Ohio Administrative Code › Title 4729:7 › Chapter 4729:7-3 › Section 4729:7-3-01 - Definitions - prescriber compounding

Current through all regulations passed and filed through July 1, 2024
As used in Chapter 4729:7-3 of the
				Administrative Code:
(A)
								"Antineoplastic" means a dangerous drug that blocks the
			 formation of neoplasms.
(B)
								"Beyond-use date" or "beyond-use dating" means either
			 the date or time after which a compounded drug preparation must not be used, or
			 administration must not begin, and must be discarded. The beyond-use date is
			 determined from the date/time that preparation of the compounded drug is
			 initiated.
(C)
								"Business day" means any day other than Saturday,
			 Sunday or a holiday recognized by the state of Ohio on which the offices of the
			 board of pharmacy are not open for business.
(D)
								"Compounding"
			 means the preparation, mixing, assembling, packaging, and labeling of one or
			 more drugs. Compounding includes the combining, admixing, mixing, diluting,
			 reconstituting, or otherwise altering of a drug or bulk drug
			 substance.
(E)
								"Controlled substance" has the same meaning as in
			 section 3719.01 of the Revised
			 Code.
(F)
								"Dangerous drug" has the same meaning as in section
			 4729.01 of the Revised
			 Code.
(G)
								"Dilution" means a process of reducing the
			 concentration of a solute in solution, usually by mixing with a
			 solvent.
(H)
								"Hazardous drug" means any antineoplastic drug listed
			 in table one on the national institute for occupational safety and health's
			 list of antineoplastic and other hazardous drugs in healthcare settings as
			 referenced in rule 4729:7-1-01 of the Administrative Code.
(I)
								"Immediate use"
			 or "immediate use drug" means the immediate preparation of a sterile
			 non-hazardous compounded drug preparation in accordance with rule 4729:7-3-04
			 of the Administrative Code.
(J)
								"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.
(K)
								"Non-sterile
			 compounded drug" means a dangerous drug preparation intended to be non-sterile.
			 Non-sterile compounded drugs include, but are not limited to, the preparation
			 of solutions, suspensions, ointments, creams, powders, suppositories, capsules,
			 and tablets.
(L)
								"Outsourcing facility" means a facility that is engaged
			 in the compounding and sale of sterile drugs, is registered as an outsourcing
			 facility with the United States food and drug administration, and is licensed
			 in accordance with section
			 4729.52 of the Revised
			 Code.
(M)
								"Personally furnish" or "personally furnishing" means
			 the final association of a drug with a patient by a prescriber prior to the
			 distribution to a patient for use outside the prescriber's practice
			 setting.
(N)
(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 that includes any of 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.