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The Oregon Administrative Rules contain OARs filed through November 15, 2014
 
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BOARD OF PHARMACY

 

DIVISION 42

NUCLEAR PHARMACIES AND PHARMACISTS

 

855-042-0005

Purpose and Scope

(1) Any person who provides radiopharmaceutical services shall be a nuclear pharmacist or working under the supervision of a nuclear pharmacist and shall act in accordance with the State Board of Pharmacy and State Radiation Control Agency rules.

(2) These rules shall not apply to anyone who is an "authorized practitioner" as that term is defined in these rules.

(3) The requirements imposed by these nuclear pharmacy rules shall apply in addition to, and not in place of, any other requirements contained in rules of the State Board of Pharmacy, the State Radiation Control Agency, or any other state or federal agency.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: PB 7-1987, f. & ef. 7-8-87

855-042-0010

Definitions

(1) A "Nuclear Pharmacy" is a pharmacy providing radiopharmaceutical services.

(2) "Nuclear Pharmacist" means a licensed pharmacist who has met the requirements of these rules regarding training, education, and experience, and has received a letter of notification from the board indicating the board recognizes the pharmacist, based on evidence submitted, as qualified to provide radiopharmaceutical services.

(3) "Radiopharmaceutical Services" shall mean, but shall not be limited to, the compounding, dispensing, labeling and delivery or radiopharmaceuticals; the participation in radiopharmaceutical selection and radiopharmaceutical utilization reviews; the proper and safe storage and distribution of radiopharmaceuticals; the maintenance of radiopharmaceutical quality assurance; the responsibility for advising, where necessary or where regulated, of therapeutic values, hazards and use of radiopharmaceuticals; and the offering or performing of those acts, services, operations or transactions necessary in the conduct, operation management and control of a nuclear pharmacy.

(4) A "Radiopharmaceutical" is any substance defined as a drug in Section 201(g)(1) of the federal Food, Drug and Cosmetic Act which exhibits spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons and includes any such drug which is intended to be made radioactive. This definition includes nonradioactive reagent kits and nuclide generators which are intended to be used in the preparation of any such substance but does not include drugs such as carbon-containing compounds or potassium-containing compounds or potassium-containing salts which contain trace quantities of naturally occurring radionuclides.

(5) "Radiopharmaceutical Quality Assurance" means, but is not limited to, the performance of appropriate chemical, biological and physical tests on radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment authentication of product history and the keeping of proper records.

(6) "Internal Test Assessment" means, but is not limited to, conducting those tests of quality assurance necessary to insure the integrity of the test.

(7) "Authentication of Product History" means, but is not limited to, identifying the purchasing source, the ultimate fate, and intermediate handling of any component of a radiopharmaceutical.

(8) "Authorized Practitioner" means a practitioner duly authorized by law to possess, use, and administer radiopharmaceuticals.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: PB 7-1987, f. & ef. 7-8-87

855-042-0015

Nuclear Pharmacies

(1) Every nuclear pharmacy shall have a nuclear pharmacist designated on the nuclear pharmacy registration as the pharmacist-in-charge who shall be responsible for the nuclear pharmacy's compliance with laws and rules, both state and federal, pertaining to the practice of nuclear pharmacy. All personnel performing tasks in the preparation and distribution of radio-pharmaceuticals shall be under the supervision of a nuclear pharmacist. The nuclear pharmacy pharmacist-in-charge shall see that directives from the board are communicated to the owner(s), management, other pharmacists, and interns of the nuclear pharmacy. A pharmacist may be pharmacist-in-charge for no more than one nuclear pharmacy at any one given time.

(2) Nuclear pharmacies shall have adequate space, commensurate with the scope of services to be provided. The nuclear pharmacy area shall be separate from the pharmacy areas for nonradio-pharmaceuticals and shall be secured from access by unauthorized personnel. Detailed floor plans shall be submitted to the State Board of Pharmacy and the State Radiation Control Agency before approval of the registration.

