CHAPTER 1. UNIFORM FOOD, DRUG, AND COSMETIC ACT: GENERAL PROVISIONS
IC 16-42
ARTICLE 42. REGULATION OF FOOD, DRUGS, ANDCOSMETICS
IC 16-42-1
Chapter 1. Uniform Food, Drug, and Cosmetic Act: GeneralProvisions
IC 16-42-1-1
Purpose of act
Sec. 1. (a) IC 16-42-1 through IC 16-42-4 are intended tosafeguard the public health and promote the public welfare byprotecting the:
(1) consuming public from injury by product use; and
(2) purchasing public from injury by merchandising deceit;
flowing from intrastate commerce in food, drugs, devices, andcosmetics.
(b) IC 16-42-1 through IC 16-42-4 are intended to be uniform withthe Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.)and with the Federal Trade Commission Act (15 U.S.C. 41 et seq.)to the extent they expressly outlaw the false advertisement of food,drugs, devices, and cosmetics.
(c) IC 16-42-1 through IC 16-42-4 thus promote uniformity ofsuch statutes and their administration and enforcement throughoutthe United States.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-1.1
Duties of state veterinarian and state board of animal health
Sec. 1.1. (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.68. Amended by P.L.2-2008,SEC.41.
IC 16-42-1-2
Authority to adopt certain federal regulations
Sec. 2. The purpose of IC 16-42-1 through IC 16-42-4 being topromote uniformity with the Federal Act, in safeguarding the publichealth and in promoting public welfare, the state department mayadopt, insofar as applicable, the regulations promulgated under theFederal Act and the Fair Packaging and Labeling Act (15 U.S.C.1451 et seq.).
As added by P.L.2-1993, SEC.25.
IC 16-42-1-3
Adoption of regulations; notice and hearing
Sec. 3. Except to the extent that the state department adopts theapplicable regulations promulgated by the federal securityadministrator under the Federal Act (21 U.S.C. 301 et seq.), the statedepartment, before adopting a rule contemplated by section 6 or 9 ofthis chapter, IC 16-42-2-1, IC 16-42-2-3(11), IC 16-42-3-4(4),IC 16-42-3-4(6), IC 16-42-3-4(7), or IC 16-42-3-4(8) shall giveappropriate notice of the proposal and of the time and place for apublic hearing to be held as provided by law.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-4
Construction of act and rules
Sec. 4. IC 16-42-1 through IC 16-42-4 and rules adopted underthose provisions shall, insofar as applicable, be interpreted andconstrued to effectuate the general purpose to enact state legislationuniform with the Federal Act (21 U.S.C. 301 et seq.).
As added by P.L.2-1993, SEC.25.
IC 16-42-1-5
Federal agency references; successor agency
Sec. 5. Whenever this chapter refers to a department or an agencyof the federal government, the term includes a department or anagency of the federal government to which the duties, powers, orfunctions are transferred or given.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-6
Registration of manufacturer, processor, repackager, or wholesaledistributor; maintaining place of business in state
Sec. 6. (a) A manufacturer, processor, repackager, or wholesaledistributor of food, drugs, or cosmetics who maintains a place ofbusiness in Indiana shall file with the state department, upon formsto be furnished by the state department, a written statement of thename and address of the owner, the character of the business, and thebusiness address of each place of business in Indiana.
(b) A new place of business for the manufacture, processing,repacking, or wholesale distribution of food, drugs, or cosmetics maynot be established in Indiana until the place of business has beenregistered as provided in this chapter.
(c) If ownership of a registered place of business changes, the newowner shall reregister the place of business before operating thesame.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-7
Misleading advertising or labeling; evaluation of representations
Sec. 7. If:
(1) an article is alleged to be misbranded because the labeling
is misleading; or
(2) an advertisement is alleged to be false because theadvertisement is misleading;
in determining whether the labeling or advertisement is misleading,there shall be taken into account among other items not onlyrepresentations made or suggested by statement, word, design,device, sound, or any combination of those methods, but also theextent to which the labeling or advertisement fails to reveal facts thatare material in the light of representations or that are material withrespect to consequences that may result from the use of the article towhich the labeling or advertisement relates under the conditions ofuse prescribed in the labeling or advertisement or under conditionsof use that are customary or usual.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-8
Labeling requirements; visibility
Sec. 8. A labeling requirement under IC 16-42-1 throughIC 16-42-4 is not considered to be complied with unless:
(1) the word, statement, or other information appearing on thelabel also appears on the outside container or wrapper, if any,of the retail package of the article; or
(2) the word, statement, or other information appearing on thelabel is easily seen through the outside container or wrapper.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-9
Advertisements; curative or therapeutic effect for certain diseases
Sec. 9. (a) This section does not apply to an advertisement that:
(1) is disseminated only to members of the medical, dental,pharmaceutical, and other legally recognized professionsdealing with the healing arts;
(2) appears only in the scientific periodicals of thoseprofessions; or
(3) is disseminated only for the purpose of public healtheducation by persons not commercially interested in the sale ofsuch drugs or devices.
