CHAPTER 19. DRUGS: INDIANA LEGEND DRUG ACT
IC 16-42-19
Chapter 19. Drugs: Indiana Legend Drug Act
IC 16-42-19-1
Intent of chapter
Sec. 1. This chapter is intended to supplement IC 16-42-1 throughIC 16-42-4.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-2
"Drug" defined
Sec. 2. As used in this chapter, "drug" means the following:
(1) Articles or substances recognized in United StatesPharmacopeial Convention, Inc.; The United StatesPharmacopeia, Twenty-Second Edition (1990) or United StatesPharmacopeial Convention, Inc.; The National Formulary,Seventeenth Edition (1990) as revised by United StatesPharmacopeial Convention, Inc.; Supplement 1 to The UnitedStates Pharmacopeia, Twenty-Second Edition and The NationalFormulary, Seventeenth Edition (1990); and any supplementsprinted after 1990.
(2) Articles or substances intended for use in the diagnosis,cure, mitigation, treatment, or prevention of disease in humanbeings or other animals.
(3) Articles other than food intended to affect the structure orany function of the body of human beings or other animals.
(4) Articles intended for use as a component of any articlespecified in subdivision (1), (2), or (3).
(5) Devices.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.1.
IC 16-42-19-3
"Drug order" defined
Sec. 3. As used in this chapter, "drug order" means an order thatmeets the following conditions:
(1) Is:
(A) a written order in a hospital or other health careinstitution for an ultimate user for a drug or device, issuedand signed by a practitioner; or
(B) an order transmitted by other means of communicationfrom a practitioner that is immediately reduced to writing bythe pharmacist, registered nurse, or other licensed healthcare practitioner authorized by the hospital or institution.
(2) Contains the following:
(A) The name and bed number of the patient.
(B) The name and strength or size of the drug or device.
(C) Unless specified by individual institutional policy orguidelines, the amount to be dispensed either in quantity ordays.
(D) Adequate directions for the proper use of the drug or
device when administered to the patient.
(E) The name of the prescriber.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-4
"Investigational or new drug" defined
Sec. 4. As used in this chapter, "investigational or new drug"means a drug that is limited by state law to use under professionalsupervision of a practitioner authorized by law to prescribe oradminister the drug.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-5
"Practitioner" defined
Sec. 5. As used in this chapter, "practitioner" means any of thefollowing:
(1) A physician licensed under IC 25-22.5.
(2) A veterinarian licensed to practice veterinary medicine inIndiana.
(3) A dentist licensed to practice dentistry in Indiana.
(4) A podiatrist licensed to practice podiatric medicine inIndiana.
(5) An optometrist who is:
(A) licensed to practice optometry in Indiana; and
(B) certified under IC 25-24-3.
(6) An advanced practice nurse who meets the requirements ofIC 25-23-1-19.5.
(7) A physician assistant licensed under IC 25-27.5 who isdelegated prescriptive authority under IC 25-27.5-5-6.
As added by P.L.2-1993, SEC.25. Amended by P.L.185-1993, SEC.1;P.L.157-2006, SEC.6; P.L.90-2007, SEC.2; P.L.177-2009, SEC.8.
IC 16-42-19-6
"Precursor" defined
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 processedor synthesized into a legend drug; and
(2) is used or produced primarily for use in the manufacture ofa legend drug by persons other than persons:
(A) licensed to manufacture the legend drug by the Indianaboard of pharmacy;
(B) registered by the state department; or
(C) licensed to practice pharmacy by the Indiana board ofpharmacy.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-7
"Prescription" defined
Sec. 7. As used in this chapter, "prescription" means: (1) a written order to or for an ultimate user for a drug or devicecontaining the name and address of the patient, the name andstrength or size of the drug or device, the amount to bedispensed, adequate directions for the proper use of the drug ordevice by the patient, and the name of the practitioner, issuedand signed by a practitioner; or
(2) an order transmitted by other means of communication froma practitioner that is:
(A) immediately reduced to writing by the pharmacist orpharmacist intern (as defined in IC 25-26-13-2); or
(B) for an electronically transmitted prescription:
(i) has the electronic signature of the practitioner; and
(ii) is recorded by the pharmacist in an electronic format.
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.6.
