Special Requirements for a Specific License to Manufacture, Assemble, Repair, or Distribute

Commodities, Products, or Devices Which Contain Radioactive Material (A) Licensing Requirements to Produce for Noncommercial Transfer Positron Emission Tomography (PET) Radioactive Drugs. An application from a medical facility, educational institution, or Federal facility to produce Positron Emission Tomography (PET) radioactive drugs for noncommercial transfer to licensees in its consortium authorized for medical use under 105 CMR 120.500, or equivalent Nuclear Regulatory Commission, or Agreement State requirements shall include: (1) A request for authorization for the production of PET radionuclides or evidence of an existing license issued under 105 CMR 120.100 or equivalent Nuclear Regulatory Commission, or Agreement State requirements for a PET radionuclide production facility within its consortium from which it receives PET radionuclides. (2) Evidence that the applicant is qualified to produce radioactive drugs for medical use by meeting one of the criteria in 105 CMR 120.128(J)(1)(b). (3) Identification of individual(s) authorized to prepare the PET radioactive drugs if the applicant is a pharmacy, and documentation that each individual meets the requirements of an authorized nuclear pharmacist as specified in 105 CMR 120.128(J)(2)(b). (4) Information identified in 105 CMR 120.128(J)(1)(c) on the PET drugs to be noncommercially transferred to members of its consortium. (B) Licensing Requirements to Initially Transfer Source Material to Persons Generally Licensed under 105 CMR 120.121(A). (1) An application for a specific license to initially transfer source material for use under 105 CMR 120.121(A), or equivalent regulations of the NRC or an Agreement State, will be approved if: (a) The applicant satisfies the general requirements specified in 105 CMR 120.125; and (b) The applicant submits adequate information on, and the Agency approves the methods to be used for quality control, labeling, and providing safety instructions to recipients. (2) Each person licensed under 105 CMR 120.128(B) shall label the immediate container of each quantity of source material with the type of source material and quantity of material and the words, “‘radioactive material”. (3) Each person licensed under 105 CMR 120.128(B) shall ensure that the quantities and concentrations of source material are as labeled and indicated in any transfer records. (4) Each person licensed under 105 CMR 120.128(B) shall provide the information specified in 105 CMR 120.128(B)(4) to each person to whom source material is transferred for use under 105 CMR 120.121(A) or equivalent provisions in the NRC or Agreement State regulations. This information must be transferred before the source material is transferred for the first time in each calendar year to the particular recipient. The required information includes: (a) A copy of 105 CMR 120.121(A) through (C), (F), and (G) and 105 CMR 120.140, or relevant equivalent regulations of the NRC or Agreement State. (b) Appropriate radiation safety precautions and instructions relating to handling, use, storage, and disposal of the material. (5) Each person licensed under 105 CMR 120.128(B) shall report transfers as follows: (a) File a report with the Agency by an appropriate method listed in 105 CMR 120.013. The report shall include the following information: 1. The name, address, and license number of the person who transferred the source material; 2. For each general licensee under 105 CMR 120.121(A) or equivalent NRC or Agreement State provisions to whom greater than 50 grams (0.11 lb) of source material has been transferred in a single calendar quarter, the name and address of the general licensee to whom source material is distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred; and 3. The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients. (b) File a report with each responsible NRC or Agreement State agency that identifies all persons, operating under provisions equivalent to 105 CMR 120.121(A), to whom greater than 50 grams (0.11 lb) of source material has been transferred within a single calendar quarter. The report shall include the following information specific to those transfers made to the NRC or Agreement State being reported to: 1. The name, address, and license number of the person who transferred the source material; and 2. The name and address of the general licensee to whom source material was distributed; a responsible agent, by name and/or position and phone number, of the general licensee to whom the material was sent; and the type, physical form, and quantity of source material transferred. 3. The total quantity of each type and physical form of source material transferred in the reporting period to all such generally licensed recipients within the NRC's jurisdiction or the Agreement State. (c) Submit each report by January 31 of each year covering all transfers for the st previous calendar year. If no transfers were made to persons generally licensed under 105 CMR 120.121(A) or equivalent NRC or Agreement State provisions during the current period, a report shall be submitted to the Agency indicating so. If no transfers have been made to general licensees within a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon request of that agency. If no transfers have been made to NRC general licensees during the reporting period, this information shall be reported to the NRC. (6) Each person licensed under 105 CMR 120.128(B) shall maintain all information that supports the reports required by this section concerning each transfer to a general licensee for a period of one year after the event is included in a report to the NRC or to an Agreement State agency. (C) Requirements for Other Specific Licenses (Reserved). (D) Licensing Requirements to Manufacture or Initially Transfer Devices Containing Radioactive Material to Persons Generally Licensed under 105 CMR 120.122(D). (1) An application for a specific license to manufacture or distribute devices containing radioactive material, excluding special nuclear material, to persons generally licensed under 105 CMR 120.122(D) or equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State will be approved if: (a) the applicant satisfies the general requirements of 105 CMR 120.125; (b) the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control, labels, proposed uses, installation, servicing, leak testing, operating and safety instructions, and potential hazards of the device to provide reasonable assurance that: 1. the device can be safely operated by persons not having training in radiological protection; 2. under ordinary conditions of handling, storage, and use of the device, the radioactive material contained in the device will not be released or inadvertently removed from the device, and it is unlikely that any person will receive in one year a dose in excess of 10% of the annual limits specified in 105 CMR 120.211(A), and 3. under accident conditions such as fire and explosion associated with handling, storage, and use of the device, it is unlikely that any person would receive an external radiation dose or dose commitment in excess of the following organ doses: a. Whole body; head and trunk; active blood-forming organs; gonads; or lens of eye . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 rems (150 mSv) b. Hands and forearms; feet and ankles; localized areas of skin averaged over areas no larger than one square centimeter . . . . . . . . . . . . . . . 200 rems (2 Sv) c. Other organs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 rems (500 mSv); and (c) each device bears a durable, legible, clearly visible label or labels approved by the Agency, which contain in a clearly identified and separate statement: 1. instructions and precautions necessary to assure safe installation, operation, and servicing of the device; documents such as operating and service manuals may be identified in the label and used to provide this information; 2. the requirement, or lack of requirement, for leak testing, or for testing any "on-off" mechanism and indicator, including the maximum time interval for such testing, and the identification of radioactive material by isotope, quantity of radioactivity, and date of determination of the quantity; and 3. the information called for in one of the following statements, as appropriate, in the same or substantially similar form: The receipt, possession, use, and transfer of this device, Model , Serial No. , are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. This label shall be maintained on the device in a legible condition. Removal of this label is prohibited. [The model, serial number, and name of the manufacturer or distributor may be omitted from the label provided the information is elsewhere specified in labeling affixed to the device.] CAUTION - RADIOACTIVE MATERIAL Name of Manufacturer or Distributor [Note: Devices licensed under 10 CFR 32.53 prior to January 19, 1975 may bear labels authorized by the regulations in effect on January 1, 1975.] (d) each device having a separable source housing that provides the primary shielding for the source also bears, on the source housing, a durable label containing the device model number and serial number, the isotope and quantity, the words, “Caution-Radioactive Material”, the radiation symbol described in 105 CMR 120.237, and the name of the manufacturer or initial distributor. (e) each device meeting the criteria of 105 CMR 120 122(D)(3)(m)1., bears a permanent (e.g., embossed, etched, stamped, or engraved) label affixed to the source housing if separable, or the device if the source housing is not separable, that includes the words, “Caution-Radioactive Material”, and, if practicable, the radiation symbol described in 105 CMR 120.237. (f) the device has been registered in the Sealed Source and Device Registry. (2) In the event the applicant desires that the device be required to be tested at intervals longer than six months, either for proper operation of the "on-off" mechanism and indicator, if any, or for leakage of radioactive material or for both, the applicant shall include in the application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the device or similar devices and by design features which have a significant bearing on the probability or consequences of leakage of radioactive material from the device or failure of the "on-off" mechanism and indicator. In determining the acceptable interval for the test for leakage of radioactive material, the Agency will consider information which includes, but is not limited to: (a) primary containment or source capsule; (b) protection of primary containment; (c) method of sealing containment; (d) containment construction materials; (e) form of contained radioactive material; (f) maximum temperature withstood during prototype tests; (g) maximum pressure withstood during prototype tests; (h) maximum quantity of contained radioactive material; (i) radiotoxicity of contained radioactive material; and (j) operating experience with identical devices or similarly designed and constructed devices. (3) In the event the applicant desires that the general licensee under 105 CMR 120.122(D), or under equivalent regulations of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State be authorized to install the device, collect the sample to be analyzed by a specific licensee for leakage of radioactive material, service the device, test the "on-off" mechanism and indicator, or remove the device from installation, the applicant shall include in the application written instructions to be followed by the general licensee, estimated calendar quarter doses associated with such activity or activities, and basis for such estimates. The submitted information shall demonstrate that performance of such activity or activities by an individual untrained in radiological protection, in addition to other handling, storage, and use of devices under the general license, is unlikely to cause that individual to receive a dose in excess of 10% of the annual limits specified in 105 CMR 120.211(A). (4) Each person licensed under 105 CMR 120.128(D) to initially transfer devices to generally licensed persons shall: (a) if a device containing radioactive material is to be transferred for use under the