reglab/statecodes huggingface dataset:
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-1.8. "Authorized Distributor"

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 Code) of which the wholesale distributor is a member, and a manufacturer if the wholesale drug distributor:
(1) has a written agreement currently in effect with the manufacturer evidencing an ongoing relationship;
(2) is listed on the manufacturer's current monthly updated list of authorized distributors; or
(3) has a verifiable account with the manufacturer and a minimal transaction or volume requirement limit of:
(A) five thousand (5,000) units per company in the previous twelve (12) months; or
(B) twelve (12) purchases at the manufacturer's minimum purchasing requirement per invoice in the previous twelve (12) months.
As added by P.L.212-2005, SEC.26.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-2. "Blood"

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.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-3. "Blood Component"

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.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-3.7. "Chain Drug Warehouse"

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 drugs or devices to members of the same affiliated group that is under common ownership and control.
As added by P.L.98-2006, SEC.13.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4. "Board"

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.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4.1. "Co-Licensed Products"

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 concerning the pharmaceutical products.
As added by P.L.212-2005, SEC.27.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4.2. "Compendium"

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 specified in subdivision (1), (2), or (3).
As added by P.L.212-2005, SEC.28.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4.3. "Contraband"

Sec. 4.3. As used in this chapter, "contraband" refers to a legend drug:
(1) that is counterfeit;
(2) that is stolen;
(3) that is misbranded;
(4) that is obtained by fraud;
(5) that is purchased by a nonprofit institution for the nonprofit institution's own use and placed in commerce in violation of the own use agreement for the legend drug;
(6) for which a required pedigree does not exist; or
(7) for which a pedigree in existence:
(A) has been forged, counterfeited, or falsely created; or
(B) contains any altered, false, or misrepresented information.
As added by P.L.212-2005, SEC.29.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4.4. "Counterfeit"

Sec. 4.4. As used in this chapter, "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.
As added by P.L.212-2005, SEC.30.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4.5. "Deliver"

Sec. 4.5. As used in this chapter, "deliver" means the actual, constructive, or attempted transfer of a legend drug from one (1) person to another.
As added by P.L.212-2005, SEC.31.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4.6. "Designated Representative"

Sec. 4.6. As used in this chapter, "designated representative" means an individual who:
(1) is designated by a wholesale drug distributor;
(2) serves as the wholesale drug distributor's responsible individual with the board; and
(3) is actively involved in and aware of the actual daily operation of the wholesale drug distributor.
As added by P.L.212-2005, SEC.32.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-4.7. "Distribute"

Sec. 4.7. As used in this chapter, "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. The term does not include the following:
(1) Dispensing or administering a legend drug.
(2) Delivering or offering to deliver a legend drug by a common carrier in the usual course of business as a common carrier.
(3) The provision of a legend drug sample to a patient by a:
(A) practitioner;
(B) health care professional acting at the direction and under the supervision of a practitioner; or
(C) hospital's or other health care entity's pharmacy that received the drug sample in accordance with this chapter and other applicable law to administer or dispense and that is acting at the direction of a practitioner;
licensed to prescribe the legend drug.
As added by P.L.212-2005, SEC.33.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-5. "Drug Sample"

Sec. 5. As used in this chapter, "drug sample" means a unit of a legend drug that is not intended to be sold and is intended to promote the sale of the drug.
As added by P.L.182-1991, SEC.3.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-6. "Health Care Entity"

Sec. 6. As used in this chapter, "health care entity" means any organization or business that provides diagnostic, medical, surgical, dental treatment, or rehabilitative care. The term does not include a pharmacy or wholesale drug distributor.
As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005, SEC.34.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-6.5. "Label"

Sec. 6.5. As used in this chapter, "label" means a display of written, printed, or graphic matter on the immediate container of a legend drug.
As added by P.L.212-2005, SEC.35.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-6.6. "Labeling"

Sec. 6.6. As used in this chapter, "labeling" means labels and other written, printed, or graphic matter:
(1) on a legend drug or a legend drug's container or wrapper; or
(2) accompanying a legend drug.
As added by P.L.212-2005, SEC.36.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-7. "Legend Drug"

