As used in Chapter 4729-15 of the Administrative Code:
(A) "Class 100 environment" means an atmospheric environment that contains no more than one hundred particles of 0.5 microns in diameter or larger per cubic foot of air according to "Federal Standard 209E". A class 100 environment is equivalent to ISO class 5.
(B) "Class 100,000 environment" means an atmospheric environment that contains no more than one hundred thousand particles of 0.5 microns in diameter or larger per cubic foot of air according to "Federal Standard 209E". A class 100,000 environment is equivalent to ISO class 8.
(C) "Nuclear pharmacist" shall be a licensed pharmacist holding a current identification card in the state of Ohio, and meets the following standards:
(1) Be certified as a nuclear pharmacist by the "Board of Pharmaceutical Specialties"; or
(2) Meet minimal standards of training for an "authorized user" of radioactive material or for an "authorized nuclear pharmacist (ANP)" designation by the proper nuclear regulatory agency, the United States nuclear regulatory commission, or the appropriate state agency including:
(a) Have received a minimum of two hundred contact hours of didactic instruction in nuclear pharmacy and the safe handling and use of radioactive materials from an accredited college of pharmacy or a program approved by the nuclear regulatory commission, with emphasis in the following areas:
(i) Radiation physics and instrumentation;
(ii) Radiation protection;
(iii) Mathematics of radioactivity;
(iv) Radiation biology;
(v) Radiopharmaceutical chemistry.
(b) Attain a minimum of five hundred hours of clinical nuclear pharmacy training under the supervision of a pharmacist trained in nuclear pharmacy and who is an "authorized user" or an "authorized nuclear pharmacist" as defined by the nuclear regulatory commission.
(D) "Nuclear pharmacy" is a pharmacy where prescriptions for radiopharmaceuticals are filled or where radiopharmaceuticals are compounded or dispensed by a pharmacist licensed by the proper authorities to receive, possess, and use such drugs. A nuclear pharmacy shall be licensed by the United States nuclear regulatory commission or the appropriate state nuclear regulatory agencies, other appropriate state agencies, and by the state board of pharmacy.
(E) "Radiopharmaceutical," a dangerous drug as defined in division (F) of section 4729.01 of the Revised Code, shall include any article that exhibits spontaneous decay or disintegration of an unstable atomic nucleus, usually accompanied by the emission of ionizing radiation and any nonradioactive reagent kit or nuclide generator which is intended to be used in the preparation of any such article.
Five Year Review (FYR) Dates:
Promulgated Under: 119.03
Statutory Authority: 3719.28 , 4729.26
Rule Amplifies: 4729.01, 3719.01
Prior Effective Dates: 4/1/78, 9/1/89, 7/1/94, 3/1/99, 2/1/05