United States Nuclear Regulatory Commission

Office of Public Affairs

Washington, DC 20555

Phone 301-415-8200 Fax 301-415-2234

Internet:opa@nrc.gov

No. 97-176 FOR IMMEDIATE RELEASE

(Wednesday, November 26,

1997)

NRC CHANGES REGULATIONS TO PERMIT

EXEMPT DISTRIBUTION OF RADIOACTIVE DIAGNOSTIC DRUG

The Nuclear Regulatory Commission is amending its regulations to

allow a specific radioactive drug used to diagnose stomach ulcers to

be distributed to any person for administration to humans. Before

this change, only physicians authorized by the NRC or Agreement States

could receive and administer the drug.

The change does not relieve persons from the requirement to

comply with applicable Food and Drug Administration or other Federal

and State requirements governing receipt, administration and use of

drugs.

The change is in response to a 1994 petition for rulemaking from

Tri-Med Specialties, Inc. The revised regulation allows any person to

receive, possess, use and transfer capsules containing one microcurie

carbon-14 urea each for diagnostic use in patients. The NRC has

determined that the capsules present an insignificant radiation risk,

and therefore believes that regulatory control of the diagnostic use

of the drug for radiation safety is not necessary.

Under the amendments, manufacturers of the capsules and

commercial pharmacies that prepare the capsules will continue to need

an NRC license to provide high confidence of capsule contents. The

containers of the capsules must bear the words "radioactive material"

and other specific information on the contents of the container. In

addition, only those persons who are licensed will be permitted to use

the capsules for research involving human subjects.

The Tri-Med petition stated that carbon-14 urea can be used to

detect the presence of a bacterium that causes peptic ulcers, a

chronic inflammatory condition of the stomach and duodenum that

affects as many as 10 percent of people in the United States at some

time in their lives. According to a July 1994 article in the Journal

of the American Medical Association, the disease has relatively low
-2-

mortality, but results in substantial human suffering and high

economic costs. Doctors can now cure most ulcer problems with

antibiotics. The test using carbon-14 urea is non-invasive. A doctor

asks the patient to swallow the capsule with water. After 15 minutes

the patient blows into a collection bag, which is mailed to a testing

laboratory for analysis.

Before the change, only physicians who were authorized users

(e.g., physicians who met certain training and experience criteria

regarding the safe use of radioactive drugs) or persons working under

the supervision of an authorized user could administer radioactive

drugs for medical purposes.

Under the amendments, physicians or other health care workers

will not need to be authorized users in order to administer the drug,

and physicians will not need to refer their patients to nuclear

medicine physicians. This should result in cost savings to patients,

insurers, and the health care industry.

A proposed rule on this subject was published in the Federal

Register for public comment on June 16. Minor changes made to the

rule as a result of comments received are discussed in a Federal

Register notice that will be published shortly.

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