Source: http://upstate.edu/radiationsafety/nyssanitary/part16a/ra02004.php
Timestamp: 2013-05-22 15:07:46
Document Index: 539718123

Matched Legal Cases: ['art 32', 'art 32', 'art 70', 'art 32', 'art 70', 'art 32']

Table 6 General Licenses | Radiation Safety Office | SUNY Upstate Medical University
Table 6 General Licenses1
1 Radioactive material possessed or used under a general license is subject to the requirements of sections 16.6 through 16.17 under the heading "General Provisions" of this Part.
Item (a) Certain devices and equipment.
(1) A general license is hereby issued to transfer, receive, possess or use radioactive material incorporated in the following devices or equipment which have been manufactured, tested and labeled in accordance with a specific license issued by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, and authorizing distribution under the general license of this paragraph or its equivalent.
(i) Static elimination devices. Devices designed for use as static eliminators which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries of Polonium 210 per device.
(ii) Ion generating tubes. Devices designed for ionization of air which contain, as a sealed source or sources, radioactive material consisting of a total of not more than 500 microcuries of Polonium 210 per device or a total of not more than 50 millicuries of Hydrogen 3 per device.
Item (b) Certain measuring, gauging or controlling devices.
(1) A general license is hereby issued to receive, possess or use radioactive material when contained in devices designed and manufactured for the purpose of detecting, measuring, gauging, or controlling thickness, density, level, interface location, radiation leakage, or qualitative or quantitative chemical composition, or for producing light or an ionized atmosphere, when such devices are manufactured or imported in accordance with the specifications contained in a specific license issued to the supplier by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, and authorizing distribution under the general license of this paragraph or its equivalent; provided, that:
(i) such devices are labeled in accordance with the provisions of the specific license which authorizes the distribution of the devices;2
2 Regulations under the Federal Food, Drug, and Cosmetic Act authorizing the use of radioactive control devices in food production require certain additional labeling thereon which is found in section 121.3001 of the Code of Federal Regulations, Title 21.
(ii) such devices bear a label containing the following or a substantially similar statement which contains the information called for in the following statement:
The transfer, receipt, possession or use of this device, Model3 __________, Serial No.4 __________, 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 Nuclear Regulatory Commission has entered into an agreement for the exercise of regulatory authority. Removal of this label is prohibited.
(Name of supplier)3
3 The model, serial number, and name of supplier may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.
4 Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material or source material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirement may be obtained only from the United States Nuclear Regulatory Commission, Washington, DC 20555
(iii) such devices are installed on the premises of the general licensee by a person authorized to install such devices under a specific license issued to the installer by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, if a label affixed to the device at the time of receipt states that installation by a specific licensee is required. The requirement of this subparagraph does not apply while devices are held in storage in the original shipping container pending installation by a specific licensee.
(2) Persons who receive, possess or use a device pursuant to the general license contained in paragraph (1) of this item:
(i) shall within 10 days after the receipt of the device notify the department of the type of device and the name and address of the supplier;
(ii) shall not transfer, abandon, or dispose of the device except by transfer to a person duly authorized to receive such device by a specific license issued by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, and shall furnish to the department, within 30 days after any transfer, a report containing the name of the manufacturer of the device, the type of device, the manufacturer's serial number of the device, and the name and address of the person receiving the device;
(iii) shall assure that all labels affixed to the device at the time of receipt and bearing the statement, "Removal of this label is prohibited" are maintained thereon and shall comply with all instructions contained in such labels;
(iv) shall have the device tested for leakage of radioactive material and proper operation of the on-off mechanism and indicator, if any, at the time of installation of the device or replacement of the radioactive material on the premises of the general licensee and thereafter at no longer than six-month intervals or at such longer intervals not to exceed three years as are specified in the label required by subparagraph (i) of paragraph (1) of this item, provided, that devices containing only Krypton 85 need not be tested for leakage, and devices containing only Hydrogen 3 need not be tested for any purpose;
(v) shall have the tests required by subparagraph (iv) of this paragraph and all other services involving the radioactive material, its shielding and containment, performed by the supplier or other person duly authorized by a specific license issued by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, to manufacture, install, or service such devices;
(vi) shall, within 30 days after the occurrence of a failure of or damage to the shielding of the radioactive material or the on-off mechanism or indicator or upon the detection of 0.005 microcurie or more of removable radioactive material, furnish to the department a report containing the name of the manufacturer of the device, the type of device, the manufacturer's serial number of the device and a brief description of the event and the remedial action taken; and shall maintain records of all tests performed on the devices as required under this item, including the dates and results of the tests and the names of the persons conducting the tests;
(vii) shall, upon the occurrence of a failure of or damage to, or any indication of a possible failure of or damage to, the shielding or containment of the radioactive material or the on-off mechanism or indicator, immediately suspend operation of the device until it has been repaired by a person holding a specific license issued by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, to manufacture, install, or service such devices, or disposed of by transfer to a person holding a specific license issued by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State to receive the radioactive material contained in the device;
(viii) shall, be exempt from the requirements of sections 16.6 through 16.17 of this Part except that such persons shall comply with the provisions of paragraph (1) of subdivision (a) of section 16.15.