general license contained in 105 CMR 120.122(D), each person that is licensed under 105 CMR 120.128(D) shall provide the information specified in 120.128(D)(4) to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes: 1. a copy of the general license contained in 105 CMR 120.122(D); if 105 CMR 120.122(D)(3)(b) through (d) do not apply to the particular device, those paragraphs may be omitted; 2. a copy of 105 CMR 120.122, 120.009(A), 120.281, and 120.282; 3. a list of the services that can only be performed by a specific licensee; and, 4. information on acceptable disposal options including estimated costs of disposal; (b) if radioactive material is to be transferred in a device for use under an equivalent general license of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State each person that is licensed under 105 CMR 120.128(D) shall provide the information specified in 105 CMR 120.128(D)(4)(b) to each person to whom a device is to be transferred. This information must be provided before the device may be transferred. In the case of a transfer through an intermediate person, the information must also be provided to the intended user prior to initial transfer to the intermediate person. The required information includes: 1. a copy of NRC or Agreement State regulations equivalent to 105 CMR 120.122(D), 120.009(A), 120.281, and 120.282. If a copy of the 105 CMR 120.000 is provided to a prospective general licensee in lieu of the U.S. Nuclear Regulatory Commission*s, Agreement State*s, or Licensing State*s regulations, it shall be accompanied by a note explaining that use of the device is regulated by the U.S. Nuclear Regulatory Commission, the Agreement State; or Licensing State; if certain paragraphs of the regulations do not apply to the particular device, those paragraphs may be omitted; 2. a list of the services that can only be performed by a specific licensee; 3. information on acceptable disposal options including estimated costs of disposal; and, 4 the name or title, address, and phone number of the contact at the U.S. Nuclear Regulatory Commission, the Agreement State, or Licensing State from which additional information may be obtained; (c) an alternative approach to informing customers may be proposed by the licensee for approval by the Agency; (d) each device that is transferred after February 19, 2002 must meet the labeling requirements in 105 CMR 120.128(D)(1)(c) through (e); (e) if a notification of bankruptcy has been made under 105 CMR 120.131(E) or the license is to be terminated, each person licensed under 105 CMR 120.128(D) shall provide, upon request, to the Agency and to any appropriate Agreement State or NRC, records of final disposition required under 105 CMR 120.128(D)(5)(c). (5) Each person licensed under 105 CMR 120.128(D) to initially transfer devices to generally licensed persons shall comply with the requirements of 105 CMR 120.128(D)(5). (a) The person shall report to the Agency all transfers of devices to persons for use under the general license in 105 CMR 120.122(D) and all receipts of devices from persons licensed under 105 CMR 120.122(D). The report must be submitted on a quarterly basis on NRC Form 653 - “Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form. 1. The required information for transfers to general licensees includes: a. the identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use; b. the name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; c. the date of transfer; d. the type, model number, and serial number of the device transferred; and e. the quantity and type of byproduct material contained in the device. 2. If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). 3. For devices received from a 105 CMR 120.122(D) general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. 4. If the licensee makes changes to a device possessed by a 105 CMR 120.122(D) general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to informa- tion on the device label. 5. The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. 6. The report must clearly identify the specific licensee submitting the report and include the license number of the specific licensee. 7. If no transfers have been made to U.S. Nuclear Regulatory Commission Licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission. 8. If no transfers have been made to general licensees within a particular State during the reporting period, this information shall be reported to the responsible State agency upon request of that agency. (b) The person shall report all transfers of devices to persons for use under a general license in the U.S. Nuclear Regulatory Commission*s, an Agreement State*s, or a Licensing State*s regulations that are equivalent to 105 CMR 120.122(D) and all receipts of devices from general licensees in the U.S. Nuclear Regulatory Commission’s, an Agreement State*s, or a Licensing State*s jurisdiction to the responsible agency. The report must be submitted on Form 653 - “Transfers of Industrial Devices Report” or in a clear and legible report containing all of the data required by the form. 1. The required information for transfers to general licensees includes: a. the identity of each general licensee by name and mailing address for the location of use; if there is no mailing address for the location of use, an alternate address for the general licensee shall be submitted along with information on the actual location of use; b. the name, title, and phone number of the person identified by the general licensee as having knowledge of and authority to take required actions to ensure compliance with the appropriate regulations and requirements; c. the date of transfer; d. the type, model number, and serial number of the device transferred; and e. the quantity and type of byproduct material contained in the device. 2. If one or more intermediate persons will temporarily possess the device at the intended place of use before its possession by the user, the report must include the same information for both the intended user and each intermediate person, and clearly designate the intermediate person(s). 