2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-21.5. Prohibitions; Sanctions

Sec. 21.5. (a) A person may not perform, cause the performance of, or aid the performance of the following:
(1) The manufacture, repackaging, sale, delivery, holding, or offering for sale of a legend drug that is adulterated, misbranded, counterfeit, suspected counterfeit, or is otherwise unfit for distribution.
(2) The adulteration, misbranding, or counterfeiting of a legend drug.
(3) The receipt of a legend drug that is adulterated, misbranded, stolen, obtained by fraud or deceit, counterfeit, or suspected counterfeit, and the delivery or proffered delivery of the legend drug for pay or otherwise.
(4) The alteration, mutilation, destruction, obliteration, or removal of the whole or a part of the labeling of a legend drug or the commission of another act with respect to a legend drug that results in the legend drug being misbranded.
(5) Forging, counterfeiting, simulating, or falsely representing a legend drug using a mark, stamp, tag, label, or other identification device without the authorization of the manufacturer.
(6) The purchase or receipt of a legend drug from a person that is not licensed to distribute legend drugs to the purchaser or recipient.
(7) The sale or transfer of a legend drug to a person that is not authorized under the law of the jurisdiction in which the person receives the legend drug to purchase or receive legend drugs from the person selling or transferring the legend drug.
(8) Failure to maintain or provide records as required under this chapter.
(9) Providing the board, a representative of the board, or a state or federal official with false or fraudulent records or making false or fraudulent statements regarding a matter related to this chapter.
(10) The wholesale distribution of a legend drug that was:
(A) purchased by a public or private hospital or other health care entity;
(B) donated or supplied at a reduced price to a charitable organization; or
(C) stolen or obtained by fraud or deceit.
(11) Obtaining or attempting to obtain a legend drug by fraud, deceit, misrepresentation, or engaging in fraud, deceit, or misrepresentation in the distribution of a legend drug.
(12) Failure to obtain, authenticate, or provide a required pedigree.
(13) The receipt of a legend drug through wholesale distribution without first receiving a required pedigree attested to as accurate and complete by the wholesale drug distributor.
(14) Distributing a legend drug that was previously dispensed by a retail pharmacy or distributed by a practitioner.
(15) Failure to report an act prohibited by this section.
(b) The board may impose the following sanctions if, after a hearing under IC 4-21.5-3, the board finds that a person has violated subsection (a):
(1) Revoke the wholesale drug distributor's license issued under this chapter if the person is a wholesale drug distributor.
(2) Assess a civil penalty against the person. A civil penalty assessed under this subdivision may not be more than ten thousand dollars ($10,000) per violation.
As added by P.L.212-2005, SEC.59.