reglab/statecodes huggingface dataset:
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-6. "Precursor"

Sec. 6. As used in this chapter, "precursor" means a substance, other than a legend drug, that:
(1) is an immediate chemical intermediate that can be processed or synthesized into a legend drug; and
(2) is used or produced primarily for use in the manufacture of a legend drug by persons other than persons:
(A) licensed to manufacture the legend drug by the Indiana board of pharmacy;
(B) registered by the state department; or
(C) licensed to practice pharmacy by the Indiana board of pharmacy.
[Pre-1993 Recodification Citation: 16-6-8-2(m).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-7. "Prescription"

Sec. 7. As used in this chapter, "prescription" means:
(1) a written order to or for an ultimate user for a drug or device containing the name and address of the patient, the name and strength or size of the drug or device, the amount to be dispensed, adequate directions for the proper use of the drug or device by the patient, and the name of the practitioner, issued and signed by a practitioner; or
(2) an order transmitted by other means of communication from a practitioner that is:
(A) immediately reduced to writing by the pharmacist or pharmacist intern (as defined in IC 25-26-13-2); or
(B) for an electronically transmitted prescription:
(i) has the electronic signature of the practitioner;
(ii) is recorded by the pharmacist in an electronic format; and
(iii) is issued in accordance with IC 25-1-9.3.
[Pre-1993 Recodification Citation: 16-6-8-2(d).]
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.6; P.L.28-2019, SEC.4.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-8. "Sale"

Sec. 8. As used in this chapter, "sale" means every sale and includes the following:
(1) Manufacturing, processing, transporting, handling, packing, or any other production, preparation, or repackaging.
(2) Exposure, offer, or any other proffer.
(3) Holding, storing, or any other possession.
(4) Dispensing, giving, delivering, or any other supplying.
(5) Applying, administering, or any other using.
[Pre-1993 Recodification Citation: 16-6-8-2(i).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-9. "Warehouseman"

Sec. 9. As used in this chapter, "warehouseman" means a person who stores legend drugs for others and who has no control over the disposition of legend drugs except for the purpose of storage.
[Pre-1993 Recodification Citation: 16-6-8-2(h).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-10. "Wholesaler"

Sec. 10. As used in this chapter, "wholesaler" means a person engaged in the business of distributing legend drugs that the person has not produced or prepared to persons included in any of the classes named in section 21 of this chapter.
[Pre-1993 Recodification Citation: 16-6-8-2(g).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-11. Sale of Legend Drug Unlawful; Conditions; Exceptions

Sec. 11. (a) Except as provided in section 21 of this chapter, a person may not sell a legend drug unless either of the following conditions exist:
(1) Except as provided in subsection (b), the legend drug is dispensed by a pharmacist upon an original prescription or drug order with the drug product specified on the prescription or drug order or by the authorization of the practitioner and there is affixed to the immediate container in which the drug is delivered a label bearing the following:
(A) The name, address, and phone number of the establishment from which the drug was dispensed.
(B) The date on which the prescription for the drug was filled.
(C) The number of the prescription as filed in the prescription files of the pharmacist who filled the prescription.
(D) The name of the practitioner who prescribed the drug.
(E) The name of the patient, or if the drug was prescribed for an animal, a statement of the species of the animal.
(F) The directions for the use of the drug as contained in the prescription.
(G) If the drug contains or is derived from opium, a statement that the drug is an opioid.
(2) The legend drug is delivered by the practitioner in good faith in the course of practice and the immediate container in which the drug is delivered bears a label on which appears the following:
(A) The directions for use of the drug.
(B) The name and address of the practitioner.
(C) The name of the patient.
(D) If the drug is prescribed for an animal, a statement of the species of the animal.
This section does not prohibit a practitioner from delivering professional samples of legend drugs in their original containers in the course of the practitioner's practice when oral directions for use are given at the time of delivery.
(b) Notwithstanding subsection (a)(1), the following apply:
(1) A pharmacist at a hospital licensed under IC 16-21 may fill a drug order for a legend drug with a drug product allowed under the hospital's policies and procedures for the use, selection, and procurement of drugs.
(2) A pharmacist who fills a prescription for a legend drug must comply with IC 16-42-22 and IC 25-26-16.
[Pre-1993 Recodification Citation: 16-6-8-3(a).]
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.2; P.L.148-2019, SEC.1.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-12. Refilling Prescription or Drug Order