Sec. 7. As used in this chapter, "legend drug" has the meaning set forth in IC 16-18-2-199. The term includes any human drug required by federal law or regulation to be dispensed only by a prescription, including finished dosage forms and active ingredients subject to 21 U.S.C. 811 through 812. The term does not include a device or a device component, part, or accessory.
As added by P.L.182-1991, SEC.3. Amended by P.L.2-1993, SEC.147; P.L.212-2005, SEC.37.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-8. "Manufacturer"

Sec. 8. As used in this chapter, "manufacturer" means a person who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a legend drug.
As added by P.L.182-1991, SEC.3.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-8.3. "Misbranded"

Sec. 8.3. As used in this chapter, "misbranded" means that a legend drug's label:
(1) is false or misleading;
(2) does not bear the name and address of the manufacturer, packer, or distributor or does not contain an accurate statement of the quantities of active ingredients of the legend drug;
(3) does not show an accurate monograph for the legend drug; or
(4) does not comply with any other requirements of the federal Food, Drug, and Cosmetic Act.
As added by P.L.212-2005, SEC.38.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-8.5. "Normal Distribution Chain of Custody"

Sec. 8.5. As used in this chapter, "normal distribution chain of custody" means the route that a legend drug travels:
(1) from a manufacturer to a wholesale drug distributor, to a pharmacy, and to a patient or a patient's agent;
(2) from a manufacturer to a wholesale drug distributor, to a chain drug warehouse, to a pharmacy affiliated with the chain drug warehouse, and to a patient or a patient's agent;
(3) from a manufacturer to a chain drug warehouse, to a pharmacy affiliated with the chain drug warehouse, and to a patient or a patient's agent;
(4) from a manufacturer to a third party logistics provider, to a wholesale drug distributor, to a pharmacy, and to a patient or a patient's agent;
(5) from a manufacturer to a third party logistics provider, to a wholesale drug distributor, to a chain drug warehouse, to a pharmacy affiliated with the chain drug warehouse, and to a patient or a patient's agent;
(6) from a manufacturer to a third party logistics provider, to a chain drug warehouse, to a pharmacy affiliated with the chain drug warehouse, and to a patient or a patient's agent; or
(7) as prescribed by rules adopted by the board.
As added by P.L.212-2005, SEC.39.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-8.7. "Pedigree"

Sec. 8.7. As used in this chapter, "pedigree" means a statement or record in a written or an electronic form that is approved by the board, that:
(1) records each wholesale distribution of a legend drug from the sale by the manufacturer that leaves the normal distribution chain of custody and that includes information designated by the board through rules for each transaction; or
(2) complies with a legend drug pedigree law or regulation in another state or United States territory that meets the pedigree requirements under this chapter.
As added by P.L.212-2005, SEC.40. Amended by P.L.98-2006, SEC.14.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-9. "Person"

Sec. 9. As used in this chapter, "person" means an individual, a partnership, a business firm, a limited liability company, a corporation, or another entity, including a governmental entity.
As added by P.L.182-1991, SEC.3. Amended by P.L.8-1993, SEC.395; P.L.212-2005, SEC.41.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-9.2. "Practitioner"

Sec. 9.2. As used in this chapter, "practitioner" has the meaning set forth in IC 16-42-19-5.
As added by P.L.212-2005, SEC.42.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-9.3. "Repackage"

Sec. 9.3. As used in this chapter, "repackage" means changing the container, wrapper, quantity, or labeling of a legend drug to further the distribution of the legend drug.
As added by P.L.212-2005, SEC.43.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-10. "Sale"

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.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-10.3. "Third Party Inspection Provider"

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.24.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-10.5. "Third Party Logistics Provider"

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 this chapter.
As added by P.L.212-2005, SEC.44.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-12. "Wholesale Drug Distributor"

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) retail and hospital pharmacies that conduct wholesale distributions; and
(10) reverse distributors.
The term does not include a common carrier or person hired solely to transport prescription drugs.
As added by P.L.182-1991, SEC.3. Amended by P.L.98-2006, SEC.15.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-13. Rules

