IC 16-42 ARTICLE 42. REGULATION OF FOOD, DRUGS, AND
COSMETICS
IC 16-42-1
Chapter 1. Uniform Food, Drug, and Cosmetic Act: General
Provisions
IC 16-42-1-1 Purpose of act
Sec. 1. (a) IC 16-42-1 through IC 16-42-4 are intended to
safeguard the public health and promote the public welfare by
protecting 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, and
cosmetics.
(b) IC 16-42-1 through IC 16-42-4 are intended to be uniform with
the 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 of
such statutes and their administration and enforcement throughout
the 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 state
health commissioner under this chapter when impounding or
disposing of adulterated or misbranded products under IC 15-17-5 or
IC 15-18-1.
(b) The Indiana state board of animal health shall act in place of
the state department of health under this chapter when impounding
or disposing of adulterated or misbranded products under IC 15-17-5
or 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 to
promote uniformity with the Federal Act, in safeguarding the public
health and in promoting public welfare, the state department may
adopt, insofar as applicable, the regulations promulgated under the
Federal 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 the
applicable regulations promulgated by the federal security
administrator under the Federal Act (21 U.S.C. 301 et seq.), the state
department, before adopting a rule contemplated by section 6 or 9 of
this 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 give
appropriate notice of the proposal and of the time and place for a
public 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 under
those provisions shall, insofar as applicable, be interpreted and
construed to effectuate the general purpose to enact state legislation
uniform 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 agency
of the federal government, the term includes a department or an
agency of the federal government to which the duties, powers, or
functions are transferred or given. As added by P.L.2-1993, SEC.25.
IC 16-42-1-6 Registration of manufacturer, processor, repackager, or wholesale
distributor; maintaining place of business in state
Sec. 6. (a) A manufacturer, processor, repackager, or wholesale
distributor of food, drugs, or cosmetics who maintains a place of
business in Indiana shall file with the state department, upon forms
to be furnished by the state department, a written statement of the
name and address of the owner, the character of the business, and the
business 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 may
not be established in Indiana until the place of business has been
registered as provided in this chapter.
(c) If ownership of a registered place of business changes, the new
owner shall reregister the place of business before operating the
same. 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 the
advertisement is misleading;
in determining whether the labeling or advertisement is misleading,
there shall be taken into account among other items not only
representations made or suggested by statement, word, design,
device, sound, or any combination of those methods, but also the
extent to which the labeling or advertisement fails to reveal facts that
are material in the light of representations or that are material with
respect to consequences that may result from the use of the article to
which the labeling or advertisement relates under the conditions of
use prescribed in the labeling or advertisement or under conditions
of 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 through
IC 16-42-4 is not considered to be complied with unless:
(1) the word, statement, or other information appearing on the
label 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 the
label 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 professions
dealing with the healing arts;
(2) appears only in the scientific periodicals of those
professions; or
(3) is disseminated only for the purpose of public health
education by persons not commercially interested in the sale of
such drugs or devices.
(b) The advertisement of a drug or device that represents that
the drug or device has any effect in:
albuminuria
appendicitis
arteriosclerosis
blood poison
bone disease
Bright's disease
carbuncles
cancer
cholecystitis
diabetes
diphtheria
dropsy
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 in
medical science has made a type of self medication safe as to any of
the diseases listed in this section, the state department shall adopt
rules to authorize the advertisement of drugs having curative or
therapeutic effect for the disease, subject to conditions and
restrictions the state department considers necessary in the interests
of 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 and
examination of food, drugs, devices, and cosmetics subject to
IC 16-42-1 through IC 16-42-4. The state health commissioner or the
commissioner's authorized representative may do the following:
(1) Take a sample or specimen of any such merchandise, for
examination under IC 16-42-1 through IC 16-42-4, upon
tendering the market price to the person having the merchandise
in custody.
(2) Enter any place, establishment, or vehicle in Indiana at
reasonable times for the purpose of taking a sample or specimen
of 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 through
IC 16-42-4, pertinent records of an administrative agency of the state
are open to inspection by the state health commissioner or the
commissioner'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 through
IC 16-42-4, carriers engaged in commerce, and persons receiving
food, drugs, devices, or cosmetics in commerce or holding such
articles so received shall, upon the request of an officer or employee
designated by the state department, permit the officer or employee,
at reasonable times, to have access to and to copy all records
showing the movement in commerce of any food, drug, device, or
cosmetic, or the holding of a food, drug, device, or cosmetic during
or after the movement, and the quantity, shipper, and consignee of
the 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 request
if the request is accompanied by a statement in writing specifying the
nature or kind of food, drug, device, or cosmetic to which the request
relates.
(c) Evidence obtained under this section may not be used in a
criminal prosecution of the person from whom the evidence is
obtained. 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 through
IC 16-42-4, the state health commissioner or the commissioner's
authorized representative may do the following:
(1) Enter, at reasonable times any factory, warehouse, place of
production, or establishment subject to IC 16-42-1 through
IC 16-42-4 or enter any vehicle being used to transport or hold
food, drugs, devices, or cosmetics.
