OHIO - DRUGS & DISPENSING

March 27, 2008

Ohio state laws and regulations that affect your medical practice

I. DISPENSING MEDICATION

1. What are the specific restrictions on the dispensing of medication from a medical office?

Under Ohio law, a licensed health professional authorized to prescribe drugs may dispense medication from his/her medical office, as long as it is within his/her scope of practice. When a physician personally dispenses drugs to a patient, the physician must ensure that the drugs are labeled and packaged in accordance with state and federal drug laws and any rules and regulations adopted pursuant to those laws. The physician must also maintain records of purchases and the disposition of all drugs furnished to patients under state and federal law.

R.C. § 4729.29

2. May a physician charge for medication distributed in a medical office?

Physicians may charge for medication distributed in a medical office. Ohio law states that records of purchase and disposition of all drugs personally furnished to patients must be maintained by the prescriber, pursuant to state and federal drug laws.

R.C. § 4729.29

3. Other than a physician, who can administer or prescribe scheduled drugs in a medical office setting?

Under Ohio law, a physician may “cause schedule II, III, and V controlled substances to be administered under the prescriber’s direction and supervision.”

Also, a licensed health professional who is a clinical nurse specialist, certified nurse-midwife, or certified nurse practitioner may prescribe a schedule II controlled substance only if the collaborating physician initially prescribed the controlled substance for the patient. The amount cannot exceed that necessary for a patient’s 24 hour use.

R.C. § 3719.06

4. What information must physicians provide on a prescription?

Ohio law dictates that all prescriptions issued by a prescriber shall:

(a) Be dated as of and on the day when issued;

(b) Contain the manually printed, typewritten, or preprinted full name and address of the prescriber;

(c) Indicate a telephone number where the prescriber can be personally contacted during normal business hours;

(d) Indicate the full name and address of the patient;

(e) Indicate the drug name and strength;

(f) Indicate the quantity to dispense;

(g) Indicate the appropriate directions for use;

(h) 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;

(i) Not authorize any refills for schedule II controlled substances;

(j) Authorize refills for schedules III and IV controlled substances only as permitted by section 3719.05 of the Revised Code;

(k) 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;

(l) Identify the trade name or generic name of the drug(s) in a compounded prescription;

(m) Not be coded in such a manner that it cannot be dispensed by any pharmacy of the patient’s choice;

(n) For prescriptions issued to a patient by a prescriber, be:

(i) Manually signed on the day issued by the prescriber in the same manner as he/she would sign a check or legal document; and

(ii) Issued so that there are no more than three noncontrolled substance prescription orders per prescription form.

(o) Ifpreprinted with multiple drug name and strength combinations:

(i) There are no controlled substances among the choices; and

(ii) There is only one prescription order selected per form.

(p) Be issued in compliance with all applicable federal and state laws, rules, and regulations.

Ohio Admin. Code § 4729-5-30(B)(1)-(15)

5. Are there any restrictions regarding the dispensing of medication received as "free samples"?

A physician may furnish sample drugs if all the following apply:

(a) The sample drug is furnished free of charge;

(b) The sample drug is in the manufacturer’s original container and is plainly marked “sample;”

(c) The sample drug has been stored under the proper conditions to prevent deterioration or contamination.

(d) If the drug deteriorates with time, it must be marked with the date the drug becomes unsafe to use;

(e) The drug is distributed, stored, or discarded in a way that it may not be accessed or used by any unauthorized person.

R.C. § 3719.81

III. CONTROLLED DANGEROUS SUBSTANCES – PRESCRIPTIONREQUIREMENTS

1. What is the purpose of a prescription?

A licensed health professional may prescribe S-II, S-III, S-IV, and S-V controlled substances if acting in the course of professional practice.

R.C. § 3719.06(A)(1)(a)

2. In what form must prescriptions for controlled substances be written?

A prescription for a controlled substance must be properly executed, dated, and signed by the prescriber on the day issued. Additionally, the prescription must display the full name and address of the person for whom the controlled substance is prescribed and the full name, address, and registry number under the federal drug abuse control laws of the prescriber.

R.C. § 3719.06(C)

3. What are the requirements of prescriptions for controlled dangerous substances?

The requirements depend upon the schedule under which the controlled substance is categorized. Thus, the following will address the requirements based on schedule classifications.

(a) Schedule II (S-II)

A physician may both prescribe and administer/personally furnish S-II, S-III, S-IV, and S-V controlled substances if acting in the course of his/her professional practice. A S-II controlled substance must only be dispensed upon written prescription, or may be dispensed upon an oral prescription in emergency situations defined in the federal drug abuse control laws. A physician may generally prescribe any quantity of drugs so long as the physician conforms to appropriate standards of care.

R.C. § 3719.06(A)

(b) Schedule III (S-III), Schedule IV (S-IV), and Schedule V (S-V)

A physician may both prescribe and administer/personally furnish S-III, S-IV, and S-V controlled substances if acting in the course of his/her professional practice. However, no physician may prescribe, administer, or personally furnish a S-III anabolic steroid for the purpose of muscle building or enhancing human athletic performance, unless it has been approved for the purpose by the FDA.

5. What are the requirements for the refilling of prescriptions?

The requirements for the refilling of prescriptions depend upon the schedule of the controlled substance.

(a) Schedule II (S-II)

The refilling of a prescription for a controlled substance listed in S-II is prohibited.

R.C. § 3719.05(A)(3)

(b) Schedule III (S-III) and Schedule IV (S-IV)

A physician is prohibited from prescribing more than a 30 day supply of S-III or S-IV controlled substance for the purposes of weight reduction. No prescription for a S-III or S-IV may be refilled more than five (5) times in a six (6) month period from the date the prescription is given by a prescriber.

R.C. § 3719.05(A)(5); Ohio Admin. Code, Rule 4731-11-04

Copyright © Kern Augustine Conroy and Schoppmann, P.C. Used with permission.

Updated 2008