IC 16-42-19-8
"Sale" defined
Sec. 8. As used in this chapter, "sale" means every sale andincludes 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.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-9
"Warehouseman" defined
Sec. 9. As used in this chapter, "warehouseman" means a personwho stores legend drugs for others and who has no control over thedisposition of legend drugs except for the purpose of storage.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-10
"Wholesaler" defined
Sec. 10. As used in this chapter, "wholesaler" means a personengaged in the business of distributing legend drugs that the personhas not produced or prepared to persons included in any of theclasses named in section 21 of this chapter.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-11
Sale of legend drug unlawful; exceptions
Sec. 11. (a) Except as provided in section 21 of this chapter, aperson may not sell a legend drug unless either of the followingconditions exist:
(1) Except as provided in subsection (b), the legend drug isdispensed by a pharmacist upon an original prescription or drugorder with the drug product specified on the prescription or
drug order or by the authorization of the practitioner and thereis affixed to the immediate container in which the drug isdelivered a label bearing the following:
(A) The name, address, and phone number of theestablishment from which the drug was dispensed.
(B) The date on which the prescription for the drug wasfilled.
(C) The number of the prescription as filed in theprescription files of the pharmacist who filled theprescription.
(D) The name of the practitioner who prescribed the drug.
(E) The name of the patient, or if the drug was prescribed foran animal, a statement of the species of the animal.
(F) The directions for the use of the drug as contained in theprescription.
(2) The legend drug is delivered by the practitioner in goodfaith in the course of practice and the immediate container inwhich the drug is delivered bears a label on which appears thefollowing:
(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 thespecies of the animal.
This section does not prohibit a practitioner from deliveringprofessional samples of legend drugs in their original containers inthe course of the practitioner's practice when oral directions for useare 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 filla drug order for a legend drug with a drug product allowedunder 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 mustcomply with IC 16-42-22 and IC 25-26-16.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.2.
IC 16-42-19-12
Refilling prescription or drug order
Sec. 12. Except as authorized under IC 25-26-13-25(d), a personmay not refill a prescription or drug order for a legend drug exceptin the manner designated on the prescription or drug order or by theauthorization of the practitioner.
As added by P.L.2-1993, SEC.25. Amended by P.L.270-2001, SEC.1;P.L.204-2005, SEC.7.
IC 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 aprecursor unless the person obtains the drug: (1) on the prescription or drug order of a practitioner; or
(2) in accordance with section 11(2) or 21 of this chapter.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-14
Records
Sec. 14. A person may not fail to keep records as required bysection 22 of this chapter.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-15
Inspection of records
Sec. 15. A person may not refuse to make available and to accordfull opportunity to check a record, as required by section 22 of thischapter.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-16
Unlawful acts
Sec. 16. A person may not do any of the following:
(1) Obtain or attempt to obtain a legend drug or procure orattempt to procure the administration of a legend drug by any ofthe following:
(A) Fraud, deceit, misrepresentation, or subterfuge.
(B) The forgery or alteration of a prescription, drug order, orwritten 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 effortunlawfully to procure a legend drug or unlawfully to procurethe administration of a legend drug. Such a communication isnot considered a privileged communication.
(3) Intentionally make a false statement in a prescription, drugorder, order, report, or record required by this chapter.
(4) For the purpose of obtaining a legend drug, falsely assumethe title of or represent oneself to be a manufacturer,wholesaler, pharmacist, physician, dentist, veterinarian, or otherperson.
(5) Make or utter a false or forged prescription or false drugorder or forged written order.
(6) Affix a false or forged label to a package or receptaclecontaining legend drugs. This subdivision does not apply to lawenforcement agencies or their representatives while engaged inenforcing this chapter.
(7) Dispense a legend drug except as provided in this chapter.
As added by P.L.2-1993, SEC.25. Amended by P.L.239-1999, SEC.3.
IC 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 orcontrivance designed or generally used in smoking a legend drug.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-18
Legend drug injection devices
Sec. 18. A person may not possess or have under control withintent to violate this chapter a hypodermic syringe or needle or aninstrument adapted for the use of a legend drug by injection in ahuman being.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-19
Anabolic steroids
Sec. 19. Except as provided in section 21 of this chapter, a personmay not possess or use an anabolic steroid without a validprescription or drug order issued by a practitioner acting in the usualcourse of the practitioner's professional practice.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-20
Validity of prescriptions or drug orders
Sec. 20. (a) A prescription or drug order for a legend drug is notvalid unless the prescription or drug order is issued for a legitimatemedical purpose by a practitioner acting in the usual course of thepractitioner's business.
(b) A practitioner may not knowingly issue an invalid prescriptionor drug order for a legend drug.
