reglab/housing_qa huggingface dataset:
IN Code § 25-26-14-8.5 (2021)
2021 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.
IN Code § 25-26-14-8.7 (2021)
2021 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.
IN Code § 25-26-14-9 (2021)
2021 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.
IN Code § 25-26-14-9.2 (2021)
2021 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.
IN Code § 25-26-14-9.3 (2021)
2021 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.
IN Code § 25-26-14-10 (2021)
2021 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.
IN Code § 25-26-14-10.3 (2021)
2021 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.
IN Code § 25-26-14-10.5 (2021)
2021 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.
IN Code § 25-26-14-11 (2021)
2021 Indiana Code|Title 25. Professions and Occupations|Article 26. Pharmacists, Pharmacies, Drug Stores|Chapter 14. Wholesale Legend Drug Distributors and Third Party Logistics Providers|25-26-14-11. "Wholesale Distribution"

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;(2) the purchase or acquisition by a hospital or other health care entity that is a member of a group purchasing organization of a drug for the hospital's or health care entity's own use from the group purchasing organization or from other hospitals or health care entities that are members of the organization;(3) the sale or transfer of a drug by a charitable organization described in Section 501(c)(3) of the Internal Revenue Code, to:(A) a nonprofit affiliate of the organization; or(B) a nonprofit entity described in Section 501(c)(3) of the Internal Revenue Code that is not affiliated with the organization;to the extent otherwise permitted by law;(4) the sale of a drug among hospitals or other health care entities that are under common control;(5) the sale of a drug for emergency medical reasons, including transfers of legend drugs by a retail pharmacy to another retail pharmacy to alleviate a temporary shortage, if the gross dollar value of the transfers does not exceed five percent (5%) of the total legend drug sales revenue of either the transferor or transferee pharmacy during any twelve (12) consecutive month period;(6) the sale of a drug or the dispensing of a drug pursuant to a prescription;(7) the distribution of drug samples by manufacturers' representatives or distributors' representatives;(8) the sale of blood and blood components intended for transfusion;(9) the sale of a drug by a retail pharmacy to a practitioner (as defined in IC 25-26-13-2) for office use, if the gross dollar value of the transfers does not exceed five percent (5%) of the retail pharmacy's total legend drug sales during any twelve (12) consecutive months;(10) the sale of a drug by a retail pharmacy that is ending its business and liquidating its inventory to another retail pharmacy;(11) drug returns by a hospital, health care entity, or charitable institution conducted under 21 CFR 203.23;(12) the sale of minimal quantities of drugs by retail pharmacies to licensed practitioners for office use;(13) the distribution of prescription drugs by the original manufacturer of the finished form of the prescription drug or the distribution of the co-licensed products by a partner of the original manufacturer of the finished form of the prescription drug; or(14) drug returns that meet criteria established by rules adopted by the board.As added by P.L.182-1991, SEC.3. Amended by P.L.33-1993, SEC.47; P.L.212-2005, SEC.45; P.L.246-2019, SEC.19; P.L.264-2019, SEC.8.
IN Code § 25-26-14-12 (2021)
2021 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.
IN Code § 25-26-14-13 (2021)
2021 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.
IN Code § 25-26-14-14 (2021)
2021 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.
IN Code § 25-26-14-14.2 (2021)
2021 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.
IN Code § 25-26-14-14.5 (2021)
2021 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.
IN Code § 25-26-14-16 (2021)
2021 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.
IN Code § 25-26-14-16.6 (2021)
2021 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.
IN Code § 25-26-14-17.2 (2021)
2021 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.
IN Code § 25-26-14-17.9 (2021)
2021 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.
IN Code § 25-26-14-18 (2021)
2021 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.
IN Code § 25-26-14-19 (2021)
2021 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.
IN Code § 25-26-14-20 (2021)
2021 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.