Requirements for the Issuance of Nuclear Pharmacy Permit
Effective Jan 14, 2005MGL 112, § 24 MGL 112, § 39B MGL 112, § 42ABoard of Registration in Pharmacy
- (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 money order 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 pharmacywould be inconsistentwith, 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 finaldecision 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 withapplicable federal, state and local statutes, ordinances, and/or regulations, it shallissue a permit to the applicant nuclear pharmacy.