CHAPTER 3. UNIFORM FOOD, DRUG, AND COSMETIC ACT: ADULTERATION AND MISBRANDING OF DRUGS OR DEVICES
IC 16-42-3
Chapter 3. Uniform Food, Drug, and Cosmetic Act: Adulterationand Misbranding of Drugs or Devices
IC 16-42-3-1
Antibiotic drug defined
Sec. 1. As used in this chapter, "antibiotic drug" means any drugintended for use by man containing any quantity of any chemicalsubstance that is produced by microorganisms and that has thecapacity to inhibit or destroy microorganisms in dilute solution,including the chemically synthesized equivalent of the substance.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-2
Established name defined
Sec. 2. As used in this chapter, "established name", with respectto a drug or ingredient of a drug, means:
(1) the applicable official name designated under Section 508of the Federal Act;
(2) if there is no official name and the drug or the ingredient isan article recognized in an official compendium, the officialtitle of the drug or ingredient in the compendium; or
(3) if neither subdivision (1) nor (2) applies, the common orusual name, if any, of the drug or the ingredient.
However, when subdivision (2) applies to an article recognized in theUnited States Pharmacopoeia and in the HomeopathicPharmacopoeia under different official titles, the official title used inthe United States Pharmacopoeia applies unless the article is labeledand offered for sale as a homeopathic drug, in which case the officialtitle used in the Homeopathic Pharmacopoeia applies.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-2.5
Duties of state veterinarian and state board of animal health
Sec. 2.5. (a) The state veterinarian shall act in place of the statehealth commissioner under this chapter when impounding ordisposing of adulterated or misbranded products under IC 15-17-5 orIC 15-18-1.
(b) The Indiana state board of animal health shall act in place ofthe state department of health under this chapter when impoundingor disposing of adulterated or misbranded products under IC 15-17-5or IC 15-18-1.
As added by P.L.137-1996, SEC.70. Amended by P.L.2-2008,SEC.43.
IC 16-42-3-3
Adulterated drug or device
Sec. 3. A drug or device is considered to be adulterated under thefollowing conditions:
(1) If the drug or device consists in whole or in part of any
filthy, putrid, or decomposed substance.
(2) If the drug or device has been produced, prepared, packed,or held under unsanitary conditions under which the drug ordevice may have been contaminated with filth or made injuriousto health.
(3) If the methods used in or the facilities or controls used fora drug's manufacture, processing, packing, or holding do notconform to or are not operated or administered in conformitywith current good manufacturing practice to assure that:
(A) the drug meets the requirements of this article as tosafety; and
(B) the drug:
(i) has the identity and strength; and
(ii) meets the quality and purity characteristics;
that the drug purports or is represented to possess.
(4) If a drug's container is composed in whole or in part of anypoisonous or deleterious substance that may make the contentsinjurious to health.
(5) If:
(A) a drug bears or contains, for purposes of coloring only,a color additive that is unsafe within the meaning ofIC 16-42-2-5; or
(B) a color additive, the intended use of which in or on drugsis for purposes of coloring only, is unsafe underIC 16-42-2-5.
(6) If:
(A) the drug or device purports to be or is represented as adrug, the name of which is recognized in an officialcompendium; and
(B) the strength of the drug differs from or the drug's qualityor purity falls below the standard set forth in thatcompendium;
the determination as to strength, quality, or purity shall be madein accordance with the tests or methods of assay set forth in thecompendium or, in the absence or inadequacy of such tests ormethods of assay, those tests or methods prescribed by thefederal security administrator in regulations promulgated underthe Federal Act. A drug defined in an official compendium isnot considered to be adulterated under this subdivision becausethe drug differs from the standard of strength, quality, or purityset forth in the compendium if the drug's difference in strength,quality, or purity from the standard is plainly stated on thedrug's label. If a drug is recognized in both the United StatesPharmacopoeia and the Homeopathic Pharmacopoeia of theUnited States, the drug is subject to the requirements of theUnited States Pharmacopoeia unless the drug is labeled andoffered for sale as a homeopathic drug. In the latter case, thedrug is subject to the provisions of the HomeopathicPharmacopoeia of the United States and not to those of theUnited States Pharmacopoeia. (7) If:
(A) the drug or device is not subject to the provisions ofsubdivision (6); and
(B) the drug's or device's strength differs from or the drug'sor device's purity or quality falls below that which the drugor device purports or is represented to possess.