(2) Inspect at reasonable times, the factory, warehouse, place of
production, establishment, or vehicle and all pertinent
equipment, 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's
legally authorized agent may periodically publish reports
summarizing all judgments, decrees, and court orders given under
IC 16-42-1 through IC 16-42-4, including the nature of the charge
and 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's
legally authorized agent may cause to be disseminated information
regarding food, drugs, devices, or cosmetics in situations involving,
in the opinion of the state health commissioner or the commissioner's
legally authorized agent, imminent danger to health or gross
deception of, or fraud upon, the consumer.
(b) This section does not prohibit the state health commissioner or
the commissioner's legally authorized agent from collecting,
reporting, and illustrating the results of the commissioner's
examinations and investigations under IC 16-42-1 through
IC 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, or
cosmetic that is adulterated or misbranded.
(2) The adulteration or misbranding of a food, drug, device, or
cosmetic in intrastate commerce.
(3) The receipt in intrastate commerce of a food, drug, device, or
cosmetic that is adulterated or misbranded, and the sale of those
items 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 as
required by section 12 of this chapter.
(6) The refusal to permit entry or inspection and collecting of
samples 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 by
rules adopted under this chapter or IC 16-42-2 through
IC 16-42-4.
(8) The use by any person to the person's own advantage, or the
revelation, other than to the state health commissioner or the
state health commissioner's authorized representative or to the
courts when relevant in any judicial proceeding, any information
acquired under authority of section 13 of this chapter or
IC 16-42-3-7 through IC 16-42-3-10 concerning any method or
process that as a trade secret is entitled to protection.
(9) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing
of any other act with respect to a food, drug, device, or cosmetic
if 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 advertising
relating to the drug of any representation or suggestion that an
application with respect to the drug is effective under
IC 16-42-3-7 and IC 16-42-3-8 unless the drug complies with
those sections.
(11) The removal or disposal of a detained or embargoed article
in violation of this chapter.
(12) The giving of a guaranty or undertaking in intrastate
commerce referred to in subsection (c) that is false.
(b) A person who violates subsection (a) commits a Class A
misdemeanor. However, the offense is a Class D felony if the offense
is 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 or
undertaking signed by and containing the name and address of the
person residing in the United States from whom the accused person
received in good faith the article to the effect that the article is not
adulterated or misbranded within the meaning of this article or the
Federal Act.
(d) In addition to the remedies provided in this article, the state
health commissioner or the commissioner's legally authorized agent
may apply to the circuit or superior court for a temporary or
permanent injunction restraining any person from violating any
provision 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 of
proceedings
Sec. 17. (a) In addition to the other remedies provided in this
article, the state department shall adopt a schedule of civil penalties
that 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 adopted
under 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, impose
a civil penalty included in the schedule of civil penalties adopted
under subsection (a), or both, against a person who does any of the
following:
(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 the
performance 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 only
in a proceeding under IC 4-21.5-3-8.
(e) A proceeding commenced to impose a civil penalty may be
consolidated with any other proceeding commenced to enforce any
of 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 state
department 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 health
commissioner or the commissioner's legally authorized agent shall
affix to the merchandise a tag or other appropriate marking as
described in subsection (b).
(b) The tag or marking required in subsection (a) must do the
following:
(1) Give notice that the merchandise is or is suspected of being
adulterated or misbranded.
(2) Give notice that the merchandise has been detained or
embargoed 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 of
the merchandise by sale or otherwise until permission for
removal or disposal is given by the state department or the court.
(c) A person may not remove or dispose of detained or embargoed
merchandise by sale or otherwise without permission of the state
department or the court.
(d) The claimant may, under the supervision of the state
department, destroy the detained merchandise.
(e) If the state department finds that merchandise that has been
detained or embargoed is not adulterated or misbranded, the state
department 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 under
section 18 of this chapter has been found by the state department to
be adulterated or misbranded, the state department shall within five
(5) days cause to be filed a petition in any circuit or superior court in
whose 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 the
prosecuting attorney of the county in which a violation occurs
against the merchandise, and the petition shall be verified by the state
department. 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 state
department.
(5) Allege the particular violation that is claimed to exist.
(6) Otherwise conform to the requirements of a petition for
condemnation 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 an
adulterated or misbranded food, drug, device, or cosmetic, the court
shall promptly cause process to issue to the appropriate law
enforcement agency commanding the law enforcement agency to
seize the merchandise described in the court order and to hold the
goods for further order of the court.
(b) The appropriate law enforcement agency shall, at the time of
seizure of goods under this section, serve a copy of the process upon
the owner of the merchandise.
(c) At the expiration of thirty (30) days after the seizure of
merchandise under this section, if no claimant has appeared to
defend against the petition, the court shall order the appropriate law
enforcement 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 misbranded
foods, drugs, devices, or cosmetics; or
(2) against whom a civil or criminal liability would exist if the
merchandise is adulterated or misbranded;
may, at any time before destruction of the merchandise, appear and
file answer or demurrer to the petition. Such appearance and answer
or demurrer shall be filed in open court, or if in vacation, with the
clerk or judge of the court. The answer or demurrer must allege the
interest or liability of the party filing it. In all other respects, the
issues 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 of
change of judge, and the right of trial by jury are the same as in civil
cases. As added by P.L.2-1993, SEC.25.
IC 16-42-1-23 Election to divide libeled merchandise into lots; dismissal as to
particular lots; consent to destruction of particular lots
Sec. 23. (a) At any time before trial, the defense may file with the
court a written election to divide into lots the merchandise that is
alleged to be adulterated or misbranded. Each of the lots must be
described in the written election in such a way as to enable them to
be distinguished.
