Sec. 16. (a) A person may not engage in any of the following acts:
(1) The sale in intrastate commerce of a food, drug, device, or cosmetic that is adulterated or misbranded.
(2) The adulteration or misbranding of a food, drug, device, or cosmetic in intrastate commerce.
(3) The receipt in intrastate commerce of a food, drug, device, or cosmetic that is adulterated or misbranded, and the sale of those items in intrastate commerce for pay or otherwise.
(4) The sale of any article in violation of section 6 of this chapter, IC 16-42-3-7, IC 16-42-3-8, IC 16-42-3-9, or IC 16-42-3-10.
(5) The refusal to permit access to or copying of any record as required by section 12 of this chapter.
(6) The refusal to permit entry or inspection and collecting of samples as authorized by section 10 or 13 of this chapter.
(7) The use, without proper authority, of any mark, stamp, tag, label, or other identification device authorized or required by rules adopted under this chapter or IC 16-42-2 through IC 16-42-4.
(8) The use by any person to the person's own advantage, or the revelation, other than to the state health commissioner or the state health commissioner's authorized representative or to the courts when relevant in any judicial proceeding, any information acquired under authority of section 13 of this chapter or IC 16-42-3-7 through IC 16-42-3-10 concerning any method or process that as a trade secret is entitled to protection.
(9) The alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to a food, drug, device, or cosmetic if the act is done while the article is held for sale and results in the article being misbranded.
(10) The use on the labeling of any drug or in any advertising relating to the drug of any representation or suggestion that an application with respect to the drug is effective under IC 16-42-3-7 and IC 16-42-3-8 unless the drug complies with those sections.
(11) The removal or disposal of a detained or embargoed article in violation of this chapter.
(12) The giving of a guaranty or undertaking in intrastate commerce referred to in subsection (c) that is false.
(b) A person who violates subsection (a) commits a Class A misdemeanor. However, the offense is a Level 6 felony if the offense is committed with intent to defraud or mislead.
(c) It is a defense for a person accused of violating subsection (a)(1) or subsection (a)(3) if the person establishes a guaranty or undertaking signed by and containing the name and address of the person residing in the United States from whom the accused person received in good faith the article to the effect that the article is not adulterated or misbranded within the meaning of this article or the Federal Act.
(d) In addition to the remedies provided in this article, the state health commissioner or the commissioner's legally authorized agent may apply to the circuit or superior court for a temporary or permanent injunction restraining any person from violating any provision of this section.
[Pre-1993 Recodification Citations: 16-1-28-4; 16-1-28-5; 16-1-28-19.]
As added by P.L.2-1993, SEC.25. Amended by P.L.158-2013, SEC.247.
Structure Indiana Code
Article 42. Regulation of Food, Drugs, and Cosmetics
Chapter 1. Uniform Food, Drug, and Cosmetic Act: General Provisions
16-42-1-1.1. Duties of State Veterinarian and State Board of Animal Health
16-42-1-2. Authority to Adopt Certain Federal Regulations
16-42-1-3. Adoption of Regulations; Notice and Hearing
16-42-1-4. Construction of Act and Rules
16-42-1-5. Federal Agency References; Successor Agency
16-42-1-7. Misleading Advertising or Labeling; Evaluation of Representations
16-42-1-8. Labeling Requirements; Visibility
16-42-1-9. Advertisements; Curative or Therapeutic Effect for Certain Diseases
16-42-1-10. Samples or Specimen; Investigation and Examination
16-42-1-11. Inspection of Records
16-42-1-12. Access to and Copying of Records; Use of Evidence
16-42-1-13. Entry and Inspections
16-42-1-14. Report of Judgments, Orders, and Decrees
16-42-1-15. Dissemination of Information
16-42-1-16. Prohibited Acts; Defenses; Injunctions
16-42-1-17. Schedule of Civil Penalties; Order of Compliance; Consolidation of Proceedings
16-42-1-18. Embargo or Detention of Adulterated or Misbranded Merchandise; Tagging or Marking
16-42-1-19. Condemnation of Detained or Embargoed Merchandise; Petition
16-42-1-20. Seizure and Destruction of Embargoed or Detained Merchandise
16-42-1-21. Filing of Answer or Demurrer
16-42-1-22. Rights of Litigants
16-42-1-25. Judgment for Costs
16-42-1-26. Return of Libeled Merchandise; Liability for Damages
16-42-1-27. New Trial; Appeal; Appeal Bond
16-42-1-28. Judgment as Evidence
16-42-1-29. Costs Not Adjudicated Against Defendants
16-42-1-30. Libel for Condemnation; Procedure
16-42-1-31. Destruction of Adulterated or Misbranded Products; Expenses
16-42-1-32. Notice and Opportunity for Hearing Preceding Criminal Prosecution