Sec. 1. (a) This chapter applies to any individual, partnership, limited liability company, corporation, or business firm: (1) located in or outside Indiana; and (2) engaging in the wholesale distribution of legend drugs in Indiana. (b) Except as required by federal law or regulation, the requirements of this chapter do not apply to a manufacturer […]
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 […]
Sec. 1.7. As used in this chapter, “authenticate” means to affirmatively verify before distribution occurs that each transaction that is listed on: (1) the pedigree of a legend drug; and (2) other accompanying documentation for a legend drug; has occurred. As added by P.L.212-2005, SEC.25.
Sec. 1.8. As used in this chapter, “authorized distributor” means a wholesale drug distributor with which a manufacturer has established an ongoing relationship to distribute the manufacturer’s products. For purposes of this section, an ongoing relationship exists between a wholesale drug distributor, including any affiliated group (as defined in Section 1504 of the Internal Revenue […]
Sec. 10. As used in this chapter, “sale” includes purchase, trade, or offer to sell, purchase, or trade. As added by P.L.182-1991, SEC.3.
Sec. 10.3. As used in this chapter, “third party inspection provider” means: (1) a manufacturer; (2) a wholesale drug distributor; (3) a repackager; (4) a dispenser; or (5) an accreditation body approved by the board; that conducts an inspection of a third party logistics provider under section 30 of this chapter. As added by P.L.180-2018, […]
Sec. 10.5. As used in this chapter, “third party logistics provider” means an entity that: (1) provides or coordinates warehousing, distribution, or other services on behalf of a manufacturer, but does not take title to the legend drug or have general responsibility to direct the legend drug’s sale or disposition; and (2) is licensed under […]
Sec. 11. As used in this chapter, “wholesale distribution” means to distribute legend drugs to persons other than a consumer or patient. The term does not include: (1) a sale or transfer between a division, a subsidiary, a parent, an affiliated, or a related company under the common ownership and control of a corporate entity; […]
Sec. 12. As used in this chapter, “wholesale drug distributor” means a person engaged in wholesale distribution of legend drugs, including: (1) manufacturers; (2) repackers; (3) own-label distributors; (4) private-label distributors; (5) jobbers; (6) brokers; (7) warehouses, including manufacturers’ and distributors’ warehouses, chain drug warehouses, and wholesale drug warehouses; (8) independent wholesale drug traders; (9) […]
Sec. 13. The board shall adopt rules under IC 4-22-2 that conform with wholesale drug distributor licensing guidelines adopted by the United States Food and Drug Administration (21 CFR 205), including rules: (1) necessary to carry out the purposes of this chapter; (2) that incorporate and set detailed standards for meeting each of the license […]
Sec. 14. (a) Subject to subsection (h), a person may not engage in wholesale distributions of legend drugs without: (1) obtaining and maintaining accreditation or certification from the National Association of Boards of Pharmacy’s Verified Accredited Wholesale Distributor or an accreditation body approved by the board under subsection (g); (2) obtaining and maintaining a license […]
Sec. 14.2. (a) Notwithstanding any other law, a person located in Indiana may not engage in third party logistics of legend drugs without: (1) submitting an inspection report under section 30 of this chapter from a third party inspection provider, dated not more than one (1) year before the date of application for a license […]
Sec. 14.5. After June 30, 2006, a wholesale drug distributor may not accept or deliver a legend drug without a current, accompanying pedigree as required under section 17 of this chapter. As added by P.L.212-2005, SEC.47. Amended by P.L.98-2006, SEC.16.
Sec. 15. (a) The board shall require the following minimum information from each wholesale drug distributor as part of the license described in section 14 of this chapter and as part of any renewal of such license: (1) The name, full business address, and telephone number of the licensee. (2) All trade or business names […]
As added by P.L.212-2005, SEC.49. Repealed by P.L.98-2006, SEC.29.
Sec. 16. (a) In reviewing, for purposes of licensure or renewal of a license under this chapter, the qualifications of persons who engage in wholesale distribution of legend drugs in Indiana, the board shall consider the following factors: (1) A finding by the board that the applicant has: (A) violated a law; or (B) been […]
Sec. 16.5. (a) A wholesale drug distributor shall designate in writing on a form prescribed by the board a designated representative for each of the wholesale drug distributor’s facilities licensed under this chapter. (b) A designated representative shall submit to the board an application prescribed by the board and provide to the board the following: […]
Sec. 16.6. (a) A wholesale drug distributor that: (1) is licensed under this chapter; (2) is located outside Indiana; and (3) distributes legend drugs in Indiana; shall designate an agent in Indiana for service of process. (b) A wholesale drug distributor that does not designate an agent under subsection (a) is considered to have designated […]
Sec. 17. As a condition for receiving and retaining a wholesale drug distributor license issued under this chapter, an applicant must satisfy the board that the applicant has and will continuously maintain the following: (1) Acceptable storage and handling conditions and facilities standards for each facility at which legend drugs are received, stored, warehoused, handled, […]
Sec. 17.2. (a) A wholesale drug distributor that purchases legend drugs from another wholesale drug distributor and has reason to believe that a legend drug purchased from the other wholesale drug distributor is counterfeit, suspected counterfeit, misbranded, or adulterated shall conduct a for cause authentication of each distribution of the legend drug back to the […]
