§35.63. Determination of dosages of unsealed byproduct material for medical use.
10 C.F.R. § 35.63
A licensee shall determine and record the activity of each dosage before medical use.
For a unit dosage, this determination must be made by—
Direct measurement of radioactivity; or
A decay correction, based on the activity or activity concentration determined by—
A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
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
A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.
For other than unit dosages, this determination must be made by—
Direct measurement of radioactivity;
Combination of measurement of radioactivity and mathematical calculations; or
Combination of volumetric measurements and mathematical calculations, based on the measurement made by:
A manufacturer or preparer licensed under § 32.72 of this chapter or equivalent Agreement State requirements; or
A PET radioactive drug producer licensed under § 30.32(j) of this chapter or equivalent Agreement State requirements.
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.
A licensee shall retain a record of the dosage determination required by this section in accordance with § 35.2063.
Notes, amendments, and revision history
Amendments
[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007]
Authority
Authority: Atomic Energy Act of 1954, secs. 81, 161, 181, 182, 183, 223, 234, 274 (42 U.S.C. 2111, 2201, 2231, 2232, 2233, 2273, 2282, 2021); Energy Reorganization Act of 1974, secs. 201, 206 (42 U.S.C. 5841, 5846); 44 U.S.C. 3504 note.
Source
Source: 67 FR 20370, Apr. 24, 2002, unless otherwise noted.
Amendments
[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007]