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 paper shall be measured by using radiation detection instrumentation capable of detecting 0.005 microcurie of americium241. If any such test discloses more than 0.005 microcurie of radioactive material, the source shall be deemed to be leaking or losing americium-241 and shall not be transferred to a general licensee under § 31.8 of this chapter.

§ 32.60 [Reserved]

§ 32.61 Ice detection devices containing strontium-90; requirements for license to manufacture or initially transfer. An application for a specific license to manufacture or initially transfer ice detection devices containing strontium-90 for distribution to persons generally licensed under § 31.10 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(b) The applicant submits sufficient information regarding each type of device pertinent to evaluation of the potential radiation exposure, including:

(1) Chemical and physical form and maximum quantity of strontium-90 in the device;

(2) Details of construction and design of the source of radiation and its shielding;

(3) Radiation profile of a prototype device;

(4) Procedures for and results of prototype testing of devices to demonstrate that the strontium-90 contained in each device will not be released or be removed from the device under the most severe conditions likely to be encountered in normal handling and use; (5) Details of quality control procedures to be followed in manufacture of the device;

(6) Description of labeling to be affixed to the device;

(7) Instructions for handling and installation of the device;

(8) Any additional information, including experimental studies and tests,

required by the Commission to facilitate a determination of the safety of the device;

(c) Each device will contain no more than 50 microcuries of strontium-90 in an insoluble form;

(d) Each device will bear durable, legible labeling which includes the radiation caution symbol prescribed by § 20.203(a) of this chapter, a statement that the device contains strontium-90 and the quantity thereof, instructions for disposal and statements that the device may be possessed pursuant to a general license, that the manufacturer or civil authorities should be notified if the device is found, that removal of the labeling is prohibited and that disassembly and repair of the device may be performed only by a person holding a specific license to manufacture or service such devices;

(e) The Commission that:

determines

(1) The method of incorporation and binding of the strontium-90 in the device is such that the strontium-90 will not be released from the device under the most severe conditions which are likely to be encountered in normal use and handling of the device;

(2) The strontium-90 is incorporated or enclosed so as to preclude direct physical contact by any individual with it and is shielded so that no individual will receive a radiation exposure to a major portion of his body in excess of 0.5 rem in a year under ordinary circumstances of use;

(3) The device is so designed that it cannot be easily disassembled;

(4) The device has been subjected to and has satisfactorily passed the prototype tests prescribed by § 32.103; and

(5) Quality control procedures have been established to satisfy the requirements of § 32.62.

(Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841))

[30 FR 9905, Aug. 10, 1965, as amended at 43 FR 6923, Feb. 17, 1978]

device and shall reject any which has an observable physical defect that could affect containment of the strontium-90.

(b) Each person licensed under § 32.61 shall test each device for possible loss of strontium-90 or for contamination by wiping with filter paper an area of at least 100 square centimeters on the outside surface of the device, or by wiping the entire surface area if it is less than 100 square centimeters. The detection on the filter paper of more than 2,200 disintegrations per minute of radioactive material per 100 square centimeters of surface wiped shall be cause for rejection of the tested device.

(c) Each person licensed under § 32.61 shall take a random sample of the size required by the table in § 32.110 for Lot Tolerance Percent Defective of 5.0 percent from each inspection lot, and shall subject each unit in the sample to the following tests:

(1) Each device shall be immersed in 30 inches of water for 24 hours and shall show no visible evidence of physical contact between the water and the strontium-90. Absolute pressure of the air above the water shall then be reduced to 1 inch of mercury. Lowered pressure shall be maintained for 1 minute or until air bubbles cease to be given off by the water, whichever is the longer. Pressure shall then be increased to normal atmospheric pressure. Any device which leaks, as evidenced by physical contact between the water and the strontium-90, shall be considered as a defective unit.

(2) The immersion test water from the preceding test in paragraph (c)(1) of this section shall be measured for radioactive material. If the amount of radioactive material in the immersion test water is greater than 0.1 percent of the original amount of strontium-90 in any device, the device shall be considered as a defective unit.

(d) An application for a license or for amendment of a license may include a description of procedures proposed as alternatives to those prescribed by paragraph (c) of this section, and proposed criteria for acceptance under those procedures. The Commission will approve the proposed

alternative procedures if the applicant demonstrates that:

(1) They will consider defective any sampled device which has a leakage rate exceeding 0.1 percent of the original quantity of strontium-90 in any 24hour period; and

(2)

The operating characteristic curve or confidence interval estimate for the alternative procedures provides a Lot Tolerance Percent Defective of 5.0 percent at the consumer's risk of 0.10.