3. For devices received from a general licensee, the report must include the identity of the general licensee by name and address, the type, model number, and serial number of the device received, the date of receipt, and, in the case of devices not initially transferred by the reporting licensee, the name of the manufacturer or initial transferor. 4. If the licensee makes changes to a device possessed by a general licensee, such that the label must be changed to update required information, the report must identify the general licensee, the device, and the changes to information on the device label. 5. The report must cover each calendar quarter, must be filed within 30 days of the end of the calendar quarter, and must clearly indicate the period covered by the report. 6. The report must clearly identify the specific licensee submitting the report and must include the license number of the specific licensee. 7. If no transfers have been made to U.S. Nuclear Regulatory Commission Licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission. 8. If no transfers have been made to general licensees within a particular State during the reporting period, this information shall be reported to the responsible State agency upon request of that agency. (c) The person shall maintain all information concerning transfers and receipts of devices that supports the reports required by 105 CMR 120.128(D)(5). Records required by 105 CMR 120.128(D)(5)(c) must be maintained for a period of three years following the date of the recorded event. (E) Special Requirements for the Manufacture, Assembly, or Repair of Luminous Safety Devices for Use in Aircraft. An application for a specific license to manufacture, assemble, or repair luminous safety devices containing tritium or promethium-147 for use in aircraft, for distribution to persons generally licensed under 105 CMR 120.122(B) will be approved if: (1) the applicant satisfies the general requirements specified in 105 CMR 120.125; and (2) the applicant satisfies the requirements of 10 CFR Part 32 §§ 32.53 through 32.56. (F) Special Requirements for License to Manufacture or Initially Transfer Calibration or Reference Sources Containing Americium-241, or Radium-226 for Distribution to Persons Generally Licensed under 105 CMR 120.122(G). An application for a specific license to manufacture or initially transfer calibration or reference sources containing americium-241, or radium-226, for distribution to persons generally licensed under 105 CMR 120.122(G), will be approved if: (1) the applicant satisfies the general requirement of 105 CMR 120.125; and (2) The applicant submits sufficient information regarding each type of calibration or reference source pertinent to evaluation of the potential radiation exposure, including: (a) Chemical and physical form and maximum quantity of americium-241 or radium-226 in the source; (b) Details of construction and design; (c) Details of the method of incorporation and binding of the americium-241 or radium-226 in the source; (d) Procedures for and results of prototype testing of sources, which are designed to contain more than 0.005 microcurie of americium-241 or radium-226, to demonstrate that the americium-241 or radium-226 contained in each source will not be released or be removed from the source under normal conditions of use; (e) Details of quality control procedures to be followed in manufacture of the source; (f) Description of labeling to be affixed to the source or the storage container for the source; (g) Any additional information, including experimental studies and tests, required by the Commission to facilitate a determination of the safety of the source. (3) Each source will contain no more than 5 microcuries of americium-241 or radium-226. (4) The Agency determines, with respect to any type of source containing more than 0.005 microcurie of americium-241 or radium-226, that: (a) The method of incorporation and binding of the americium-241 or radium-226 in the source is such that the americium-241 will not be released or be removed from the source under normal conditions of use and handling of the source; and (b) The source has been subjected to and has satisfactorily passed the prototype tests prescribed by 10 CFR 32.57(e). (5) Each person licensed under 105 CMR 120.128(F) shall affix to each source, or storage container for the source, a label which shall contain sufficient information relative to safe use and storage of the source and shall include the following statement or a substantially similar statement which contains the information called for in the following statement: The receipt, possession, use, and transfer of this source, Model ______, Serial No. _______, are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or a State with which the U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Do not remove this label. CAUTION - RADIOACTIVE MATERIAL-THIS SOURCE CONTAINS AMERICIUM-241 (OR RADIUM-226). DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE. ___________________________________ Name of manufacturer or initial transferor (6) Each person licensed under 105 CMR 120.128(F) shall perform a dry wipe test upon each source containing more than 3.7 kilobecquerels (0.1 microcurie) of americium-241 or radium-226 before transferring the source to a general licensee under 105 CMR 120.122(G) or under equivalent regulations of NRC or an Agreement State. This test shall be performed by wiping the entire radioactive surface of the source with a filter paper with the application of moderate finger pressure. The radioactivity on the filter paper shall be measured using methods capable of detecting 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226. If a source has been shown to be leaking or losing more than 0.185 kilobecquerel (0.005 microcurie) of americium-241 or radium-226 by the methods described in 105 CMR 120.128(F)(6), the source shall be rejected and shall not be transferred to a general licensee under 105 CMR 120.122(G) or equivalent regulations of NRC or an Agreement State. (G) Requirements for Other Specific Licenses (Reserved). (H) Manufacture and Distribution of Radioactive Material for Certain In Vitro Clinical or Laboratory Testing Under General License. An