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PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR TRANSFER CERTAIN
ITEMS CONTAINING BYPRODUCT MATERIAL
PART 32--SPECIFIC DOMESTIC LICENSES TO MANUFACTURE OR
TRANSFER CERTAIN ITEMS CONTAINING BYPRODUCT MATERIAL
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Sec.
32.1 Purpose and scope.
32.2 Definitions.
32.3 Maintenance of records.
32.8 Information collection requirements: OMB approval.
Subpart A--Exempt Concentrations and Items
32.11 Introduction of byproduct material in exempt concentrations into products or materials, and transfer of ownership or
possession: Requirements for license.
32.12 Same: Records and material transfer reports.
32.13 Same: Prohibition of introduction.
32.14 Certain items containing byproduct material; requirements for license to apply or initially transfer.
32.15 Same: Quality assurance, prohibition of transfer, and labeling.
32.16 Certain items containing byproduct material: Records and reports of transfer.
32.17 [Removed].
32.18 Manufacture, distribution and transfer of exempt quantities of byproduct material: Requirements for license.
32.19 Same: Conditions of licenses.
32.20 Same: Records and material transfer reports.
32.21 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.
32.21a Same: Conditions of license.
32.22 Self-luminous products containing tritium, krypton-85 or promethium-147: Requirements for license to manufacture,
process, produce, or initially transfer.
32.23 Same: Safety criteria.
32.24 Same: Table of organ doses.
32.25 Conditions of licenses issued under § 32.22:
Quality control, labeling, and reports of transfer.
32.26 Gas and aerosol detectors containing byproduct material: Requirements for license to manufacture, process, produce,
or initially transfer.
32.27 Same: Safety criteria.
32.28 Same: Table of organ doses.
32.29 Conditions of licenses issued under § 32.26:
Quality control, labeling, and reports of transfer.
32.40 [Removed].
Subpart B--Generally Licensed Items
32.51 Byproduct material contained in devices for
use under § 31.5; requirements for license to manufacture or initially
transfer.
32.51a Same: Conditions of licenses.
32.52 Same: Material transfer reports and records.
32.53 Luminous safety devices for use in aircraft: Requirements for license to manufacture, assemble, repair or initially
transfer.
32.54 Same: Labeling of devices.
32.55 Same: Quality assurance; prohibition of transfer.
32.56 Same: Material transfer reports.
32.57 Calibration or reference sources containing americium-241 or radium-226: Requirements for license to manufacture or initially
transfer.
32.58 Same: Labeling of devices.
32.59 Same: Leak testing of each source.
32.60 [Reserved]
32.61 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer.
32.62 Same: Quality assurance; prohibition of transfer.
32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general
license.
32.72 Manufacture, preparation, or transfer for commercial distribution of radioactive drugs containing byproduct material
for medical use under part 35.
32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use.
32.101 Schedule B--prototype tests for luminous safety devices for use in aircraft.
32.102 Schedule C—prototype tests for calibration or reference sources containing americium-241 or radium-226.
32.103 Schedule D--prototype tests for ice detection devices containing strontium 90.
Subpart C--Quality Control Sampling Procedures
32.110 Acceptance sampling procedures under certain specific licenses.
Subpart D--Specifically Licensed Items
32.201 Serialization of nationally tracked sources.
32.210 Registration of product information.
Subpart E--Violations
32.301 Violations.
32.303 Criminal penalties.
Authority: Secs. 81, 161, 182, 183, 68 Stat.
935, 948, 953, 954, as amended (42 U.S.C.
2111, 2201, 2232, 2233); sec. 201, 88 Stat.
1242, as amended (42 U.S.C. 5841); sec. 1704,
112 Stat. 2750 (44 U.S.C. 3504 note); sec.
651(e), Pub. L. 109–58, 119 Stat. 806–810 (42
U.S.C. 2014, 2021, 2021b, 2111).
Source: 30 FR 8192, June 26, 1965, unless otherwise
noted.
[72 FR 55928, Oct. 1, 2007; 72 FR 58488, Oct. 16, 2007]
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