CFR > Title 10 - Energy > CHAPTER I—NUCLEAR REGULATORY COMMISSION > PART 35—MEDICAL USE OF BYPRODUCT MATERIAL > SUBPART B—General Administrative Requirements (§35.24 to §35.59) > 35.41—Procedures for administrations requiring a written directive.

35.41—Procedures for administrations requiring a written directive.

(a) For any administration requiring a written directive, the licensee shall develop, implement, and maintain written procedures to provide high confidence that:
(1) The patient's or human research subject's identity is verified before each administration; and
(2) Each administration is in accordance with the written directive.
(b) At a minimum, the procedures required by paragraph (a) of this section must address the following items that are applicable to the licensee's use of byproduct material—
(1) Verifying the identity of the patient or human research subject;
(2) Verifying that the administration is in accordance with the treatment plan, if applicable, and the written directive;
(3) Checking both manual and computer-generated dose calculations; and
(4) Verifying that any computer-generated dose calculations are correctly transferred into the consoles of therapeutic medical units authorized by §§ 35.600 or 35.1000.
(c) A licensee shall retain a copy of the procedures required under paragraph (a) in accordance with § 35.2041.

Code of Federal Regulations

[67 FR 20370, Apr. 24, 2002, as amended at 72 FR 45151, Aug. 13, 2007]