Current through Reg. 50, No. 187; September 24, 2024
In order to insure compliance with the general safety
requirements as previously set forth above, the following minimum requirements
shall be met by a nuclear pharmacy. These requirements are in addition to the
general requirements for space and equipment for other types of pharmacies, the
requirements of the Department of Health for the control of radiation hazards,
and the applicable requirements of the Federal Food and Drug Administration.
Such minimum permit requirements are set forth as follows:
(1) Space:
(a) The area for the storage, compounding,
distribution and disposal of radiopharmaceuticals shall be adequate to
completely separate such radioactive pharmaceuticals from pharmacy areas which
contain non-radioactive medicinal drugs;
(b) The Hot lab, storage area, and
compounding and dispensing area shall be a minimum of 150 square
feet.
(2) Equipment:
(a) Fume hood with appropriate air sampling
equipment;
(b) Shielded radiation
containment drawing station;
(c)
Dose calibrator;
(d) Well
scintillation counters;
(e) Area
rate meters;
(f) Geiger-Mueller
(GM) Survey meters;
(g)
Refrigerator;
(h)
Microscope;
(i) Syringe shields;
and,
(j) Personnel radiation
detection devices.
(3)
Supplies:
(a) Syringes and vials required to
perform practice;
(b) Disposable
gloves and protective lab coats;
(c) Appropriate supplies to ensure sterile
practices for I.V. solutions;
(d)
Appropriate supplies to perform thin layer chromotography;
(e) Lead transport shields for syringes and
vials. No person shall utilize reusable unit dose transport containers for
radioactive doses without either an effective process to decontaminate the
transport container of blood and other biohazardous substances or an effective
mechanism to avoid contamination of the transport container. No person shall
re-use a unit dose transport container that remains contaminated with blood or
other biohazardous subtances. Any unit dose transport container that is
returned with the tamper-evident seal broken and the unit dose syringe included
shall be considered to be contaminated.
(f) D.O.T. Type 7A approved transport
containers and other labels and supplies for shipping radioactive
materials.
(4) Current
references:
(a) Chapter 465, F.S.;
(b) Chapter 404, F.S.;
(c) Chapter 893, F.S.;
(d) Chapters 64B16-26 and 64B16-28, F.A.C.,
Rules of the Florida Board of Pharmacy;
(e) Chapter 64E-5, F.A.C., Rules of the
Department of Health;
(f) Title 10
C.F.R., Code of Federal Regulations, FDA Regulations;
(g) Title 49 C.F.R., Code of Federal
Regulations, Department of Transportation Regulations;
(h) United States Pharmacopeia/National
Formulary;
(i) USP-DI.
It shall be acceptable, in lieu of an actual hard copy, to
maintain these materials in a readily available electronic data
format.
Rulemaking Authority 465.005, 465.022 FS. Law Implemented
465.0193, 465.022(1) FS.
New 1-7-76, Formerly 21S-3.04, Amended 12-11-86, 4-4-88,
Formerly 21S-3.004, Amended 7-31-91, Formerly 21S-28.902, 61F10-28.902, Amended
2-26-95, Formerly 59X-28.902, Amended 4-26-01,
4-5-05.
