Ohio Admin. Code 4729:5-5-01

Current through all regulations passed and filed through November 4, 2024

Section 4729:5-5-01 - Definitions - outpatient pharmacies

As used in Chapter 4729:5-5 of the Administrative Code:

(A) "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 and authorization of subsequent modifications of that prescription.

(B) "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.

(C) "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.

(D) "Original prescription" means any of the following issued in accordance with division 4729:5 of the Administrative Code:

(1) A prescription issued by a prescriber in writing;

(2) An oral prescription transcribed by a pharmacist, pharmacy intern, or certified pharmacy technician;

(3) An electronically transmitted prescription; or

(4) A prescription transmitted by use of a facsimile machine.

(E) "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, to provide personal review and approval of all professional activities.

(F) "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.

(G) "Pharmacist" means an individual who holds a current pharmacist license pursuant to Chapter 4729. of the Revised Code.

(H) "Outpatient pharmacy" means any pharmacy, including a clinic pharmacy, where drugs are dispensed for outpatient use. It does not include institutional pharmacies or institutional facilities, as defined in agency 4729 of the Administrative Code, where drugs are dispensed for use by inpatients. An outpatient pharmacy shall comply with all requirements set forth in this chapter.

(I)

(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 performed the action requiring positive identification. 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.

(2) A method relying on a magnetic card reader, a bar code reader, a proximity badge reader, or randomly generated questions for identification must also include a private personal identifier for entry into a secure mechanical or electronic system.

(J) "Practice of pharmacy" has the same meaning as in division (B) of section 4729.01 of the Revised Code.

(K) "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.

(L) "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.

Ohio Admin. Code 4729:5-5-01

Effective: 12/1/2020
Five Year Review (FYR) Dates: 12/01/2025
Promulgated Under: 119.03
Statutory Authority: 3719.28, 4729.26
Rule Amplifies: 4729.01