Sec. 12. Except as authorized under IC 25-26-13-25(d), a person may not refill a prescription or drug order for a legend drug except in the manner designated on the prescription or drug order or by the authorization of the practitioner.
[Pre-1993 Recodification Citation: 16-6-8-3(b).]
As added by P.L.2-1993, SEC.25. Amended by P.L.270-2001, SEC.1; P.L.204-2005, SEC.7.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-13. Possession or Use of Legend Drug or Precursor

Sec. 13. A person may not possess or use a legend drug or a precursor unless the person obtains the drug:
(1) on the prescription or drug order of a practitioner;
(2) in accordance with section 11(a)(2) or 21 of this chapter; or
(3) in accordance with rules adopted by the board of pharmacy under IC 25-26-23.
[Pre-1993 Recodification Citation: 16-6-8-3(c).]
As added by P.L.2-1993, SEC.25. Amended by P.L.119-2011, SEC.3; P.L.32-2021, SEC.48.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-14. Records

Sec. 14. A person may not fail to keep records as required by section 22 of this chapter.
[Pre-1993 Recodification Citation: 16-6-8-3(d).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-15. Inspection of Records

Sec. 15. A person may not refuse to make available and to accord full opportunity to check a record, as required by section 22 of this chapter.
[Pre-1993 Recodification Citation: 16-6-8-3(e).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-16. Unlawful Acts

Sec. 16. Except as provided in section 30 of this chapter, a person may not do any of the following:
(1) Obtain or attempt to obtain a legend drug or procure or attempt to procure the administration of a legend drug by any of the following:
(A) Fraud, deceit, misrepresentation, or subterfuge.
(B) The forgery or alteration of a prescription, drug order, or written order.
(C) The concealment of a material fact.
(D) The use of a false name or the giving of a false address.
(2) Communicate information to a physician in an effort unlawfully to procure a legend drug or unlawfully to procure the administration of a legend drug. Such a communication is not considered a privileged communication.
(3) Intentionally make a false statement in a prescription, drug order, order, report, or record required by this chapter.
(4) For the purpose of obtaining a legend drug, falsely assume the title of or represent oneself to be a manufacturer, wholesaler, pharmacist, physician, dentist, veterinarian, or other person.
(5) Make or utter a false or forged prescription or false drug order or forged written order.
(6) Affix a false or forged label to a package or receptacle containing legend drugs. This subdivision does not apply to law enforcement agencies or their representatives while engaged in enforcing this chapter.
(7) Dispense a legend drug except as provided in this chapter.
[Pre-1993 Recodification Citation: 16-6-8-3(f).]
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.3; P.L.48-2015, SEC.1.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-17. Legend Drug Smoking Devices

Sec. 17. A person may not possess or have under the person's control with intent to violate this chapter an instrument or contrivance designed or generally used in smoking a legend drug.
[Pre-1993 Recodification Citation: 16-6-8-3(g).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-18. Legend Drug Injection Devices; Violation

Sec. 18. (a) A person may not possess with intent to:
(1) violate this chapter; or
(2) commit an offense described in IC 35-48-4;
a hypodermic syringe or needle or an instrument adapted for the use of a controlled substance or legend drug by injection in a human being.
(b) A person who violates subsection (a) commits a Level 6 felony.
[Pre-1993 Recodification Citation: 16-6-8-3(h).]
As added by P.L.2-1993, SEC.25. Amended by P.L.187-2015, SEC.23.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-19. Anabolic Steroids

Sec. 19. Except as provided in section 21 of this chapter, a person may not possess or use an anabolic steroid without a valid prescription or drug order issued by a practitioner acting in the usual course of the practitioner's professional practice.
[Pre-1993 Recodification Citation: 16-6-8-3(i).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-20. Validity of Prescriptions or Drug Orders

Sec. 20. (a) Except as provided in section 30 of this chapter, a prescription or drug order for a legend drug is not valid unless the prescription or drug order is issued for a legitimate medical purpose by a practitioner acting in the usual course of the practitioner's business.
(b) A practitioner may not knowingly issue an invalid prescription or drug order for a legend drug.
(c) A pharmacist may not knowingly fill an invalid prescription or drug order for a legend drug.
[Pre-1993 Recodification Citation: 16-6-8-3.5.]
As added by P.L.2-1993, SEC.25. Amended by P.L.48-2015, SEC.2.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-21. Authorized Sale or Possession

