Code of Federal Regulations · Section

§ 35.2063 — Records Of Dosages Of Unsealed Byproduct Material For Medical Use

10 C.F.R. § 35.2063

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(a) A licensee shall maintain a record of dosage determinations required by § 35.63 for 3 years.

(b) The record must contain—

(1) The radiopharmaceutical;

(2) The patient's or human research subject's name, or identification number if one has been assigned;

(3) The prescribed dosage, the determined dosage, or a notation that the total activity is less than 1.1 MBq (30 µCi);

(4) The date and time of the dosage determination; and

(5) The name of the individual who determined the dosage.

10 C.F.R. § 35.2061 10 C.F.R. § 35.2067

Authorizing Statute