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. 97-092 FOR IMMEDIATE RELEASE

(Thursday, June 12, 1997)

NRC CONSIDERS CHANGING REGULATIONS TO PERMIT

EXEMPT DISTRIBUTION OF RADIOACTIVE DIAGNOSTIC DRUG

The Nuclear Regulatory Commission is considering amending

its regulations to allow a specific radioactive drug used to

diagnose stomach ulcers to be distributed to any person for

administration to humans. Currently only physicians authorized

by the NRC or Agreement States may receive and administer the

drug.

The proposed change would 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 from Tri-Med

Specialties, Inc. It would allow any person to receive, possess,

use and transfer carbon-14 urea capsules, not exceeding one

microcurie each, for diagnostic use in patients. The NRC has

determined that the capsules present a minimal radiation risk,

and therefore believes that regulatory control of the drug for

radiation safety is not necessary.

Under the proposed revisions to NRC regulations,

manufacturers of the capsules and commercial pharmacies that

prepare the capsules would continue to need an NRC license to

provide high confidence of capsule contents. The containers of

the capsules would have to bear the words "radioactive material"

and other specific information on the contents of the container.

In addition, only those persons who were licensed would 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 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.

The NRC's Advisory Committee on the Medical Uses of Isotopes

discussed the petition at its October 1995 meeting. The committee

endorsed making this diagnostic test widely available.

Currently Part 35 of the Commission's regulations permits

only physicians who are authorized users (e.g., physicians who

meet certain training and experience criteria regarding the safe

use of radioactive drugs) or persons working under the

supervision of an authorized user to administer radioactive drugs

for medical purposes.

Under the proposed amendments, physicians or other health

care workers would not need to be authorized users in order to

administer the drug, and physicians would not need to refer their

patients to nuclear medicine physicians. This should result in

cost savings to patients, insurers and the health care industry.

Interested persons are invited to submit comments on the

proposed rule change within 30 days after publication of a

Federal Register notice on this subject (expected about June 16).

They may be mailed to the Secretary, U.S. Nuclear Regulatory

Commission, Washington, DC 20555-0001, Attention: Rulemakings

and Adjudications Staff, or submitted electronically as described

in the Federal Register notice.

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