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 prerequisites set forth in this chapter; and
(3) establishing reasonable fees to carry out this chapter.
As added by P.L.182-1991, SEC.3.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-14. Accreditation and License for Wholesale Distribution of Legend Drugs; Provisional 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 issued by the board; and
(3) paying any reasonable fee required by the board.
(b) The board may not issue or renew the license of a wholesale drug distributor that does not comply with this chapter.
(c) The board shall require a separate license for each facility or location where wholesale distribution operations are conducted.
(d) An agent or employee of any licensed wholesale drug distributor does not need a license and may lawfully possess pharmaceutical drugs when acting in the usual course of business or employment.
(e) The issuance of a license under this chapter does not affect tax liability imposed by the department of state revenue or the department of local government finance on any wholesale drug distributor.
(f) The board may adopt rules that permit out-of-state wholesale drug distributors to obtain a license on the basis of reciprocity if:
(1) an out-of-state wholesale drug distributor possesses a valid license granted by another state and the legal standards for licensure in the other state are comparable to the standards under this chapter; and
(2) the other state extends reciprocity to wholesale drug distributors licensed in Indiana.
However, if the requirements for licensure under this chapter are more restrictive than the standards of the other state, the out-of-state wholesale drug distributor must comply with the additional requirements of this chapter to obtain a license under this chapter.
(g) The board may adopt rules under IC 4-22-2 to approve an accreditation body to:
(1) evaluate a wholesale drug distributor's operations to determine compliance with:
(A) professional standards;
(B) this chapter; and
(C) any other applicable law; and
(2) perform inspections of each facility and location where wholesale distribution operations are conducted by the wholesale drug distributor.
(h) The board may issue a provisional wholesale drug distributor license to an applicant that is located in Indiana and in the process of obtaining accreditation or certification from:
(1) the National Association of Boards of Pharmacy's Verified Accredited Wholesale Distributor; or
(2) an accreditation body approved by the board under subsection (g).
As added by P.L.182-1991, SEC.3. Amended by P.L.90-2002, SEC.456; P.L.212-2005, SEC.46; P.L.180-2018, SEC.25.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-14.2. Inspection and License Required for Third Party Logistics of Legend Drugs

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 from the board;
(2) obtaining and maintaining a license issued by the board; and
(3) paying any reasonable fee required by the board.
(b) The board may not issue a license to a third party logistics provider that does not comply with this chapter.
(c) The board shall require a separate license for each facility or location where third party logistics provider operations are conducted.
(d) An agent or employee of any licensed third party logistics provider does not need a license and may lawfully possess pharmaceutical drugs when acting in the usual course of business or employment.
(e) The issuance of a license under this chapter does not affect tax liability imposed by the department of state revenue or the department of local government finance on any third party logistics provider.
As added by P.L.180-2018, SEC.26.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-14.5. Pedigree Required

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.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-15.5. Repealed

As added by P.L.212-2005, SEC.49. Repealed by P.L.98-2006, SEC.29.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-16. Distributor Qualifications; Criminal History and Financial Background Check

