Sec. 11. (a) Except as provided in section 21 of this chapter, a person may not sell a legend drug unless either of the following conditions exist:

(1) Except as provided in subsection (b), the legend drug is dispensed by a pharmacist upon an original prescription or drug order with the drug product specified on the prescription or drug order or by the authorization of the practitioner and there is affixed to the immediate container in which the drug is delivered a label bearing the following:

(A) The name, address, and phone number of the establishment from which the drug was dispensed.

(B) The date on which the prescription for the drug was filled.

(C) The number of the prescription as filed in the prescription files of the pharmacist who filled the prescription.

(D) The name of the practitioner who prescribed the drug.

(E) The name of the patient, or if the drug was prescribed for an animal, a statement of the species of the animal.

(F) The directions for the use of the drug as contained in the prescription.

(G) If the drug contains or is derived from opium, a statement that the drug is an opioid.

(2) The legend drug is delivered by the practitioner in good faith in the course of practice and the immediate container in which the drug is delivered bears a label on which appears the following:

(A) The directions for use of the drug.

(B) The name and address of the practitioner.

(C) The name of the patient.

(D) If the drug is prescribed for an animal, a statement of the species of the animal.

This section does not prohibit a practitioner from delivering professional samples of legend drugs in their original containers in the course of the practitioner’s practice when oral directions for use are given at the time of delivery.

     (b) Notwithstanding subsection (a)(1), the following apply:

(1) A pharmacist at a hospital licensed under IC 16-21 may fill a drug order for a legend drug with a drug product allowed under the hospital’s policies and procedures for the use, selection, and procurement of drugs.

(2) A pharmacist who fills a prescription for a legend drug must comply with IC 16-42-22 and IC 25-26-16.

[Pre-1993 Recodification Citation: 16-6-8-3(a).]

As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.2; P.L.148-2019, SEC.1.