(c) A pharmacist may not knowingly fill an invalid prescriptionor drug order for a legend drug.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-21
Authorized sale or possession
Sec. 21. Sections 11, 13, 19, and 25(b) of this chapter are notapplicable to the following:
(1) The sale of legend drugs to persons included in any of theclasses named in subdivision (2), or to the agents or employeesof such persons for use in the usual course of their business orpractice or in the performance of their official duties.
(2) Possession of legend drugs by the following persons or theiragents or employees for such use:
(A) Pharmacists.
(B) Practitioners.
(C) Persons who procure legend drugs for handling by orunder the supervision of pharmacists or practitionersemployed by them or for the purpose of lawful research,teaching, or testing and not for resale.
(D) Hospitals and other institutions that procure legenddrugs for lawful administration by practitioners. (E) Manufacturers and wholesalers.
(F) Carriers and warehousemen.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-22
Manufacturers and wholesalers; records
Sec. 22. (a) Manufacturers and wholesalers shall maintain recordsof the movement in commerce of legend drugs for two (2) yearsimmediately following the date of the last entry on those records andshall make those records available, at reasonable times, to lawenforcement agencies and their representatives in the enforcement ofthis chapter.
(b) Evidence obtained under this section may not be used in acriminal prosecution of the person from whom obtained.
As added by P.L.2-1993, SEC.25.
IC 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 amachine for storage and dispensing of drugs. The term does notinclude devices or instruments used by practitioners in the diagnosis,cure, mitigation, treatment, or prevention of disease in human beingsor other animals.
(b) A person may not maintain, operate, or use any type ofmechanical device in which any legend drug or narcotic drug isstored or held for the purpose of dispensing the drug from themechanical device. However, the mechanical device may be used forthe storage and dispensing of legend drugs if:
(1) the mechanical device is used in a:
(A) pharmacy that holds a permit issued by the Indianaboard of pharmacy;
(B) remote location under the jurisdiction of the board ofpharmacy; or
(C) health care facility that is licensed under IC 16-28 orIC 16-21-2; and
(2) the mechanical device is operated under the directsupervision and control of a:
(A) registered pharmacist; or
(B) practitioner;
who is directly responsible for dispensing the drug from themechanical device.
(c) Inspectors of the Indiana board of pharmacy may inspect thepremises of any person suspected of violating this section.
As added by P.L.2-1993, SEC.25. Amended by P.L.98-2006, SEC.1.
IC 16-42-19-24
Nuisance; place of illegal use or storage; prohibited acts
Sec. 24. (a) A store, shop, warehouse, dwelling house, apartment,building, vehicle, boat, aircraft, or any other place that is used: (1) by a person for the purpose of unlawfully using a legenddrug; or
(2) for the unlawful keeping or selling of the legend drug;
is a common nuisance.
(b) A person may not:
(1) keep or maintain a common nuisance; or
(2) frequent or visit a place knowing the place to be used for apurpose;
as described in subsection (a).
As added by P.L.2-1993, SEC.25.
IC 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 whois not a practitioner or lawful manufacturer of anabolic steroids maynot do any of the following:
(1) Knowingly or intentionally manufacture or deliver ananabolic steroid, pure or adulterated.
(2) Possess, with intent to manufacture or deliver, an anabolicsteroid.
As added by P.L.2-1993, SEC.25.
IC 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 anyprovision of this chapter;
it is not necessary to negate an exception, excuse, proviso, orexemption contained in this chapter. The burden of proof of such anexception, excuse, proviso, or exemption is upon the defendant.
As added by P.L.2-1993, SEC.25.
IC 16-42-19-27
Violations; prior offenders; anabolic steroids
Sec. 27. (a) A person who knowingly violates this chapter, exceptsections 24 and 25(b) of this chapter, commits a Class D felony.However, the offense is a Class C felony if the person has a priorconviction under this subsection or IC 16-6-8-10(a) before its repeal.
(b) A person who violates section 24 of this chapter commits aClass B misdemeanor.
(c) A person who violates section 25(b) of this chapter commitsdealing in an anabolic steroid, a Class C felony. However, theoffense is a Class B felony if the person delivered the anabolicsteroid 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.
As added by P.L.2-1993, SEC.25. Amended by P.L.2-2005, SEC.58.
IC 16-42-19-28
Immunity of law enforcement officers from prosecution
Sec. 28. Law enforcement officers in the performance of theirofficial duties are exempt from prosecution for and may not beconvicted of violations of this chapter.
As added by P.L.2-1993, SEC.25.