(3) Nuclear pharmacies shall only dispense radiopharmaceuticals which comply with accepted professional standards of radiopharmaceutical quality assurance.

(4) Nuclear pharmacies shall maintain records of acquisition and disposition of all radiopharmaceuticals in accordance with applicable rules of the state Board of Pharmacy, the State Radiation Control Agency and other state and federal agencies.

(5) For nuclear pharmacies handling radiopharmaceuticals exclusively, the State Board of Pharmacy may waive regulations pertaining to the pharmacy registration for nonradiopharmaceuticals for requirements that do not pertain to the practice of nuclear pharmacy.

(6) Radiopharmaceuticals are to be dispensed only upon a prescription from a practitioner authorized to possess, use and administer radiopharmaceuticals. A nuclear pharmacy may also furnish radiopharmaceuticals for office use to these practitioners.

(7) A nuclear pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with regulations of the state radiation control agency.

(8) Prescriptions or medication orders for radiopharmaceuticals shall include:

(a) The name of the practitioner and/or institution;

(b) The name of the radiopharmaceutical;

(c) The amount of radioactivity to be contained in millicuries, microcuries, or the SI equivalent at calibration;

(d) The date and time of calibration, and volume.

(9) In addition to any labeling requirements of the state Board of Pharmacy for nonradiopharmaceuticals, the outer container of any radiopharmaceutical to be dispensed shall also be labeled with:

(a) The prescription number and the patient's name (of the words "Physician Use Only" in the absence of the name of the patient);

(b) The standard radiation symbol;

(c) The words "Caution -- Radioactive Material";

(d) The name of the radiopharmaceutical;

(e) The lot number;

(f) The amount of radioactive material contained in millicuries, microcuries, or their SI equivalent;

(g) If a liquid, the volume in milliliters;

(h) The requested calibration date and time; and

(i) Expiration date and/or time, if applicable;

(j) Specific concentration of radioactivity;

(k) The name and address of the practitioner and/or institution that ordered the radiopharmaceuticals.

(10) The immediate inner container of a radiopharmaceutical shall be labeled with:

(a) Standard radiation symbol;

(b) The words "Caution -- Radioactive Material"; and

(c) The name and prescription number of the radiopharmaceutical;

(d) The prescription number;

(e) The name of the nuclear pharmacy;

(f) The date; and

(g) The amount of radioactive material in millicuries, microcuries, or their SI equivalent.

(11) The amount of radioactivity shall be determined by radiometric methods for each individual preparation immediately prior to dispensing.

(12) Nuclear pharmacies may redistribute NDA (New Drug Application) approved radiopharmaceuticals to authorized persons if the pharmacy does not process the radiopharmaceuticals in any manner or violate the product packaging.

(13) The nuclear pharmacy shall have the current revisions of state laws and rules of the State Board of Pharmacy and State Radiation Control Agency.

(14) The nuclear pharmacy shall maintain a reference library commensurate with the level of radiopharmaceutical service to be provided and shall include, in addition to the requirements listed in OAR 855-041-0040;

(a) Oregon radiation control regulations;

(b) CFR Title 10, Parts 0-199, with current amendments; and

(c) CFR Title 49, Parts 106-199, with current amendments.

Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented:
Hist.: PB 7-1987, f. & ef. 7-8-87; PB 1-1994, f. & cert. ef. 2-2-94

855-042-0025

Minimum Equipment Requirements

(1) Nuclear pharmacies shall have adequate equipment commensurate with the scope of radiopharmaceutical services to be provided. A detailed list of equipment and description of use must be submitted to the State Board of Pharmacy and Radiation Control Agency before approval of the license.

(2) The State Board of Pharmacy may, for good cause shown, waive rules pertaining to the equipment and supplies required for nuclear pharmacies handling radiopharmaceuticals exclusively.

Stat. Auth.: ORS 689
Stats. Implemented:
Hist.: PB 7-1987, f. & ef. 7-8-87

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