Section 1140-06-.02 - GENERAL REQUIREMENTS(1) A nuclear pharmacy practice site shall contain adequate space, commensurate with the scope of services required and provided. The board may, upon request, exempt a nuclear pharmacy practice site handling radioactive drugs exclusively from the minimum space requirements for pharmacy practice sites.(2) The compounding and dispensing area for radioactive drugs shall be separate from the compounding and dispensing area for non-radioactive drugs, and shall be secured from unauthorized personnel.(3) All pharmacy practice sites handling radiopharmaceuticals shall provide adequate radioactive storage and product decay area, preferably separate from and exclusive of the hot laboratory and the compounding, dispensing, quality assurance, and office areas. (4) A nuclear pharmacy practice site shall only dispense radiopharmaceuticals which comply with acceptable professional standards of radiopharmaceutical quality assurance.(5) A pharmacist may transfer to authorized persons radioactive materials not intended for drug use, in accordance with T.C.A.68-202-206. A nuclear pharmacy practice site may also furnish radiopharmaceuticals for office use to authorized practitioners for individual patient use.(6) In addition to any labeling requirements of the board for non-radioactive drugs, the immediate outer container of a radioactive drug to be dispensed shall also be labeled with: (a) the standard radiation symbol;(b) the words "Caution - Radioactive Material";(e) the amount of radioactive material contained, in millicuries or microcuries;(f) if a liquid, the volume;(g) the calibration time for the amount of radioactivity contained;(h) the expiration time; and(i) the name, address, and telephone number of the nuclear pharmacy practice site.(7) The immediate container shall be labeled with:(a) the standard radiation symbol;(b) the words "Caution - Radioactive Material";(c) the name of the drug; and(d) the medical or prescription order number.(8) The amount of radioactivity shall be determined by radiometric methods for each product immediately prior to dispensing.(9) A nuclear pharmacy practice site shall conduct and keep proper records of appropriate internal test assessments on all radiopharmaceuticals, with interpretation of the resulting data to determine suitability for use in humans.(10) A nuclear pharmacy practice site shall conduct authentication of product history by identifying and keeping proper records of the purchasing source, the ultimate fate, and any intermediate handling of any component of a radiopharmaceutical.Tenn. Comp. R. & Regs. 1140-06-.02
Original chapter filed January 26, 1987; effective April 29, 1987. Repeal and new rule filed May 11, 1998; effective July 25, 1998.Authority: T.C.A. § 63-10-404(4),(11),(16),(28), § 63-10-504(b)(1), § 63-10-504(b)(1),(2), § 63-10-504(j).