Ohio Administrative Code
Title 4729:5 - Dangerous Drugs
Chapter 4729:5-9 - Drug Repositories
Section 4729:5-9-01 - Definitions
Current through all regulations passed and filed through September 16, 2024
As used in Chapter 4729:5-9 of the Administrative Code:
(A) "Institutional facility" means any of the following:
(B) "Institutional pharmacy" means a pharmacy that primarily provides inpatient pharmacy services to an institutional facility in accordance with this chapter.
(C) "Audit trail" means all materials and documents required for the entire processing of a prescription, which shall be sufficient to document or reconstruct the origin of the prescription order, and authorization of subsequent modifications of that order.
(D) "Automated drug storage system" means a mechanical system used for the secure storage of dangerous drugs used as floor stock or contingency drugs outside of an institutional pharmacy that collects, controls, and maintains transaction information and records.
(E) "Contingency drugs" are a supply of non-patient specific dangerous drugs which may be required to meet the therapeutic needs of patients or staff when either apply:
(F) "Dispense" means the final association of a drug with a particular patient pursuant to a prescription, medication 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.
In the case of an automated drug storage system meeting the requirements of rule 4729:5-9-03.4 of the Administrative Code, the final association with the name of a particular inpatient will be deemed to have occurred when the pharmacist has given final approval to the patient specific order in the system.
(G) "Electronic drug record keeping system" means a system of storing drug records electronically and, when required, capturing positive identification.
(H) "Inpatient" means any person who receives drugs for use while within an institutional facility.
(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) "Medication order" or "inpatient prescription" means a written, electronic, facsimile, or oral order for a drug to be dispensed or administered in treating an inpatient.
(K) "OARRS report" means a report of information related to a specific person generated by the drug database established and maintained pursuant to section 4729.75 of the Revised Code.
(L) "Outpatient" means any person who receives drugs for use outside of an institutional facility.
(M) "Medications removed on override function" or "override medications" means a dangerous drug that may be removed from floor stock or contingency drugs prior to pharmacist review because the institutional facility's interdisciplinary committee has determined that the clinical status of the patient would be compromised by delay.
(N) "Personal supervision" or "direct supervision" means a pharmacist shall be physically present in the pharmacy, or in the area where the practice of pharmacy is occurring, and provides personal review and approval of all professional activities.
(O) "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 an institutional facility. A prescriber at an institutional facility who personally furnishes a dangerous drug shall comply with the requirements of rule 4729:5-19-02 of the Administrative Code.
(P) "Pharmacist" means an individual who holds a current pharmacist license under Chapter 4729. of the Revised Code.
(Q) "Pharmacy," except when used in a context that refers to the practice of pharmacy, means any area, room, rooms, place of business, department, or portion of any of the foregoing where the practice of pharmacy is conducted.
(R)
(S) "Point of care location" means a location within an institutional facility that stores dangerous drugs and all the following apply:
(T) "Practice of pharmacy" has the same meaning as in division (B) of section 4729.01 of the Revised Code.
(U) "Readily retrievable" means that records maintained in accordance with this chapter shall be kept in such a manner that, upon request, they can be produced for review no later than three business days to an agent, officer or inspector of the board.
(V) "Responsible person" has the same meaning as defined in rule 4729:5-2-01 of the Administrative Code and is responsible for the supervision and control of dangerous drugs as required in division (B) of section 4729.55 of the Revised Code, adequate safeguards as required in division (C) of section 4729.55 of the Revised Code, security and control of dangerous drugs, and maintaining all drug records otherwise required.
(W) "Skilled nursing care" has the same meaning as in section 3721.01 of the Revised Code.
(X) "Tamper-evident" means a package, storage container or other physical barrier is sealed or secured in such a way that access to the drugs stored within is not possible without leaving visible proof that such access has been attempted or made.
Replaces: 4729-17-01