N.J. Admin. Code § 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) An individual practitioner may administer or dispense directly a controlled substance listed in Schedule II in the course of his or her professional practice without a prescription, subject to N.J.A.C. 13:45H-7.6.

(c) An institutional practitioner may administer or dispense directly (but not prescribe) a controlled substance listed in Schedule II only pursuant to a written prescription signed by the prescribing individual practitioner or to an order for medication made by an individual practitioner which is dispensed for immediate administration to the ultimate user.

(d) In the case of an emergency situation, as defined by the Secretary of the Federal Department of Health and Human Services in 21 CFR 290.10, a pharmacist may dispense a controlled substance listed in Schedule II upon receiving oral authorization of a prescribing individual practitioner, provided that:

1. The quantity prescribed and dispensed is limited to the amount adequate to treat the patient during the emergency period not to exceed 72 hours (dispensing beyond the emergency period must be pursuant to a written prescription signed by the prescribing individual practitioner);

2. The prescription shall be immediately reduced to writing by the pharmacist and shall contain all information required in N.J.A.C. 13:45H-7.5(a), except for the signature of the prescribing individual practitioner;

3. If the prescribing individual practitioner is not known to the pharmacist, he must make a reasonable effort to determine that the oral authorization came from a registered individual practitioner, which may include a callback to the prescribing individual practitioner using his phone number as listed in the telephone directory and/or other good faith efforts to insure his identity; and

4. Within seven days after authorizing an emergency oral prescription, the prescribing individual practitioner shall cause a written prescription for the emergency quantity prescribed (not to exceed the amount for a 72-hour period) to be delivered to the dispensing pharmacist. In addition to conforming to the requirements of N.J.A.C. 13:45H-7.4, the prescription shall have written on its face "Authorization for Emergency Dispensing," and the date of the oral order. The written prescription may be delivered to the pharmacist in person or by mail, but if delivered by mail it must be postmarked within the seven-day period. Upon receipt, the dispensing pharmacist shall attach this prescription to the oral emergency prescription, which had earlier been reduced to writing. The pharmacist shall notify the Drug Control Unit and the nearest office of the DEA in his or her district if the prescribing individual practitioner fails to deliver a written prescription to him or her; failure of the pharmacist to do so shall void the authority conferred by this paragraph to dispense with a written prescription of a prescribing individual practitioner.

(e) If permitted by Federal law, and in accordance with Federal requirements, an electronic prescription shall serve as the original signed prescription.

(f) A practitioner shall not prescribe or dispense a Schedule II controlled substance to an individual patient in excess of the limits set forth at N.J.A.C. 13:35-7.6, except that prescriptions for patients in a long-term care facility (LTCF) may be in amounts as set forth in N.J.A.C. 13:45H-7.10(d).

(g) A practitioner may transmit a facsimile prescription for a Schedule II controlled substance in accordance with N.J.A.C. 13:35-7.4.

Notes

N.J. Admin. Code § 13:45H-7.8

Amended by 47 N.J.R. 2300(a), effective 9/8/2015