Sec. 21. Sections 11, 13, 19, and 25(b) of this chapter are not applicable to the following:
(1) The sale of legend drugs to persons included in any of the classes named in subdivision (2), or to the agents or employees of such persons for use in the usual course of their business or practice or in the performance of their official duties.
(2) Possession of legend drugs by the following persons or their agents or employees for such use:
(A) Pharmacists.
(B) Practitioners.
(C) Persons who procure legend drugs for handling by or under the supervision of pharmacists or practitioners employed by them or for the purpose of lawful research, teaching, or testing and not for resale.
(D) Hospitals and other institutions that procure legend drugs for lawful administration by practitioners.
(E) Manufacturers and wholesalers.
(F) Carriers and warehousemen.
[Pre-1993 Recodification Citation: 16-6-8-4.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-22. Manufacturers and Wholesalers; Records

Sec. 22. (a) Manufacturers and wholesalers shall maintain records of the movement in commerce of legend drugs for two (2) years immediately following the date of the last entry on those records and shall make those records available, at reasonable times, to law enforcement agencies and their representatives in the enforcement of this chapter.
(b) Evidence obtained under this section may not be used in a criminal prosecution of the person from whom obtained.
[Pre-1993 Recodification Citation: 16-6-8-5.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-23. Mechanical Device for Storage or Dispensing of Drugs; Restrictions; Inspection of Premises

Sec. 23. (a) As used in this section, "mechanical device" means a machine for storage and dispensing of drugs. The term does not include devices or instruments used by practitioners in the diagnosis, cure, mitigation, treatment, or prevention of disease in human beings or other animals.
(b) A person may not maintain, operate, or use any type of mechanical device in which any legend drug or narcotic drug is stored or held for the purpose of dispensing the drug from the mechanical device. However, the mechanical device may be used for the storage and dispensing of legend drugs if:
(1) the mechanical device is used in a:
(A) pharmacy that holds a permit issued by the Indiana board of pharmacy;
(B) remote location under the jurisdiction of the board of pharmacy; or
(C) health care facility that is licensed under IC 16-28 or IC 16-21-2; and
(2) the mechanical device is operated under the direct supervision and control of a:
(A) registered pharmacist; or
(B) practitioner;
who is directly responsible for dispensing the drug from the mechanical device.
(c) Inspectors of the Indiana board of pharmacy may inspect the premises of any person suspected of violating this section.
[Pre-1993 Recodification Citation: 16-6-8-6.]
As added by P.L.2-1993, SEC.25. Amended by P.L.98-2006, SEC.1.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-24. Repealed

[Pre-1993 Recodification Citation: 16-6-8-7.]
As added by P.L.2-1993, SEC.25. Repealed by P.L.59-2016, SEC.3.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-25. Anabolic Steroids; Unlawful Acts

Sec. 25. (a) A practitioner may not prescribe, order, distribute, supply, or sell an anabolic steroid for any of the following:
(1) Enhancing performance in an exercise, sport, or game.
(2) Hormonal manipulation intended to increase muscle mass, strength, or weight without a medical necessity.
(b) Except as provided in section 21 of this chapter, a person who is not a practitioner or lawful manufacturer of anabolic steroids may not do any of the following:
(1) Knowingly or intentionally manufacture or deliver an anabolic steroid, pure or adulterated.
(2) Possess, with intent to manufacture or deliver, an anabolic steroid.
[Pre-1993 Recodification Citation: 16-6-8-12.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-26. Pleading

Sec. 26. In:
(1) any complaint, information, affidavit, or indictment; and
(2) any action or proceeding brought for the enforcement of any provision of this chapter;
it is not necessary to negate an exception, excuse, proviso, or exemption contained in this chapter. The burden of proof of such an exception, excuse, proviso, or exemption is upon the defendant.
[Pre-1993 Recodification Citation: 16-6-8-9.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-27. Violations; Prior Offenders; Anabolic Steroids

Sec. 27. (a) This section does not apply to section 11(a)(1)(G) of this chapter (opioid labeling requirement).
(b) Unless otherwise specified, a person who knowingly violates this chapter, except sections 25(b) and 30(c) of this chapter, commits a Level 6 felony. However, the offense is a Level 5 felony if the person has a prior conviction under this subsection or IC 16-6-8-10(a) before its repeal.
(c) A person who violates section 25(b) of this chapter commits dealing in an anabolic steroid, a Level 5 felony. However, the offense is a Level 4 felony if the person delivered the anabolic steroid to a person who is:
(1) less than eighteen (18) years of age; and
(2) at least three (3) years younger than the delivering person.
(d) A person who violates section 30(c) of this chapter commits a Class A infraction.
[Pre-1993 Recodification Citation: 16-6-8-10.]
As added by P.L.2-1993, SEC.25. Amended by P.L.2-2005, SEC.58; P.L.158-2013, SEC.248; P.L.48-2015, SEC.3; P.L.187-2015, SEC.24; P.L.59-2016, SEC.4; P.L.148-2019, SEC.2.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-28. Immunity of Law Enforcement Officers From Prosecution

