Ohio Code 3719.08 – Label required
(A) As used in this division, “repackager” and “outsourcing facility” have the same meanings as in section 4729.01 of the Revised Code.
Terms Used In Ohio Code 3719.08
- Controlled substance: means a drug, compound, mixture, preparation, or substance included in schedule I, II, III, IV, or V. See Ohio Code 3719.01
- Manufacturer: means a person who manufactures a controlled substance, as "manufacture" is defined in section 3715. See Ohio Code 3719.01
- Person: means any individual, corporation, government, governmental subdivision or agency, business trust, estate, trust, partnership, association, or other legal entity. See Ohio Code 3719.01
- Pharmacist: means a person licensed under Chapter 4729 of the Revised Code to engage in the practice of pharmacy. See Ohio Code 3719.01
- Wholesaler: means a person who, on official written orders other than prescriptions, supplies controlled substances that the person has not manufactured, produced, or prepared personally and includes a "wholesale distributor of dangerous drugs" as defined in section 4729. See Ohio Code 3719.01
Whenever a manufacturer sells a controlled substance, and whenever a wholesaler, repackager, or outsourcing facility sells a controlled substance in a package the wholesaler, repackager, or outsourcing facility has prepared, the manufacturer or the wholesaler, repackager, or outsourcing facility, as the case may be, shall securely affix to each package in which the controlled substance is contained a label showing in legible English the name and address of the vendor and the quantity, kind, and form of controlled substance contained therein. No person, except a pharmacist for the purpose of dispensing a controlled substance upon a prescription shall alter, deface, or remove any label so affixed.
(B) Except as provided in division (C) of this section, when a pharmacist dispenses any controlled substance on a prescription for use by a patient, or supplies a controlled substance to a licensed health professional authorized to prescribe drugs for use by the professional in personally furnishing patients with controlled substances, the pharmacist shall affix to the container in which the controlled substance is dispensed or supplied a label showing the following:
(1) The name and address of the pharmacy dispensing or supplying the controlled substance;
(2) The name of the patient for whom the controlled substance is prescribed and, if the patient is an animal, the name of the owner and the species of the animal;
(3) The name of the prescriber;
(4) All directions for use stated on the prescription or provided by the prescriber;
(5) The date on which the controlled substance was dispensed or supplied;
(6) The name, quantity, and strength of the controlled substance and, if applicable, the name of the distributor or manufacturer.
(C) The requirements of division (B) of this section do not apply when a controlled substance is prescribed or supplied for administration to an ultimate user who is institutionalized.
(D) A licensed health professional authorized to prescribe drugs who personally furnishes a controlled substance to a patient shall comply with division (A) of section 4729.291 of the Revised Code with respect to labeling and packaging of the controlled substance.
(E) No person shall alter, deface, or remove any label affixed pursuant to this section as long as any of the original contents remain.
(F) Every label for a schedule II, III, or IV controlled substance shall contain the following warning:
“Caution: federal law prohibits the transfer of this drug to any person other than the patient for whom it was prescribed.”