(b) The advertisement of a drug or device that represents thatthe drug or device has any effect in:
albuminuria
appendicitis
arteriosclerosis
blood poison
bone disease
Bright's disease
carbuncles
cancer
cholecystitis
diabetes
diphtheriadropsy
erysipelas
gallstones
heart and vascular diseases
high blood pressure
mastoiditis
measles
mumps
nephritis
otitis media
paralysis
pneumonia
poliomyelitis (infantile paralysis)
prostate gland disorders
pyelitis
scarlet fever
sexual impotence
sinus infection
smallpox
tuberculosis
tumors
typhoid
uremia
venereal disease
meningitis
is considered false for purposes of IC 35-43-5-3.
(c) Whenever the state department determines that an advance inmedical science has made a type of self medication safe as to any ofthe diseases listed in this section, the state department shall adoptrules to authorize the advertisement of drugs having curative ortherapeutic effect for the disease, subject to conditions andrestrictions the state department considers necessary in the interestsof public health.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-10
Samples or specimen; investigation and examination
Sec. 10. The state department shall cause the investigation andexamination of food, drugs, devices, and cosmetics subject toIC 16-42-1 through IC 16-42-4. The state health commissioner or thecommissioner's authorized representative may do the following:
(1) Take a sample or specimen of any such merchandise, forexamination under IC 16-42-1 through IC 16-42-4, upontendering the market price to the person having the merchandisein custody.
(2) Enter any place, establishment, or vehicle in Indiana atreasonable times for the purpose of taking a sample or specimenof merchandise for examination.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-11
Inspection of records
Sec. 11. For the purpose of enforcing IC 16-42-1 throughIC 16-42-4, pertinent records of an administrative agency of the stateare open to inspection by the state health commissioner or thecommissioner's authorized representative.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-12
Access to and copying of records; use of evidence
Sec. 12. (a) For the purpose of enforcing IC 16-42-1 throughIC 16-42-4, carriers engaged in commerce, and persons receivingfood, drugs, devices, or cosmetics in commerce or holding sucharticles so received shall, upon the request of an officer or employeedesignated by the state department, permit the officer or employee,at reasonable times, to have access to and to copy all recordsshowing the movement in commerce of any food, drug, device, orcosmetic, or the holding of a food, drug, device, or cosmetic duringor after the movement, and the quantity, shipper, and consignee ofthe food, drug, device, or cosmetic.
(b) It is unlawful for a carrier or person described in subsection (a)to fail to permit access to and copying of such records upon requestif the request is accompanied by a statement in writing specifying thenature or kind of food, drug, device, or cosmetic to which the requestrelates.
(c) Evidence obtained under this section may not be used in acriminal prosecution of the person from whom the evidence isobtained.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-13
Inspection of factories, warehouses, and vehicles
Sec. 13. For the purpose of enforcing IC 16-42-1 throughIC 16-42-4, the state health commissioner or the commissioner'sauthorized representative may do the following:
(1) Enter, at reasonable times any factory, warehouse, place ofproduction, or establishment subject to IC 16-42-1 throughIC 16-42-4 or enter any vehicle being used to transport or holdfood, drugs, devices, or cosmetics.
(2) Inspect at reasonable times, the factory, warehouse, place ofproduction, establishment, or vehicle and all pertinentequipment, finished and unfinished materials, containers,labeling, and advertisements.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-14
Report of judgments, orders, and decrees
Sec. 14. The state health commissioner or the commissioner'slegally authorized agent may periodically publish reportssummarizing all judgments, decrees, and court orders given under
IC 16-42-1 through IC 16-42-4, including the nature of the chargeand the disposition of the charge.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-15
Dissemination of information
Sec. 15. (a) The state health commissioner or the commissioner'slegally authorized agent may cause to be disseminated informationregarding food, drugs, devices, or cosmetics in situations involving,in the opinion of the state health commissioner or the commissioner'slegally authorized agent, imminent danger to health or grossdeception of, or fraud upon, the consumer.
(b) This section does not prohibit the state health commissioner orthe commissioner's legally authorized agent from collecting,reporting, and illustrating the results of the commissioner'sexaminations and investigations under IC 16-42-1 throughIC 16-42-4.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-16
Prohibited acts; defenses; injunctions
Sec. 16. (a) A person may not engage in any of the following acts:
(1) The sale in intrastate commerce of a food, drug, device, orcosmetic that is adulterated or misbranded.
