Or. Admin. Code § 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.
Notes
Stat. Auth.: ORS 475.035 & 689.205
Stats. Implemented:
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