(b) If different parties are defending as to separate lots, the court
shall proceed to docket as many separate actions as there are separate
defendants.
(c) The state department may dismiss as to any lot without
prejudice to the proceeding against all other lots in the same seizure.
Those defending may consent to the destruction of any lot without
prejudice to their right to defend against the condemnation of all
other 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 the
judgment shall specify whether the contents of each separate lot are
adulterated or misbranded. The court shall order the destruction by
the appropriate law enforcement agency of all lots found to be
adulterated or misbranded and the return by the appropriate law
enforcement agency of all lots not found to be adulterated or
misbranded. 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 a
defendant, except as provided in subsection (b).
(b) When merchandise is ordered destroyed, the court may give
judgment against the defendant for that part of the costs occasioned
by 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 the
merchandise to the place of seizure. The appropriate law
enforcement agency and the appropriate law enforcement agency's
bondsmen are liable for any damage to the merchandise while in the
custody of the appropriate law enforcement agency if the damage
was due to negligence, willfulness, or carelessness upon the part of
the appropriate law enforcement agency or the appropriate law
enforcement agency's agents.
(b) No subsequent proceeding in the cause or new trial may in any
way 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 appeal
to the supreme court or the court of appeals in the manner provided
by law for appeals in civil actions.
(b) An appeal bond shall be fixed in an amount that covers the
reasonable costs of preserving the condemned merchandise for the
probable time of appeal and the court costs.
(c) If an appeal is not prosecuted to determination or if the
judgment of the trial court is affirmed, the defendant bringing the
appeal is liable for the following:
(1) The costs adjudged against the defendant or defendants in the
trial court.
(2) The costs of appeal.
(3) The actual reasonable cost of preserving the condemned
merchandise during the appeal period.
(d) The court of appeals and the supreme court shall dispose of
appeals brought under this chapter as speedily as possible with due
regard 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 this
chapter 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 in
accordance with this chapter are to be determined and collected in
the manner provided by law for the determination and collection of
costs 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, the
procedure for condemnation proceedings under this chapter must
conform, 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 embargoed
merchandise is adulterated or misbranded, the merchandise must,
after entry of the judgment or decree, be destroyed at the expense of
the 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 the
claimant's agent.
(c) If the adulteration or misbranding of merchandise can be
corrected by proper labeling or processing of the merchandise, the
court may order the merchandise to be delivered to the claimant for
labeling or processing under the supervision of the state department
under 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 so
labeled or processed, is executed.
The expense of the supervision of labeling and processing shall be
paid by the claimant. The bond shall be returned to the claimant of
the merchandise on representation to the court by the state health
commissioner or the commissioner's legally authorized agent that the
merchandise no longer violates IC 16-42-1 through IC 16-42-4 and
that the expenses of supervision by the state department have been
paid. 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 is
reported by the state health commissioner or the commissioner's
authorized agent to a prosecuting attorney for the institution of a
criminal proceeding, the person against whom the proceeding is
contemplated shall be given appropriate notice and an opportunity to
present the person's views to the state health commissioner or the
commissioner's authorized agent, either orally or in writing, with
regard 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 state
health commissioner or the commissioner's authorized agent to
report, for the institution of proceedings under those provisions,
minor violations of those provisions whenever the state health
commissioner or the commissioner's legally authorized agent
believes 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 recklessly
violates or fails to comply with this chapter commits a Class B
misdemeanor.
(b) Each day a violation continues constitutes a separate offense. As added by P.L.2-1993, SEC.25.
IC 16-42 ARTICLE 42. REGULATION OF FOOD, DRUGS, AND
COSMETICS
IC 16-42-1
Chapter 1. Uniform Food, Drug, and Cosmetic Act: General
Provisions
IC 16-42-1-1 Purpose of act
Sec. 1. (a) IC 16-42-1 through IC 16-42-4 are intended to
safeguard the public health and promote the public welfare by
protecting 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, and
cosmetics.
(b) IC 16-42-1 through IC 16-42-4 are intended to be uniform with
the 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 of
such statutes and their administration and enforcement throughout
the 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 state
health commissioner under this chapter when impounding or
disposing of adulterated or misbranded products under IC 15-17-5 or
IC 15-18-1.
(b) The Indiana state board of animal health shall act in place of
the state department of health under this chapter when impounding
or disposing of adulterated or misbranded products under IC 15-17-5
or 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 to
promote uniformity with the Federal Act, in safeguarding the public
health and in promoting public welfare, the state department may
adopt, insofar as applicable, the regulations promulgated under the
Federal 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 the
applicable regulations promulgated by the federal security
administrator under the Federal Act (21 U.S.C. 301 et seq.), the state
department, before adopting a rule contemplated by section 6 or 9 of
this 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 give
appropriate notice of the proposal and of the time and place for a
public 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 under
those provisions shall, insofar as applicable, be interpreted and
construed to effectuate the general purpose to enact state legislation
uniform 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 agency
of the federal government, the term includes a department or an
agency of the federal government to which the duties, powers, or
functions are transferred or given. As added by P.L.2-1993, SEC.25.
