Source: https://kanterella.com/wiki/10_CFR_32.72
Timestamp: 2020-01-28 03:19:06
Document Index: 245298325

Matched Legal Cases: ['§ 32', 'art 35', 'art 32', 'ART 32', '§ 32', '§ 32', '§ 32']

10 CFR 32.72 - kanterella
10 CFR 32.72
Specifically Licensed Items ===§ 32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material for medical use under part 35===
(i) A label is affixed to each transport radiation shield, whether it is constructed of lead, glass, plastic, or other material, of a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL"; the name of the radioactive drug or its abbreviation; and the quantity of radioactivity at a specified date and time. For radioactive drugs with a half life greater than 100 days, the time may be omitted.
(ii) A label is affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.
(1) May prepare radioactive drugs for medical use, as defined in 10 CFR 35.2, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in paragraph (b)(2) and (b)(4) of this section, or an individual under the supervision of an authorized nuclear pharmacist as specified in 10 CFR 35.27.
; 59 FR 65244, Dec. 19, 1994, as amended at 60 FR 324, Jan. 4, 1995; 67 FR 20370, Apr. 24, 2002; 67 FR 62872, Oct. 9, 2002; 67 FR 77652, Dec. 19, 2002; 71 FR 15007, Mar. 27, 2006; 72 FR 45150, Aug. 13, 2007; 72 FR 55929 Oct. 1, 2007; 77 FR 43695, Jul. 25, 2012]
NRC website 10 CFR 32.72
Title 10 Part 32 - PART 32-SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
1, Purpose and scope
3, Maintenance of records
11, Exempt Concentrations and Items
12, Same: Records and material transfer reports
13, Same: Prohibition of introduction
14, Certain items containing byproduct material; requirements for license to apply or initially transfer
15, Same: Quality assurance, prohibition of transfer, and labeling
16, Certain items containing byproduct material: Records and reports of transfer
18, Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license
19, Same: Conditions of licenses
20, Same: Records and material transfer reports
21, Radioactive drug: Manufacture, preparation, or transfer for commercial distribution of capsules containing carbon-14 urea each for "in vivo" diagnostic use for humans to persons exempt from licensing; Requirements for a license
22, Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture, process, produce, or initially transfer
23, Same: Safety criteria
24, Same: Table of organ doses
25, Conditions of licenses issued under § 32.22: Quality control, labeling, and reports of transfer
26, Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer
27, Same: Safety criteria
28, Same: Table of organ doses
29, Conditions of licenses issued under § 32.26: Quality control, labeling, and reports of transfer
30, Certain industrial devices containing byproduct material: Requirements for license to manufacture, process, produce, or initially transfer
31, Certain industrial devices containing byproduct material: Safety criteria
32, Conditions of licenses issued under § 32.30: Quality control, labeling, and reports of transfer
51, Generally Licensed Items
52, Same: Material transfer reports and records
53, Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially transfer
54, Same: Labeling of devices
55, Same: Quality assurance; prohibition of transfer
56, Same: Material transfer reports
57, Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially transfer
58, Same: Labeling of devices
59, Same: Leak testing of each source
61, Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer
62, Same: Quality assurance; prohibition of transfer
71, Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license
72, Specifically Licensed Items
74, Manufacture and distribution of sources or devices containing byproduct material for medical use
201, Serialization of nationally tracked sources
210, Sealed Source and Device Registration
301, Violations
303, Criminal penalties
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This page was last edited on 13 August 2014, at 00:02.