Indiana Code 25-26-14-21.5. Prohibitions; sanctions
(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.
Terms Used In Indiana Code 25-26-14-21.5
- adulterated: refers to a legend drug that:
Indiana Code 25-26-14-1.5
- authenticate: means to affirmatively verify before distribution occurs that each transaction that is listed on:
Indiana Code 25-26-14-1.7
- board: refers to the Indiana board of pharmacy established under IC 25-26-13-3. See Indiana Code 25-26-14-4
- counterfeit: refers to a legend drug, or the container, seal, or labeling of a legend drug, that, without authorization, bears the trademark, trade name, or other identifying mark or imprint of a manufacturer, processor, packer, or distributor other than the person that manufactured, processed, packed, or distributed the legend drug. See Indiana Code 25-26-14-4.4
- distribute: means to sell, offer to sell, deliver, offer to deliver, broker, give away, or transfer a legend drug, whether by passage of title or physical movement, or both. See Indiana Code 25-26-14-4.7
- Fraud: Intentional deception resulting in injury to another.
- health care entity: means any organization or business that provides diagnostic, medical, surgical, dental treatment, or rehabilitative care. See Indiana Code 25-26-14-6
- Jurisdiction: (1) The legal authority of a court to hear and decide a case. Concurrent jurisdiction exists when two courts have simultaneous responsibility for the same case. (2) The geographic area over which the court has authority to decide cases.
- label: means a display of written, printed, or graphic matter on the immediate container of a legend drug. See Indiana Code 25-26-14-6.5
- labeling: means labels and other written, printed, or graphic matter:
Indiana Code 25-26-14-6.6
- legend drug: has the meaning set forth in IC 16-18-2-199. See Indiana Code 25-26-14-7
- manufacturer: means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a legend drug. See Indiana Code 25-26-14-8
- misbranded: means that a legend drug's label:
Indiana Code 25-26-14-8.3
- pedigree: means a statement or record in a written or an electronic form that is approved by the board, that:
Indiana Code 25-26-14-8.7
- person: means an individual, a partnership, a business firm, a limited liability company, a corporation, or another entity, including a governmental entity. See Indiana Code 25-26-14-9
- practitioner: has the meaning set forth in IC 16-42-19-5. See Indiana Code 25-26-14-9.2
- sale: includes purchase, trade, or offer to sell, purchase, or trade. See Indiana Code 25-26-14-10
- wholesale distribution: means to distribute legend drugs to persons other than a consumer or patient. See Indiana Code 25-26-14-11
- wholesale drug distributor: means a person engaged in wholesale distribution of legend drugs, including:
Indiana Code 25-26-14-12
(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.