(8) If the drug or device is a drug and any substance has been:
(A) mixed or packed with the drug or device so as to reducethe drug's or device's quality or strength; or
(B) substituted wholly or in part for the drug.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-4
Misbranded drug or device
Sec. 4. A drug or device is considered to be misbranded under anyof the following conditions:
(1) If the labeling of the drug or device is false or misleading inany way.
(2) If the drug or device is in package form unless the drug ordevice bears a label containing:
(A) the name and place of business of the manufacturer,packer, or distributor; and
(B) an accurate statement of the quantity of the contents interms of weight, measure, or numerical count.
However, under clause (B) reasonable variations shall bepermitted and exemptions as to small packages shall beestablished by rules adopted by the state department.
(3) If any word, statement, or other information required toappear on the label or labeling, under this chapter or a ruleadopted under IC 16-42-1-2 is not prominently placed on thedrug or device with conspicuousness (as compared with otherwords, statements, designs, or devices in the labeling) and insuch terms that make the label likely to be read and understoodby the ordinary individual under customary conditions ofpurchase and use.
(4) If the drug or device:
(A) is for use by humans; and
(B) contains any quantity of the narcotic or hypnoticsubstance alpha-eucaine, barbituric acid, beta-eucaine,bromal, cannabis, carbromal, chloral, coca, cocaine, codeine,heroin, marijuana, morphine, opium, paraldehyde, peyote,methamphetamine, or sulphonmethane, or any chemicalderivative of such substance, which derivative afterinvestigation has been found to be and is designated as habitforming, by rules adopted by the state department underIC 16-42-1 through IC 16-42-4 or by regulations issuedunder 21 U.S.C. 352(d);
unless the label on the drug or device bears the name andquantity or proportion of that substance or derivative and thestatement "Warning . May Be Habit Forming". (5) If a drug, unless the following conditions are met:
(A) The label on the drug bears, to the exclusion of any othernonproprietary name except the applicable systematicchemical name or the chemical formula, the following:
(i) The established name of the drug, if any.
(ii) If the drug is fabricated from at least two (2)ingredients, the established name and quantity of eachactive ingredient, including the kind and quantity orproportion of any alcohol and, whether active or not, theestablished name and quantity or proportion of anybromides, ether, chloroform, acetanilid, acetphenetidin,amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine,arsenic, digitalis, digitalis glucosides, mercury, ouabain,strophanthin, strychnine, thyroid, or any derivative orpreparation of those substances contained in the drug.However, the requirement for stating the quantity of theactive ingredients, other than the quantity of thosespecifically named in this subdivision, applies only toprescription drugs.
(B) If a prescription drug, the established name of the drugor ingredient on the label (and on any labeling on which aname for the drug or ingredient is used) is printedprominently and in type at least half as large as that used forany proprietary name or designation for the drug oringredient.
However, to the extent that compliance with the requirementsof clause (A)(ii) or clause (B) is impracticable, exemptions shallbe allowed under rules adopted by the state department or byregulations promulgated under the Federal Act.
(6) Unless the drug's or device's labeling bears:
(A) adequate directions for use; and
(B) adequate warnings against use in those pathologicalconditions or by children where the drug's or device's usemay be dangerous to health or against unsafe dosage ormethods or duration of administration or application in themanner and form that is necessary for the protection ofusers.
However, if any requirement of clause (A) as applied to anydrug or device is not necessary for the protection of the publichealth, the state department shall adopt rules exempting thedrug or device from that requirement.
(7) If a drug purports to be a drug the name of which isrecognized in an official compendium, unless the drug ispackaged and labeled as prescribed in the compendium.However, the method of packing may be modified with theconsent of the state department in accordance with regulationspromulgated by the federal security administrator under theFederal Act. Whenever a drug is recognized in both the UnitedStates Pharmacopoeia and the Homeopathic Pharmacopoeia ofthe United States, the drug is subject to the requirements of the
United States Pharmacopoeia with respect to packaging andlabeling unless the drug is labeled and offered for sale as ahomeopathic drug. In that case the drug is subject to theHomeopathic Pharmacopoeia of the United States and not to theUnited States Pharmacopoeia.
