10 C.F.R. § 35.13   License amendments.


Title 10 - Energy


Title 10: Energy
PART 35—MEDICAL USE OF BYPRODUCT MATERIAL
Subpart A—General Information

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§ 35.13   License amendments.

A licensee shall apply for and must receive a license amendment—

(a) Before it receives, prepares, or uses byproduct material for a type of use that is permitted under this part, but that is not authorized on the licensee's current license issued under this part;

(b) Before it permits anyone to work as an authorized user, authorized nuclear pharmacist, or authorized medical physicist under the license, except—

(1) For an authorized user, an individual who meets the requirements in §§35.59 and 35.190(a), 35.290(a), 35.390(a), 35.392(a), 35.394(a), 35.490(a), 35.590(a), and 35.690(a);

(2) For an authorized nuclear pharmacist, an individual who meets the requirements in §§35.55(a) and 35.59;

(3) For an authorized medical physicist, an individual who meets the requirements in §§35.51(a) and (c) and 35.59;

(4) An individual who is identified as an authorized user, an authorized nuclear pharmacist, or authorized medical physicist—

(i) On a Commission or Agreement State license or other equivalent permit or license recognized by NRC that authorizes the use of byproduct material in medical use or in the practice of nuclear pharmacy;

(ii) On a permit issued by a Commission or Agreement State specific license of broad scope that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy;

(iii) On a permit issued by a Commission master material licensee that is authorized to permit the use of byproduct material in medical use or in the practice of nuclear pharmacy; or

(iv) By a commercial nuclear pharmacy that has been authorized to identify authorized nuclear pharmacists.

(c) Before it changes Radiation Safety Officers, except as provided in §35.24(c);

(d) Before it receives byproduct material in excess of the amount or in a different form, or receives a different radionuclide than is authorized on the license;

(e) Before it adds to or changes the areas of use identified in the application or on the license, except for areas of use where byproduct material is used only in accordance with either §35.100 or §35.200;

(f) Before it changes the address(es) of use identified in the application or on the license; and

(g) Before it revises procedures required by §§35.610, 35.642, 35.643, and 35.645, as applicable, where such revision reduces radiation safety.

[67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002, as amended at 70 FR 16361, Mar. 30, 2005; 71 FR 15008, Mar. 27, 2006]

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