(A) A person licensed under rule 3701:1-46-33 of the Administrative Code to manufacture, assemble, or initially transfer devices containing tritium or promethium-147 for distribution to persons generally licensed under rule 3701:1-46-07 of the Administrative Code shall, except as provided in paragraph (B) of this rule, affix to each device a label containing the radiation symbol prescribed by rule 3701:1-38-18 of the Administrative Code, such other information as may be required by the director including disposal instructions when appropriate, and the following or a substantially similar statement which contains the information called for in the following statement:
(1) Devices licensed by the United States nuclear regulatory commission prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.
(2) The receipt, possession, use, and transfer of this device, model _______, serial no. ___, containing ______ (identity and quantity of radioactive material) are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or of a state with which the United States nuclear regulatory commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label.
(Name of manufacturer, assembler, or initial transferor.) The model, serial number, and name of manufacturer, assembler, or initial transferor may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.
(B) If the director determines that it is not feasible to affix a label to the device containing all the information called for in paragraph (A) of this rule, the director may waive the requirements of that paragraph and require in lieu thereof that:
(1) A label be affixed to the device identifying:
(a) The manufacturer, assembler, or initial transferor; and
(b) The type of radioactive material; and
(2) A leaflet bearing the following information be enclosed in or accompany the container in which the device is shipped:
(a) The name of the manufacturer, assembler, or initial transferor,
(b) The type and quantity of radioactive material,
(c) The model number,
(d) A statement that the receipt, possession, use, and transfer of the device are subject to a general license or the equivalent and the regulations of the United States nuclear regulatory commission or of an agreement state, and
(e) Such other information as may be required by the director, including disposal instructions when appropriate.