(8) If a drug or device has been found by the federal securityadministrator or the state department to be a drug liable todeterioration, unless the drug or device is packaged in a formand manner and the drug's or device's label bears a statement ofsuch precautions as the federal security administrator or thestate department requires by rule or regulation as necessary forthe protection of the public health. A rule or regulation may notbe established for any drug recognized in an officialcompendium until the federal security administrator or the statedepartment informs the appropriate body charged with therevision of the compendium of the need for the packaging orlabeling requirements and that body fails within a reasonabletime to prescribe requirements.
(9) If a drug's container is made, formed, or filled as to bemisleading.
(10) If a drug is an imitation of another drug.
(11) If a drug is offered for sale under the name of another drug.
(12) If a drug is or purports to be or is represented to be a drugcomposed wholly or partly of insulin, unless:
(A) the drug is from a batch with respect to which acertificate or release has been issued under Section 506 ofthe Federal Act; and
(B) the certificate or release is in effect with respect to thedrug.
(13) If a drug is or purports to be or is represented to be a drugcomposed wholly or partly of any kind of penicillin,streptomycin, chloretetracycline, chloramphenicol, bacitracin,or any other antibiotic drug, or any derivative of those drugs,unless:
(A) the drug is from a batch with respect to which acertificate or release has been issued under Section 507 ofthe Federal Act; and
(B) the certificate or release is in effect with respect to thatdrug.
However, this subdivision does not apply to any drug or classof drugs exempted by regulations promulgated under Section507(c) or 507(d) of the Federal Act.
(14) If a drug or device is dangerous to health when used in thedosage, or with the frequency or duration prescribed,recommended, or suggested in the labeling of the drug ordevice.
(15) Under the conditions described in section 6 of this chapter.
As added by P.L.2-1993, SEC.25. Amended by P.L.17-2001, SEC.3.
IC 16-42-3-5 Exemption of drugs or devices in transit for further processing,labeling, or repackaging
Sec. 5. A drug or device that, in accordance with the practice ofthe trade, is to be processed, labeled, or repacked in substantialquantities at an establishment other than the establishment where thedrug or device was originally processed or packed, is exempt fromthe labeling and packaging requirements of IC 16-42-1 throughIC 16-42-4 while the drug or device is in transit in intrastatecommerce from one (1) establishment to the other if the transit ismade in good faith for completion purposes only. However, the drugor device is otherwise subject to the applicable provisions ofIC 16-42-1 through IC 16-42-4.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-6
Drugs dispensed on prescription
Sec. 6. (a) This section applies to a drug intended for use byhumans that:
(1) is a habit forming drug to which section 4(4) of this chapterapplies;
(2) because of:
(A) the drug's toxicity or other potential for harmful effect;
(B) the method of the drug's use; or
(C) the collateral measures necessary to the drug's use;
is not safe for use except under the supervision of a practitionerlicensed by law to administer the drug; or
(3) is limited by an approved application under Section 505 ofthe Federal Act or section 7 or 8 of this chapter to use under theprofessional supervision of a practitioner licensed by law toadminister the drug.
(b) A drug described in subsection (a) may be dispensed only:
(1) upon a written or an electronically transmitted prescriptionof a practitioner licensed by law to administer the drug;
(2) upon an oral prescription of the practitioner that is reducedpromptly to writing and filed by the pharmacist or pharmacistintern (as defined in IC 25-26-13-2); or
(3) by refilling a prescription if the refilling is authorized by theprescriber either in the original prescription, by anelectronically transmitted order that is recorded in an electronicformat, or by oral order that is reduced promptly to writing oris entered into an electronic format and filed by the pharmacistor pharmacist intern (as defined in IC 25-26-13-2).
(c) If a prescription for a drug described in subsection (a) does notindicate how many times the prescription may be refilled, if any, theprescription may not be refilled unless the pharmacist issubsequently authorized to do so by the practitioner.
(d) The act of dispensing a drug contrary to subsection (a), (b), or(c) is considered to be an act that results in a drug being misbrandedwhile held for sale.