Item (c) Luminous safety devices for aircraft.
(1) A general license is hereby issued to receive, possess or use Hydrogen 3 or Promethium 147 contained in luminous safety devices for use in aircraft, provided:
(i) each device contains not more than 10 curies of Hydrogen 3 or 300 millicuries of Promethium 147; and
(ii) each device has been manufactured, assembled or imported in accordance with a specific license issued by the United States Nuclear Regulatory Commission, or each device has been manufactured, assembled or imported in accordance with the specifications contained in a specific license issued by the department, the New York State Department of Labor, the New York City Department of Health, or any agreement State pursuant to licensing requirements equivalent to those in section 32.53 of 10 CFR Part 32 of the regulations of the United States Nuclear Regulatory Commission.
(2) Persons who receive, possess or use luminous safety devices pursuant to the general license in paragraph (1) of this item are exempt from the requirements of section 16.6 through 16.17 of this Part except that they shall comply the provisions of paragraph (1) of subdivision (a) of section 16.15.
(3) This general license does not authorize the manufacture, assembly or repair of luminous safety devices containing Hydrogen 3 or Promethium 147.
(4) This general license does not authorize the receipt, possession or use of Promethium 147 contained in instrument dials.
Item (d) Ownership of radioactive material.
A general license is hereby issued to own radioactive material without regard to quantity. Notwithstanding any other provisions of this Part, this general license does not authorize the manufacture, production, transfer, receipt, possession or use of radioactive material.
Item (e) Calibration and reference sources.
(1) A general license is hereby issued to those persons listed below to transfer, receive, possess or use, in accordance with the provisions of paragraphs (3) and (4) of this item, Americium 241 in the form of calibration or reference sources:
(i) any person who holds a specific license issued by the department, the State Department of Labor or the New York City Department of Health, which authorizes him to transfer, receive, possess or use radioactive material; and
(ii) any person who holds a specific license issued by the United States Nuclear Regulatory Commission which authorizes him to transfer, receive, possess or use, special nuclear material.
(2) A general license is hereby issued to transfer, receive, possess or use plutonium in the form of calibration or reference sources in accordance with the provisions of paragraphs (4) and (5) of this item to any person who holds a specific license issued by the department, the State Department of Labor or the New York City Department of Health, which authorizes him to transfer, receive, possess or use radioactive material.
(3) The general licenses in paragraphs (1) and (2) of this item apply only to calibration or reference sources which have been manufactured in accordance with the specifications contained in a specific license issued to the manufacturer or importer of the sources by the United States Nuclear Regulatory Commission pursuant to section 32.57 of 10 CFR Part 32 or section 70.39 of 10 CFR Part 70 or which have been manufactured or imported in accordance with the specifications contained in a specific license issued by the department, the State Department of Labor, the New York City Department of Health, or any agreement State pursuant to licensing requirements equivalent to those contained in section 32.57 of 10 CFR Part 32 or section 70.39 of 10 CFR Part 70 of the regulations of the United States Nuclear Regulatory Commission.