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 disciplined by a regulatory agency for violating a law;
related to drug distribution in any state.
(2) A criminal conviction of the applicant.
(3) The applicant's past experience in the manufacture or distribution of legend drugs, including controlled substances.
(4) The furnishing by the applicant of false or fraudulent material in any application made in connection with drug manufacturing or distribution.
(5) Suspension or revocation of any license held by the applicant or the applicant's owner or the imposition of sanctions against the applicant or the applicant's owner by the federal or a state or local government for the manufacture or distribution of any drugs, including controlled substances.
(6) Compliance with licensing requirements under previously granted licenses.
(7) Compliance with requirements to maintain and make available to the board or to federal, state, or local law enforcement officials those records required under this chapter.
(8) Any other factors or qualifications the board considers relevant to the public health and safety, including whether the granting of the license would not be in the public interest.
(b) In reviewing an application for licensure or renewal of a license under this chapter, the board shall consider the results of criminal history and financial background checks for:
(1) the designated representative or the most senior individual responsible for facility operations, purchasing, and inventory control;
(2) the supervisor or the designated representative or the most senior individual under subdivision (1); and
(3) principals and owners with more than a ten percent (10%) interest in the wholesale drug distributor, if the wholesale drug distributor is a nonpublicly held company.
(c) The criminal history and financial background checks conducted under subsection (b) must:
(1) be conducted at the applicant's expense;
(2) include a criminal history for all current and previous states of residence of the applicant;
(3) include the criminal history in the federal district where the applicant currently resides;
(4) include information from the previous seven (7) years; and
(5) be approved by the board.
(d) An applicant shall provide and attest to:
(1) an affirmation that the applicant has not been involved in or convicted of any criminal or prohibited acts; or
(2) a statement providing a complete disclosure of the applicant's past criminal convictions and violations of state and federal laws;
regarding drugs.
As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005, SEC.50; P.L.98-2006, SEC.18.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-16.6. Designated Agent; Service of Process

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 the secretary of state to be the wholesale drug distributor's true and lawful attorney, upon whom legal process may be served in an action or a proceeding against the wholesale drug distributor arising from the wholesale drug distributor's wholesale distribution operations.
(c) The board shall mail a copy of any service of process to a wholesale drug distributor by certified mail, return receipt requested, postage prepaid, at the address designated by the wholesale drug distributor on the application for licensure submitted under this chapter.
(d) Service of process on the secretary of state is sufficient in an action or a proceeding against a wholesale drug distributor that is not licensed under this chapter.
As added by P.L.212-2005, SEC.52.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-17.2. For Cause Authentication

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 manufacturer.
(b) A wholesale drug distributor that has engaged in the distribution of a legend drug for which a purchasing wholesale drug distributor conducts a for cause authentication under subsection (a) shall provide, upon request, detailed information regarding the distribution of the legend drug, including the:
(1) date of purchase of the legend drug;
(2) lot number of the legend drug;
(3) sales invoice number of the legend drug; and
(4) contact information, including name, address, telephone number, and electronic mail address of the wholesale drug distributor that sold the legend drug.
(c) If a wholesale drug distributor conducts a for cause authentication under subsection (a) and is unable to authenticate each distribution of the legend drug, the wholesale drug distributor shall quarantine the legend drug and report the circumstances to the board and the federal Food and Drug Administration, if applicable, not more than ten (10) business days after completing the attempted authentication.
(d) If a wholesale drug distributor authenticates the distribution of a legend drug back to the manufacturer under subsection (a), the wholesale drug distributor shall maintain records of the authentication for three (3) years and shall produce the records for the board and the federal Food and Drug Administration upon request.
As added by P.L.212-2005, SEC.54. Amended by P.L.98-2006, SEC.21.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-17.3. Repealed

As added by P.L.212-2005, SEC.55. Repealed by P.L.98-2006, SEC.29.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-17.9. Use of Trade or Business Name

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.98-2006, SEC.23.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-18. Denial of License; Review of Board Action

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 agreement with the board has the right of review of the accreditation body's decision by the board.
As added by P.L.182-1991, SEC.3. Amended by P.L.98-2006, SEC.24.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-19. Inspection of Premises; Recordkeeping

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 location apart from the principal office of the wholesale drug distributor or the location where the drugs were stored and from which the drugs were shipped, if the records are made available for inspection within two (2) working days of a request by the board. The records may be kept in any form permissible under federal law applicable to legend recordkeeping.
As added by P.L.182-1991, SEC.3.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-20. Employee Qualifications

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.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-21. Renewal of Licenses; Lapsed Licenses

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 distributor before the first day of the month before the month in which the license expires. If an application for renewal has not been filed and the required fee paid before the license expiration date, the wholesale drug distributor license shall lapse and become void.
(c) A lapsed license may be reinstated only by meeting the requirements under IC 25-1-8-6.
(d) A wholesale drug distributor may not be open for business after the license has lapsed, until the renewal is completed.
As added by P.L.182-1991, SEC.3. Amended by P.L.269-2001, SEC.26; P.L.1-2006, SEC.465.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-22. Violations of Chapter; License Revocation; Penalties

