OAR 333-102-0250
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License

An application for a specific license to manufacture or distribute radioactive material for use under the general license specified in OAR 333-102-0130 (General Licenses — Radioactive Material Other than Source Material: General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing) or equivalent may be approved if:

(1)

The applicant satisfies the general requirements specified in OAR 333-102-0200 (General Licenses — Radioactive Material Other than Source Material: General Requirements for the Issuance of Specific Licenses).

(2)

The radioactive material is to be prepared for distribution in prepackaged units of:

(a)

Carbon-14 in units not exceeding ten microcuries (370 kBq) each;

(b)

Cobalt-57 in units not exceeding ten microcuries (370 kBq) each;

(c)

Hydrogen-3 (tritium) in units not exceeding 50 microcuries (1.85 MBq) each;

(d)

Iodine-125 in units not exceeding ten microcuries (370 kBq) each;

(e)

Mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each;

(f)

Iodine-131 in units not exceeding ten microcuries (370 kBq) each;

(g)

Iron-59 in units not exceeding 20 microcuries (740 kBq) each;

(h)

Selenium-75 in units not exceeding ten microcuries (370 kBq) each;

(i)

Cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries) each.

(3)

Each prepackaged unit bears a durable, clearly visible label:

(a)

Identifying the radioactive contents as to chemical form and radionuclide and indicating that the amount of radioactivity does not exceed ten microcuries (370 kBq) of iodine-125, iodine-131, carbon-14, cobalt-57 or selenium-75; 50 microcuries (1.85 MBq) of hydrogen-3 (tritium); 20 microcuries (740 kBq) of iron-59; or mock iodine-125 in units not exceeding 0.05 microcurie (1.85 kBq) of iodine-129 and 0.005 microcurie (185 Bq) of americium-241 each or colbalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries); and

(b)

Displaying the radiation caution symbol described in OAR 333-120-0400 (Precautionary Procedures: Caution Signs) and the words, CAUTION, RADIOACTIVE MATERIAL and Not for Internal or External Use in Humans or Animals.

(4)

One of the following statements, as appropriate, or a substantially similar statement which contains the information called for in one of the following statements, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package:

(a)

This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation there from, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of the U.S. Nuclear Regulatory Commission or of a state with which the Commission has entered into an agreement for the exercise of regulatory authority.
____________________________
Name of manufacturer

(b)

This radioactive material may be received, acquired, possessed and used only by physicians, veterinarians, clinical laboratories or hospitals and only for in vitro clinical or laboratory tests not involving internal or external administration of the material, or the radiation there from, to human beings or animals. Its receipt, acquisition, possession, use and transfer are subject to the regulations and a general license of a Licensing State.
________________________
Name of manufacturer

(5)

The label affixed to the unit, or the leaflet or brochure which accompanies the package, contains adequate information as to the precautions to be observed in handling and storing such radioactive material. In the case of the mock iodine-125 reference or calibration source, the information accompanying the source must also contain directions to the licensee regarding the waste disposal requirements in OAR 333-120-0500 (Waste Disposal: General Requirements).

Source: Rule 333-102-0250 — Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License, https://secure.­sos.­state.­or.­us/oard/view.­action?ruleNumber=333-102-0250.