(4) Persons who transfer, receive, possess or use one or more calibration or reference sources pursuant to these general licenses:
(i) shall not possess at any one time, at any one location of storage of use, more than five microcuries of Americium 241 and five microcuries of Plutonium in such sources;
(ii) shall not transfer, receive, possess or use such source unless the source, or the storage container, bears a label which includes the following statement or a substantially similar statement which contains the information called for in the following statement:
The transfer, receipt, possession or use of this source Model 5__________, Serial No.6 __________, are subject to a general license and the regulations of the United States Nuclear Regulatory Commission or of a State with which the 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) (PLUTONIUM)7. DO NOT TOUCH RADIOACTIVE PORTION OF THIS SOURCE.
5The model, serial number, and name of supplier may be omitted from this label provided they are elsewhere specified in labeling affixed to the device.
6 Authority to transfer possession or control by the manufacturer, processor, or producer of any equipment, device, commodity, or other product containing byproduct material or source material whose subsequent possession, use, transfer, and disposal by all other persons are exempted from regulatory requirement may be obtained only from the United States Nuclear Regulatory Commission, Washington, DC 20555
7 Showing only the name of the appropriate material.
(iii) shall not transfer, abandon, or dispose of such source except by transfer to a person authorized by a license from the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or an agreement State to receive the source;
(iv) shall store such source, except when the source is being used, in a closed container adequately designed and constructed to contain Americium 241 or Plutonium which might otherwise escape during storage; and,
(v) shall not use such source for any purpose other than the calibration of radiation detectors or the standardization of other sources.
(5) These general licenses do not authorize the manufacture of calibration or reference sources containing Americium 241 or Plutonium.
(6) A general license is hereby issued to transfer, receive, possess or use sealed radioactive materials sources in individual quantities each of which does not exceed the applicable quantity set forth in Table 3 of this Appendix, to any person who holds a specific license issued by the department.
(7) Notwithstanding paragraph (6) of this item, a general license is hereby issued to transfer, receive, possess or use up to 10 individual sealed sources containing up to 20 microcuries of Radium 226 each to any person who holds a specific license issued by the department.
(8) Persons who transfer, receive, possess or use sources pursuant to paragraphs (6) and/or (7) of this item:
(i) shall not transfer, abandon, or dispose of such sources except by transfer to a person duly authorized to receive such sources by the department, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State;
(ii) shall store such sources, except when being used, in a secure location.
Item (f) Ice detection devices.
(1) A general license is hereby issued to transfer, receive, possess or use Strontium 90 contained in ice detection devices, provided each device contains not more than 50 microcuries of Strontium 90 and each device has been manufactured or imported in accordance with a specific license issued by the United States Nuclear Regulatory Commission or each device has been manufactured or imported in accordance with the specifications contained in a specific license issued by the department, the State Department of Labor, the New York City Department of Health or any agreement State pursuant to licensing requirements equivalent to those in section 32.61 of 10 CFR Part 32 of the regulations of the United States Nuclear Regulatory Commission.
(2) Persons who transfer, receive, possess or use Strontium 90 contained in ice detection devices pursuant to the general license in paragraph (1) of this item:
(i) shall, upon occurrence of visually observable damage, such as a bend or crack or discoloration from overheating, to the device, discontinue use of the device until it has been inspected, tested for leakage and repaired by a person holding a specific license from the United States Nuclear Regulatory Commission or an agreement State to manufacture or service such devices; or shall dispose of the device pursuant to the provisions of section 16.8 of this Part.
(iii) are exempt from the requirements of section 16.6 through 16.17 of this Part except that such persons shall comply with the provisions of section 16.8 and paragraph (1) of subdivision (a) of section 16.15.
(3) This general license does not authorize the manufacture, assembly, disassembly or repair of Strontium 90 in ice detection devices.
Item (g) Source material.