(e) A drug dispensed by filling or refilling a prescription of a
practitioner licensed by law to administer the drug is exempt fromthe requirements of section 4(2), 4(3), 4(4), 4(5), 4(6), 4(7), 4(8), and4(9) of this chapter if the drug bears a label containing the following:
(1) The name and address of the dispenser.
(2) The serial number and date of the prescription or of theprescription's filling.
(3) The name of the drug's prescriber and, if stated in theprescription, the name of the patient.
(4) The directions for use and cautionary statements, if any,contained in the prescription.
This exemption does not apply to any drugs dispensed in the courseof the conduct of a business of dispensing drugs pursuant todiagnosis by mail or to a drug dispensed in violation of subsection(a), (b), (c), or (d).
(f) The state department may adopt rules to remove drugs subjectto section 4(4) of this chapter, section 7 of this chapter, or section 8of this chapter from the requirements of subsections (a) through (d)when the requirements are not necessary for the protection of publichealth. Drugs removed from the prescription requirements of theFederal Act by regulations issued under the Federal Act may also, byrules adopted by the state department, be removed from therequirement of subsections (a) through (d).
(g) A drug that is subject to subsections (a) through (d) isconsidered to be misbranded if at any time before dispensing thedrug's label fails to bear the statement "Caution: Federal LawProhibits Dispensing Without Prescription" or "Caution: State LawProhibits Dispensing Without Prescription". A drug to whichsubsections (a) through (d) do not apply is considered to bemisbranded if, at any time before dispensing, the drug's label bearsthe caution statement described in this subsection.
(h) This section does not relieve a person from a requirementprescribed by or under authority of law with respect to drugsincluded within the classifications of narcotic drugs or marijuana asdefined in the applicable federal and state laws relating to narcoticdrugs and marijuana.
(i) A drug may be dispensed under subsection (b) upon anelectronically transmitted prescription only to the extent permitted byfederal law.
As added by P.L.2-1993, SEC.25. Amended by P.L.144-1996,SEC.12; P.L.204-2005, SEC.4.
IC 16-42-3-7
New drugs; federal qualification; testing; application to introducedrug
Sec. 7. (a) This section does not apply under the circumstancesdescribed in section 9 of this chapter.
(b) A person may not sell, deliver, offer for sale, hold for sale,give away, or introduce into intrastate commerce any new drugunless:
(1) an application to sell, deliver, offer for sale, hold for sale,
give away, or introduce into intrastate commerce a new drughas been approved and the approval has not been withdrawnunder Section 505 of the Federal Act; or
(2) if not subject to the Federal Act the drug has been tested andhas been found to be safe for use and effective in use under theconditions prescribed, recommended, or suggested in thelabeling of the drug.
(c) Before selling or offering for sale the new drug, there must befiled with the state department an application setting forth thefollowing:
(1) Full reports of investigations that have been made to showwhether or not the drug is safe for use and whether the drug iseffective in use.
(2) A full list of the articles used as components of the drug.
(3) A full statement of the composition of the drug.
(4) A full description of the methods used in and the facilitiesand controls used for the manufacture, processing, and packingof the drug.
(5) Such samples of the drug and of the articles used ascomponents of the drug that the state department requires.
(6) Specimens of the labeling proposed to be used for the drug.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-8
New drugs; time for application to take effect
Sec. 8. (a) This section does not apply under the circumstancesdescribed in section 9 of this chapter.
(b) An application provided for under section 7 of this chapterbecomes effective on the one hundred eightieth day after the filingof the application. However, if the state department finds, after duenotice to the applicant and giving the applicant an opportunity for ahearing that:
(1) the drug is not safe or not effective for use under theconditions prescribed, recommended, or suggested in theproposed labeling of the drug;
(2) the methods used in and the facilities and controls used forthe manufacture, processing, and packing of the drugs areinadequate to preserve the drug's identity, strength, quality, andpurity; or
(3) based on a fair evaluation of all material facts, that thelabeling is false or misleading in any particular;
the state department shall, before the effective date of theapplication, issue an order refusing to permit the application tobecome effective.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-9
New drugs; exemption
Sec. 9. (a) Sections 7 and 8 of this chapter do not apply to thefollowing: (1) To a drug dispensed on a written or an electronicallytransmitted prescription signed by or with an electronicsignature of a physician, dentist, or veterinarian (except a drugdispensed in the course of the conduct of a business ofdispensing drugs pursuant to diagnosis by mail) if the physician,dentist, or veterinarian is licensed by law to administer the drug,and the drug bears a label containing the name and place ofbusiness of the dispenser, the serial number and date of theprescription, and the name of the physician, dentist, orveterinarian.
