Ohio Admin. Code 4729:5-5-15 - Manner of issuance of a prescription

(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

Notes

Ohio Admin. Code 4729:5-5-15

Effective: 12/1/2020
Five Year Review (FYR) Dates: 12/01/2025
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28
Rule Amplifies: 3719.05, 4729.38, 4729.39, 4729.37, 4729.281, 4729.01, 3719.06, 4729.26, 3719.28
Prior Effective Dates: 04/01/1978, 01/01/1981, 02/15/1982, 07/01/1990, 07/01/1994, 11/25/1994, 09/01/1996, 02/01/1998, 03/01/1999, 03/31/2000, 01/01/2001, 02/01/2002, 02/01/2003, 02/01/2005, 01/01/2006, 04/27/2007, 10/19/2007, 01/01/2009, 01/01/2010, 01/01/2011, 10/27/2011, 10/16/2015, 12/29/2017, 03/01/2018