(2) The adulteration or misbranding of a food, drug, device, orcosmetic in intrastate commerce.
(3) The receipt in intrastate commerce of a food, drug, device, orcosmetic that is adulterated or misbranded, and the sale of thoseitems in intrastate commerce for pay or otherwise.
(4) The sale of any article in violation of IC 16-42-1-6,IC 16-42-3-7, IC 16-42-3-8, IC 16-42-3-9, or IC 16-42-3-10.
(5) The refusal to permit access to or copying of any record asrequired by section 12 of this chapter.
(6) The refusal to permit entry or inspection and collecting ofsamples as authorized by section 10 or 13 of this chapter.
(7) The use, without proper authority, of any mark, stamp, tag,label, or other identification device authorized or required byrules adopted under this chapter or IC 16-42-2 throughIC 16-42-4.
(8) The use by any person to the person's own advantage, or therevelation, other than to the state health commissioner or thestate health commissioner's authorized representative or to thecourts when relevant in any judicial proceeding, any informationacquired under authority of section 13 of this chapter orIC 16-42-3-7 through IC 16-42-3-10 concerning any method orprocess that as a trade secret is entitled to protection.
(9) The alteration, mutilation, destruction, obliteration, orremoval of the whole or any part of the labeling of, or the doingof any other act with respect to a food, drug, device, or cosmeticif the act is done while the article is held for sale and results in
the article being misbranded.
(10) The use on the labeling of any drug or in any advertisingrelating to the drug of any representation or suggestion that anapplication with respect to the drug is effective underIC 16-42-3-7 and IC 16-42-3-8 unless the drug complies withthose sections.
(11) The removal or disposal of a detained or embargoed articlein violation of this chapter.
(12) The giving of a guaranty or undertaking in intrastatecommerce referred to in subsection (c) that is false.
(b) A person who violates subsection (a) commits a Class Amisdemeanor. However, the offense is a Class D felony if the offenseis committed with intent to defraud or mislead.
(c) It is a defense for a person accused of violating subsection(a)(1) or subsection (a)(3) if the person establishes a guaranty orundertaking signed by and containing the name and address of theperson residing in the United States from whom the accused personreceived in good faith the article to the effect that the article is notadulterated or misbranded within the meaning of this article or theFederal Act.
(d) In addition to the remedies provided in this article, the statehealth commissioner or the commissioner's legally authorized agentmay apply to the circuit or superior court for a temporary orpermanent injunction restraining any person from violating anyprovision of this section.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-17
Schedule of civil penalties; order of compliance; consolidation ofproceedings
Sec. 17. (a) In addition to the other remedies provided in thisarticle, the state department shall adopt a schedule of civil penaltiesthat may be levied to enforce the following:
(1) This chapter, IC 16-42-2-6, IC 16-42-2-7, and IC 16-42-18.
(2) The rules adopted under this chapter, IC 16-42-2-6,IC 16-42-2-7, and IC 16-42-18 by the state department.
(b) A penalty included in the schedule of civil penalties adoptedunder subsection (a) may not exceed one thousand dollars ($1,000)for each violation per day.
(c) The state department may issue an order of compliance, imposea civil penalty included in the schedule of civil penalties adoptedunder subsection (a), or both, against a person who does any of thefollowing:
(1) Fails to comply with this chapter, IC 16-42-2-6, IC 16-42-2-7,or IC 16-42-18 or a rule adopted under this chapter,IC 16-42-2-6, IC 16-42-2-7, or IC 16-42-18.
(2) Interferes with or obstructs the state department in theperformance of duties under this chapter, IC 16-42-2-6,IC 16-42-2-7, or IC 16-42-18.
(d) An order of compliance may be issued under IC 4-21.5-3-6,
IC 4-21.5-3-8, or IC 4-21.5-4. A civil penalty may be imposed onlyin a proceeding under IC 4-21.5-3-8.
(e) A proceeding commenced to impose a civil penalty may beconsolidated with any other proceeding commenced to enforce anyof the following:
(1) This chapter, IC 16-42-2-6, IC 16-42-2-7, or IC 16-42-18.