Sec. 28. Law enforcement officers in the performance of their official duties are exempt from prosecution for and may not be convicted of violations of this chapter.
[Pre-1993 Recodification Citation: 16-6-8-11.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-29. Repealed

As added by P.L.131-2014, SEC.8. Amended by P.L.129-2018, SEC.18. Repealed by P.L.10-2020, SEC.2.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 19. Drugs: Indiana Legend Drug Act › 16-42-19-30. Investigation of Suspected Legend Drugs; Records

Sec. 30. (a) Sections 16 and 20 of this chapter do not apply to the actions of a:
(1) person who is employed or retained as an investigator by a pharmaceutical manufacturer described in subdivision (3);
(2) practitioner; or
(3) pharmaceutical manufacturer that is approved by the federal Food and Drug Administration;
performed in an investigation of a pharmaceutical manufacturer's legend drug that is suspected of being counterfeited, adulterated, or misbranded.
(b) A drug sample collected during an investigation described in subsection (a) may only be used for testing or a civil or criminal action. A drug sample collected during an investigation may not be resold or provided for human consumption.
(c) A pharmaceutical manufacturer that collects drug samples during an investigation described in subsection (a) shall:
(1) maintain records of the drug samples; and
(2) make these records available, at a reasonable time, to law enforcement agencies or the agencies' representatives in the enforcement of this chapter.
As added by P.L.48-2015, SEC.4.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-1. Powers of Enforcement Officers

Sec. 1. (a) Each member of the Indiana board of pharmacy, designated employees of the Indiana board of pharmacy, and all law enforcement officers of Indiana are primarily responsible for the enforcement of all statutes and rules of Indiana relating to controlled substances. However, the Indiana board of pharmacy is primarily responsible for making accountability audits of the supply and inventory of controlled substances.
(b) An officer or employee of the Indiana board of pharmacy designated by the board may do any of the following:
(1) Carry firearms in the performance of the officer's or employee's official duties.
(2) Execute and serve search warrants, arrest warrants, administrative inspection warrants, subpoenas, and summonses issued under the authority of this state.
(3) Make arrests without warrant for any offense relating to controlled substances committed in the officer's or employee's presence or if the officer or employee has probable cause to believe that the person to be arrested has committed or is committing a felony relating to controlled substances.
(4) Make seizures of property under this chapter.
(5) Perform other law enforcement duties that the Indiana board of pharmacy designates.
[Pre-1993 Recodification Citation: 16-6-8.5-1.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-3. Injunctions

Sec. 3. Any court of record has jurisdiction to restrain or enjoin violations of laws relating to controlled substances.
[Pre-1993 Recodification Citation: 16-6-8.5-3.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-4. Cooperative Arrangements and Confidentiality

Sec. 4. (a) The Indiana board of pharmacy shall cooperate with federal and other state agencies in discharging the board's responsibilities concerning traffic in controlled substances and in suppressing the abuse of controlled substances. To this end, the board may do the following:
(1) Arrange for the exchange of information among governmental officials concerning the use and abuse of controlled substances.
(2) Coordinate and cooperate in training programs concerning controlled substance law enforcement at local, state, and federal levels.
(3) Cooperate with the Drug Enforcement Administration by establishing a centralized unit to accept, catalog, file, and collect statistics, including records of drug dependent persons and other controlled substance law offenders within Indiana, and make the information available for federal, state, and local law enforcement purposes. The board may not furnish the name or identity of a patient or research subject whose identity cannot be obtained under subsection (c).
(4) Conduct programs of eradication aimed at destroying wild or illicit growth of plant species from which controlled substances may be extracted.
(b) Results, information, and evidence received from the Drug Enforcement Administration relating to the regulatory functions of this chapter, including the results of inspections conducted by the Drug Enforcement Administration, may be relied on and acted upon by the Indiana board of pharmacy in the exercise of the board's regulatory functions.
(c) A practitioner engaged in medical practice or research is not required or compelled to furnish the name or identity of a patient or research subject to the Indiana board of pharmacy. A practitioner may not be compelled in any state or local civil, criminal, administrative, legislative, or other proceedings to furnish the name or identity of an individual that the practitioner is obligated to keep confidential.
[Pre-1993 Recodification Citation: 16-6-8.5-4.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-6. Burden of Proof; Liabilities

