10 CFR 35.63, Determination of Dosages of Unsealed Byproduct Material for Medical Use
Determination of dosages of unsealed byproduct material for medical use
a
(a) A licensee shall determine and record the activity of each dosage before medical use.
b
(b) For a unit dosage, this determination must be made by-
- (1) Direct measurement of radioactivity; or
- (2) A decay correction, based on the activity or activity concentration determined by-
- (i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
- (ii) An NRC or Agreement State licensee for use in research in accordance with a Radioactive Drug Research Committee-approved protocol or an Investigational New Drug (IND) protocol accepted by FDA; or
- (iii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.
c
(c) For other than unit dosages, this determination must be made by-
- (1) Direct measurement of radioactivity;
- (2) Combination of measurement of radioactivity and mathematical calculations; or
- (3) Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
- (i) A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
- (ii) A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.
d
(d) Unless otherwise directed by the authorized user, a licensee may not use a dosage if the dosage does not fall within the prescribed dosage range or if the dosage differs from the prescribed dosage by more than 20 percent.
e
(e) A licensee shall retain a record of the dosage determination required by this section in accordance with § 35.2063.
Federal Register
[[[FR::http://frwebgate.access.gpo.gov/cgi-bin/getpage.cgi?dbname=2007_register&page=55931&position=1%7C72 FR 55931, Oct. 1, 2007]]]
External Links
[[URL::http://www.nrc.gov/reading-rm/doc-collections/cfr/part035/part035-0063.html%7CNRC website 10 CFR 35.63]]