(e) No person licensed under § 32.61 shall transfer to persons generally licensed under § 31.10 of this chapter:

(1) Any device which has been tested and found defective under the criteria and procedures specified in this § 32.62 unless the defective units have been repaired or reworked and then met the tests set out in paragraph (c) of this section; or

(2) Any inspection lot which has been rejected as a result of the procedures in § 32.110 or alternative procedures in paragraph (d) of this section, unless the defective units have been sorted and removed or have been repaired or reworked and have then met the tests set out in paragraph (c) of this section.

(Sec. 161, as amended, Pub. L. 83-703, 68 Stat. 948 (42 U.S.C. 2201); sec. 201, as amended, Pub. L. 93-438, 88 Stat. 1243 (42 U.S.C. 5841))

[30 FR 9905, Aug. 10, 1965, as amended at 39 FR 22130, June 20, 1974; 39 FR 26397, July 19, 1974; 43 FR 6923, Feb. 17, 1978]

§ 32.70 Manufacture and distribution of byproduct materials for medical use under general license.

An application for a specific license to distribute byproduct material for use by physicians under the general license of § 35.31 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(b) The applicant submits evidence that the byproduct material is to be manufactured, labeled, and packaged in accordance with a new drug application which the Commissioner of Food and Drugs, Food and Drug Administration, has approved, or in accordance

with a license for a biologic product issued by the Secretary, Department of Health, Education, and Welfare;

(c) The following statement, or a substantially similar statement which contains the information called for in the following statement, appears on the label affixed to the container or appears in the leaflet or brochure which accompanies the package: 1

This radioactive drug may be received, possessed and used only by physicians licensed to dispense drugs in the practice of medicine. 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)

[30 FR 8192, June 26, 1965, as amended at 40 FR 8786, Mar. 3, 1975]

§ 32.71 Manufacture and distribution of byproduct material for certain in vitro clinical or laboratory testing under general license.

An application for a specific license to manufacturer or distribute byproduct material for use under the general license of § 31.11 of this chapter will be approved if:

(a) The applicant satisfies the general requirements specified in § 30.33 of this chapter.

(b) The byproduct material is to be prepared for distribution in prepackaged units of:

(1) Iodine-125 in units not exceeding 10 microcuries each.

(2) Iodine-131 in units not exceeding 10 microcuries each.

(3) Carbon-14 in units not exceeding 10 microcuries each.

(4) Hydrogen-3 (tritium) in units not exceeding 50 microcuries each.

(5) Iron-59 in units not exceeding 20 microcuries each.

(6) Selenium-75 in units not exceeding 10 microcuries each.

(7) Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129

'Radioactive drugs licensed under § 32.70 prior to January 19, 1975, may bear labels authorized by the regulations in effect on January 1, 1975.

and 0.005 microcurie of americium-241 each.

(c) Each prepackaged unit bears a durable, clearly visible label:

(1) Identifying the radioactive contents as to chemical form and radionuclide, and indicating that the amount of radioactivity does not exceed 10 microcuries of iodine-131, iodine-125, selenium-75, or carbon-14; 50 microcuries of hydrogen-3 (tritium); or 20 microcuries of iron-59; or Mock Iodine-125 in units not exceeding 0.05 microcurie of iodine-129 and 0.005 microcurie of americium-241 each; and

(2) Displaying the radiation caution symbol described in § 20.203(a)(1) of this chapter and the words, "Caution, Radioactive Material", and "Not for Internal or External Use in Humans or Animals."

(d) 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: '

The radioactive material may be received, acquired, possessed, and used only by physicians, veterinarians in the practice of veterinary medicine, 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 Commission has entered into an agreement for the exercise of regulatory authority.

(Name of Manufacturer)

(e) 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 byproduct material. In the case of the Mock Iodine-125 reference or calibration source, the information accompanying the source must also con

'Labels authorized by the regulations in effect on September 26, 1979, may be used until one year from September 27, 1979.

90-029 0-82--20

tain directions to the licensee regarding the waste disposal requirements set out in § 20.301 of Part 20 of this chapter.

(Sec. 201, Pub. L. 93-438, 88 Stat. 1242 (42 U.S.C. 5841))

[33 FR 16553, Nov. 14, 1968, as amended at 38 FR 34110, Dec. 11, 1973; 39 FR 26148, July 17, 1974; 40 FR 8786, Mar. 3, 1975; 42 FR 21604, Apr. 28, 1977; 42 FR 26987, May 26, 1977; 44 FR 50325, Aug. 28, 1979]

§ 32.72 Manufacture and distribution of radiopharmaceuticals containing byproduct material for medical use under group licenses.