333‑102‑0001
Purpose and Scope 333‑102‑0005
Exemptions: Unimportant Quantities of Source Material 333‑102‑0010
Exemptions — Radioactive Material Other than Source Material: Exempt Concentrations 333‑102‑0015
Exemptions: Certain Items Containing Radioactive Material 333‑102‑0025
Exemptions: Gas and Aerosol Detectors Containing Byproduct Material 333‑102‑0030
Exemptions: Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 333‑102‑0032
Exemptions: Self Luminous Products and Sources Containing Radium-226 333‑102‑0033
Exemptions: Certain Industrial Devices 333‑102‑0035
Exemptions: Exempt Quantities 333‑102‑0040
Exemptions: In Vivo Testing in Humans for H. Pylori Using Carbon-14 Labeled Urea 333‑102‑0075
Licenses: Types of Licenses 333‑102‑0101
General Licenses — Small Quantities of Source Material 333‑102‑0102
General Licenses — Requirements for License to Initially Transfer Source Material for Use Under the Small Quantities of Source Materials General License 333‑102‑0104
General Licenses — Conditions of Licenses to Initially Transfer Source Material for Use Under the ’Small Quantities of Source Material’ General License: Quality Control, Labeling, Safety Instructions, and Records and Reports 333‑102‑0106
General Licenses — Depleted Uranium in Industrial Products and Devices 333‑102‑0110
General Licenses — Radioactive Material Other than Source Material: Luminous Safety Devices for Aircraft 333‑102‑0115
General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices 333‑102‑0120
General Licenses — Radioactive Material Other than Source Material: Ownership of Radioactive Material 333‑102‑0125
General Licenses — Radioactive Material Other than Source Material: Calibration and Reference Sources 333‑102‑0130
General Licenses — Radioactive Material Other than Source Material: General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing 333‑102‑0135
General Licenses — Radioactive Material Other than Source Material: Ice Detection Devices 333‑102‑0190
General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses 333‑102‑0200
General Licenses — Radioactive Material Other than Source Material: General Requirements for the Issuance of Specific Licenses 333‑102‑0203
General Licenses — Radioactive Material Other than Source Material: Definitions 333‑102‑0235
General Licenses — Radioactive Material Other than Source Material: Requirements for License to Manufacture, or Initially Transfer Radioactive Material Contained in Devices Granted a General License Under OAR 333-102-0115 333‑102‑0245
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Introduction of Radioactive Material in Exempt Concentrations into Products or Materials, and Transfer of Ownership or Possession: Requirements for License 333‑102‑0247
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records and Material Transfer Reports 333‑102‑0250
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under a General License 333‑102‑0255
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Distribution of Radioactive Material in Exempt Quantities 333‑102‑0260
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Incorporation of Naturally Occurring and Accelerator-Produced Radioactive Material into Gas and Aerosol Detectors 333‑102‑0265
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Requirements for the Manufacture, Assembly or Repair of Luminous Safety Devices for Use in Aircraft 333‑102‑0270
Special Requirements for License to Manufacture Calibration Sources Containing Americium-241, Plutonium or Radium-226 for Distribution to Persons Granted a General License by OAR 333-102-0125 333‑102‑0275
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Licensing the Manufacture and Distribution of Ice Detection Devices 333‑102‑0285
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture, Preparation, or Transfer for Commercial Distribution of Radiopharmaceutical Drugs Containing Byproduct Material for Medical Use Under Division 116 333‑102‑0290
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Manufacture and Distribution of Sources or Devices Containing Byproduct Material for Medical Use 333‑102‑0293
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-Volume Applications 333‑102‑0297
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Sealed Source or Device Evaluation 333‑102‑0300
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Issuance of Specific Licenses 333‑102‑0305
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specific Terms and Conditions of License 333‑102‑0310
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas 333‑102‑0315
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Application for Renewal of Licenses 333‑102‑0320
Amendment of Licenses at Request of Licensee 333‑102‑0325
Authority Action on Applications to Renew and Amend 333‑102‑0327
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Specifically Licensed Items — Registration of Product Information 333‑102‑0330
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Transfer of Material 333‑102‑0335
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Modification, Revocation and Termination of Licenses 333‑102‑0340
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reciprocal Recognition of Licenses 333‑102‑0345
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Procedures in Regulatory Review 333‑102‑0350
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reporting Requirements 333‑102‑0355
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records 333‑102‑0360
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Right to Cause the Withholding or Recall of Byproduct Material 333‑102‑0365
Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Third Party Method 333‑102‑0900
Transport: Special Requirements for Specific Licenses of Broad Scope 333‑102‑0910
Transport: Specific Terms and Conditions for Broad Licenses
Last Updated

Jun. 8, 2021

Rule 333-102-0250’s source at or​.us