Ohio Administrative Code › Title 4729:5 - Dangerous Drugs › Chapter 4729:5-6 - Nuclear Pharmacies › Section 4729:5-6-01 - Definitions - nuclear pharmacies and radiopharmaceuticals

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:5-6 of the
				Administrative Code:
(A)
								"Radiopharmaceutical," "radiopharmaceutical
			 preparation," or "radioactive drug" means a finished dosage form of a dangerous
			 drug that contains a radioactive substance in association with one or more
			 other ingredients and that is intended to diagnose, stage a disease, monitor
			 treatment, or provide therapy. A radiopharmaceutical includes any
			 nonradioactive reagent kit or radionuclide generator that is intended to be
			 used in the preparation of any such substance. The terms "radiopharmaceutical"
			 and "radioactive drug" are commonly used interchangeably.
(B)
								"Authorized
			 nuclear pharmacist" means a licensed pharmacist that meets the requirements in
			 rule
			 3701:1-58-20
			 of the Administrative Code.
(C)
								"Beyond-use date"
			 means the assigned date and time beyond which the radiopharmaceutical must not
			 be administered.
(D)
								"Compounding" has the same meaning as in USP
			 <825>.
(E)
								"Dangerous drug" has the same meaning as in section
			 4729.01
			 of the Revised Code.
(F)
								"Dispense" means the final association of a drug with a
			 particular patient pursuant to a prescription, drug order, or other lawful
			 order of a prescriber and the professional judgment of and the responsibility
			 for interpreting, preparing, compounding, labeling, and packaging a specific
			 drug.
(G)
								"Final check" means the final verification check for
			 accuracy and conformity to the formula of the compounded preparation or product
			 being prepared, correct ingredients and calculations, accurate and precise
			 measurements, appropriate conditions and procedures, and appearance of the
			 final product.
(H)
								"Kit" means a commercially manufactured package
			 containing all ingredients required to prepare a radiopharmaceutical with the
			 exception of the radionuclide.
(I)
								"Licensed health
			 professional authorized to prescribe drugs" or "prescriber" has the same
			 meaning as in rule
			 4729:5-1-02
			 of the Administrative Code but shall be limited to a prescriber practicing
			 within the prescriber's applicable scope of practice.
(J)
								"Non-sterile
			 compounded drug" means a dangerous drug preparation intended to be
			 nonsterile.
(K)
								"Nuclear pharmacy" is a pharmacy licensed as a terminal
			 distributor of dangerous drugs where prescriptions for radiopharmaceuticals are
			 prepared, compounded, dispensed, or repackaged. A nuclear pharmacy shall also
			 be licensed by the United States nuclear regulatory commission or the
			 appropriate state nuclear regulatory agency.
(L)
								"Personal
			 supervision" means the person specified in rule shall be physically present at
			 the licensed location to provide personal review and approval of all
			 professional activities.
(M)
(1)
									"Positive
			 identification" means a method of identifying a person that does not rely on
			 the use of a private personal identifier such as a password, but must use a
			 secure means of identification such as the following:
(a)
										A manual
			 signature on a hard copy record;
(b)
										A magnetic card
			 reader;
(c)
										A bar code reader;
(d)
										A biometric
			 method;
(e)
										A proximity badge reader;
(f)
										A board approved
			 system of randomly generated personal questions;
(g)
										A printout of
			 every transaction that is verified and manually signed within a reasonable
			 period of time by the individual who prescribed, administered, or dispensed the
			 dangerous drug. The printout must be maintained for three years and made
			 readily retrievable; or
(h)
										Other effective methods for identifying individuals
			 that have been approved by the board.