(2) A rule adopted under this chapter, IC 16-42-2-6,IC 16-42-2-7, or IC 16-42-18.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-18
Embargo or detention of adulterated or misbranded merchandise;tagging or marking
Sec. 18. (a) Whenever a duly authorized agent of the statedepartment finds or has probable cause to believe that any food,drug, device, or cosmetic is:
(1) adulterated; or
(2) so misbranded as to be dangerous or fraudulent;
within the meaning of IC 16-42-1 through IC 16-42-4, the state healthcommissioner or the commissioner's legally authorized agent shallaffix to the merchandise a tag or other appropriate marking asdescribed in subsection (b).
(b) The tag or marking required in subsection (a) must do thefollowing:
(1) Give notice that the merchandise is or is suspected of beingadulterated or misbranded.
(2) Give notice that the merchandise has been detained orembargoed as follows:
(A) Five (5) days in the case of food.
(B) Ten (10) days in the case of drugs and cosmetics.
(3) Contain a warning to all persons not to remove or dispose ofthe merchandise by sale or otherwise until permission forremoval or disposal is given by the state department or the court.
(c) A person may not remove or dispose of detained or embargoedmerchandise by sale or otherwise without permission of the statedepartment or the court.
(d) The claimant may, under the supervision of the statedepartment, destroy the detained merchandise.
(e) If the state department finds that merchandise that has beendetained or embargoed is not adulterated or misbranded, the statedepartment shall remove the tag or marking.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-19
Condemnation of detained or embargoed merchandise; petition
Sec. 19. (a) When merchandise detained or embargoed undersection 18 of this chapter has been found by the state department tobe adulterated or misbranded, the state department shall within five(5) days cause to be filed a petition in any circuit or superior court inwhose jurisdiction the merchandise is detained or embargoed for
condemnation of the merchandise as provided in this chapter.
(b) The proceedings shall be brought in the name of the state by theprosecuting attorney of the county in which a violation occursagainst the merchandise, and the petition shall be verified by the statedepartment. The petition must do the following:
(1) Describe the merchandise.
(2) State the location of the merchandise.
(3) State the name of the person, firm, limited liability company,or corporation in actual possession.
(4) State the name of the owner, if known, to the statedepartment.
(5) Allege the particular violation that is claimed to exist.
(6) Otherwise conform to the requirements of a petition forcondemnation of an adulterated or misbranded food, drug,device, or cosmetic in the United States courts.
As added by P.L.2-1993, SEC.25. Amended by P.L.8-1993, SEC.252.
IC 16-42-1-20
Seizure and destruction of embargoed or detained merchandise
Sec. 20. (a) Upon the filing of a petition for condemnation of anadulterated or misbranded food, drug, device, or cosmetic, the courtshall promptly cause process to issue to the appropriate lawenforcement agency commanding the law enforcement agency toseize the merchandise described in the court order and to hold thegoods for further order of the court.
(b) The appropriate law enforcement agency shall, at the time ofseizure of goods under this section, serve a copy of the process uponthe owner of the merchandise.
(c) At the expiration of thirty (30) days after the seizure ofmerchandise under this section, if no claimant has appeared todefend against the petition, the court shall order the appropriate lawenforcement agency to destroy the seized merchandise.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-21
Filing of answer or demurrer
Sec. 21. A person:
(1) having an interest in the alleged adulterated or misbrandedfoods, drugs, devices, or cosmetics; or
(2) against whom a civil or criminal liability would exist if themerchandise is adulterated or misbranded;
may, at any time before destruction of the merchandise, appear andfile answer or demurrer to the petition. Such appearance and answeror demurrer shall be filed in open court, or if in vacation, with theclerk or judge of the court. The answer or demurrer must allege theinterest or liability of the party filing it. In all other respects, theissues shall be raised as in other civil actions.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-22 Rights of litigants
Sec. 22. The right of change of venue from the county, the right ofchange of judge, and the right of trial by jury are the same as in civilcases.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-23
Election to divide libeled merchandise into lots; dismissal as toparticular lots; consent to destruction of particular lots
Sec. 23. (a) At any time before trial, the defense may file with thecourt a written election to divide into lots the merchandise that isalleged to be adulterated or misbranded. Each of the lots must bedescribed in the written election in such a way as to enable them tobe distinguished.
(b) If different parties are defending as to separate lots, the courtshall proceed to docket as many separate actions as there are separatedefendants.
(c) The state department may dismiss as to any lot withoutprejudice to the proceeding against all other lots in the same seizure.Those defending may consent to the destruction of any lot withoutprejudice to their right to defend against the condemnation of allother lots in the same seizure.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-24
Judgment
Sec. 24. The court or jury trying the cause shall determine and thejudgment shall specify whether the contents of each separate lot areadulterated or misbranded. The court shall order the destruction bythe appropriate law enforcement agency of all lots found to beadulterated or misbranded and the return by the appropriate lawenforcement agency of all lots not found to be adulterated ormisbranded.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-25
Judgment for costs
Sec. 25. (a) A personal judgment may not be given against adefendant, except as provided in subsection (b).