Sec. 6. (a) It is not necessary for the state to negate any exemption or exception in this chapter or in IC 35-48 in a complaint, an information, an indictment, or other pleading or in a trial, hearing, or other proceeding under this chapter or under IC 35-48. The burden of proof of an exemption or exception is on the person claiming the exemption or exception.
(b) In the absence of proof that a person is the duly authorized holder of an appropriate registration or order form issued under IC 35-48-3, a person is presumed not to be the holder of the registration or form.
[Pre-1993 Recodification Citation: 16-6-8.5-6.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-7. Judicial Review

Sec. 7. All final determinations, findings, and conclusions of the Indiana board of pharmacy under this chapter are conclusive decisions of the matters involved. A person aggrieved by the decision may obtain review of the decision in accordance with IC 4-21.5-5. Findings of fact by the Indiana board of pharmacy, if supported by substantial evidence, are conclusive.
[Pre-1993 Recodification Citation: 16-6-8.5-7.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-8. Education Programs

Sec. 8. The addiction services bureau of the division of mental health and addiction shall carry out educational programs designed to prevent and deter misuse and abuse of controlled substances. In connection with these programs, the bureau may do the following:
(1) Promote better recognition of the problems of misuse and abuse of controlled substances within the regulated industry and among interested groups and organizations.
(2) Assist the regulated industry and interested groups and organizations in contributing to the reduction of misuse and abuse of controlled substances.
(3) Consult with interested groups and organizations to aid the groups and organizations in solving administrative and organizational problems.
(4) Evaluate procedures, projects, techniques, and controls conducted or proposed as part of educational programs on misuse and abuse of controlled substances.
(5) Disseminate the results of research on misuse and abuse of controlled substances to promote a better public understanding of what problems exist and what can be done to combat the problems.
(6) Assist in the education and training of state and local law enforcement officials in efforts to control misuse and abuse of controlled substances.
[Pre-1993 Recodification Citation: 16-6-8.5-8(a).]
As added by P.L.2-1993, SEC.25. Amended by P.L.215-2001, SEC.86.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-9. Research

Sec. 9. The addiction services bureau of the division of mental health and addiction shall encourage research on misuse and abuse of controlled substances. In connection with the research and in furtherance of the enforcement of laws relating to controlled substances, the bureau may do the following:
(1) Establish methods to assess accurately the effects of controlled substances and identify and characterize those with potential for abuse.
(2) Make studies and undertake programs of research to do the following:
(A) Develop new or improved approaches, techniques, systems, equipment, and devices to strengthen the enforcement of laws relating to controlled substances.
(B) Determine patterns of misuse and abuse of controlled substances and the social effects of such behavior.
(C) Improve methods for preventing, predicting, understanding, and dealing with the misuse and abuse of controlled substances.
(3) Enter into contracts with public agencies, postsecondary educational institutions, and private organizations or individuals for the purpose of conducting research, demonstrations, or special projects that bear directly on misuse and abuse of controlled substances.
[Pre-1993 Recodification Citation: 16-6-8.5-8(b).]
As added by P.L.2-1993, SEC.25. Amended by P.L.215-2001, SEC.87; P.L.2-2007, SEC.195.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-10. Contracts for Educational and Research Activities

Sec. 10. The addiction services bureau of the division of mental health and addiction may enter into contracts for educational and research activities without performance bonds.
[Pre-1993 Recodification Citation: 16-6-8.5-8(c).]
As added by P.L.2-1993, SEC.25. Amended by P.L.215-2001, SEC.88.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-11. Anonymity of Research Subjects

Sec. 11. The Indiana board of pharmacy may authorize persons engaged in research on the use and effects of controlled substances to withhold the names and other identifying characteristics of individuals who are the subjects of the research. Persons who obtain this authorization may not be compelled in any civil, criminal, administrative, legislative, or other proceeding to identify the individuals who are the subjects of research for which the authorization was obtained.
[Pre-1993 Recodification Citation: 16-6-8.5-8(d).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 20. Drugs: Enforcement of Pharmacy Laws and Rules › 16-42-20-12. Possession and Distribution of Controlled Substances for Research Purposes

Sec. 12. The Indiana board of pharmacy may authorize the possession and distribution of controlled substances by persons engaged in research. Persons who obtain this authorization are exempt from state prosecution for possession and distribution of controlled substances to the extent of the authorization.
[Pre-1993 Recodification Citation: 16-6-8.5-8(e).]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 21. Drugs: Drug Samples › 16-42-21-1. "Controlled Substance"