application for a specific license to manufacture or distribute radioactive material for use under the general license of 105 CMR 120.122(I) will be approved if: (1) the applicant satisfies the general requirements specified in 105 CMR 120.125. (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. (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 cobalt-57 in units not exceeding 0.37 megabecquerel (10 microcuries); and (b) displaying the radiation caution symbol described in 105 CMR 120.237(A) and the words, “CAUTION, RADIOACTIVE MATERIAL”, and “Not for Internal or External Use in Humans or Animals”. (4) the following statement or a substantially similar statement which contains the information called for in the following statement, appears on a label affixed to each prepackaged unit or appears in a leaflet or brochure which accompanies the package: 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 therefrom, 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 U.S. Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. 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 set out in 105 CMR 120.251. (I) Licensing the Manufacture and Distribution of Ice Detection Devices. An application for a specific license to manufacture and distribute ice detection devices to persons generally licensed under 105 CMR 120.122(J) will be approved if: (1) the applicant satisfies the general requirements of 105 CMR 120.125; and (2) the criteria of 10 CFR Part 32, §§ 32.61 and 32.62 are met. (J) Manufacture, Preparation, or Transfer for Commercial Distribution of Drugs Containing Radioactive Material for Medical Use under 105 CMR 120.500. (1) An application for a specific license to manufacture, prepare, or transfer for commercial distribution radioactive drugs containing radioactive material for use by persons authorized pursuant to 105 CMR 120.500 will be approved if: (a) the applicant satisfies the general requirements specified in 105 CMR 120.125; (b) the applicant submits evidence that the applicant is at least one of the following: 1. registered or licensed with the U.S. Food and Drug Administration (FDA) as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding, or processing of a drug under 21 CFR 207.20(a); 2. registered or licensed with a State agency as a drug manufacturer; 3. licensed as a pharmacy by a State Board of Pharmacy; 4. operating as a nuclear pharmacy pursuant to 247 CMR 13.00: Registration Requirements and Minimal Professional Standards for Nuclear Pharmacies; 5. operating as a nuclear pharmacy within a Federal medical institution; or 6. a Positron Emission Tomography (PET) drug production facility registered with a State agency. (c) the applicant submits information on the radionuclide; the chemical and physical form; the maximum activity per vial, syringe, generator, or other container of the radioactive drug; and the shielding provided by the packaging to show it is appropriate for safe handling and storage of the radioactive drugs by medical use licensees; and (d) the applicant commits to the following labeling requirements: 1. 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”, 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. 2. 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. (2) A licensee pursuant to 105 CMR 120.128(J)(1)(b)3. or (b)4. or (b)5.: (a) may prepare radioactive drugs for medical use, as defined in 105 CMR 120.502, provided that the radioactive drug is prepared by either an authorized nuclear pharmacist, as specified in 105 CMR 120.128(J)(2)(b) and (d), or an individual under the supervision of an authorized nuclear pharmacist as specified in 105 CMR 120.519. (b) may allow a pharmacist to work as an authorized nuclear pharmacist if: 1. this individual qualifies as an authorized nuclear pharmacist as defined in 105 CMR 120.502; or 2. this individual meets the requirements specified in 105 CMR 120.526(B) and 120.529 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or 3. this individual is designated as an authorized nuclear pharmacist in accordance with 105 CMR 120.128(J)(2)(d). (c) is permitted to perform the actions authorized in 105 CMR 120.128(J)(2)(a) and (b) in spite of more restrictive language in license conditions. (d) may designate a pharmacist, as defined in 105 CMR 120.005, as an authorized nuclear pharmacist if: 1. The individual was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and 2. The individual practiced at a pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other pharmacies before August 8, 2009, or an earlier date as noticed by the NRC. (e) shall provide to the Agency: 1. A copy of each individual's certification by a specialty board whose certification process has been recognized by the Agency, Nuclear Regulatory Commission or an Agreement State as specified in 105 CMR 120.526(A); or 2. The Agency, Agreement State or Nuclear Regulatory Commission license; or 3. The Nuclear Regulatory Commission master materials licensee permit; or 4. The permit issued by a licensee or Nuclear Regulatory Commission master materials permittee of broad scope or the authorization from a commercial nuclear pharmacy authorized to list its own authorized nuclear pharmacist; or 5. Documentation that only accelerator-produced radioactive materials were used in the practice of nuclear pharmacy at a Government agency or Federally recognized Indian Tribe before November 30, 2007 or at all other locations of use before August 8, 2009, or an earlier date as noticed by the NRC; and 6. A copy of the State pharmacy licensure or registration, no later than 30 days after the date that the licensee allows, under 105 CMR 120.128(J)(2)(b)1. and 3. of 105 CMR 120.128(J), the individual to work as an authorized nuclear pharmacist. (3) A licensee shall possess and use instrumentation to measure the radioactivity of radioactive drugs. The licensee shall have procedures for use of the instrumentation. The licensee shall measure, by direct measurement or by combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta-, or photon-emitting radioactive drugs prior to transfer for commercial distribution. In addition, the licensee shall: (a) perform tests before