North Carolina Administrative Code › Title 21 - OCCUPATIONAL LICENSING BOARDS AND COMMISSIONS › Chapter 46 - BOARD OF PHARMACY › Section .2700 - NUCLEAR PHARMACY › Section 46 .2704 - REQ FOR PHARMACIES PROVIDING RADIOPHARMACEUTICAL SERVICES

Current through Register Vol. 39, No. 2, July 15, 2024
(a) The permit to operate a pharmacy
				providing radiopharmaceutical services shall be issued by the Board only to a
				qualified nuclear pharmacist. All personnel performing tasks in the preparation
				and distribution of radiopharmaceuticals shall be under the direct supervision
				of a qualified nuclear pharmacist. A qualified nuclear pharmacist shall be
				responsible for all operations of the pharmacy related to radiopharmaceutical
				services and shall be in personal attendance at all times that the pharmacy
				renders radiopharmaceutical services.
(b) In emergency situations, and in the
				absence of a qualified nuclear pharmacist, designated qualified licensed
				professionals as identified by the pharmacist-manager in established written
				policies and procedures may have access to the area designated as the nuclear
				pharmacy area, and these individuals may prepare single doses of
				radiopharmaceuticals for the immediate emergency only and must document such
				activities.
(c) The nuclear
				pharmacy area shall be secured from entry by unauthorized personnel as
				identified by the pharmacist-manager in established written policies and
				procedures.
(d) Nuclear pharmacies
				shall maintain records of acquisition, inventory and disposition of all
				radiopharmaceuticals in accordance with Section .2300 of this Chapter and the
				applicable regulations of the North Carolina Division of Radiation
				Protection.
(e) All pharmacies
				handling radiopharmaceuticals shall provide a radioactive storage and product
				decay area that provides sufficient protection from radioactivity of all areas
				surrounding the nuclear pharmacy area. Floor plans shall be submitted and
				approved by the Board staff before a nuclear pharmacy permit is
				issued.
(f) Radiopharmaceuticals
				are to be dispensed only upon a prescription or medication order from a
				licensed medical practitioner authorized to possess, use and administer
				radiopharmaceuticals.
(g) The
				library of a nuclear pharmacy shall contain, in addition to the volumes
				required by Rule .1601(a)(3) of this Chapter, copies of current state and
				federal regulations governing the safe storage, handling, use, dispensing,
				transport, and disposal of radiopharmaceuticals.
(h) All pharmacies performing
				Radiopharmaceutical Services shall have in effect a procedures manual setting
				forth the procedures and policies of the pharmacy regarding Radiopharmaceutical
				Quality Assurance. This manual shall at all times be readily available for
				review by Board personnel.
(i)
				Permit holders must obtain licensure from the North Carolina Division of
				Radiation Protection and the number of that license. Copies of the Division's
				inspection report shall be made available upon request for inspection by Board
				personnel.
Authority
				  G.S.
				  90-85.6;
				  90-85.34;
Eff. October
				  1, 1990;
Amended Eff. February 1, 2005;
Pursuant to
				  G.S.
				  150B-21.3A, rule is necessary without
				  substantive public interest Eff. October 3,
				  2017.