NEW JERSEY REGISTER
VOLUME 35, NUMBER 14
MONDAY, JULY 21, 2003
LAW AND PUBLIC SAFETY
DIVISION OF CONSUMER AFFAIRS
STATE BOARD OF MEDICAL EXAMINERS
ADDITION OF SINCALIDE, A SYNTHETIC CHOLECYSTOKININ, TO LIST OF APPROVED NON-
RADIOACTIVE MATERIALS LICENSED NUCLEAR MEDICINE TECHNOLOGISTS MAY ADMINISTER
Adopted Amendment: N.J.A.C. 13:35-6.20
Proposed: September 3, 2002 at 34 N.J.R. 3058(a).
Adopted: December 10, 2002 by the State Board of Medical Examiners, William V. Harrer, M.D., President.
Filed: June 20, 2003 as R.2003 d.286, with a substantive change not requiring additional public notice and comment (see N.J.A.C. 1:30-6.3).
Authority: N.J.S.A. 45:9-2 and 45:1-15.1.
Effective Date: July 21, 2003.
Expiration Date: September 20, 2004.
Summary of Public Comments and Agency Responses:
The Board received written comments from the following individuals or
representatives of organizations:
1. Henry J. Powsner, M.D., Chairman, Commission on Radiation Protection, New
Jersey Department of Environmental Protection, Division of Environmental
Safety, Health and Analytical Programs.
2. Robert S. Rigolosi, President, Medical Society of New Jersey.
COMMENT: The commenters support the adopted amendment because it will improve
patient care by ensuring the timely administration of "Kinevak (CCK)" during
nuclear medicine procedures and allow physicians and nurses to perform other
RESPONSE: The Board thanks the commenters and agrees that the adopted rule
will greatly improve patient care.
COMMENT: A commenter states that the adopted amendment specifically permits
administration of "Kinevak (CCK)" which is a branch name of synthetic
cholecystokinin. The commenter states that the rule as written would only
permit Kinevak to be administered by a licensed nuclear medicine technologist.
The commenter adds that there is currently a shortage of Kinevak and that they
expect the manufacturer to resume production in early 2003. The commenter
states that a number of nuclear medicine departments are presently using
Sincalide, the generic name of synthetic cholecystokinin, which is prepared by
some compounding pharmacies. The commenter recommends that the language of the
adopted rule be amended to replace Kinevak with Sincalide, a synthetic
cholecystokinin. The revised language would permit all forms of cholecystokinin
to be administered by a licensed nuclear medicine technologist.
RESPONSE: The Board agrees with the commenter's suggestion and has made the
technical change upon adoption. The change in the rule reflects the lack of
availability of "Kinevak" and permits licensed nuclear medicine technologists
to administer the same drug in its generic or brand name form.
Federal Standards Statement
A Federal standards analysis is not required because the adopted amendment
does not involve any Federal standards or requirements.
Full text of the adoption follows:
<< NJ ADC 13:35-6.20 >>
13:35-6.20 Physician delegation of tasks to radiologic technologists and nuclear medicine technologists
(a)-(l) (No change.)
(m) A physician may direct the LNMT to administer, under direct physician supervision, nonradioactive pharmaceuticals as follows:
1.-4. (No change.)
5. Vitamin B-12;
6. Intravenous flush solutions such as saline or heparin; and
7. <<-Kinevac (CCK)->> <<+Sincalide, a synthetic cholecystokinin+>>.
(n)-(p) (No change.)