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 drug distributor of not more than one thousand dollars ($1,000) for each occurrence. If the licensed wholesale drug distributor fails to pay the civil penalty within the time specified by the board, the board may suspend the license without additional proceedings.
As added by P.L.182-1991, SEC.3.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-23. Purchase From Unlicensed Person; Offense

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 of this section is a Level 6 felony.
As added by P.L.182-1991, SEC.3. Amended by P.L.158-2013, SEC.286.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-24. Injunction

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 applicable federal or state law including this chapter, upon a showing that the practices were or are likely to be performed or offered to be performed without a permit or license.
(b) An action brought under this section must be commenced either in the county where the conduct occurred or is likely to occur or in the county where the defendant resides.
(c) An action brought under this section is in addition to any other penalty provided by law and may be brought concurrently with other actions to enforce this chapter.
As added by P.L.182-1991, SEC.3.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-25. Refusal of Inspection; Offense

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 offense under this section.
As added by P.L.182-1991, SEC.3. Amended by P.L.158-2013, SEC.287.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-26. Offenses

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 defraud or deceive:
(A) fails to obtain or deliver to another person a complete and accurate required pedigree concerning a legend drug before:
(i) obtaining the legend drug from another person; or
(ii) transferring the legend drug to another person; or
(B) falsely swears or certifies that the person has authenticated any documents related to the wholesale distribution of legend drugs;
(2) who knowingly or intentionally:
(A) destroys, alters, conceals, or fails to maintain a complete and accurate required pedigree concerning a legend drug in the person's possession;
(B) purchases or receives legend drugs from a person not authorized to distribute legend drugs in wholesale distribution;
(C) sells, barters, brokers, or transfers a legend drug to a person not authorized to purchase the legend drug in the jurisdiction in which the person receives the legend drug in a wholesale distribution;
(D) forges, counterfeits, or falsely creates a pedigree;
(E) falsely represents a factual matter contained in a pedigree; or
(F) fails to record material information required to be recorded in a pedigree; or
(3) who:
(A) possesses a required pedigree concerning a legend drug;
(B) knowingly or intentionally fails to authenticate the matters contained in the pedigree as required; and
(C) distributes or attempts to further distribute the legend drug;
commits a Level 6 felony.
As added by P.L.182-1991, SEC.3. Amended by P.L.212-2005, SEC.60; P.L.158-2013, SEC.288.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-27. Offenses

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.158-2013, SEC.289.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-29. Third Party Logistics Provider License Requirements

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 following to the board:
(1) Documentation that the out-of-state third party logistics provider is licensed as a third party logistics provider by:
(A) the state from which the out-of-state third party logistics provider engages in third party logistics of legend drugs, if that state licenses third party logistics providers; or
(B) the federal Food and Drug Administration.
(2) An inspection report under section 30 of this chapter, dated not more than five (5) years from the date of application for a license from the board, issued by:
(A) the licensing authority in the state where the third party logistics provider is located; or
(B) a third party inspection provider.
(3) Payment of any reasonable fee required by the board.
As added by P.L.180-2018, SEC.28.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-30. Third Party Logistics Provider Inspection Report Standards

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) Maintaining access to warehouse space of suitable size to facilitate safe operations, including a suitable area to quarantine suspect product.
(2) Maintaining adequate security.
(3) Having written policies and procedures to:
(A) address receipt, security, storage, inventory, shipment, and distribution of a product;
(B) identify, record, and report confirmed losses or thefts;
(C) correct errors and inaccuracies in inventories;
(D) provide support for manufacturer recalls;
(E) prepare for, protect against, and address any reasonably foreseeable crisis that affects security or operation at the third party logistics provider's facility, such as a strike, fire, or flood;
(F) ensure that any expired product is segregated from other products and returned to the manufacturer or repackager or destroyed;
(G) maintain the capability to trace the receipt and outbound distribution of a product and supplies and records of inventory; and
(H) quarantine or destroy a suspect product if directed to do so by the respective manufacturer, wholesale distributor, dispenser, or an authorized government agency.
As added by P.L.180-2018, SEC.29.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-31. Third Party Logistics Provider Renewal; Expiration; Requirements