Sec. 1. As used in this chapter, "controlled substance" has the meaning set forth in IC 35-48-1.
[Pre-1993 Recodification Citation: 16-6-12-1.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 21. Drugs: Drug Samples › 16-42-21-2. "Drug Sample"

Sec. 2. As used in this chapter, "drug sample" means a legend drug or a controlled substance that is manufactured, packaged, labeled, or otherwise marketed to be distributed and dispensed without consideration.
[Pre-1993 Recodification Citation: 16-6-12-2.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 21. Drugs: Drug Samples › 16-42-21-3. "Practitioner"

Sec. 3. As used in this chapter, "practitioner" means any of the following:
(1) A licensed physician.
(2) A dentist licensed to practice dentistry in Indiana.
(3) A podiatrist licensed to practice podiatry in Indiana.
(4) A veterinarian licensed to practice veterinary medicine in Indiana.
(5) An optometrist who is:
(A) licensed to practice optometry in Indiana; and
(B) certified under IC 25-24-3.
(6) An advanced practice registered nurse licensed and granted the authority to prescribe legend drugs under IC 25-23.
[Pre-1993 Recodification Citation: 16-6-12-6.]
As added by P.L.2-1993, SEC.25. Amended by P.L.157-2006, SEC.7; P.L.105-2008, SEC.1; P.L.129-2018, SEC.19.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 21. Drugs: Drug Samples › 16-42-21-4. Delivery of Drug Samples to Ultimate User After Removal From Original Packaging or After Expiration Date; Offense

Sec. 4. A person who:
(1) is a manufacturer, wholesaler, practitioner, or pharmacist, or is an employee or agent of a manufacturer, wholesaler, practitioner, or pharmacist; and
(2) either:
(A) knowingly or intentionally removes a drug sample from its original packaging, repackages the drug sample, and delivers the drug sample to an ultimate user in exchange for money or other property; or
(B) knowingly or intentionally delivers a drug sample to an ultimate user when the expiration date listed by the manufacturer on the drug sample has passed;
commits a Class B misdemeanor.
[Pre-1993 Recodification Citation: 16-6-12-8.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-1. "Brand Name"

Sec. 1. As used in this chapter, "brand name" means the proprietary or trade name selected by the drug manufacturer and placed upon a drug or the drug's container, label, or wrappings at the time of packaging.
[Pre-1993 Recodification Citation: 16-6-8.1-1 part.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-2. Repealed

[Pre-1993 Recodification Citation: 16-6-8.1-1 part.]
As added by P.L.2-1993, SEC.25. Repealed by P.L.239-1999, SEC.9.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-3. "Customer"

Sec. 3. As used in this chapter, "customer" means the individual for whom a prescription is written or electronically transmitted or the individual's representative.
[Pre-1993 Recodification Citation: 16-6-8.1-1 part.]
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.8.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-4. "Generically Equivalent Drug Product"

Sec. 4. (a) As used in this chapter, "generically equivalent drug product" means a multiple source drug product:
(1) that contains an identical quantity of identical active ingredients in the identical dosage forms (but not necessarily containing the same inactive ingredients) that meet the identical physical and chemical standards in The United States Pharmacopeia (USP) described in IC 16-42-19-2, or its supplements, as the prescribed brand name drug; and
(2) if applicable, for which the manufacturer or distributor holds either an approved new drug application or an approved abbreviated new drug application unless other approval by law or of the federal Food and Drug Administration is required.
(b) A drug does not constitute a generically equivalent drug product if it is listed by the federal Food and Drug Administration on or after July 1, 1987, as having actual or potential bioequivalence problems.
[Pre-1993 Recodification Citation: 16-6-8.1-1 part.]
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.4.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-4.5. "Practitioner"

Sec. 4.5. As used in this chapter, "practitioner" means any of the following:
(1) A licensed physician.
(2) A dentist licensed to practice dentistry in Indiana.
(3) A podiatrist licensed to practice podiatric medicine in Indiana.
(4) An optometrist who is:
(A) licensed to practice optometry in Indiana; and
(B) certified under IC 25-24-3.
(5) An advanced practice registered nurse licensed and granted the authority to prescribe legend drugs under IC 25-23.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.5; P.L.157-2006, SEC.8; P.L.129-2018, SEC.20.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-5. "Substitute"

