Fla. Admin. Code R. 64B16-28.901

Current through Reg. 50, No. 222; November 13, 2024

Section 64B16-28.901 - Nuclear Pharmacy - General Requirements

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.

Fla. Admin. Code Ann. R. 64B16-28.901

Rulemaking Authority 465.005, 465.022 FS. Law Implemented 465.003(11)(a)3., 465.003(14), (15), 465.0126, 465.014 FS.

New 1-7-76, Formerly 21S-3.03, Amended 12-11-86, 4-4-88, Formerly 21S-3.003, 21S-28.901, 61F10-28.901, Amended 2-26-95, Formerly 59X-28.901, Amended 4-5-05, 1-1-10, 12-31-13.