initial use, periodically, and following repair, on each instrument for accuracy, linearity, and geometry dependence, as appropriate for the use of the instrument; and make adjustments when necessary; and (b) check each instrument for constancy and proper operation at the beginning of each day of use. (4) A licensee shall satisfy the labeling requirements in 105 CMR 120.128(J)(1)(d). (5) Nothing in 105 CMR 120.128(J) relieves the licensee from complying with applicable FDA, other Federal, and State requirements governing radioactive drugs. (K) Manufacture and Distribution of Generators or Reagent Kits for Preparation of Radiopharmaceuticals Containing Radioactive Material . An application for a specific license to manufacture and distribute generators or reagent kits containing radioactive material for preparation of radiopharmaceuticals by persons licensed pursuant to 105 CMR 120.100 for the uses listed in 105 CMR 120.547 will be approved if: (1) the applicant satisfies the general requirements specified in 105 CMR 120.125; (2) the applicant submits evidence that: (a) the generator or reagent kit is to be manufactured, labeled and packaged in accordance with the Federal Food, Drug and Cosmetic Act or the Public Health Service Act, such as a new drug application (NDA) approved by the Food and Drug Administration (FDA), or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) that has been accepted by the FDA; or (b) the manufacture and distribution of the generator or reagent kit are not subject to the Federal Food, Drug and Cosmetic Act and the Public Health Service Act. (3) the applicant submits information on the radionuclide, chemical and physical form, packaging including maximum activity per package, and shielding provided by the packaging of the radioactive material contained in the generator or reagent kit; (4) the label affixed to the generator or reagent kit contains information on the radionuclide, quantity, and date of assay; and (5) the label affixed to the generator or reagent kit, or the leaflet or brochure which accompanies the generator or reagent kit, contains: (a) adequate information, from a radiation safety standpoint, on the procedures to be followed and the equipment and shielding to be used in eluting the generator or processing radioactive material with the reagent kit; and (b) a statement that this generator or reagent kit, as appropriate, is approved for use by persons licensed by the Agency pursuant to 105 CMR 120.547 or under equivalent licenses of the U.S. Nuclear Regulatory Commission, an Agreement State, or a Licensing State. The labels, leaflets, or brochures required by 105 CMR 120.128(K) are in addition to the labeling required by the Food and Drug Administration (FDA) and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA. (L) Manufacture and Distribution of Sources or Devices Containing Radioactive Material for Medical Use. An application for a specific license to manufacture and distribute sources and devices containing radioactive material to persons licensed pursuant to 105 CMR 120.500 for use as a calibration, transmission, or reference source or for the uses listed in 105 CMR 120.559, 120.568, 120.570 and 120.589 will be approved if: (1) the applicant satisfies the general requirements in 105 CMR 120.125; (2) the applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: S))))))))))))))))))))))))))))Q Although the Agency does not regulate the manufacture and distribution of reagent kits that do not contain radioacitve material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing radioactive material as part of its licensing and regulation of the users of radioactive material. Any manufacturer of reagent kits that do not contain radioactive material who desires to have his reagent kits approved by the Agency for use by persons licensed pursuant to 105 CMR 120.547 may submit the pertinent information specified in 105 CMR 120.128(K). (a) the radioactive material contained, its chemical and physical form, and amount; (b) details of design and construction of the source or device; (c) procedures for, and results of, prototype tests to demonstrate that the source or device will maintain its integrity under stresses likely to be encountered in normal use and accidents; (d) for devices containing radioactive material, the radiation profile of a prototype device; (e) details of quality control procedures to assure that production sources and devices meet the standards of the design and prototype tests; (f) procedures and standards for calibrating sources and devices; (g) legend and methods for labeling sources and devices as to their radioactive content; and (h) instructions for handling and storing the source or device from the radiation safety standpoint; these instructions are to be included on a durable label attached to the source or device or attached to a permanent storage container for the source or device; provided, that instructions which are too lengthy for such label may be summarized on the label and printed in detail on a brochure which is referenced on the label. (3) the label affixed to the source or device, or to the permanent storage container for the source or device, contains information on the radionuclide, quantity, and date of assay, and a statement that the Agency has approved the distribution of the (name of source or device) to persons licensed to use radioactive material identified in 105 CMR 120.535, 120.559, 120.568, and 120.570 or under equivalent licenses of the U.S. Nuclear Regulatory Commission or an Agreement State; (4) the source or device has been registered in the Sealed Source and Device Registry; (5) in the event the applicant desires that the source or device be required to be tested for leakage of radioactive material at intervals longer than six months, he or she shall include in his or her application sufficient information to demonstrate that such longer interval is justified by performance characteristics of the source or device or similar sources or devices and by design features that have a significant bearing on the probability or consequences of leakage of radioactive material from the source; and (6) in determining