459.300 - Specific licenses: Manufacture, preparation or transfer for commercial distribution of radioactive drugs

459.300. Specific licenses: Manufacture, preparation or transfer for commercial distribution of radioactive drugs

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 under a license issued by the Nuclear Regulatory Commission or any other agreement state will be approved if:

(a) The applicant satisfies the general requirements specified in NAC 459.238;

(b) The applicant submits evidence that the applicant is:

(1) Registered or licensed as the owner or operator of a drug establishment that engages in the manufacture, preparation, propagation, compounding or processing of a drug by:

(I) The United States Food and Drug Administration pursuant to 21 C.F.R. § 207.20(a); or

(II) An agency of this State pursuant to equivalent regulations;

(2) Licensed as a pharmacy by the State Board of Pharmacy;

(3) Operating as a nuclear pharmacy within a medical facility; or

(4) A positron emission tomography drug production facility licensed by or registered with a state agency;

(c) The applicant submits information on the radionuclide, chemical and physical form, maximum activity per vial, syringe, generator or other container of the radioactive drug and shielding provided by the packaging of the radioactive material to demonstrate that it is appropriate for safe handling and storage of radioactive drugs by licensees authorized to use radioactive material for medical use; and

(d) The applicant complies with the following labeling requirements:

(1) A label must be affixed to each transport radiation shield of the radioactive drug, including, without limitation, shields made of lead, glass or plastic, to be transferred for commercial distribution. The label must set forth or contain the radiation symbol, the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL," the name of the radioactive drug, or its abbreviation, and the quantity of radioactivity at the time and date specified on the label. For radioactive drugs with a half-life of more than 100 days, the time may be omitted from the label.

(2) A label must be affixed to each syringe, vial or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must set forth the radiation symbol, the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier which ensures that the syringe, vial or other container can be correlated with the information on the transport radiation shield label.

2. A licensee who is licensed as a pharmacy by the State Board of Pharmacy or who is operating as a nuclear pharmacy within a medical facility:

(a) May prepare a radioactive drug for medical use if the radioactive drug is prepared by an authorized nuclear pharmacist as specified in paragraphs (b) and (c) or a person under the supervision of an authorized nuclear pharmacist as defined in 10 C.F.R. § 35.27.

(b) May allow a pharmacist to work as an authorized nuclear pharmacist if the pharmacist qualifies as an authorized nuclear pharmacist, as defined in 10 C.F.R. § 35.2, or if the pharmacist meets the requirements of 10 C.F.R. §§ 35.55(b) and 35.59, and the licensee has received an approved license amendment which identifies the pharmacist as an authorized nuclear pharmacist.

(c) May designate a pharmacist as an authorized nuclear pharmacist if the pharmacist:

(1) Was a nuclear pharmacist preparing only radioactive drugs containing accelerator-produced radioactive material; and

(2) Practiced at a pharmacy at a government agency or federally recognized Indian tribe before November 30, 2007, or at any other pharmacy before August 8, 2009, or an earlier date as noticed by the Nuclear Regulatory Commission.

(d) Shall provide to the Division:

(1) A copy of the certification by a specialty board whose certification process has been recognized by the Nuclear Regulatory Commission or an agreement state as provided in 10 C.F.R. § 35.55(a) with the written attestation signed by a preceptor as required by 10 C.F.R. § 35.55(b)(2);

(2) A copy of:

(I) The Nuclear Regulatory Commission or agreement state license;

(II) The Nuclear Regulatory Commission master materials licensee permit; or

(III) The permit issued by a licensee or Nuclear Regulatory Commission master materials permittee of broad scope;

(3) The authorization from a commercial nuclear pharmacy that is authorized to list its own authorized nuclear pharmacist or documentation which indicates 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 Nuclear Regulatory Commission; and

(4) A copy of the license or registration of the pharmacy or nuclear pharmacy within 30 days after the pharmacist performs any of the activities set forth in this subsection.

3. A licensee who prepares radioactive drugs for medical use pursuant to this section shall:

(a) Possess and use an instrument to measure the radioactivity of alpha-, beta- or photon-emitting radioactive drugs;

(b) Have procedures for the use of the instrument;

(c) Measure, by direct measurement or by a combination of measurements and calculations, the amount of radioactivity in dosages of alpha-, beta- or photon-emitting radioactive drugs before transfer for commercial distribution;

(d) Perform tests before initial use, periodically and following repair on each instrument for accuracy, linearity and geometry dependence, as appropriate for the instrument, and make adjustments to the instrument if necessary; and

(e) Check each instrument for constancy and proper operation at the beginning of each day of use.

4. The provisions of this section do not relieve a licensee of his or her duty to comply with any other federal, state or local requirement governing the receipt, administration or use of drugs or radioactive drugs.

Bd. of Health, Radiation Control Reg. §§ 3.5.5.10-3.5.5.10.1.4.2, eff. 2-28-80-NAC A 9-6-88; 11-1-95; R084-98, 1-26-99; R085-06, 11-13-2006; R149-07, 1-30-2008; R185-08, 5-7-2010

NRS 459.201

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