IC 16-42-1-6 Registration of manufacturer, processor, repackager, or wholesale
distributor; maintaining place of business in state
Sec. 6. (a) A manufacturer, processor, repackager, or wholesale
distributor of food, drugs, or cosmetics who maintains a place of
business in Indiana shall file with the state department, upon forms
to be furnished by the state department, a written statement of the
name and address of the owner, the character of the business, and the
business 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 may
not be established in Indiana until the place of business has been
registered as provided in this chapter.
(c) If ownership of a registered place of business changes, the new
owner shall reregister the place of business before operating the
same. 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 the
advertisement is misleading;
in determining whether the labeling or advertisement is misleading,
there shall be taken into account among other items not only
representations made or suggested by statement, word, design,
device, sound, or any combination of those methods, but also the
extent to which the labeling or advertisement fails to reveal facts that
are material in the light of representations or that are material with
respect to consequences that may result from the use of the article to
which the labeling or advertisement relates under the conditions of
use prescribed in the labeling or advertisement or under conditions
of 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 through
IC 16-42-4 is not considered to be complied with unless:
(1) the word, statement, or other information appearing on the
label 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 the
label 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 professions
dealing with the healing arts;
(2) appears only in the scientific periodicals of those
professions; or
(3) is disseminated only for the purpose of public health
education by persons not commercially interested in the sale of
such drugs or devices.
(b) The advertisement of a drug or device that represents that
the drug or device has any effect in:
albuminuria
appendicitis
arteriosclerosis
blood poison
bone disease
Bright's disease
carbuncles
cancer
cholecystitis
diabetes
diphtheria
dropsy
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 in
medical science has made a type of self medication safe as to any of
the diseases listed in this section, the state department shall adopt
rules to authorize the advertisement of drugs having curative or
therapeutic effect for the disease, subject to conditions and
restrictions the state department considers necessary in the interests
of 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 and
examination of food, drugs, devices, and cosmetics subject to
IC 16-42-1 through IC 16-42-4. The state health commissioner or the
commissioner's authorized representative may do the following:
(1) Take a sample or specimen of any such merchandise, for
examination under IC 16-42-1 through IC 16-42-4, upon
tendering the market price to the person having the merchandise
in custody.
(2) Enter any place, establishment, or vehicle in Indiana at
reasonable times for the purpose of taking a sample or specimen
of 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 through
IC 16-42-4, pertinent records of an administrative agency of the state
are open to inspection by the state health commissioner or the
commissioner'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 through
IC 16-42-4, carriers engaged in commerce, and persons receiving
food, drugs, devices, or cosmetics in commerce or holding such
articles so received shall, upon the request of an officer or employee
designated by the state department, permit the officer or employee,
at reasonable times, to have access to and to copy all records
showing the movement in commerce of any food, drug, device, or
cosmetic, or the holding of a food, drug, device, or cosmetic during
or after the movement, and the quantity, shipper, and consignee of
the 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 request
if the request is accompanied by a statement in writing specifying the
nature or kind of food, drug, device, or cosmetic to which the request
relates.
(c) Evidence obtained under this section may not be used in a
criminal prosecution of the person from whom the evidence is
obtained. 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 through
IC 16-42-4, the state health commissioner or the commissioner's
authorized representative may do the following:
(1) Enter, at reasonable times any factory, warehouse, place of
production, or establishment subject to IC 16-42-1 through
IC 16-42-4 or enter any vehicle being used to transport or hold
food, drugs, devices, or cosmetics.
(2) Inspect at reasonable times, the factory, warehouse, place of
production, establishment, or vehicle and all pertinent
equipment, 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's
legally authorized agent may periodically publish reports
summarizing all judgments, decrees, and court orders given under
IC 16-42-1 through IC 16-42-4, including the nature of the charge
and 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's
legally authorized agent may cause to be disseminated information
regarding food, drugs, devices, or cosmetics in situations involving,
in the opinion of the state health commissioner or the commissioner's
legally authorized agent, imminent danger to health or gross
deception of, or fraud upon, the consumer.
(b) This section does not prohibit the state health commissioner or
the commissioner's legally authorized agent from collecting,
reporting, and illustrating the results of the commissioner's
examinations and investigations under IC 16-42-1 through
IC 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, or
cosmetic that is adulterated or misbranded.
(2) The adulteration or misbranding of a food, drug, device, or
cosmetic in intrastate commerce.
(3) The receipt in intrastate commerce of a food, drug, device, or
cosmetic that is adulterated or misbranded, and the sale of those
items 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 as
required by section 12 of this chapter.
(6) The refusal to permit entry or inspection and collecting of
samples 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 by
rules adopted under this chapter or IC 16-42-2 through
IC 16-42-4.
(8) The use by any person to the person's own advantage, or the
revelation, other than to the state health commissioner or the
state health commissioner's authorized representative or to the
courts when relevant in any judicial proceeding, any information
acquired under authority of section 13 of this chapter or
IC 16-42-3-7 through IC 16-42-3-10 concerning any method or
process that as a trade secret is entitled to protection.
(9) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing
of any other act with respect to a food, drug, device, or cosmetic
if 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 advertising
relating to the drug of any representation or suggestion that an
application with respect to the drug is effective under
IC 16-42-3-7 and IC 16-42-3-8 unless the drug complies with
those sections.
(11) The removal or disposal of a detained or embargoed article
in violation of this chapter.
(12) The giving of a guaranty or undertaking in intrastate
commerce referred to in subsection (c) that is false.