(b) When merchandise is ordered destroyed, the court may givejudgment against the defendant for that part of the costs occasionedby the defendant.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-26
Return of libeled merchandise; liability for damages
Sec. 26. (a) Whenever the court orders the return of merchandise,the appropriate law enforcement agency shall immediately return themerchandise to the place of seizure. The appropriate lawenforcement agency and the appropriate law enforcement agency's
bondsmen are liable for any damage to the merchandise while in thecustody of the appropriate law enforcement agency if the damagewas due to negligence, willfulness, or carelessness upon the part ofthe appropriate law enforcement agency or the appropriate lawenforcement agency's agents.
(b) No subsequent proceeding in the cause or new trial may in anyway involve any returned merchandise.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-27
New trial; appeal; appeal bond
Sec. 27. (a) A defendant may move for a new trial and may appealto the supreme court or the court of appeals in the manner providedby law for appeals in civil actions.
(b) An appeal bond shall be fixed in an amount that covers thereasonable costs of preserving the condemned merchandise for theprobable time of appeal and the court costs.
(c) If an appeal is not prosecuted to determination or if thejudgment of the trial court is affirmed, the defendant bringing theappeal is liable for the following:
(1) The costs adjudged against the defendant or defendants in thetrial court.
(2) The costs of appeal.
(3) The actual reasonable cost of preserving the condemnedmerchandise during the appeal period.
(d) The court of appeals and the supreme court shall dispose ofappeals brought under this chapter as speedily as possible with dueregard to the rights of the parties involved.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-28
Judgment as evidence
Sec. 28. A judgment in a condemnation proceeding under thischapter is not admissible as evidence in any other legal proceeding.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-29
Costs not adjudicated against defendants
Sec. 29. All costs not adjudicated against the defendants inaccordance with this chapter are to be determined and collected inthe manner provided by law for the determination and collection ofcosts in unsuccessful criminal prosecutions.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-30
Libel for condemnation; procedure
Sec. 30. Except as otherwise provided in this chapter, theprocedure for condemnation proceedings under this chapter mustconform, as nearly as possible, to the procedure for civil actions.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-31
Destruction of adulterated or misbranded products; expenses
Sec. 31. (a) If the court finds that detained or embargoedmerchandise is adulterated or misbranded, the merchandise must,after entry of the judgment or decree, be destroyed at the expense ofthe claimant, under the supervision of the state department.
(b) All:
(1) court costs and fees; and
(2) storage and other proper expenses;
shall be taxed against the claimant of the merchandise or theclaimant's agent.
(c) If the adulteration or misbranding of merchandise can becorrected by proper labeling or processing of the merchandise, thecourt may order the merchandise to be delivered to the claimant forlabeling or processing under the supervision of the state departmentunder the following conditions:
(1) After entry of the decree or judgment.
(2) After costs, fees, and expenses have been paid.
(3) After sufficient bond, conditioned that the merchandise be solabeled or processed, is executed.
The expense of the supervision of labeling and processing shall bepaid by the claimant. The bond shall be returned to the claimant ofthe merchandise on representation to the court by the state healthcommissioner or the commissioner's legally authorized agent that themerchandise no longer violates IC 16-42-1 through IC 16-42-4 andthat the expenses of supervision by the state department have beenpaid.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-32
Notice and opportunity for hearing preceding criminal prosecution
Sec. 32. Before any violation of IC 16-42-1 through IC 16-42-4 isreported by the state health commissioner or the commissioner'sauthorized agent to a prosecuting attorney for the institution of acriminal proceeding, the person against whom the proceeding iscontemplated shall be given appropriate notice and an opportunity topresent the person's views to the state health commissioner or thecommissioner's authorized agent, either orally or in writing, withregard to the contemplated proceeding.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-33
Minor violations
Sec. 33. IC 16-42-1 through IC 16-42-4 does not require the statehealth commissioner or the commissioner's authorized agent toreport, for the institution of proceedings under those provisions,minor violations of those provisions whenever the state healthcommissioner or the commissioner's legally authorized agentbelieves that the public interest will be adequately served in the
circumstances by a suitable written notice or warning.
As added by P.L.2-1993, SEC.25.
IC 16-42-1-34
Chapter violations; offenses
Sec. 34. (a) Except as otherwise provided, a person who recklesslyviolates or fails to comply with this chapter commits a Class Bmisdemeanor.
(b) Each day a violation continues constitutes a separate offense.
As added by P.L.2-1993, SEC.25.