The process employed by any permit holder in this state
concerning the handling of radioactive materials must involve appropriate
procedures for the purchase, receipt, storage, manipulation, compounding,
distribution and disposal of radioactive materials. In order to insure the
public health and safety in this respect, a nuclear pharmacy in this state
shall meet the following general requirements:
(1) Each nuclear pharmacy shall designate a
nuclear pharmacist as the prescription department manager who shall be
responsible for compliance with all laws and regulations, both state and
federal pertaining to radiopharmaceuticals and radiopharmaceutical services. A
nuclear pharmacist must personally supervise the operation of only one nuclear
pharmacy during all times when radiopharmaceutical services are being
performed.
(2) The nuclear pharmacy
area shall be secured from access by unauthorized personnel.
(3) Each nuclear pharmacy shall maintain
accurate records of the acquisition, inventory, distribution, and disposal of
all radiopharmaceuticals.
(4) All
nuclear pharmacies shall provide a secured radioactive storage and decay
area.
(5) Nuclear pharmacies shall
comply with all applicable laws and regulations of federal and state agencies
for the procurement, secure storage, inventory, preparation, distribution and
disposal of radiopharmaceuticals and other drugs.
(6) Radiopharmaceuticals are to be
distributed only upon a prescription order from an authorized licensed medical
practitioner or through the practitioner's agent.
(7) A nuclear pharmacist may transfer
radioactive materials in accordance with all applicable laws and
regulations.
(8) A nuclear
pharmacist upon receiving an oral prescription order for a radiopharmaceutical
shall immediately have the prescription order reduced to writing. The
pharmacist may delegate this duty to a registered pharmacy technician only as
authorized by Rule
64B16-27.410, F.A.C. The
prescription order shall contain at least the following:
(a) The name of the user or his
agent;
(b) The date of distribution
and the time of calibration of the radiopharmaceutical;
(c) The name of the procedure;
(d) The name of the
radiopharmaceutical;
(e) The dose
or quantity of the radiopharmaceutical;
(f) Any specific instructions; and,
(g) The initials of the person who
received the prescription order.
(h) The patient's name must be obtained and
recorded prior to dispensing, if the prescription order is for a therapeutic or
blood product radiopharmaceutical.
(9) The immediate outer container shield of a
radiopharmaceutical to be dispensed shall be labeled with:
(a) The name of and address of the
pharmacy;
(b) The name of the
prescriber;
(c) The date of the
original filling;
(d) The standard
radiation symbol;
(e) The words
"Caution Radioactive Material";
(f)
The name of the procedure;
(g) The
prescription order number of the radiopharmaceutical;
(h) The radionuclide and chemical
form;
(i) The amount of
radioactivity and the calibration date and time;
(j) The expiration date and time;
(k) The volume if a liquid;
(l) The number of items or weight, if a
solid;
(m) The number of ampules or
vials, if a gas;
(n) Molybdenum 99
content to USP limits, applies only to Tc 99m products; and,
(o) The name of the patient for therapeutic
or blood-product radiopharmaceuticals or the words "Physician's Use Only" for
diagnostic radiopharmaceuticals. If the prescription order is for a therapeutic
or blood-product radiopharmaceutical, the patient's name must be obtained and
recorded prior to dispensing. The requirements of this subsection shall be met
when the name of the patient is readily retrievable from the physician upon
demand.
(p) The initials of the
pharmacist who dispensed the medication.
(10) The immediate inner container label of a
radiopharmaceutical to be distributed shall be labeled with:
(a) The standard radiation symbol;
(b) The words "Caution Radioactive
Material";
(c) The
radionuclide;
(d) The chemical
form;
(e) The prescription order
number of the radiopharmaceutical.
