Code of Massachusetts Regulations
247 CMR - BOARD OF REGISTRATION IN PHARMACY
Title 247 CMR 13.00 - Registration Requirements And Minimal Professional Standards For Nuclear Pharmacies
Section 13.03 - Requirements for the Issuance of Nuclear Pharmacy Permit

Universal Citation: 247 MA Code of Regs 247.13

Current through Register 1531, September 27, 2024

(1) An applicant for an initial permit to establish a nuclear pharmacy shall be made by submitting to the Board a fully and properly completed application form provided by the Board.

(2) An application for a nuclear pharmacy permit shall be accompanied by a check or moneyorder in the required amount payable to the "Commonwealth of Massachusetts Board of Registration in Pharmacy".

(3) No permit shall be issued to a proposed nuclear pharmacy unless there are maintained on the pharmacy premises the following publications:

(a) The most recent edition of the United States Pharmacopoeia, including the latest supplement thereto;

(b) the most recent edition of Remington's Pharmaceutical Sciences; and

(c) current texts on the practice of nuclear pharmacy and radiation safety.

(4) No permit shall be issued to a proposed nuclear pharmacy by the Board unless said proposed nuclear pharmacy maintains on the premises the following equipment:

(a) A dose preparation station;

(b) a dose calibrator;

(c) an exhaust hood and filter system for handling radioactive gases or volatile radioactive materials;

(d) a refrigerator for exclusive storage of radioactive materials or reagent kits which require refrigeration;

(e) chromatographic apparatus as required for radiopharmaceutical quality assurance;

(f) a portable radiation survey meter capable of detecting 0.005 microcuries of radio-nuclides;

(g) area radiation detection room monitors;

(h) personnel dosimeters;

(i) a single-channel or multichannel scintillation analyzer; and

(j) supplies necessary for dispensing including, but not limited to, sterile multi-dose vials, syringes, disposable alcohol swabs, and adequate shielding for each dosage dispensed.

(5) No permit shall be issued to a proposed nuclear pharmacy by the Board unless said proposed pharmacy conforms to the following conditions:

(a) The premises are clean and sanitary; and

(b) no entrances or exits shall connect directly with other places of business.

(6) Prior to acting upon any application for the issuance of a permit for a nuclear pharmacy, the Board may require the applicant to appear before the Board to discuss the merits of the application.

(7) The Board shall issue a nuclear pharmacy permit to such person as it deems qualified to conduct such a pharmacy; provided, however, that the Board may deny the issuance of a permit if, in its discretion, it determines that such pharmacy would be inconsistent with, or opposed to, the best interest of the public health, welfare, and safety.

(8) The Board shall, within 150 days after the filing of an application for an initial nuclear pharmacy permit, render a final decision denying or allowing the issuance of such permit. Failure to render such decision; except when failure to act is caused by the delay of the applicant, shall constitute the approval of the application and the permit shall be issued.

(9) The Board shall not issue a nuclear pharmacy permit to a corporation unless it appears to the satisfaction of the Board that such nuclear pharmacy is managed and operated by a registered pharmacist in good standing with the Board.

(10) When the Board is satisfied that a proposed nuclear pharmacy has complied with the requirements of 247 CMR 13.00 and shall be operated in compliance with applicable federal, state and local statutes, ordinances, and/or regulations, it shall issue a permit to the applicant nuclear pharmacy.

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