Sec. 5. As used in this chapter, "substitute" means to dispense a generically equivalent drug product in place of the brand name drug product prescribed by the practitioner.
[Pre-1993 Recodification Citation: 16-6-8.1-1 part.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-5.5. Limitation of Effect of Chapter

Sec. 5.5. Nothing in this chapter authorizes any substitution other than substitution of a generically equivalent drug product.
As added by P.L.239-1999, SEC.6.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-6. Prescription Forms

Sec. 6. (a) Each written prescription issued by a practitioner must have two (2) signature lines printed at the bottom of the prescription form, one (1) of which must be signed by the practitioner for the prescription to be valid. Under the blank line on the left side of the form must be printed the words "Dispense as written.". Under the blank line on the right side of the form must be printed the words "May substitute.".
(b) Each electronically transmitted prescription issued by a practitioner must:
(1) have an electronic signature; and
(2) include the electronically transmitted instructions "Dispense as written." or "May substitute.".
[Pre-1993 Recodification Citation: 16-6-8.1-2(a).]
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.9.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-7. Repealed

[Pre-1993 Recodification Citation: 16-6-8.1-2(b).]
As added by P.L.2-1993, SEC.25. Repealed by P.L.239-1999, SEC.9.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-8. Requirements for Substitution

Sec. 8. (a) For substitution to occur for a prescription other than a prescription filled under the Medicaid program (42 U.S.C. 1396 et seq.), the children's health insurance program established under IC 12-17.6-2, the biosimilar biological products requirements under IC 16-42-25, or the Medicare program (42 U.S.C. 1395 et seq.):
(1) the practitioner must:
(A) sign on the line under which the words "May substitute" appear; or
(B) for an electronically transmitted prescription, electronically transmit the instruction "May substitute."; and
(2) the pharmacist must inform the customer of the substitution.
(b) This section does not authorize any substitution other than substitution of a generically equivalent drug product.
[Pre-1993 Recodification Citation: 16-6-8.1-2(c).]
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.7; P.L.291-2001, SEC.233; P.L.204-2005, SEC.10; P.L.96-2014, SEC.5.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-9. Transmission of Practitioner's Instructions to Pharmacist

Sec. 9. If the practitioner communicates instructions to the pharmacist orally or electronically, the pharmacist shall:
(1) indicate the instructions in the pharmacist's own handwriting on the written copy of the prescription order; or
(2) record the electronically transmitted instructions in an electronic format.
[Pre-1993 Recodification Citation: 16-6-8.1-2(d).]
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.11.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-10. Substitution Prohibited

Sec. 10. (a) If a prescription is filled under the Medicaid program (42 U.S.C. 1396 et seq.), the children's health insurance program established under IC 12-17.6-2, or the Medicare program (42 U.S.C. 1395 et seq.), the pharmacist shall substitute a generically equivalent drug product and inform the customer of the substitution if the substitution would result in a lower price unless:
(1) the words "Brand Medically Necessary" or words of similar meaning are:
(A) written in the practitioner's own writing on the form; or
(B) electronically transmitted with an electronically transmitted prescription; or
(2) the practitioner has indicated that the pharmacist may not substitute a generically equivalent drug product by:
(A) orally stating that a substitution is not permitted; or
(B) for an electronically transmitted prescription, indicating with the electronic prescription that a substitution is not permitted.
(b) If a practitioner orally states that a generically equivalent drug product may not be substituted, the practitioner must subsequently forward to the pharmacist a written or electronically transmitted prescription with the "Brand Medically Necessary" instruction appropriately indicated in the physician's own handwriting.
(c) This section does not authorize any substitution other than substitution of a generically equivalent drug product.
[Pre-1993 Recodification Citation: 16-6-8.1-2(e).]
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.8; P.L.291-2001, SEC.234; P.L.204-2005, SEC.12; P.L.32-2013, SEC.1.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-11. Substitution of Generic Drugs; Identification of Brand Name Drug

Sec. 11. If under this section a pharmacist substitutes a generically equivalent drug product for a brand name drug product prescribed by a practitioner, the prescription container label must identify the brand name drug for which the substitution is made and the generic drug. The identification required under this subsection must take the form of the following statement on the drug container label, with the generic name and the brand name inserted on the blank lines:
"_____________ Generic for _____________".
[Pre-1993 Recodification Citation: 16-6-8.1-2(f).]
As added by P.L.2-1993, SEC.25. Amended by P.L.186-1993, SEC.1.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 22. Drugs: Generic Drugs › 16-42-22-12. Identification of Manufacturer or Distributor of Dispensed Drug Product on Prescription