(1) A general license is hereby issued authorizing use and transfer of not more than 15 pounds of source material at any one time by persons in the following categories:
(i) pharmacists using the source material solely for the compounding of medicinals;
(ii) physicians using the source material for medicinal purposes;
(iii) persons receiving possession of source material from pharmacists and physicians in the form of medicinals or drugs;
(iv) commercial and industrial firms, and research, educational, and medical institutions for research, development, educational, or commercial purposes;
and provided, that no such person shall, pursuant to this general license, receive more than a total of 150 pounds of source material in any one calendar year.
(2) Persons who transfer, receive, possess or use source material pursuant to the general license issued in paragraph (1) of this item are exempt from the provisions of sections 16.6 through 16.17 of this Part to the extent that such transfer, receipt, possession or use is within the terms of such general license; provided, however, that this exemption shall not be deemed to apply to any such person who is also in possession of source material under a specific license issued pursuant to this Part.
(3) A general license is hereby issued authorizing the receipt of title to source material without regard to quantity. The general license under this paragraph does not authorize any person to transfer, receive, possess or use source material.
Item (h) Validity of licenses issued by other agencies.
(1) A general license is hereby issued to the holder of a license issued by the State Department of Labor, New York City Department of Health, United States Nuclear Regulatory Commission or any agreement State to bring, possess or use radioactive material covered by such license within the department's jurisdiction for a period not in excess of 180 days in any 12 consecutive months, except as otherwise permitted in paragraph (2) of this item, provided that:
(i) such license does not limit the holder's possession or use of such material to a specific installation or installations;
(ii) such holder, at least three days prior to bringing such material within the department's jurisdiction, files with the department a notice indicating the period, type and location of proposed possession and use within the department's jurisdiction, and a copy of the license. At the discretion of the department, oral notification to the department may be accepted in lieu of the filing requirement;
(iii) such holder supplies such additional information as the department may request;
(iv) such holder, during the period of his possession and use of such material within the department's jurisdiction, complies with all applicable sections in this Part except section 16.100;
(v) such holder, during such period, complies with all the terms and conditions of his license or permit, except such terms or conditions which may be inconsistent with the sections in this Part; and
(vi) such holder shall not transfer, abandon, or dispose of the radioactive material possessed or used under this general license except by transfer to a person:
(a) who holds a valid license issued by the department, the State Department of Labor, the United States Nuclear Regulatory Commission or any agreement State to receive such radioactive material; or
(b) who is exempt from the requirements for a license for such material pursuant to the provision of Appendix 1, Table 1, item (a).
(2) Any holder of a license issued by the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or an agreement State which authorizes the holder to manufacture, install or service a device described in Appendix 1, Table 6, item (b), paragraph (1), and which is not limited as to specific installation or installations may install or service such devices without obtaining a license from the department provided that:
(i) such person shall file a report with the department within 30 days after the end of each calendar quarter in which any device is transferred to or installed within the department's jurisdiction. Each such report shall identify the name and address of each person receiving a device, the type of device transferred, and the quantity and type of radioactive material contained in the device;
(ii) the device is manufactured, labeled, installed and serviced in accordance with terms and conditions of the license issued to such person;
(iii) such person shall assure that any labels required to be affixed to the device bear a statement that "Removal of this label is prohibited"; and
(iv) the person to whom he transfers such device or on whose premises he services or installs such a device has a copy of the general license requirements or equivalent requirements outlined under Appendix 1, Table 6, item (b), paragraph (2).
The department may withdraw, limit, or qualify its acceptance of any specific license issued by another agency, or any product distributed pursuant to such licensing document upon determining that such action is necessary in order to prevent undue hazard to public health and safety or property.
Item (i) "In vitro" clinical or laboratory testing.8
8 The new drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.
(1) A general license is hereby issued to any physician, clinical laboratory or hospital to transfer, receive, possess or use, for any of the following stated tests, in accordance with the provisions of paragraphs (2) through (5) of this item, the following radioactive materials in prepackaged units:
(i) Iodine 125, Iodine 131, Carbon 14, Selenium 75 or Cobalt 57 in units not exceeding 10 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.
