Sec. 1.5. As used in this chapter, "adulterated" refers to a legend drug that:
(1) consists in whole or in part of a filthy, putrid, or decomposed substance;
(2) has been produced, prepared, packed, or held under unsanitary conditions and may have been contaminated or rendered injurious to health;
(3) has been subjected to conditions in the manufacture, processing, packing, or holding of the legend drug that do not conform to current standards of manufacturing to ensure that the legend drug is safe for use and possesses the identity, strength, quality, and purity characteristics that the legend drug is represented to possess;
(4) is contained in a container composed of a poisonous or deleterious substance that may render the legend drug injurious to health;
(5) bears or contains, for purposes of coloring only, a color additive that is unsafe;
(6) is of a different strength, quality, or purity from the official compendium standard for the legend drug; or
(7) does not meet the considerations of the federal Food, Drug, and Cosmetic Act.
As added by P.L.212-2005, SEC.24.
Structure Indiana Code
Title 25. Professions and Occupations
Article 26. Pharmacists, Pharmacies, Drug Stores
Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers
25-26-14-1. Application of Chapter
25-26-14-1.8. "Authorized Distributor"
25-26-14-3.7. "Chain Drug Warehouse"
25-26-14-4.1. "Co-Licensed Products"
25-26-14-4.6. "Designated Representative"
25-26-14-6. "Health Care Entity"
25-26-14-8.5. "Normal Distribution Chain of Custody"
25-26-14-10.3. "Third Party Inspection Provider"
25-26-14-10.5. "Third Party Logistics Provider"
25-26-14-11. "Wholesale Distribution"
25-26-14-12. "Wholesale Drug Distributor"
25-26-14-14.2. Inspection and License Required for Third Party Logistics of Legend Drugs
25-26-14-14.5. Pedigree Required
25-26-14-16. Distributor Qualifications; Criminal History and Financial Background Check
25-26-14-16.5. Designated Representative; Application; Experience Requirement; Continuing Education
25-26-14-16.6. Designated Agent; Service of Process
25-26-14-17. Applicant Assurances as Condition of License
25-26-14-17.2. For Cause Authentication
25-26-14-17.9. Use of Trade or Business Name
25-26-14-18. Denial of License; Review of Board Action
25-26-14-19. Inspection of Premises; Recordkeeping
25-26-14-20. Employee Qualifications
25-26-14-21. Renewal of Licenses; Lapsed Licenses
25-26-14-21.5. Prohibitions; Sanctions
25-26-14-22. Violations of Chapter; License Revocation; Penalties
25-26-14-23. Purchase From Unlicensed Person; Offense
25-26-14-25. Refusal of Inspection; Offense
25-26-14-29. Third Party Logistics Provider License Requirements
25-26-14-30. Third Party Logistics Provider Inspection Report Standards
25-26-14-31. Third Party Logistics Provider Renewal; Expiration; Requirements