(b) A person who violates subsection (a) commits a Class A
misdemeanor. However, the offense is a Class D felony if the offense
is 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 or
undertaking signed by and containing the name and address of the
person residing in the United States from whom the accused person
received in good faith the article to the effect that the article is not
adulterated or misbranded within the meaning of this article or the
Federal Act.
(d) In addition to the remedies provided in this article, the state
health commissioner or the commissioner's legally authorized agent
may apply to the circuit or superior court for a temporary or
permanent injunction restraining any person from violating any
provision 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 of
proceedings
Sec. 17. (a) In addition to the other remedies provided in this
article, the state department shall adopt a schedule of civil penalties
that 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 adopted
under 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, impose
a civil penalty included in the schedule of civil penalties adopted
under subsection (a), or both, against a person who does any of the
following:
(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 the
performance 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 only
in a proceeding under IC 4-21.5-3-8.
(e) A proceeding commenced to impose a civil penalty may be
consolidated with any other proceeding commenced to enforce any
of 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 state
department 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 health
commissioner or the commissioner's legally authorized agent shall
affix to the merchandise a tag or other appropriate marking as
described in subsection (b).
(b) The tag or marking required in subsection (a) must do the
following:
(1) Give notice that the merchandise is or is suspected of being
adulterated or misbranded.
(2) Give notice that the merchandise has been detained or
embargoed 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 of
the merchandise by sale or otherwise until permission for
removal or disposal is given by the state department or the court.
(c) A person may not remove or dispose of detained or embargoed
merchandise by sale or otherwise without permission of the state
department or the court.
(d) The claimant may, under the supervision of the state
department, destroy the detained merchandise.
(e) If the state department finds that merchandise that has been
detained or embargoed is not adulterated or misbranded, the state
department 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 under
section 18 of this chapter has been found by the state department to
be adulterated or misbranded, the state department shall within five
(5) days cause to be filed a petition in any circuit or superior court in
whose 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 the
prosecuting attorney of the county in which a violation occurs
against the merchandise, and the petition shall be verified by the state
department. 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 state
department.
(5) Allege the particular violation that is claimed to exist.
(6) Otherwise conform to the requirements of a petition for
condemnation 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 an
adulterated or misbranded food, drug, device, or cosmetic, the court
shall promptly cause process to issue to the appropriate law
enforcement agency commanding the law enforcement agency to
seize the merchandise described in the court order and to hold the
goods for further order of the court.
(b) The appropriate law enforcement agency shall, at the time of
seizure of goods under this section, serve a copy of the process upon
the owner of the merchandise.
(c) At the expiration of thirty (30) days after the seizure of
merchandise under this section, if no claimant has appeared to
defend against the petition, the court shall order the appropriate law
enforcement 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 misbranded
foods, drugs, devices, or cosmetics; or
(2) against whom a civil or criminal liability would exist if the
merchandise is adulterated or misbranded;
may, at any time before destruction of the merchandise, appear and
file answer or demurrer to the petition. Such appearance and answer
or demurrer shall be filed in open court, or if in vacation, with the
clerk or judge of the court. The answer or demurrer must allege the
interest or liability of the party filing it. In all other respects, the
issues 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 of
change of judge, and the right of trial by jury are the same as in civil
cases. As added by P.L.2-1993, SEC.25.
IC 16-42-1-23 Election to divide libeled merchandise into lots; dismissal as to
particular lots; consent to destruction of particular lots
Sec. 23. (a) At any time before trial, the defense may file with the
court a written election to divide into lots the merchandise that is
alleged to be adulterated or misbranded. Each of the lots must be
described in the written election in such a way as to enable them to
be distinguished.
(b) If different parties are defending as to separate lots, the court
shall proceed to docket as many separate actions as there are separate
defendants.
(c) The state department may dismiss as to any lot without
prejudice to the proceeding against all other lots in the same seizure.
Those defending may consent to the destruction of any lot without
prejudice to their right to defend against the condemnation of all
other 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 the
judgment shall specify whether the contents of each separate lot are
adulterated or misbranded. The court shall order the destruction by
the appropriate law enforcement agency of all lots found to be
adulterated or misbranded and the return by the appropriate law
enforcement agency of all lots not found to be adulterated or
misbranded. 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 a
defendant, except as provided in subsection (b).
(b) When merchandise is ordered destroyed, the court may give
judgment against the defendant for that part of the costs occasioned
by 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 the
merchandise to the place of seizure. The appropriate law
enforcement agency and the appropriate law enforcement agency's
bondsmen are liable for any damage to the merchandise while in the
custody of the appropriate law enforcement agency if the damage
was due to negligence, willfulness, or carelessness upon the part of
the appropriate law enforcement agency or the appropriate law
enforcement agency's agents.
(b) No subsequent proceeding in the cause or new trial may in any
way 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 appeal
to the supreme court or the court of appeals in the manner provided
by law for appeals in civil actions.
(b) An appeal bond shall be fixed in an amount that covers the
reasonable costs of preserving the condemned merchandise for the
probable time of appeal and the court costs.
(c) If an appeal is not prosecuted to determination or if the
judgment of the trial court is affirmed, the defendant bringing the
appeal is liable for the following:
(1) The costs adjudged against the defendant or defendants in the
trial court.
(2) The costs of appeal.
(3) The actual reasonable cost of preserving the condemned
merchandise during the appeal period.