(ii) Iron 59 in units not exceeding 20 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.
(iii) Hydrogen 3 in units not exceeding 50 microcuries each for use in in vitro clinical or laboratory tests not involving internal or external administration of radioactive material, or the radiation therefrom, to human beings or animals.
(2) No person shall transfer, receive, possess or use radioactive material pursuant to the general license established by paragraph (1) of this item until he has filed Form GEN 373, "Registration Certificate - In Vitro Testing with Radioactive Materials Under General License", with the State Department of Health and received from such department a validated copy of Form GEN 373 with registration certificate number assigned. The physician, clinical laboratory or hospital shall furnish on Form GEN 373 the following information and such other information as may be required by such form:
(i) name and address of the physician, clinical laboratory or hospital;
(ii) the location of use;
(iii) a statement that the applicant or the applicant's representative, if he is a laboratory director9 or assists the laboratory director, holds an effective Certificate of Qualification as such to perform in vitro radionuclide procedures issued by the Clinical Laboratory Center, Division of Laboratories and Research, New York State Department of Health; and
9 The term laboratory director means a person responsible for administration of the technical and scientific operation of a clinical laboratory or blood bank, including supervision of procedures and reporting of findings of tests.
(iv) a statement that the physician, clinical laboratory or hospital has appropriate radiation measuring instruments to carry out in vitro clinical or laboratory tests with radioactive materials as authorized under the general license in paragraph (1) of this item and that such tests will be performed only by personnel competent in the use of such instruments and in the handling of the radioactive materials.
(3) A person who receives, possesses or uses radioactive material pursuant to the general license established by paragraph (1) of this item shall comply with the following:
(i) the general licensee shall not possess at any one time, pursuant to the general license in paragraph (1) of this item, at any one location of storage or use more than:
(a) 200 microcuries of Iodine 125, Iodine 131, Iron 59, Selenium 75 and/or Cobalt 57;
(b) 100 microcuries of Carbon 14; or
(c) 1000 microcuries of Hydrogen 3.
(ii) the general licensee shall store the radioactive material, until used, in the original shipping container or in a container providing equivalent radiation protection;
(iii) the general licensee shall use the radioactive material only for the uses authorized by paragraph (1) of this item;
(iv) the general licensee shall neither transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the State Department of Health, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, nor transfer the radioactive material in any manner other than in the unopened, labeled shipping container as received from the supplier.
(4) The general licensee shall not receive, possess or use radioactive material pursuant to paragraph (1) of this item:
(i) except as prepackaged units which are labeled in accordance with the provisions of a specific license issued by the United States Nuclear Regulatory Commission pursuant to 10 CFR 32.71 or which are labeled in accordance with the provisions of a specific license issued by the State Department of Health, the State Department of Labor, the New York City Department of Health or any agreement State pursuant to licensing requirements equivalent to those contained in 10 CFR 32.71 which authorizes the manufacture of Iodine 125, Iodine 131, Iron 59, Carbon 14, Hydrogen 3, Selenium 75 or Cobalt 57 for distribution to persons generally licensed under paragraph (1) of this item or its equivalent; and
(ii) unless the following statement or a statement substantially similar thereto containing 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, 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, possession, use, and transfer are subject to the regulations and a general license of the United States Nuclear Regulatory Commission or of a State with which the commission has entered into an agreement for the exercise of regulatory authority.
(5) The physician, clinical laboratory or hospital possessing or using radioactive materials under the general license of paragraph (1) of this item shall report in duplicate to the department, any changes in the information furnished by him in the Form GEN 373, "Registration Certificate - In Vitro Testing with Radioactive Material Under General License." The report shall be submitted within 30 days after the effective date of such change.
