Title 25, PROFESSIONS AND OCCUPATIONS

Sec. 2. The information derived from or as the result of professional services is confidential and privileged. However, this section does not prohibit a certified public accountant, a public accountant, or an accounting practitioner from disclosing any data required to be disclos…

Sec. 3. (a) The following definitions apply throughout this section: (1) "Client provided records" means accounting or other records belonging to the client that are provided to the licensee by or on behalf of the client. (2) "Client records prepared by the licensee" means accoun…

Sec. 4. A statement, record, schedule, working paper, or memorandum may not be sold, transferred, or bequeathed without the consent of the client or the client's personal representative or assignee, to anyone except for surviving partners, members, stockholders, new partners, or …

Sec. 5. (a) This chapter does not prohibit a temporary transfer of work papers or other material necessary to carry out peer reviews, conduct an investigation or proceeding related to a peer review, or comply with the disclosure of information under this chapter. (b) A licensee i…

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 regula…

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 in…

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.212-200…

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 whole…

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 provide…

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…

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 com…

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, incl…

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 incorp…

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 a…

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…

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 …

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 appl…

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 a…

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 …

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 faciliti…

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…

Sec. 17.8. (a) A wholesale drug distributor licensed under this chapter that purchases legend drugs from a wholesale drug distributor that is not licensed under this chapter shall act with due diligence as required under this section and rules adopted by the board. However, the d…

Sec. 17.9. A wholesale drug distributor licensed under this chapter may not use a trade name or business name identical to a trade name or business name used by an unrelated wholesale drug distributor licensed under this chapter. As added by P.L.212-2005, SEC.57. Amended by P.L.9…

Sec. 18. (a) Any applicant denied a license or renewal under this chapter has the right of review of the board's action under IC 4-21.5. (b) An applicant that is denied the accreditation under section 14 of this chapter from an accreditation body that has entered into an agreemen…

Sec. 19. (a) A person authorized by the board may enter and inspect, during normal business hours, all open premises that appear to be used by a wholesale drug distributor. (b) Wholesale drug distributors may keep records regarding purchase and sales transactions at a central loc…

Sec. 2. As used in this chapter, "blood" means whole blood collected from a single donor and processed either for transfusion or further manufacturing. As added by P.L.182-1991, SEC.3.

Sec. 20. A person employed in wholesale distribution must have appropriate education or experience to assume responsibility for positions related to compliance with licensing requirements. As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005, SEC.58; P.L.98-2006, SEC.25.

Sec. 21. (a) A wholesale drug distributor license expires at midnight of the renewal date specified by the Indiana professional licensing agency under IC 25-1-5-4 in each even-numbered year. (b) The board shall mail renewal application forms to each licensed wholesale drug distri…

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 …

Sec. 22. (a) The board, upon a showing of a violation of this chapter, may revoke, suspend, or limit a license issued under this chapter after a proceeding under IC 4-21.5. (b) After a proceeding under IC 4-21.5, the board may assess a civil penalty against a licensed wholesale d…

Sec. 23. A person that knowingly purchases or receives a legend drug from any source other than a person licensed under this chapter, including a wholesale distributor, manufacturer, pharmacy distributor, or pharmacy commits a Class A misdemeanor. A subsequent unrelated violation…

Sec. 24. (a) Upon application by the board, a circuit or superior court may grant an injunction, a restraining order, or other order to enjoin a person from offering to engage or engaging in the performance of any practices for which a permit or license is required by any applica…

Sec. 25. A wholesale drug distributor that fails to allow an authorized person to enter and inspect a facility as provided in section 19 of this chapter commits a Class A misdemeanor. However, the offense is a Level 6 felony if the person has a prior unrelated conviction for an o…

Sec. 26. (a) A person who knowingly or intentionally engages in the wholesale distribution of a legend drug without a license issued under this chapter commits a Level 6 felony. (b) A person who engages in the wholesale distribution of a legend drug and: (1) who, with intent to d…

Sec. 27. A wholesale drug distributor that fails to comply with the conditions and requirements described in section 17, 17.2, 17.8, 17.9, or 20 of this chapter commits a Level 6 felony. As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005, SEC.61; P.L.98-2006, SEC.26; P.L.15…

Sec. 29. (a) A third party logistics provider located in another state seeking to engage in third party logistics of legend drugs in Indiana must be licensed with the board. (b) To obtain a license from the board, an out-of-state third party logistics provider must provide the fo…

Sec. 3. As used in this chapter, "blood component" means that part of blood separated by physical or mechanical means. As added by P.L.182-1991, SEC.3.

Sec. 3.7. As used in this chapter, "chain drug warehouse" means a permanent physical location for drugs or devices, or both, that: (1) is licensed as a wholesale distributor; (2) acts as a central warehouse; and (3) primarily performs intracompany sales and transfers of legend dr…

Sec. 30. (a) The board shall develop standards for inspections of third party logistics providers to be included on an inspection report. (b) The report shall include whether the third party logistics provider's facility is compliant with the following storage practices: (1) Main…

Sec. 31. (a) A third party logistics provider license expires at midnight of the renewal date specified by the Indiana professional licensing agency under IC 25-1-5-4 in each even-numbered year. (b) If an application for renewal has not been filed and the required fee paid before…

Sec. 32. The board shall adopt rules under IC 4-22-2 to establish requirements for a third party logistics license, license fees, and other relevant matters consistent with the Drug Supply Chain Security Act (21 U.S.C. 360eee et seq.). As added by P.L.180-2018, SEC.31. Amended by…

Sec. 4. As used in this chapter, "board" refers to the Indiana board of pharmacy established under IC 25-26-13-3. As added by P.L.182-1991, SEC.3.

Sec. 4.1. As used in this chapter, "co-licensed products" means pharmaceutical products: (1) that have been approved by the federal Food and Drug Administration; and (2) concerning which two (2) or more parties have the right to engage in a business activity or occupation concern…

Sec. 4.2. As used in this chapter, "compendium" refers to: (1) the United States Pharmacopoeia; (2) the Homeopathic Pharmacopoeia of the United States; (3) the National Formulary; (4) a drug approved by the federal Food and Drug Administration; or (5) a supplement to a document s…