(d) The court of appeals and the supreme court shall dispose of
appeals brought under this chapter as speedily as possible with due
regard 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 this
chapter 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 in
accordance with this chapter are to be determined and collected in
the manner provided by law for the determination and collection of
costs 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, the
procedure for condemnation proceedings under this chapter must
conform, 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 embargoed
merchandise is adulterated or misbranded, the merchandise must,
after entry of the judgment or decree, be destroyed at the expense of
the 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 the
claimant's agent.
(c) If the adulteration or misbranding of merchandise can be
corrected by proper labeling or processing of the merchandise, the
court may order the merchandise to be delivered to the claimant for
labeling or processing under the supervision of the state department
under 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 so
labeled or processed, is executed.
The expense of the supervision of labeling and processing shall be
paid by the claimant. The bond shall be returned to the claimant of
the merchandise on representation to the court by the state health
commissioner or the commissioner's legally authorized agent that the
merchandise no longer violates IC 16-42-1 through IC 16-42-4 and
that the expenses of supervision by the state department have been
paid. 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 is
reported by the state health commissioner or the commissioner's
authorized agent to a prosecuting attorney for the institution of a
criminal proceeding, the person against whom the proceeding is
contemplated shall be given appropriate notice and an opportunity to
present the person's views to the state health commissioner or the
commissioner's authorized agent, either orally or in writing, with
regard 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 state
health commissioner or the commissioner's authorized agent to
report, for the institution of proceedings under those provisions,
minor violations of those provisions whenever the state health
commissioner or the commissioner's legally authorized agent
believes 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 recklessly
violates or fails to comply with this chapter commits a Class B
misdemeanor.
(b) Each day a violation continues constitutes a separate offense. As added by P.L.2-1993, SEC.25.
IC 16-42 ARTICLE 42. REGULATION OF FOOD, DRUGS, AND
COSMETICS
IC 16-42-1
Chapter 1. Uniform Food, Drug, and Cosmetic Act: General
Provisions
IC 16-42-1-1 Purpose of act
Sec. 1. (a) IC 16-42-1 through IC 16-42-4 are intended to
safeguard the public health and promote the public welfare by
protecting 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, and
cosmetics.
(b) IC 16-42-1 through IC 16-42-4 are intended to be uniform with
the 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 of
such statutes and their administration and enforcement throughout
the 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 state
health commissioner under this chapter when impounding or
disposing of adulterated or misbranded products under IC 15-17-5 or
IC 15-18-1.
(b) The Indiana state board of animal health shall act in place of
the state department of health under this chapter when impounding
or disposing of adulterated or misbranded products under IC 15-17-5
or 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 to
promote uniformity with the Federal Act, in safeguarding the public
health and in promoting public welfare, the state department may
adopt, insofar as applicable, the regulations promulgated under the
Federal 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 the
applicable regulations promulgated by the federal security
administrator under the Federal Act (21 U.S.C. 301 et seq.), the state
department, before adopting a rule contemplated by section 6 or 9 of
this 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 give
appropriate notice of the proposal and of the time and place for a
public 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 under
those provisions shall, insofar as applicable, be interpreted and
construed to effectuate the general purpose to enact state legislation
uniform 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 agency
of the federal government, the term includes a department or an
agency of the federal government to which the duties, powers, or
functions are transferred or given. As added by P.L.2-1993, SEC.25.
IC 16-42-1-6 Registration of manufacturer, processor, repackager, or wholesale
distributor; maintaining place of business in state
Sec. 6. (a) A manufacturer, processor, repackager, or wholesale
distributor of food, drugs, or cosmetics who maintains a place of
business in Indiana shall file with the state department, upon forms
to be furnished by the state department, a written statement of the
name and address of the owner, the character of the business, and the
business 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 may
not be established in Indiana until the place of business has been
registered as provided in this chapter.
(c) If ownership of a registered place of business changes, the new
owner shall reregister the place of business before operating the
same. 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 the
advertisement is misleading;
in determining whether the labeling or advertisement is misleading,
there shall be taken into account among other items not only
representations made or suggested by statement, word, design,
device, sound, or any combination of those methods, but also the
extent to which the labeling or advertisement fails to reveal facts that
are material in the light of representations or that are material with
respect to consequences that may result from the use of the article to
which the labeling or advertisement relates under the conditions of
use prescribed in the labeling or advertisement or under conditions
of 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 through
IC 16-42-4 is not considered to be complied with unless:
(1) the word, statement, or other information appearing on the
label 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 the
label 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 professions
dealing with the healing arts;
(2) appears only in the scientific periodicals of those
professions; or
(3) is disseminated only for the purpose of public health
education by persons not commercially interested in the sale of
such drugs or devices.
(b) The advertisement of a drug or device that represents that
the drug or device has any effect in:
albuminuria
appendicitis
arteriosclerosis
blood poison
bone disease
Bright's disease
carbuncles
cancer
cholecystitis
diabetes
diphtheria
dropsy
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 in
medical science has made a type of self medication safe as to any of
the diseases listed in this section, the state department shall adopt
rules to authorize the advertisement of drugs having curative or
therapeutic effect for the disease, subject to conditions and
restrictions the state department considers necessary in the interests
of 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 and
examination of food, drugs, devices, and cosmetics subject to
IC 16-42-1 through IC 16-42-4. The state health commissioner or the
commissioner's authorized representative may do the following:
(1) Take a sample or specimen of any such merchandise, for
examination under IC 16-42-1 through IC 16-42-4, upon
tendering the market price to the person having the merchandise
in custody.