Item (j) Medical diagnostic uses.10,11
(1) A general license is hereby issued to any physician to transfer, receive, possess or use radioactive materials set forth below for the stated diagnostic uses; provided, however, that the use is in accordance with the respective provisions of paragraphs (2), (3) and (4) of this item; the radioactive materials are in the form of capsules, disposable syringes, or other prepackaged individual doses; and the radioactive material has been manufactured in accordance with a specific license issued by the United States Nuclear Regulatory Commission pursuant to 10 CFR 32.70 or which has been manufactured in accordance with a specific license issued by the department, the New York State Department of Labor, the New York City Department of Health or any agreement State pursuant to licensing requirements equivalent to those contained in 10 CFR 32.70 authorizing distribution under the general license granted in this item or its equivalent:
1010 CFR 32.70 (regulations of the United States Nuclear Regulatory Commission) or any equivalent licensing requirement requires manufacturers of radiopharmaceuticals which are under the general license in this paragraph to affix a certain identifying label to the container or in the leaflet or brochure which accompanies the radiopharmaceutical.
11 The new drug provisions of the Federal Food, Drug and Cosmetic Act also govern the availability and use of any specific diagnostic drugs in interstate commerce.
(i) Iodine 125 and/or Iodine 131 as sodium iodide for measurement of thyroid uptake;
(ii) Iodine 125 and/or Iodine 131 as iodinated human serum albumin (IHSA) for determinations of blood and blood plasma volume;
(iii) Cobalt 57, Cobalt 58 and/or Cobalt 60 for the measurement of intestinal absorption of cyanocobalamin;
(iv) Chromium 51 as sodium radiochromate for determination of red blood cell volumes and studies of red blood cell survival time.
(2) No physician shall transfer, receive, possess or use radioactive material pursuant to the general license established by paragraph (1) of this item until he has filed Form GEN 371, "Registration Certificate - Medical Use of Radioactive Material Under General License" with the department and received from the department a validated copy of the Form GEN 371 with registration number assigned. The generally licensed physician shall furnish on Form GEN 371 the following information and such other information as may be required by that form:
(i) name and address of the physician;
(ii) a statement that the physician is a duly licensed physician authorized to dispense drugs in the practice of medicine in New YorkState;
(iii) a statement that the physician, if he is a laboratory director12 or assists the laboratory director, holds an effective certificate of qualification as such to perform radiobioassay procedures issued by the Clinical Laboratory Center, Division of Laboratories and Research, New York State Department of Health; and
12 The term laboratory director means a person responsible for administration of the technical and scientific operation of a clinical laboratory or blood bank, including supervision of procedures and reporting of findings of tests.
(iv) a statement that the physician has appropriate radiation measuring instruments to carry out the diagnostic procedures for which he proposes to use radioactive material under the general license of this item and that he is competent in the use of such instruments.
(3) A physician who receives, possesses or uses a pharmaceutical containing radioactive material pursuant to the general license established by paragraph (1) of this item shall comply with the following:
(i) he shall not possess at any one time, pursuant to the general license in paragraph (1) of this item, more than:
(a) 200 microcuries of Iodine 131,
(b) 200 microcuries of Iodine 125,
(c) 5 microcuries of Cobalt 57,
(d) 5 microcuries of Cobalt 58,
(e) 5 microcuries of Cobalt 60, and
(f) 200 microcuries of Chromium 51;
(ii) he shall store the pharmaceutical until administered in the original shipping container, or a container providing equivalent radiation protection;
(iii) he shall use the pharmaceutical only for the uses authorized by paragraph (1) of this item;
(iv) he shall not administer the pharmaceutical to a woman with confirmed pregnancy or to a person under 18 years of age; and
(v) he shall not transfer the radioactive material to a person who is not authorized to receive it pursuant to a license issued by the State Department of Health, the State Department of Labor, the New York City Department of Health, the United States Nuclear Regulatory Commission or any agreement State, or in any manner other than in the unopened, labeled shipping container as received from the supplier, except by administering it to a patient.
(4) The generally licensed physician possessing or using radioactive material under the general license of paragraph (1) of this item shall report in duplicate to the State Department of Health, any changes in the information furnished by him in the "Registration Certificate - Medical Use of Radioactive Material Under General License", Form GEN 371. The report shall be submitted within 30 days after effective date of such change.