Table 6 General Licenses Part 2

Item (i) "In vitro" clinical or laboratory testing.⁹

⁹ 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 director¹⁰ 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

¹⁰ 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.

                           _____________________________

                           Name of manufacturer

(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.^11,12

(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:

¹¹10 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.

¹² 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 director¹³ 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

¹³ 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.

Appendix 16-A Index