(2) Enter any place, establishment, or vehicle in Indiana at
reasonable times for the purpose of taking a sample or specimen
of 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 through
IC 16-42-4, pertinent records of an administrative agency of the state
are open to inspection by the state health commissioner or the
commissioner'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 through
IC 16-42-4, carriers engaged in commerce, and persons receiving
food, drugs, devices, or cosmetics in commerce or holding such
articles so received shall, upon the request of an officer or employee
designated by the state department, permit the officer or employee,
at reasonable times, to have access to and to copy all records
showing the movement in commerce of any food, drug, device, or
cosmetic, or the holding of a food, drug, device, or cosmetic during
or after the movement, and the quantity, shipper, and consignee of
the 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 request
if the request is accompanied by a statement in writing specifying the
nature or kind of food, drug, device, or cosmetic to which the request
relates.
(c) Evidence obtained under this section may not be used in a
criminal prosecution of the person from whom the evidence is
obtained. 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 through
IC 16-42-4, the state health commissioner or the commissioner's
authorized representative may do the following:
(1) Enter, at reasonable times any factory, warehouse, place of
production, or establishment subject to IC 16-42-1 through
IC 16-42-4 or enter any vehicle being used to transport or hold
food, drugs, devices, or cosmetics.
(2) Inspect at reasonable times, the factory, warehouse, place of
production, establishment, or vehicle and all pertinent
equipment, 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's
legally authorized agent may periodically publish reports
summarizing all judgments, decrees, and court orders given under
IC 16-42-1 through IC 16-42-4, including the nature of the charge
and 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's
legally authorized agent may cause to be disseminated information
regarding food, drugs, devices, or cosmetics in situations involving,
in the opinion of the state health commissioner or the commissioner's
legally authorized agent, imminent danger to health or gross
deception of, or fraud upon, the consumer.
(b) This section does not prohibit the state health commissioner or
the commissioner's legally authorized agent from collecting,
reporting, and illustrating the results of the commissioner's
examinations and investigations under IC 16-42-1 through
IC 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, or
cosmetic that is adulterated or misbranded.
(2) The adulteration or misbranding of a food, drug, device, or
cosmetic in intrastate commerce.
(3) The receipt in intrastate commerce of a food, drug, device, or
cosmetic that is adulterated or misbranded, and the sale of those
items 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 as
required by section 12 of this chapter.
(6) The refusal to permit entry or inspection and collecting of
samples 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 by
rules adopted under this chapter or IC 16-42-2 through
IC 16-42-4.
(8) The use by any person to the person's own advantage, or the
revelation, other than to the state health commissioner or the
state health commissioner's authorized representative or to the
courts when relevant in any judicial proceeding, any information
acquired under authority of section 13 of this chapter or
IC 16-42-3-7 through IC 16-42-3-10 concerning any method or
process that as a trade secret is entitled to protection.
(9) The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the doing
of any other act with respect to a food, drug, device, or cosmetic
if 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 advertising
relating to the drug of any representation or suggestion that an
application with respect to the drug is effective under
IC 16-42-3-7 and IC 16-42-3-8 unless the drug complies with
those sections.
(11) The removal or disposal of a detained or embargoed article
in violation of this chapter.
(12) The giving of a guaranty or undertaking in intrastate
commerce referred to in subsection (c) that is false.
(b) A person who violates subsection (a) commits a Class A
misdemeanor. However, the offense is a Class D felony if the offense
is 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 or
undertaking signed by and containing the name and address of the
person residing in the United States from whom the accused person
received in good faith the article to the effect that the article is not
adulterated or misbranded within the meaning of this article or the
Federal Act.
(d) In addition to the remedies provided in this article, the state
health commissioner or the commissioner's legally authorized agent
may apply to the circuit or superior court for a temporary or
permanent injunction restraining any person from violating any
provision 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 of
proceedings
Sec. 17. (a) In addition to the other remedies provided in this
article, the state department shall adopt a schedule of civil penalties
that 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 adopted
under 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, impose
a civil penalty included in the schedule of civil penalties adopted
under subsection (a), or both, against a person who does any of the
following:
(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 the
performance 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 only
in a proceeding under IC 4-21.5-3-8.
(e) A proceeding commenced to impose a civil penalty may be
consolidated with any other proceeding commenced to enforce any
of 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 state
department 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 health
commissioner or the commissioner's legally authorized agent shall
affix to the merchandise a tag or other appropriate marking as
described in subsection (b).
(b) The tag or marking required in subsection (a) must do the
following:
(1) Give notice that the merchandise is or is suspected of being
adulterated or misbranded.
(2) Give notice that the merchandise has been detained or
embargoed 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 of
the merchandise by sale or otherwise until permission for
removal or disposal is given by the state department or the court.
(c) A person may not remove or dispose of detained or embargoed
merchandise by sale or otherwise without permission of the state
department or the court.
(d) The claimant may, under the supervision of the state
department, destroy the detained merchandise.
