§ 16-42-19-11 — Sale of legend drug unlawful; conditions; exceptions

Indiana § 16-42-19-11

• Jurisdiction: Indiana
• Title 16: HEALTH
• Art. 42: REGULATION OF FOOD, DRUGS, AND
• Ch. 19: Drugs: Indiana Legend Drug Act

Text

(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).]

Legislative History

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