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 the license expiration date, the third party logistics provider's license shall lapse and become void.
(c) A third party logistics provider shall provide the third party logistics provider's latest inspection report, dated not more than two (2) years from the date of renewal, issued by:
(1) the licensing authority in the state where the third party logistics provider is located; or
(2) a third party inspection provider.
As added by P.L.180-2018, SEC.30.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers › 25-26-14-32. Third Party Logistics Provider Rules

Sec. 32. (a) The board shall adopt rules under IC 4-22-2, including emergency rules adopted in the manner provided under IC 4-22-2-37.1, 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.).
(b) An emergency rule adopted by the board under this section expires on the date the emergency rule is amended or repealed by a later rule adopted under IC 4-22-2-22.5 through IC 4-22-2-36.
As added by P.L.180-2018, SEC.31.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 16. Drug Regimens › 25-26-16-1. "Protocol"

Sec. 1. As used in this chapter, "protocol" means the policies, procedures, and protocols of a:
(1) hospital listed in IC 16-18-2-161(a)(1);
(2) physician licensed under IC 25-22.5; or
(3) physician group practice;
concerning the adjustment of a patient's drug regimen by, or other patient care services delegated to, a pharmacist licensed under this article.
As added by P.L.114-1996, SEC.2. Amended by P.L.1-2009, SEC.143; P.L.197-2011, SEC.110; P.L.202-2017, SEC.13; P.L.207-2021, SEC.41.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 16. Drug Regimens › 25-26-16-1.5. "Therapeutic Alternative"

Sec. 1.5. As used in this chapter, "therapeutic alternative" means a drug product that:
(1) has a different chemical structure from;
(2) is in the same pharmacological or therapeutic class as; and
(3) usually can be expected to have similar therapeutic effects and adverse reaction profiles when administered to patients in therapeutically equivalent doses as;
another drug.
As added by P.L.207-2021, SEC.42.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 16. Drug Regimens › 25-26-16-2. Adjustment

Sec. 2. For purposes of this chapter, a pharmacist adjusts a drug regimen if the pharmacist:
(1) changes the duration of treatment for a current drug therapy;
(2) adjusts a drug's strength, dosage form, frequency of administration, or route of administration;
(3) discontinues the use of a drug;
(4) adds a drug to the treatment regimen;
(5) issues a new prescription for the purposes of subdivision (1), (2), or (4); or
(6) makes a therapeutic substitution.
As added by P.L.114-1996, SEC.2. Amended by P.L.202-2017, SEC.14; P.L.207-2021, SEC.43.
2023 Indiana Code › Title 25. Professions and Occupations › Article 26. Pharmacists, Pharmacies, Drug Stores › Chapter 16. Drug Regimens › 25-26-16-3. Protocol Upon Hospital Admission

Sec. 3. (a) At the time of admission to a hospital that has adopted a protocol under this chapter, the following apply:
(1) The admitting practitioner shall signify in writing in the form and manner prescribed by the hospital whether the protocol applies in the care and treatment of the patient.
(2) A pharmacist may adjust the drug therapy regimen of the patient pursuant to the:
(A) written authorization of the admitting practitioner under subdivision (1); and
(B) protocols of the hospital.
The pharmacist shall review the appropriate medical records of the patient to determine whether the admitting practitioner has authorized the use of a specific protocol before adjusting the patient's drug therapy regimen. The admitting practitioner may at any time modify or cancel a protocol by entering the modification or cancellation in the patient's medical record.
(b) The authorization of the admitting practitioner to use the protocol shall be entered immediately in the patient's medical record, if required by the protocol.
As added by P.L.114-1996, SEC.2. Amended by P.L.98-2006, SEC.27; P.L.197-2011, SEC.111.