(e) If the state department finds that merchandise that has been
detained or embargoed is not adulterated or misbranded, the state
department 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 under
section 18 of this chapter has been found by the state department to
be adulterated or misbranded, the state department shall within five
(5) days cause to be filed a petition in any circuit or superior court in
whose 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 the
prosecuting attorney of the county in which a violation occurs
against the merchandise, and the petition shall be verified by the state
department. 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 state
department.
(5) Allege the particular violation that is claimed to exist.
(6) Otherwise conform to the requirements of a petition for
condemnation 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 an
adulterated or misbranded food, drug, device, or cosmetic, the court
shall promptly cause process to issue to the appropriate law
enforcement agency commanding the law enforcement agency to
seize the merchandise described in the court order and to hold the
goods for further order of the court.
(b) The appropriate law enforcement agency shall, at the time of
seizure of goods under this section, serve a copy of the process upon
the owner of the merchandise.
(c) At the expiration of thirty (30) days after the seizure of
merchandise under this section, if no claimant has appeared to
defend against the petition, the court shall order the appropriate law
enforcement 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 misbranded
foods, drugs, devices, or cosmetics; or
(2) against whom a civil or criminal liability would exist if the
merchandise is adulterated or misbranded;
may, at any time before destruction of the merchandise, appear and
file answer or demurrer to the petition. Such appearance and answer
or demurrer shall be filed in open court, or if in vacation, with the
clerk or judge of the court. The answer or demurrer must allege the
interest or liability of the party filing it. In all other respects, the
issues 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 of
change of judge, and the right of trial by jury are the same as in civil
cases. As added by P.L.2-1993, SEC.25.
IC 16-42-1-23 Election to divide libeled merchandise into lots; dismissal as to
particular lots; consent to destruction of particular lots
Sec. 23. (a) At any time before trial, the defense may file with the
court a written election to divide into lots the merchandise that is
alleged to be adulterated or misbranded. Each of the lots must be
described in the written election in such a way as to enable them to
be distinguished.
(b) If different parties are defending as to separate lots, the court
shall proceed to docket as many separate actions as there are separate
defendants.
(c) The state department may dismiss as to any lot without
prejudice to the proceeding against all other lots in the same seizure.
Those defending may consent to the destruction of any lot without
prejudice to their right to defend against the condemnation of all
other 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 the
judgment shall specify whether the contents of each separate lot are
adulterated or misbranded. The court shall order the destruction by
the appropriate law enforcement agency of all lots found to be
adulterated or misbranded and the return by the appropriate law
enforcement agency of all lots not found to be adulterated or
misbranded. 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 a
defendant, except as provided in subsection (b).
(b) When merchandise is ordered destroyed, the court may give
judgment against the defendant for that part of the costs occasioned
by 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 the
merchandise to the place of seizure. The appropriate law
enforcement agency and the appropriate law enforcement agency's
bondsmen are liable for any damage to the merchandise while in the
custody of the appropriate law enforcement agency if the damage
was due to negligence, willfulness, or carelessness upon the part of
the appropriate law enforcement agency or the appropriate law
enforcement agency's agents.
(b) No subsequent proceeding in the cause or new trial may in any
way 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 appeal
to the supreme court or the court of appeals in the manner provided
by law for appeals in civil actions.
(b) An appeal bond shall be fixed in an amount that covers the
reasonable costs of preserving the condemned merchandise for the
probable time of appeal and the court costs.
(c) If an appeal is not prosecuted to determination or if the
judgment of the trial court is affirmed, the defendant bringing the
appeal is liable for the following:
(1) The costs adjudged against the defendant or defendants in the
trial court.
(2) The costs of appeal.
(3) The actual reasonable cost of preserving the condemned
merchandise during the appeal period.
(d) The court of appeals and the supreme court shall dispose of
appeals brought under this chapter as speedily as possible with due
regard 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 this
chapter 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 in
accordance with this chapter are to be determined and collected in
the manner provided by law for the determination and collection of
costs 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, the
procedure for condemnation proceedings under this chapter must
conform, 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 embargoed
merchandise is adulterated or misbranded, the merchandise must,
after entry of the judgment or decree, be destroyed at the expense of
the 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 the
claimant's agent.
(c) If the adulteration or misbranding of merchandise can be
corrected by proper labeling or processing of the merchandise, the
court may order the merchandise to be delivered to the claimant for
labeling or processing under the supervision of the state department
under 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 so
labeled or processed, is executed.
The expense of the supervision of labeling and processing shall be
paid by the claimant. The bond shall be returned to the claimant of
the merchandise on representation to the court by the state health
commissioner or the commissioner's legally authorized agent that the
merchandise no longer violates IC 16-42-1 through IC 16-42-4 and
that the expenses of supervision by the state department have been
paid. 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 is
reported by the state health commissioner or the commissioner's
authorized agent to a prosecuting attorney for the institution of a
criminal proceeding, the person against whom the proceeding is
contemplated shall be given appropriate notice and an opportunity to
present the person's views to the state health commissioner or the
commissioner's authorized agent, either orally or in writing, with
regard 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 state
health commissioner or the commissioner's authorized agent to
report, for the institution of proceedings under those provisions,
minor violations of those provisions whenever the state health
commissioner or the commissioner's legally authorized agent
believes 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 recklessly
violates or fails to comply with this chapter commits a Class B
misdemeanor.
(b) Each day a violation continues constitutes a separate offense. As added by P.L.2-1993, SEC.25.
