10 CFR 35.2063 - Records of dosages of unsealed byproduct material for medical use.

§ 35.2063 Records of dosages of unsealed byproduct material for medical use.

(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.

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.

United States Code

Title 10 published on 10-May-2017 03:48

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 10 CFR Part 35 after this date.

  • 2014-12-19; vol. 79 # 244 - Friday, December 19, 2014
    1. 79 FR 75735 - Organizational Changes and Conforming Amendments
      GPO FDSys XML | Text
      Final rule.
      This final rule is effective on December 19, 2014.
      10 CFR Parts 1, 2, 30, 31, 32, 34, 35, 37, 40, 51, 61, 62, 70, 71, 72, 73, 74, 75, 140, and 150
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