Current through all regulations passed and filed through September 16, 2024
(A)
A prescription,
to be valid, must be issued for a legitimate medical purpose by an individual
prescriber acting in the usual course of the prescriber's professional
practice. The responsibility for the proper prescribing is upon the prescriber,
but a corresponding responsibility rests with the pharmacist who dispenses the
prescription. An order purporting to be a prescription issued not in the usual
course of bona fide treatment of a patient is not a prescription and the person
knowingly dispensing such a purported prescription, as well as the person
issuing it, shall be subject to the penalties of law.
(B)
A pharmacist
dispensing an outpatient prescription shall comply with the requirements of
this chapter, including, but not limited to, the following:
(1)
Ensure that
patient information is profiled pursuant to rule
4729:5-5-07 of the
Administrative Code;
(2)
Perform prospective drug utilization review pursuant to
rule 4729:5-5-08 of the
Administrative Code; and
(3)
Ensure that the drug is labeled pursuant to rule
4729:5-5-06 of the
Administrative Code.
(C)
Prescriptions:
(1)
The front of hard copy prescriptions for controlled
substance dangerous drugs shall be clearly notated to indicate receipt by the
pharmacy in a manner that does not destroy any of the original information
contained on the prescription but prevents the unauthorized duplication of the
prescription.
(2)
When a pharmacist dispenses a drug pursuant to an
original prescription, the pharmacist must record the date of such dispensing
and the pharmacist's positive identification.
(3)
When a pharmacist
dispenses a drug pursuant to an authorized refill of a prescription, the
pharmacist must record the date of such dispensing and the pharmacist's
positive identification.
(D)
Oral
prescriptions:
(1)
A pharmacist shall make a record of the full name of
the prescriber and, if transmitted by the prescriber's agent, the full name of
the agent. The pharmacist is responsible for ensuring the validity of the
source of the oral prescription.
(2)
Upon receiving a
prescription from a recording device or voice mail service, a pharmacist shall
transcribe the information. The pharmacist must document on the original
prescription the full name of the prescriber and, if transmitted by the
prescriber's agent, the full name of the agent. The pharmacist is responsible
for ensuring the validity of the prescription removed from the recording device
or voice mail service.
(3)
A licensed pharmacy intern may receive telephone
prescriptions and remove prescriptions from a recording device or voice mail
service if the pharmacist on duty who is personally supervising the activity of
the intern determines that the intern is competent to perform this
function.
(a)
The intern shall immediately transcribe the prescription, document the full
name of the prescriber and, if transmitted by the prescriber's agent, the full
name of the agent and shall review the prescription with the pharmacist on
duty. Prior to dispensing, positive identification of the intern and the
pharmacist on duty shall be recorded to identify the responsibility for the
receipt of the oral order.
(b)
The pharmacist on
duty is responsible for the accuracy of the prescription.
(c)
The pharmacist on
duty must be immediately available to answer questions or discuss the
prescription with the prescriber or the prescriber's agent.
(4)
A
certified pharmacy technician may receive telephone prescriptions and remove
prescriptions from a recording device or voice mail service for non-controlled
drugs in accordance with rule
4729:3-3-04 of the
Administrative Code.
(E)
Facsimile
prescriptions:
A facsimile shall only be valid as a
prescription if a pharmacy retains a printed copy of a facsimile prescription
or an electronic copy of the facsimile prescription in accordance with rule
4729:5-5-03 of the
Administrative Code. The facsimile prescription shall comply with the
requirements of rule
4729:5-3-11 of the
Administrative Code.
(F)
Electronic
prescriptions:
(1)
A pharmacy receiving electronic prescriptions directly
into its computer system shall ensure original prescription information
received from the prescriber is maintained in accordance with rule
4729:5-5-03 of the
Administrative Code.
(2)
A pharmacy computer system receiving electronic
prescriptions shall:
(a)
Comply with the applicable provisions of 21 C.F.R. 1311
(05/01/19); and
(b)
Have the capability to receive an ICD-10-CM medical
diagnosis code for all controlled substance prescriptions pursuant to rule
4729:5-5-15 of the
Administrative Code.
(G)
Except as
provided for in section
4729.46 of the Revised Code, a
pharmacist shall not dispense a dangerous drug for the first time beyond six
months from the date of issuance of a prescription.
(H)
The quantity
prescribed shall be considered the quantity dispensed, unless the quantity
dispensed meets any of the following:
(1)
If the dispensed
prescription is less than the quantity prescribed, the pharmacist shall note
the quantity dispensed on the original prescription or within a computerized
recordkeeping system.
(2)
If the quantity dispensed on a prescription is greater
than the quantity prescribed, the pharmacist shall record on the original
prescription or within a computerized recordkeeping system the name of the
authorizing prescriber, the full name of the agent of the prescriber, if
applicable, the quantity authorized to be dispensed, and the date that the
authorization was obtained.
(3)
A prescription
dispensed in accordance with section
4729.40 of the Revised Code. The
pharmacist shall note the quantity dispensed on the original prescription or
within a computerized recordkeeping system.
(I)
Where a
prescription is written using a generic name, or where the pharmacist dispenses
an equivalent drug product pursuant to the provisions of sections
4729.38 and
4729.381 of the Revised Code,
the brand name or drug name and name of the manufacturer or distributor of the
drug or the national drug code (NDC) number of the drug dispensed must be
recorded in the record of dispensing by the pharmacist.
(J)
(1)
A prescription issued by a prescriber who experiences a
change of status, as defined in paragraph (J)(2) of this rule, that precludes a
continued prescriber-patient relationship may be dispensed by a pharmacist in
accordance with the following:
(a)
In the exercise of the pharmacist's professional
judgment:
(i)
The drug is essential to sustain the life of the patient or
continue therapy for a chronic condition of the patient; or
(ii)
Failure to
dispense the drug to the patient could result in harm to the health of the
patient.
(b)
The prescription was issued prior to the prescriber's
change of status, as defined in paragraph (J)(2) of this rule, and in
accordance with all applicable provisions of state and federal laws, rules and
regulations.
(c)
For a non-controlled substance prescription, a
pharmacist may dispense up to a thirty-day supply as provided in the
prescription or, if the standard unit of dispensing for the drug exceeds a
thirty-day supply, the amount of the drug dispensed shall not exceed the
standard unit of dispensing. The pharmacist shall exercise professional
judgment in determining the amount of the drug to be dispensed.
(d)
For a controlled
substance prescription, a pharmacist may dispense up to a seventy-two-hour
supply as provided in the prescription. The pharmacist shall exercise
professional judgment in determining the amount of the drug to be
dispensed.
(2)
A change of status includes, but is not limited to, the
following: death, incapacity, suspension, surrender or revocation of the
prescriber's license or registration, or permanent relocation.
(3)
A prescription
for a dangerous drug dispensed in accordance with paragraph (J)(1) of this rule
is considered void after the initial dispensing and may not be dispensed again.
Following the initial dispensing of the drug, a pharmacist shall utilize a
manual or electronic method for invalidating the prescription to prevent
further dispensing.
Replaces: 4729-5-21
