. If an authorized agent transmits the facsimile prescription, the full name and title of the transmitting agent.

(f) A pharmacist shall seek verbal verification of a facsimile prescription from the prescribing practitioner whenever the pharmacist has reason to question the authenticity, accuracy or appropriateness of the prescription. A pharmacist may accept verbal verification regarding the authenticity or legibility of a facsimile prescription from a prescribing practitioner's authorized agent. A pharmacist shall not fill a facsimile prescription where there is a question regarding authenticity, accuracy or appropriateness if such verification is not provided.

(g) A pharmacist shall retain a printed copy of a facsimile prescription, or an electronic reproduction of the facsimile prescription that is readily retrievable and printable, for a minimum of five years pursuant to N.J.S.A. 45:14-15. The printed copy shall be of non-fading legibility.

(h) A pharmacist may fill a prescription for a Schedule II controlled substance transmitted by facsimile provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance, except as provided in (h)1, 2 and 3 below.

1. A prescription for a Schedule II <<+narcotic+>> substance prescribed for pain management to be compounded for the direct administration to a patient by parenteral, intravenous, intramuscular, subcutaneous or intraspinal infusion may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription and shall be maintained pursuant to the requirements of (g) above.

2. A prescription for a Schedule II <<+narcotic+>> substance prescribed for pain management for a resident of a long term care facility may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The facsimile shall serve as the original written prescription and shall be maintained pursuant to the requirements of (g) above.

3. A prescription for a Schedule II substance prescribed for pain management for a patient receiving services from a hospice certified by Medicare under Title XVIII or licensed by the State may be transmitted by the practitioner or the practitioner's agent to the dispensing pharmacy by facsimile. The practitioner or the practitioner's agent shall note on the facsimile prescription that the patient is a hospice patient. The facsimile shall serve as the original written prescription and shall be maintained pursuant to the requirements of (g) above.

(i) A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance transmitted by facsimile consistent with the requirements of this section. The facsimile prescription shall serve as the original written prescription.

(j) A pharmacist shall not enter into any agreement with a prescribing practitioner that requires that facsimile prescriptions be transmitted to a particular pharmacy or in any way denies a patient the right to have his or her prescription transmitted by facsimile to a pharmacy of the patient's choice.

<< NJ ADC 13:39-5.8B >>

13:39-5.8B Electronically transmitted prescriptions

(a) A pharmacist may accept for dispensing an electronic prescription, consistent with the requirements of this section. For purposes of this section, "electronic prescription" means a prescription which is transmitted by a computer device in a secure manner<<+, including computer to computer and computer to facsimile transmissions+>>.

(b) A pharmacist shall not fill an electronic prescription transmitted by anyone other than a practitioner authorized to prescribe medications pursuant to N.J.S.A. 45:14-14, or the prescribing practitioner's authorized agent. If the electronic prescription is transmitted by the practitioner's authorized agent, the transmission shall include the full name and title of the agent.

(c) The permitholder shall ensure that the electronic system utilized to receive prescriptions shall have adequate security and system safeguards designed to prevent and detect unauthorized access, modification or manipulation of the prescriptions.

(d) The computer or device used to receive electronically transmitted prescriptions shall be located within the pharmacy prescription area.

<<+(e) An electronic prescription shall contain all information required to be included on a written prescription pursuant to New Jersey State Board of Medical Examiners rule N.J.A.C. 13:35-7.2(d), except that a handwritten original signature and an NJPB shall not be required for the prescription.+>>

<<-(e)->><<+(f)+>> A pharmacist shall seek verbal verification of an electronic prescription from the prescribing practitioner whenever the pharmacist has reason to question the authenticity, accuracy or appropriateness of the prescription. A pharmacist may accept verbal verification regarding the authenticity or legibility of an electronic prescription from a prescribing practitioner's authorized agent. A pharmacist shall not fill the electronic prescription where there is a question regarding authenticity, accuracy or appropriateness if such verification is not provided.

<<-(f)->><<+(g)+>> A pharmacist shall retain a printed copy of an electronic prescription, or a record of an electronic prescription that is readily retrievable and printable, for a minimum of five years pursuant to N.J.S.A. 45:14-15. The printed copy shall be of non-fading legibility.

<<-(g)->><<+(h)+>> A pharmacist may fill a prescription for a Schedule II controlled substance transmitted electronically, provided that the original signed prescription is presented to the pharmacist prior to the dispensing of the controlled substance. If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription.

<<-(h)->><<+(i)+>> A pharmacist may fill a prescription for a Schedule III, IV or V controlled substance transmitted electronically, provided that the pharmacist has obtained the original signed prescription, an oral prescription, or a facsimile prescription from the prescribing practitioner or the prescribing practitioner's authorized agent prior to the dispensing. If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription.

<<-(i)->><<+(j)+>> A pharmacist shall not enter into any agreement with a prescribing practitioner that requires that electronic prescriptions be transmitted to a particular pharmacy or in any way denies a patient the right to have his or her prescription transmitted electronically to a pharmacy of the patient's choice.

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