ML20198L375
| ML20198L375 | |
| Person / Time | |
|---|---|
| Issue date: | 09/17/1997 |
| From: | Paperiello C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Knapp M NRC OFFICE OF NUCLEAR REGULATORY RESEARCH (RES) |
| Shared Package | |
| ML20198K526 | List: |
| References | |
| FRN-62FR63634, RULE-PR-30, RULE-PR-32 AF70-2-013, AF70-2-13, NUDOCS 9801160010 | |
| Download: ML20198L375 (3) | |
Text
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<Trottier Tse y#,ue:%,t File p* . UNITED STATES o B e NUCLEAR REGULATORY COMMISSION U
! WASHINGTON, D.C. 30665mi-
~ September 17, 1997 NG, JR.
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MEMORANDUM TO: Malcolm R Knapp, Acting Director -
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Office of Nuclear Regulatory Research .
FROM: Carl J. Paperiello, Director "
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- Office of Nuclear Material Safety and Safeguards
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SUBJECT:
OFFICE CONCURRENCE ON " FINAL RULE: EXEMPTION OF A RADIOACTIVE DRUG CONTAINING ONE MICROCURIE OF CARBON-14 UREA (PARTS 30 AND 32)"
The starf has reviewed the September 5,1997, versions of the Commission paper and The Federal Registe,t Notice for the " Final, Rule: Exemption of a Radioactive Drug Containing One Microcurie of Carbon 14 Urea (Parts 30 and 32)." All comments identified by my staff have been incorporated into these versions of the documents. We concur,
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CONTACT: Donna-Beth Howe, Ph.D., NMSS/IMNS (301)416-7848 b
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United States Nu5 lear _RegOlatory Commission-
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& p No.397.176 FOR IMEDIATE RELEASE :
(Wednesday, November 26, 1997).
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- _ NRC CHANGES REGULATIONS TO PERMIT ,
j 4 EXEMPT DISTRIBUTION OF RADI0 ACTIVE DIAGNOSTIC DRUG- r .
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The puclear; Regulatory Commission is anending its regulations to allow a
__ specific radioactive drug used to diagnose stomach ulcers to be distributed to any-
- person for ahinistration to humans. Before this change, only physicians authorized
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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 A&inistration or other Federal and State requirements ,
-governing receipt. ahi.iistration 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 F -
- use in patients. :The NRC has determined that, the capsules present an insignificant radiation risk, and therefore believes that regulatory contrn1 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 o0 capsule contents. The containers of the capsules must bear the words
" radioactive material" and other specific information on the contents of the-
, contai.ner. In addition, only those persons who are licensed will be permitted to
- use the capsules for research involving hinan subjects.
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- Tiie Tri Med petition stated that carbon 14 urea can be used to detect the
. presence of a bacterium that causes peptic ulcers, a chronic inflamatory condition 4of the stoma@ and duodenum that'affects as many as 10 percent of pgle in the; 3":
United States ct some time irntheir lives. According to a July 1994 article in the
- _ ._ ! Journal of.the American Medical Association, the disease has relatively low A" ,~ ~ : mortality, but results-in substantial human suffering and hit economic costs. *
' Doctors can now cure most ulcer: problems with antibiotics. The test _ using carbon 14 Lurea is non invasive. - A doctor asks the patient to swallow the capsule with water.
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4 After 15 minutes the patient blows into a collection bag, which is mailed to a testing laboratory for analysis, w
- 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 m ed 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 coments received are dise.ned in a Federal Register notice that will. be published shortly.
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