§ 35.63. Determination of dosages of unsealed byproduct material for medical use.
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/us/cfr/t10/s§ 35.63·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)A licensee shall determine and record the activity of each dosage before medical use.
(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)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)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)A licensee shall retain a record of the dosage determination required by this section in accordance with § 35.2063. [67 FR 20370, Apr. 24, 2002, as amended at 72 FR 55931, Oct. 1, 2007]
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§ 35.63
Determination of dosages of unsealed byproduct material for medical use.
Fed. Reg.×7
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