Conn. Agencies Regs. § 20-576-61

Current through December 27, 2024
Section 20-576-61 - General requirements for pharmacies providing radiopharmaceutical services
(a) A license to operate a nuclear pharmacy shall only be issued to a person who is, or who employs, a nuclear pharmacist.
(b)
(1) A nuclear pharmacist shall:
(A) be responsible for all operations of the nuclear pharmacy;
(B) supervise the operation of only one nuclear pharmacy; and
(C) be present at all times that radiopharmaceutical services are being performed and at all times that the nuclear pharmacy is open for business.
(2) The license to operate a nuclear pharmacy shall be effective only if the pharmacy also holds appropriate federal and state licenses and permits to possess and distribute radioactive materials. Copies of all inspection reports prepared by any nuclear licensing agency shall be made available for department or commission inspection upon request.
(c) Nuclear pharmacies shall:
(1) have adequate space and equipment, commensurate with the scope of services required and provided;
(2) include, but are not limited to, the following areas: radiopharmaceutical preparation and dispensing area; radioactive material shipping and receiving area; radioactive material storage area and radioactive waste decay area;
(3) be secured from entry by unauthorized personnel;
(4) maintain records, including, but not limited to, the acquisition, inventory and disposition of all radiopharmaceuticals;
(5) compound and dispense radiopharmaceuticals that meet accepted standards of radiopharmaceutical quality, including, but not limited to, standards established by the United States Nuclear Regulatory Commission; and
(6) dispense radiopharmaceuticals only upon receipt of an order from a licensed practitioner or the practitioner's agent, or from a person authorized by the United States Nuclear Regulatory Commission or agreement state agency to possess such radiopharmaceuticals.
(d)
(1) A nuclear pharmacist may transfer to authorized persons and United States Nuclear Regulatory Commission licensed medical practitioners radioactive materials not intended for drug use, in accordance with the regulations of the United States Nuclear Regulatory Commission and the Regulations of Connecticut State Agencies. A nuclear pharmacy may also furnish radiopharmaceuticals and other drug products for office use to these practitioners for individual patient use.
(2) Nuclear pharmacies may redistribute United States Food and Drug Administration approved radioactive drugs if the nuclear pharmacy does not process the radioactive drugs in any manner nor violate the product packaging. Drugs dispensed in this manner are not subject to the labeling requirements of section 20-576-62(c) of the Regulations of Connecticut State Agencies.

Conn. Agencies Regs. § 20-576-61

Adopted effective November 30, 2006