CHAPTER 3. UNIFORM FOOD, DRUG, AND COSMETIC ACT: ADULTERATION AND MISBRANDING OF DRUGS OR DEVICES
IC 16-42-3
Chapter 3. Uniform Food, Drug, and Cosmetic Act: Adulteration
and Misbranding of Drugs or Devices
IC 16-42-3-1
Antibiotic drug defined
Sec. 1. As used in this chapter, "antibiotic drug" means any drug
intended for use by man containing any quantity of any chemical
substance that is produced by microorganisms and that has the
capacity to inhibit or destroy microorganisms in dilute solution,
including the chemically synthesized equivalent of the substance.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-2
Established name defined
Sec. 2. As used in this chapter, "established name", with respect
to a drug or ingredient of a drug, means:
(1) the applicable official name designated under Section 508
of the Federal Act;
(2) if there is no official name and the drug or the ingredient is
an article recognized in an official compendium, the official
title of the drug or ingredient in the compendium; or
(3) if neither subdivision (1) nor (2) applies, the common or
usual name, if any, of the drug or the ingredient.
However, when subdivision (2) applies to an article recognized in the
United States Pharmacopoeia and in the Homeopathic
Pharmacopoeia under different official titles, the official title used in
the United States Pharmacopoeia applies unless the article is labeled
and offered for sale as a homeopathic drug, in which case the official
title used in the Homeopathic Pharmacopoeia applies.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-2.5
Duties of state veterinarian and state board of animal health
Sec. 2.5. (a) The state veterinarian shall act in place of the 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.70. Amended by P.L.2-2008,
SEC.43.
IC 16-42-3-3
Adulterated drug or device
Sec. 3. A drug or device is considered to be adulterated under the
following conditions:
(1) If the drug or device consists in whole or in part of any
filthy, putrid, or decomposed substance.
(2) If the drug or device has been produced, prepared, packed,
or held under unsanitary conditions under which the drug or
device may have been contaminated with filth or made injurious
to health.
(3) If the methods used in or the facilities or controls used for
a drug's manufacture, processing, packing, or holding do not
conform to or are not operated or administered in conformity
with current good manufacturing practice to assure that:
(A) the drug meets the requirements of this article as to
safety; and
(B) the drug:
(i) has the identity and strength; and
(ii) meets the quality and purity characteristics;
that the drug purports or is represented to possess.
(4) If a drug's container is composed in whole or in part of any
poisonous or deleterious substance that may make the contents
injurious to health.
(5) If:
(A) a drug bears or contains, for purposes of coloring only,
a color additive that is unsafe within the meaning of
IC 16-42-2-5; or
(B) a color additive, the intended use of which in or on drugs
is for purposes of coloring only, is unsafe under
IC 16-42-2-5.
(6) If:
(A) the drug or device purports to be or is represented as a
drug, the name of which is recognized in an official
compendium; and
(B) the strength of the drug differs from or the drug's quality
or purity falls below the standard set forth in that
compendium;
the determination as to strength, quality, or purity shall be made
in accordance with the tests or methods of assay set forth in the
compendium or, in the absence or inadequacy of such tests or
methods of assay, those tests or methods prescribed by the
federal security administrator in regulations promulgated under
the Federal Act. A drug defined in an official compendium is
not considered to be adulterated under this subdivision because
the drug differs from the standard of strength, quality, or purity
set forth in the compendium if the drug's difference in strength,
quality, or purity from the standard is plainly stated on the
drug's label. If a drug is recognized in both the United States
Pharmacopoeia and the Homeopathic Pharmacopoeia of the
United States, the drug is subject to the requirements of the
United States Pharmacopoeia unless the drug is labeled and
offered for sale as a homeopathic drug. In the latter case, the
drug is subject to the provisions of the Homeopathic
Pharmacopoeia of the United States and not to those of the
United States Pharmacopoeia.
(7) If:
(A) the drug or device is not subject to the provisions of
subdivision (6); and
(B) the drug's or device's strength differs from or the drug's
or device's purity or quality falls below that which the drug
or device purports or is represented to possess.
(8) If the drug or device is a drug and any substance has been:
(A) mixed or packed with the drug or device so as to reduce
the drug's or device's quality or strength; or
(B) substituted wholly or in part for the drug.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-4
Misbranded drug or device
Sec. 4. A drug or device is considered to be misbranded under any
of the following conditions:
(1) If the labeling of the drug or device is false or misleading in
any way.
(2) If the drug or device is in package form unless the drug or
device bears a label containing:
(A) the name and place of business of the manufacturer,
packer, or distributor; and
(B) an accurate statement of the quantity of the contents in
terms of weight, measure, or numerical count.
However, under clause (B) reasonable variations shall be
permitted and exemptions as to small packages shall be
established by rules adopted by the state department.