the acceptable interval for test of leakage of radioactive material, the Agency will consider information that includes, but is not limited to: (a) primary containment or source capsule; (b) protection of primary containment; (c) method of sealing containment; (d) containment construction materials; (e) form of contained radioactive material; (f) maximum temperature withstood during prototype tests; (g) maximum pressure withstood during prototype tests; (h) maximum quantity of contained radioactive material; (i) radiotoxicity of contained radioactive material; and (j) operating experience with identical sources or devices or similarly designed and constructed sources or devices. (M) Requirements for License to Manufacture and Distribute Industrial Products Containing Depleted Uranium for Mass-volume Applications. (1) An application for a specific license to manufacture industrial products and devices containing depleted uranium for use pursuant to 105 CMR 120.121(E) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State will be approved if: (a) the applicant satisfies the general requirements specified in 105 CMR 120.125; (b) the applicant submits sufficient information relating to the design, manufacture, prototype testing, quality control procedures, labeling or marking, proposed uses, and potential hazards of the industrial product or device to provide reasonable assurance that possession, use, or transfer of the depleted uranium in the product or device is not likely to cause any individual to receive a radiation dose in excess of 10% of the annual limits specified in 105 CMR 120.211(A); and (c) the applicant submits sufficient information regarding the industrial product or device and the presence of depleted uranium for a mass-volume application in the product or device to provide reasonable assurance that unique benefits will accrue to the public because of the usefulness of the product or device. (2) In the case of an industrial product or device whose unique benefits are questionable, the Agency will approve an application for a specific license under 105 CMR 120.128(M) only if the product or device is found to combine a high degree of utility and low probability of uncontrolled disposal and dispersal of significant quantities of depleted uranium into the environment. (3) The Agency may deny any application for a specific license under 105 CMR 120.128(M) if the end use(s) of the industrial product or device cannot be reasonably foreseen. (4) Each person licensed pursuant to 105 CMR 120.128(M)(1) shall: (a) maintain the level of quality control required by the license in the manufacture of the industrial product or device, and in the installation of the depleted uranium into the product or device; (b) label or mark each unit to: 1. identify the manufacturer of the product or device and the number of the license under which the product or device was manufactured, the fact that the product or device contains depleted uranium, and the quantity of depleted uranium in each product or device; and 2. state that the receipt, possession, use, and transfer of the product or device are subject to a general license or the equivalent and the regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. (c) assure that the depleted uranium before being installed in each product or device has been impressed with the following legend clearly legible through any plating or other covering: "Depleted Uranium"; (d) 1. furnish a copy of the general license contained in 105 CMR 120.121(E) and a copy of form MRCP 120.100-1 to each person to whom he or she transfers depleted uranium in a product or device for use pursuant to the general license contained in 105 CMR 120.121(E); or 2. furnish a copy of the general license contained in the U.S. Nuclear Regulatory Commission's or Agreement State's regulation equivalent to 105 CMR 120.121(E) and a copy of the U.S. Nuclear Regulatory Commission's or Agreement State's certificate, or alternatively, furnish a copy of the general license contained in 105 CMR 120.121(E) and a copy of form MRCP 120.100-1 to each person to whom he or she transfers depleted uranium in a product or device for use pursuant to the general license of the U.S. Nuclear Regulatory Commission or an Agreement State, with a note explaining that use of the product or device is regulated by the U.S. Nuclear Regulatory Commission or an Agreement State under requirements substantially the same as those in 105 CMR 120.121(E). (e) report to the Agency all transfers of industrial products or devices to persons for use under the general license in 105 CMR 120.121(E). Such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Agency and the general licensee, the type and model number of device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such a product or device is transferred to the generally licensed person. If no transfers have been made to persons generally licensed under 105 CMR 120.121(E) during the reporting period, the report shall so indicate; (f) 1. report to the U.S. Nuclear Regulatory Commission all transfers of industrial products or devices to persons for use under the U.S. Nuclear Regulatory Commission general license in 10 CFR Part 40, § 40.25; 2. report to the responsible State agency all transfers of devices manufactured and distributed pursuant to 105 CMR 120.128(M) for use under a general license in that State's regulations equivalent to 105 CMR 120.121(E); 3. such report shall identify each general licensee by name and address, an individual by name and/or position who may constitute a point of contact between the Agency and the general licensee, the type and model number of the device transferred, and the quantity of depleted uranium contained in the product or device. The report shall be submitted within 30 days after the end of each calendar quarter in which such product or device is transferred to the generally licensed person; 4. if no transfers have been made to U.S. Nuclear Regulatory Commission licensees during the reporting period, this information shall be reported to the U.S. Nuclear Regulatory Commission; and 5. if no transfers have been made to general licensees within a