WAC 246-235-100   Manufacture, preparation, or commercial transfer of radiopharmaceuticals for medical use.  (1) An application for a specific license to manufacture and, prepare, or transfer for commercial distribution radiopharmaceuticals containing radioactive material for use by persons licensed under chapter 246-240 WAC for medical use in humans will be approved if:

     (a) The applicant satisfies the general requirements specified in WAC 246-235-020;

     (b) The applicant submits evidence that:

     (i) The applicant is registered or licensed with the U.S. Food and Drug Administration (FDA) as a drug manufacturer; or

     (ii) The applicant is licensed as a nuclear pharmacy by the state board of pharmacy;

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

     (d) The applicant satisfies the labeling requirements specified by the state board of pharmacy in WAC 246-903-020. For a drug manufacturer, the labels required by this subsection are in addition to the labeling required by the Food and Drug Administration (FDA) and may be separate from or, with the approval of FDA, may be combined with the labeling required by FDA.

     (2) A nuclear pharmacy licensee:

     (a) May prepare radiopharmaceuticals for medical use provided the radiopharmaceutical is prepared by or under the supervision of an authorized nuclear pharmacist.

     (b) May allow a pharmacist to work as an authorized nuclear pharmacist if:

     (i) This individual qualifies as an authorized nuclear pharmacist as defined in WAC 246-240-010;

     (ii) This individual meets the state board of pharmacy requirements in WAC 246-903-030, Nuclear pharmacists, and the requirements of WAC 246-240-081 and the licensee has received an approved license amendment identifying this individual as an authorized nuclear pharmacist; or

     (iii) This individual is designated as an authorized nuclear pharmacist in accordance with (d) of this subsection.

     (c) The actions authorized in (a) and (b) of this subsection are permitted in spite of more restrictive language in license conditions.

     (d) May designate a pharmacist as an authorized nuclear pharmacist if the individual is identified as of December 2, 1994, as an "authorized user" on a nuclear pharmacy license issued by the department, the U.S. NRC, or an agreement state.

     (e) Shall provide to the department a copy of each individual's letter of notification from the state board of pharmacy recognizing the individual as a nuclear pharmacist, within thirty days of the date the licensee allows the individual to work as an authorized nuclear pharmacist under (b) of this subsection.

     (3) A manufacturer or nuclear pharmacy licensee shall possess and use instrumentation to measure the radioactivity of radiopharmaceuticals. 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 radiopharmaceuticals, 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) Nothing in this section relieves the licensee from complying with applicable FDA, other federal, and state requirements governing radiopharmaceuticals.



[Statutory Authority: RCW 70.98.050. 07-14-131, § 246-235-100, filed 7/3/07, effective 8/3/07; 06-05-019, § 246-235-100, filed 2/6/06, effective 3/9/06; 98-13-037, § 246-235-100, filed 6/8/98, effective 7/9/98. Statutory Authority: RCW 70.98.050 and 70.98.080. 91-15-112 (Order 184), § 246-235-100, filed 7/24/91, effective 8/24/91. Statutory Authority: RCW 43.70.040. 91-02-049 (Order 121), recodified as § 246-235-100, filed 12/27/90, effective 1/31/91. Statutory Authority: RCW 70.98.050. 81-01-011 (Order 1570), § 402-22-110, filed 12/8/80. Statutory Authority: RCW 70.98.080. 79-12-073 (Order 1459), § 402-22-110, filed 11/30/79, effective 1/1/80. Formerly WAC 402-20-076.]