(a) An application for a specific license to manufacture and distribute radiopharmaceuticals containing byproduct material for use by persons licensed pursuant to § 35.14 of this chapter for the uses listed in Group I, Group II, Group IV, or Group V of Schedule A, § 35.100 of this chapter will be approved if:

(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(2) The applicant submits evidence that:

(i) The radiopharmaceutical containing byproduct material will 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), a biologic product license issued by FDA, or a "Notice of Claimed Investigational Exemption for a New Drug” (IND) accepted by FDA; or

(ii) The manufacture and distribution of the radiopharmaceutical containing byproduct material is 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 byproduct material that is appropriate for safe handling and storage of radiopharmaceuticals by group licens

ees; and

(4)(i) The label affixed to each package of the radiopharmaceutical con

tains information on the radionuclide, quantity, and date of assay, and the label affixed to each package, or the leaflet or brochure which accompanies each package, contains a statement that the radiopharmaceutical is licensed by the U.S. Nuclear Regulatory Commission for distribution to persons licensed pursuant to § 35.14 and § 35.100 Group I, Group II, Group IV, or Group V of 10 CFR Part 35, as appropriate, or under equivalent licenses of Agreement States or that an application for such license has been filed with the Atomic Energy Commission on or before October 15, 1974 and is still pending.

(ii) The labels, leaflets or brochures required by this paragraph 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.

(b) If an application is filed pursuant to paragraph (a) of this section on or before October 15, 1974, for a license to manufacturer and distribute a radiopharmaceutical that was distributed commercially on or before August 16, 1974, the applicant may continue the distribution of such radiopharmaceutical to group licensees until the Commission issues the license or notifies the applicant otherwise.

[39 FR 26148, July 17, 1974]

§ 32.73 Manufacture and distribution of generators or reagent kits for preparation of radiopharmaceuticals containing byproduct material.

(a) An application for a specific license to manufacture and distribute generators or reagent kits containing byproduct material for preparation of radiopharmaceuticals by persons licensed pursuant to § 35.14 of this chapter for the uses listed in Group III of Schedule A, § 35.100 of this chapter will be approved if (See Note 1):

(1) The applicant satisfies the general requirements specified in § 30.33 of this chapter;

(2) The applicant submits evidence that:

(i) 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 new drug application (NDA) approved by the Food and Drug Administration (FDA), a biologic product license issued by FDA, or a "Notice of Claimed Investigational Exemption for a New Drug" (IND) accepted by FDA; or

(ii) 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.

NOTE 1. Although the Commission does not regulate the manufacture and distribution of reagent kits that do not contain byproduct material, it does regulate the use of such reagent kits for the preparation of radiopharmaceuticals containing byproduct material as part of its licensing and regulation of the users of byproduct material. Any manufacturer of reagent kits that do not contain byproduct material who desires to have his reagent kits approved by the Commission for use by persons licensed pursuant to 35.14 and Group III of Schedule A, § 35.100 of this chapter may submit the pertinent information specified in this § 32.73.

(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 byproduct 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:

(i) 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

(ii) A statement that this generator or reagent kit (as appropriate) is approved for use by persons licensed by the U.S. Nuclear Regulatory Commission pursuant to §§ 35.14 and 35.100 Group III of 10 CFR Part 35 or under

equivalent licenses of Agreement States, or that an application for such license has been filed with the Atomic Energy Commission on or before October 15, 1974 and is still pending.

The labels, leaflets or brochures required by this paragraph are in addition to the labeling required by FDA and they may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

(b) If an application is filed pursuant to paragraph (a) of this section on or before October 15, 1974, for a license to manufacture and distribute a generator or reagent kit that was distributed commercially on or before August 16, 1974, the applicant may continue the distribution of such generator or reagent kit until the Commission issues the license or notifies the applicant otherwise.

[39 FR 26148, July 17, 1974]

§ 32.74 Manufacture and distribution of sources or devices containing byproduct material for medical use.

(a) An application for a specific license to manufacture and distribute sources and devices containing byproduct material to persons licensed pursuant to § 35.14 of this chapter for use as a calibration or reference source or for the uses listed in Group VI Schedule A, § 35.100 of this chapter will be approved if:

(1) The applicant satisfies the general requirements in § 30.33 of this chapter;

(2) The applicant submits sufficient information regarding each type of source or device pertinent to an evaluation of its radiation safety, including: (i) The byproduct material tained, its chemical and physical form, and amount;

con

(ii) Details of design and construction of the source or device;

(iii) 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;

(iv) For devices containing byproduct material, the radiation profile of a prototype device;