(A) No person shall receive, possess, or transfer radiopharmaceuticals except in accordance with section 4729.51 of the Revised Code.
(B) No person, other than a nuclear pharmacist, shall be personally in full and actual charge of a nuclear pharmacy.
(C) No person shall conduct a nuclear pharmacy except in accordance with section 4729.28 of the Revised Code, state board of pharmacy rules, regulations of the United States nuclear regulatory commission or the appropriate state nuclear regulatory agencies, and regulations of other appropriate state agencies.
(D) No person shall utilize reusable unit dose transport containers for radioactive dosages without either an effective process to decontaminate the transport container of blood or other biohazardous substances or an effective mechanism to avoid contamination of the transport container.
(E) No person shall re-use a unit dose transport container that remains contaminated with blood or other biohazardous substances. Any unit dose transport container that is returned with the tamper-evident seal broken and the unit dose syringe included must be considered to be contaminated.
(F) This rule does not apply to:
(1) An individual prescriber who prepares radiopharmaceuticals for administration to the prescriber's patients as provided in section 4729.29 of the Revised Code.
(2) The transfer of radioactive material not intended for use as a drug to authorized persons.
(3) The occasional transfer of bulk quantities of radiopharmaceuticals to other authorized persons to meet shortages.
R.C. 119.032 review dates: 03/07/2014 and 05/22/2019
Promulgated Under: 119.03
Statutory Authority: 3715.69, 3719.28, 4729.26
Rule Amplifies: 3715.63, 3719.09, 4729.27, 4729.28, 4729.51
Prior Effective Dates: 4/1/1978, 9/1/1989, 7/1/1994, 3/1/1999, 4/27/2007