Sec. 12. The pharmacist shall record on the prescription in writing or in an electronic format for an electronically transmitted prescription the name of the manufacturer or distributor, or both, of the actual drug product dispensed under this chapter.
[Pre-1993 Recodification Citation: 16-6-8.1-2(g).]
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.13.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 23. Drugs: Use of Amygdalin (Laetrile) › 16-42-23-1. Health Care Facilities; Restrictions on Use

Sec. 1. Except as provided in section 8 of this chapter, a hospital or other health care facility may not interfere with the physician-patient relationship by restricting or forbidding the use of amygdalin (laetrile) as an adjunct to recognized, customary, or accepted modes of therapy in the treatment of any malignancy, disease, illness, or physical condition if the following conditions exist:
(1) Amygdalin (laetrile) is prescribed or administered by a physician holding an unlimited license for the practice of medicine in Indiana.
(2) The patient has signed the "written informed request" as set forth in section 5 of this chapter.
[Pre-1993 Recodification Citation: 16-8-8-1.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 23. Drugs: Use of Amygdalin (Laetrile) › 16-42-23-2. Disciplinary Action Against Attending Physician

Sec. 2. A physician may not be subjected to disciplinary action by the medical licensing board of Indiana for prescribing or administering amygdalin (laetrile) to a patient under the physician's care as an adjunct to recognized, customary, or accepted modes of therapy in the treatment of a malignancy, a disease, an illness, or a physical condition if the patient has signed the written informed request as set forth in section 5 of this chapter.
[Pre-1993 Recodification Citation: 16-8-8-2.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 23. Drugs: Use of Amygdalin (Laetrile) › 16-42-23-3. Prescription or Administration Permitted With Written Informed Request

Sec. 3. A physician may prescribe or administer amygdalin (laetrile) instead of or in addition to customary or accepted modes of therapy in the treatment of a malignancy, a disease, an illness, or a physical condition of a patient who has signed the written informed request as set forth in section 5 of this chapter.
[Pre-1993 Recodification Citation: 16-8-8-3.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 23. Drugs: Use of Amygdalin (Laetrile) › 16-42-23-4. Construction of Chapter

Sec. 4. (a) This chapter does not constitute an endorsement of amygdalin (laetrile) for the treatment of a malignancy, a disease, an illness, or a physical condition.
(b) This chapter does not prevent a physician from prescribing amygdalin (laetrile) as a dietary supplement to a patient not suffering from a known malignancy, disease, illness, or physical condition upon execution of the written informed request.
[Pre-1993 Recodification Citation: 16-8-8-4.]
As added by P.L.2-1993, SEC.25.
2023 Indiana Code › Title 16. Health › Article 42. Regulation of Food, Drugs, and Cosmetics › Chapter 23. Drugs: Use of Amygdalin (Laetrile) › 16-42-23-5. Written Informed Request Form

Sec. 5. (a) The written informed request must be on a form prepared by and obtained from the medical licensing board of Indiana and must be in substance as follows:
WRITTEN INFORMED REQUEST
FOR PRESCRIPTION OF AMYGDALIN
(LAETRILE) FOR MEDICAL
TREATMENT
Patient's name __________________________
Address _________________________________
Age ________ Sex ___________
Name and address of prescribing physician
_________________________________________
Malignancy, disease, illness, or physical condition diagnosed for medical treatment by amygdalin (laetrile) or the use of amygdalin as a dietary supplement:
________________________________________
________________________________________
My physician has explained the following to me:
(1) That the manufacture and distribution of amygdalin (laetrile) has been banned by the Federal Food and Drug Administration.
(2) That neither the American Cancer Society, the American Medical Association, nor the Indiana State Medical Association recommend use of amygdalin (laetrile) in the treatment of a malignancy, a disease, an illness, or a physical condition.
(3) That there are alternative recognized treatments for the malignancy, disease, illness, or physical condition from which I suffer that my physician has offered to provide for me, including the following:
(Here describe)
______________________________________
______________________________________
Notwithstanding this explanation, I request prescription and use of amygdalin (laetrile):
(1) in the medical treatment of the malignancy, disease, illness, or physical condition from which I suffer ( ); or
(2) as a dietary supplement ( ).
(Check (1) or (2))
________________________________________
Patient or person signing for patient
ATTEST:
__________________________________
Prescribing physician
(b) A copy of the written informed request shall be forwarded after execution to the medical licensing board of Indiana for appropriate filing.
[Pre-1993 Recodification Citation: 16-8-8-5.]
As added by P.L.2-1993, SEC.25.