4729:5-5-06. Labeling of drugs dispensed on prescription

(A) No drug may be dispensed by outpatient prescription unless a label is affixed to the container in which such drug is dispensed, and such label includes:

(1) The name or "doing business as" (DBA) name and address of the pharmacy as it appears on the terminal distributor of dangerous drugs license;

(2) The full name of the patient for whom the drug is prescribed; 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;

(3) The full name of the prescriber or the first initial of the prescriber's first name and the full last name of the prescriber;

(4) Directions for use of the drug;

(5) The date of dispensing;

(6) Any cautions which may be required by federal or state law;

(7) The serial number of the prescription;

(8) The proprietary name, if any, or the generic name and the name of the distributor or national drug code of the drug dispensed, and the strength, if more than one strength of the drug is marketed. The dispensing pharmacist may omit the name and strength of the drug only if the prescriber specifically requests omission and such request is documented; and

(9) The quantity of drug dispensed.

(B) The term "affix" means the prescription label must be attached or fastened to the drug's container.

(C) A label meeting the requirements in paragraph (A) of this rule may be placed on the packaging of a commercially manufactured dangerous drug product.

Replaces: 4729-5-16

Effective: 12/1/2020
Five Year Review (FYR) Dates: 12/01/2025
Promulgated Under: 119.03
Statutory Authority: 4729.26, 3719.28, 3715.69
Rule Amplifies: 4729.37, 4729.28, 4729.27, 4729.01, 3719.08, 3719.01, 3715.64, 4729.38
Prior Effective Dates: 09/10/1976, 08/01/1984, 09/01/1985, 07/01/1991, 02/01/1998, 03/01/1999, 01/01/2010, 101/2016