64B16-28.902. Nuclear Pharmacy - Minimum Requirements

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.

Specific Authority 465.005, 465.022 FS. Law Implemented 465.0193, 465.022(1) FS. History–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.