Section 4729:5-6-02 - Applicability(A) The provisions in this chapter apply to the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals for humans and animals prepared by a pharmacy, including an institutional facility, licensed as a terminal distributor of dangerous drugs. These standards apply to all radiopharmaceuticals, including those with radionuclides that emit a single photon, a positron, or a therapeutic particle, and intravascular radioactive devices (e.g. radioactive microspheres).(B) This chapter does not apply to the preparation, preparation with minor deviation, compounding, dispensing, personally furnishing, and repackaging of non-radioactive drugs, including those used as pharmacologic adjuncts for certain nuclear medicine procedures. These drugs shall be prepared in accordance with the applicable provisions of division 4729:7 of the Administrative Code.(C) Except if specifically stated in this chapter, an outpatient pharmacy shall also comply with Chapter 4729:5-5 of the Administrative Code.(D) Except if specifically stated in this chapter, an institutional pharmacy shall also comply with Chapter 4729:5-9 of the Administrative Code.(E) Except if specifically stated in this chapter, a nonresident nuclear pharmacy shall comply with the requirements of rule 4729:5-8-05 of the Administrative Code.(F) All terminal distributors of dangerous drugs engaged in the preparation, preparation with minor deviation, compounding, dispensing, or repackaging of radiopharmaceuticals for humans and animals shall comply with Chapter 3701:1-58 of the Administrative Code.Ohio Admin. Code 4729:5-6-02
Effective: 2/1/2022
Five Year Review (FYR) Dates: 02/01/2027
Promulgated Under: 119.03
Statutory Authority: 4729.26
Rule Amplifies: 4729.54