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Oregon Administrative Rules

Division 102

Or. Admin. R. ch. 333, div. 102

Licensing of Radioactive Material

Oregon Health Authority

0001Purpose and Scope 0005Exemptions: Unimportant Quantities of Source Material 0010Exemptions — Radioactive Material Other than Source Material: Exempt Concentrations 0015Exemptions: Certain Items Containing Radioactive Material 0025Exemptions: Gas and Aerosol Detectors Containing Byproduct Material 0030Exemptions: Self-Luminous Products Containing Tritium, Krypton-85, or Promethium-147 0032Exemptions: Self Luminous Products and Sources Containing Radium-226 0033Exemptions: Certain Industrial Devices 0035Exemptions: Exempt Quantities 0040Exemptions: In Vivo Testing in Humans for H. Pylori Using Carbon-14 Labeled Urea 0075Licenses: Types of Licenses 0101General Licenses — Small Quantities of Source Material 0102General Licenses — Requirements for License to Initially Transfer Source Material for Use Under the Small Quantities of Source Materials General License 0104General 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 0106General Licenses — Depleted Uranium in Industrial Products and Devices 0110General Licenses — Radioactive Material Other than Source Material: Luminous Safety Devices for Aircraft 0115General Licenses — Radioactive Material Other than Source Material: Certain Measuring, Gauging and Controlling Devices 0120General Licenses — Radioactive Material Other than Source Material: Ownership of Radioactive Material 0125General Licenses — Radioactive Material Other than Source Material: Calibration and Reference Sources 0130General Licenses — Radioactive Material Other than Source Material: General License for Use of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing 0135General Licenses — Radioactive Material Other than Source Material: Ice Detection Devices 0190General Licenses — Radioactive Material Other than Source Material: Application for Specific Licenses 0200General Licenses — Radioactive Material Other than Source Material: General Requirements for the Issuance of Specific Licenses 0203General Licenses — Radioactive Material Other than Source Material: Definitions 0235General 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 0245Special 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 0247Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records and Material Transfer Reports 0250Special 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 0255Special 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 0260Special 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 0265Special 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 0270Special 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 0275Special 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 0285Special 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 0290Special 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 0293Special 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 0297Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Sealed Source or Device Evaluation 0300Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Issuance of Specific Licenses 0305Specific Terms and Conditions of License 0310Expiration and Termination of Licenses and Decommissioning of Sites and Separate Buildings or Outdoor Areas 0315Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Application for Renewal of Licenses 0320Amendment of Licenses at Request of Licensee 0325Authority Action on Applications to Renew and Amend 0327Special 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 0330Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Transfer of Material 0335Special 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 0340Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reciprocal Recognition of Licenses 0345Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Special Procedures in Regulatory Review 0350Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Reporting Requirements 0355Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Records 0360Special 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 0365Special Requirement for a Specific License to Manufacture, Assemble, Repair or Distribute Commodities, Products or Devices Which Contain Radioactive Material: Third Party Method 0900Transport: Special Requirements for Specific Licenses of Broad Scope 0910Transport: Specific Terms and Conditions for Broad Licenses