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MONDAY, JULY 7, 2003

Limitations On Prescribing, Administering Or Dispensing Of Controlled Substances;
Special Exceptions For Management Of Pain Implantable Infusion Pumps


Adopted Amendment: N.J.A.C. 13:35-7.6

Proposed: October 7, 2002 at 34 N.J.R. 3441(a).

Adopted: February 19, 2003 by William V. Harrer, MD, President, State Board of Medical Examiners.

Filed: June 10, 2003 as R.2003 d.263, without change.

Authority: N.J.S.A. 45:9-2.

Effective Date: July 7, 2003.
Expiration Date: September 20, 2004.

Summary of Public Comment and Agency Response:

The official comment period ended December 6, 2002. The Board received no comments.

Federal Standards Statement

A Federal standards analysis is not required because there are no Federal standards or requirements applicable to the adopted amendment.

Full text of the adoption follows:

< < NJ ADC 13:35-7.6 > >

13:35-7.6 Limitations on prescribing, administering or dispensing of controlled substances; special exceptions for management of pain

(a)-(b) (No change.)

(c) A practitioner may exceed the 120 dosage unit or 30-day supply limitations for Schedule II controlled substances in (b) above in the following circumstances:

1. For the 120 dosage unit limitation, the practitioner follows a treatment plan designed to achieve effective pain management which has been tailored to the needs of a patient who is suffering pain from cancer, intractable pain or terminal illness. The treatment plan shall state objectives by which treatment success is to be evaluated, such as pain relief and improved physical and psychological function, and shall indicate if any further diagnostic evaluations or other treatments are planned. The practitioner shall discuss the risks and benefits of the use of controlled substances with the patient, guardian or authorized representative; and

2. With regards to the 30-day supply limitation, a practitioner may prescribe the use of an implantable infusion pump which is utilized to achieve pain management for patients suffering from cancer, intractable pain or terminal illness. A prescription for such an implantable infusion pump may provide up to a 90-day supply as long as the physician evaluates and documents the patient's continued need at least every 30 days.

(d)-(g) (No change.)
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