particular Agreement State during the reporting period, this information shall be reported to the responsible Agreement State agency upon the request of that agency. (g) keep records showing the name, address, and point of contact for each general licensee to whom he or she transfers depleted uranium in industrial products or devices for use pursuant to the general license provided in 105 CMR 120.121(E) or equivalent regulations of the U.S. Nuclear Regulatory Commission or an Agreement State. The records shall be maintained for a period of two years and shall show the date of each transfer, the quantity of depleted uranium in each product or device transferred, and compliance with the report requirements of 105 CMR 120.100. (N) Sealed Source and Device Registration - Registration of Product Information and Inactivation of Certificates of Registration of Sealed Sources and Devices. (1) Any manufacturer or initial distributor of a sealed source or device containing a sealed source may submit a request to the Agency for evaluation of radiation safety information about its product and for its registration. (2) The request for review must be sent to the Agency in duplicate by an appropriate method listed in 105 CMR 120.013. (3) The request for review of a sealed source or a device must include sufficient information about the design, manufacture, prototype testing, quality control program, labeling, proposed uses and leak testing and, for a device, the request must also include sufficient information about installation, service and maintenance, operating and safety instructions, and its potential hazards, to provide reasonable assurance that the radiation safety properties of the source or device are adequate to protect health and minimize danger to life and property. (4) The Agency normally evaluates a sealed source or a device using radiation safety criteria in accepted industry standards. If these standards and criteria do not readily apply to a particular case, the Agency formulates reasonable standards and criteria with the help of the manufacturer or distributor. The Agency shall use criteria and standards sufficient to ensure that the radiation safety properties of the device or sealed source are adequate to protect health and minimize danger to life and property. (5) After completing the evaluation and determining that requirements for registration have been met, the Agency shall issue a certificate of registration to the person making the request. The certificate of registration acknowledges the availability of the submitted information for inclusion in an application for a specific license proposing use of the product, or concerning use under an exemption from licensing or general license as applicable for the category of certificate. (6) The person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with: (a) The statements and representations, including quality control program, contained in the request; and (b) The provisions of the registration certificate. (7) Authority to manufacture or initially distribute a sealed source or device to specific licensees may be provided in the license without the issuance of a certificate of registration in the following cases: (a) Calibration and reference sources containing no more than: 1. 37 MBq (1 mCi), for beta and/or gamma emitting radionuclides; or 2. 0.37 MBq (10 :Ci), for alpha emitting radionuclides; or (b) The intended recipients are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in any form in the case of unregistered sources or, for registered sealed sources contained in unregistered devices, are qualified by training and experience and have sufficient facilities and equipment to safely use and handle the requested quantity of radioactive material in unshielded form, as specified in their licenses; and 1. The intended recipients are licensed under 105 CMR 120.127 or comparable provisions of NRC or an Agreement State; 2. The recipients are authorized for research and development; or 3. The sources and devices are to be built to the unique specifications of the particular recipient and contain no more than 740 GBq (20 Ci) of tritium or 7.4 GBq (200 mCi) of any other radionuclide. (8) After the certificate is issued, the Agency may conduct an additional review as it determines is necessary to ensure compliance with current regulatory standards. In conducting its review, the Agency will complete its evaluation in accordance with criteria specified in 105 CMR 120.128(N). The Agency may request such additional information as it considers necessary to conduct its review and the certificate holder shall provide the information as requested. (9) A certificate holder who no longer manufactures or initially transfers any of the sealed source(s) or device(s) covered by a particular certificate issued by the Agency shall request inactivation of the registration certificate. Such a request must be made to the Agency by an appropriate method listed in 105 CMR 120.013 and must normally be made no later than two years after initial distribution of all of the source(s) or device(s) covered by the certificate has ceased. However, if the certificate holder determines that an initial transfer was in fact the last initial transfer more than two years after that transfer, the certificate holder shall request inactivation of the certificate within 90 days of this determination and briefly describe the circumstances of the delay. (10) If a distribution license is to be terminated in accordance with 105 CMR 120.132, the licensee shall request inactivation of its registration certificates associated with that distribution license before the Agency will terminate the license. Such a request for inactivation of certificate(s) must indicate that the license is being terminated and include the associated specific license number. (11) A specific license to manufacture or initially transfer a source or device covered only by an inactivated certificate no longer authorizes the licensee to initially transfer such sources or devices for use. Servicing of devices must be in accordance with any conditions in the certificate, including in the case of an inactive certificate.