(2) To a drug exempted by rule of the state department and thatis intended solely for investigational use by experts qualified byscientific training and experience to investigate the safety andeffectiveness of drugs.
(3) To a drug sold in Indiana or introduced into intrastatecommerce at any time before the enactment of the Federal Act,if the drug's labeling contained the same representationsconcerning the conditions of the drug's use.
(4) To any drug that is licensed under the Public Health ServiceAct of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 etseq.) or under the Animal Virus-Serum Toxin Act of March 4,1913 (13 Stat. 832; 21 U.S.C. 151 et seq.).
(5) To a drug subject to section 4(10) of this chapter.
(b) Rules exempting drugs intended for investigational use undersubsection (a)(2) may, within the discretion of the state departmentamong other conditions relating to the protection of the public health,provide for conditioning the exemption upon the following:
(1) The submission to the state department, before any clinicaltesting of a new drug is undertaken, of reports by themanufacturer or the sponsor of the investigation of the drug orpreclinical tests, including tests on animals, of the drugadequate to justify the proposed clinical testing.
(2) The manufacturer or the sponsor of the investigation of anew drug proposed to be distributed to investigators for clinicaltesting obtaining a signed agreement from each of theinvestigators that patients to whom the drug is administered willbe under the manufacturer's or sponsor's personal supervisionor under the supervision of investigators responsible to themanufacturer or sponsor and that the manufacturer or sponsorwill not supply the drug to any other investigator or to clinicsfor administration to human beings.
(3) The establishment and maintenance of the records and themaking of the reports to the state department by themanufacturer or the sponsor of the investigation of the drug ofdata (including analytical reports by investigators) obtained asthe result of the investigational use of the drug that the statedepartment finds will enable the state department to evaluatethe safety and effectiveness of the drug if an application is filedunder section 8 of this chapter.
(c) Rules exempting drugs intended for investigational use under
subsection (a)(2) must provide that the exemption is conditionedupon the manufacturer or the sponsor of the investigation requiringthat experts using the drugs for investigational purposes certify to themanufacturer or sponsor that the experts will inform any humanbeings to whom the drugs or any controls used in connection with thedrugs are being administered that the drugs are being used forinvestigational purposes and will obtain the consent of the humanbeings or their representatives, except where they consider it notfeasible or, in their professional judgment, contrary to the bestinterests of the human beings.
(d) This section does not require a clinical investigator to submitdirectly to the state department reports on the investigational use ofdrugs. The regulations adopted under Section 505(i) of the FederalAct are the rules in Indiana. The state may adopt rules, whether ornot in accordance with regulations promulgated under the FederalAct.
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.5.
IC 16-42-3-10
New drugs; revocation of order refusing application to take effect;revocation of approved application
Sec. 10. (a) An order refusing to permit an application undersection 7 or 8 of this chapter to become effective may be revoked bythe state department.
(b) The state department may, after affording an opportunity forpublic hearing and judicial appeal, revoke an application approvedunder section 7 or 8 of this chapter if the state department finds anyof the following:
(1) That the drug, based on evidence acquired after approval,may not be safe or effective for the intended use.
(2) That the facilities or controls used in the manufacture,processing, or labeling of the drug may present a hazard to thepublic health.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-11
Representation of antiseptic
Sec. 11. The representation of a drug in the labeling oradvertisement as an antiseptic is considered to be a representationthat the drug is a germicide, except if a drug purporting to be orrepresented as an antiseptic for inhibitory use as a wet dressing,ointment, dusting powder, or other use involves prolonged contactwith the body.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-12
Violation of chapter; offenses
Sec. 12. (a) Except as otherwise provided, a person whorecklessly violates or fails to comply with this chapter commits aClass B misdemeanor. (b) Each day a violation continues constitutes a separate offense.
As added by P.L.2-1993, SEC.25.