Determination of dosages of unsealed byproduct material for medical use.

§ 35.63 Determination of dosages of unsealed byproduct material for medical use. (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]