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)
All outpatient
prescriptions issued by a prescriber shall:
(1)
Be dated as of
and on the day when issued.
(2)
Contain the
manually printed, typewritten, or preprinted full name, professional title, and
address of the prescriber. The prescriber's address shall include the physical
address of the prescriber's practice location.
(3)
Indicate a
telephone number where the prescriber can be contacted during normal business
hours.
(4)
Indicate the full name and residential address of the
patient; or, if the patient is an animal, the last name of the owner, name of
animal (if applicable), and species of the animal or animals. The patient or
owner's residential address shall include a physical street
address.
(5)
Indicate the drug name and strength.
(6)
Indicate the
quantity to dispense.
(7)
Indicate the appropriate and explicit directions for
use.
(8)
Specify the number of times or the period of time for
which the prescription may be refilled. If no such authorization is given, the
prescription may not be refilled except in accordance with section
4729.281 of the Revised
Code.
(a)
Prescriptions for non-controlled substance dangerous drugs
bearing "PRN," "Ad lib," or other similar prescription refill designation
permitting the pharmacist to refill the prescription as needed by the patient,
shall be refilled only in keeping with the number of doses ordered and
according to the directions for use, and, in no instance, shall such
prescription be refilled beyond one year from the date of issue. The
prescription shall not be refilled out of context with the dosage schedule
indicated in the directions for use unless specifically authorized by the
prescriber.
(b)
Prescriptions for controlled substance dangerous drugs
bearing "PRN," "Ad lib," or other similar prescription refill designation are
not considered a valid refill authorization.
(9)
Not authorize any
refills for schedule II controlled substances.
(10)
Authorize
refills for schedules III and IV controlled substances only as permitted by
section 3719.05 of the Revised
Code.
(11)
Not authorize a refill beyond one year from the date of
issuance for schedule V controlled substances and for dangerous drugs that are
not controlled substances.
(12)
Identify the
trade name or generic name of the drug(s) in a compounded
prescription.
(13)
Not be coded in such a manner that it cannot be
dispensed by any pharmacy of the patient's choice.
(14)
For a controlled
substance:
(a)
Indicate the drug enforcement administration registration
number of the prescriber pursuant to
21 CFR
1306.05 (3/31/2010).
(b)
Except for
veterinarians licensed pursuant to Chapter 4741. of the Revised Code, indicate
either:
(i)
The
ICD-10-CM medical diagnosis code of the primary disease or condition that the
controlled substance is being used to treat. The code shall, at a minimum,
include the first four alphanumeric characters of the ICD-10-CM medical
diagnosis code, sometimes referred to as the category and the etiology (ex. M
16.5).
(ii)
For dentists licensed pursuant to Chapter 4715. of the
Revised Code, the Code on Dental Procedures and Nomenclature (CDT Code), as
published by the American dental association, of the dental treatment requiring
the controlled substance prescription.
(15)
Except for
veterinarians licensed under Chapter 4741. of the Revised Code, for all
controlled substances and products containing gabapentin: indicate the
prescriber's intended days' supply of the prescription.
(16)
For a managing
pharmacist acting as an agent of a physician pursuant to section
4729.39 of the Revised Code and
Chapter 4729:1-6 of the Administrative Code, the prescription shall include the
full name of the managing pharmacist.
(17)
Be issued in
compliance with all applicable federal and Ohio laws, rules, and
regulations.
(C)
Failure of a prescription to contain the requirements
set forth in paragraphs (B)(14)(b) and (B)(15) of this rule or of the
pharmacist to obtain the information set forth in paragraphs (B)(14)(b) and
(B)(15) of this rule shall not render the prescription, if dispensed in good
faith, to be invalid.
(D)
All prescriptions issued on paper to a patient by a
prescriber shall be:
(1)
Manually signed on the day issued by the prescriber in
the same manner as the prescriber would sign a check or legal
document.
(2)
Issued in compliance with rule
4729:5-5-05 of the
Administrative Code.
(E)
When forms are
used that create multiple copies of a prescription issued to a patient by a
prescriber, the original prescription that includes the actual signature of the
prescriber must be issued to the patient for dispensing by a
pharmacist.
(F)
Pursuant to section
4729.38 of the Revised Code, a
pharmacist shall not select a generically equivalent drug or interchangeable
biological product if either of the following applies:
(1)
In the case of a
written or electronic prescription, including a computer- generated
prescription, the prescriber handwrites or actively causes to display on the
prescription "dispense as written," "D.A.W.," "do not substitute," "brand
medically necessary," or any other statement or numerical code that indicates
the prescriber's intent to prevent substitution. Such a designation shall not
be preprinted or stamped on the prescription, but a reminder to the prescriber
of the designation procedure may be preprinted or displayed on the prescription
form or electronic system the prescriber uses to issue the
prescription.
(2)
In the case of an oral prescription, the prescriber or
the prescriber's agent specifies that the drug as prescribed is medically
necessary or otherwise indicates the prescriber's intent to prevent
substitution.
(G)
Pursuant to section
4729.40 of the Revised Code, a
pharmacist shall not dispense a quantity or amount of drug that varies from the
quantity or amount of the drug that otherwise would be dispensed unless all the
conditions are met in accordance with that section and either of the following
applies:
(1)
The prescriber includes "dispense as written" or another phrase having a
similar meaning on the prescription. Such a designation shall not be preprinted
or stamped on the prescription, but a reminder to the prescriber of the
designation procedure may be preprinted or displayed on the prescription form
or electronic system the prescriber uses to issue the
prescription.
(2)
When issuing a prescription electronically or orally,
the prescriber specifies that the quantity or amount of the drug to be
dispensed may not vary from the quantity or amount specified in the
prescription.
(H)
Pursuant to section
4729.382 of the Revised Code, a
pharmacist shall not make the substitution of an epinephrine autoinjector if
either of the following applies to the prescription:
(1)
In the case of a
written or electronic prescription, including a computer-generated
prescription, the prescriber handwrites or actively causes to display on the
prescription "dispense as written," "D.A.W.," "do not substitute," "medically
necessary as prescribed," or any other statement or numerical code that
indicates the prescriber's intent to prevent substitution. Such a designation
shall not be preprinted or stamped on the prescription, but a reminder to the
prescriber of the designation procedure may be preprinted or displayed on the
prescription form or electronic system the prescriber uses to issue the
prescription.
(2)
In the case of an oral prescription, the prescriber
specifies that the epinephrine autoinjector as prescribed is medically
necessary or otherwise indicates the prescriber's intent to prevent
substitution.
(I)
A patient or patient's caregiver shall have the
exclusive right to freedom of choice for any pharmacy to dispense
prescriptions.
(J)
A pharmacist may dispense a prescription from a
prescriber practicing outside of Ohio, if all the following apply:
(1)
The prescriber
who issued the prescription would ordinarily be entitled to issue prescriptions
under Ohio law and the state where the prescription was issued;
(2)
The prescription
meets all the requirements of this rule, including whether the prescription is
for a legitimate medical purpose in accordance with paragraph (A) of this
rule.
(3)
The prescription is transmitted in accordance with rule
4729:5-3-11 of the
Administrative Code; and
(4)
For a controlled substance prescription, the prescriber
holds a valid drug enforcement administration registration number in the state
of origin of the prescription.
Replaces: 4729-5-30, 4729-5-
30.1