(3) If any word, statement, or other information required to
appear on the label or labeling, under this chapter or a rule
adopted under IC 16-42-1-2 is not prominently placed on the
drug or device with conspicuousness (as compared with other
words, statements, designs, or devices in the labeling) and in
such terms that make the label likely to be read and understood
by the ordinary individual under customary conditions of
purchase and use.
(4) If the drug or device:
(A) is for use by humans; and
(B) contains any quantity of the narcotic or hypnotic
substance alpha-eucaine, barbituric acid, beta-eucaine,
bromal, cannabis, carbromal, chloral, coca, cocaine, codeine,
heroin, marijuana, morphine, opium, paraldehyde, peyote,
methamphetamine, or sulphonmethane, or any chemical
derivative of such substance, which derivative after
investigation has been found to be and is designated as habit
forming, by rules adopted by the state department under
IC 16-42-1 through IC 16-42-4 or by regulations issued
under 21 U.S.C. 352(d);
unless the label on the drug or device bears the name and
quantity or proportion of that substance or derivative and the
statement "Warning . May Be Habit Forming".
(5) If a drug, unless the following conditions are met:
(A) The label on the drug bears, to the exclusion of any other
nonproprietary name except the applicable systematic
chemical name or the chemical formula, the following:
(i) The established name of the drug, if any.
(ii) If the drug is fabricated from at least two (2)
ingredients, the established name and quantity of each
active ingredient, including the kind and quantity or
proportion of any alcohol and, whether active or not, the
established name and quantity or proportion of any
bromides, ether, chloroform, acetanilid, acetphenetidin,
amidopyrine, antipyrine, atropine, hyoscine, hyoscyamine,
arsenic, digitalis, digitalis glucosides, mercury, ouabain,
strophanthin, strychnine, thyroid, or any derivative or
preparation of those substances contained in the drug.
However, the requirement for stating the quantity of the
active ingredients, other than the quantity of those
specifically named in this subdivision, applies only to
prescription drugs.
(B) If a prescription drug, the established name of the drug
or ingredient on the label (and on any labeling on which a
name for the drug or ingredient is used) is printed
prominently and in type at least half as large as that used for
any proprietary name or designation for the drug or
ingredient.
However, to the extent that compliance with the requirements
of clause (A)(ii) or clause (B) is impracticable, exemptions shall
be allowed under rules adopted by the state department or by
regulations promulgated under the Federal Act.
(6) Unless the drug's or device's labeling bears:
(A) adequate directions for use; and
(B) adequate warnings against use in those pathological
conditions or by children where the drug's or device's use
may be dangerous to health or against unsafe dosage or
methods or duration of administration or application in the
manner and form that is necessary for the protection of
users.
However, if any requirement of clause (A) as applied to any
drug or device is not necessary for the protection of the public
health, the state department shall adopt rules exempting the
drug or device from that requirement.
(7) If a drug purports to be a drug the name of which is
recognized in an official compendium, unless the drug is
packaged and labeled as prescribed in the compendium.
However, the method of packing may be modified with the
consent of the state department in accordance with regulations
promulgated by the federal security administrator under the
Federal Act. Whenever a drug is recognized in both the United
States Pharmacopoeia and the Homeopathic Pharmacopoeia of
the United States, the drug is subject to the requirements of the
United States Pharmacopoeia with respect to packaging and
labeling unless the drug is labeled and offered for sale as a
homeopathic drug. In that case the drug is subject to the
Homeopathic Pharmacopoeia of the United States and not to the
United States Pharmacopoeia.
(8) If a drug or device has been found by the federal security
administrator or the state department to be a drug liable to
deterioration, unless the drug or device is packaged in a form
and manner and the drug's or device's label bears a statement of
such precautions as the federal security administrator or the
state department requires by rule or regulation as necessary for
the protection of the public health. A rule or regulation may not
be established for any drug recognized in an official
compendium until the federal security administrator or the state
department informs the appropriate body charged with the
revision of the compendium of the need for the packaging or
labeling requirements and that body fails within a reasonable
time to prescribe requirements.
(9) If a drug's container is made, formed, or filled as to be
misleading.
(10) If a drug is an imitation of another drug.
(11) If a drug is offered for sale under the name of another drug.
(12) If a drug is or purports to be or is represented to be a drug
composed wholly or partly of insulin, unless:
(A) the drug is from a batch with respect to which a
certificate or release has been issued under Section 506 of
the Federal Act; and
(B) the certificate or release is in effect with respect to the
drug.
(13) If a drug is or purports to be or is represented to be a drug
composed wholly or partly of any kind of penicillin,
streptomycin, chloretetracycline, chloramphenicol, bacitracin,
or any other antibiotic drug, or any derivative of those drugs,
unless:
(A) the drug is from a batch with respect to which a
certificate or release has been issued under Section 507 of
the Federal Act; and
(B) the certificate or release is in effect with respect to that
drug.
However, this subdivision does not apply to any drug or class
of drugs exempted by regulations promulgated under Section
507(c) or 507(d) of the Federal Act.
(14) If a drug or device is dangerous to health when used in the
dosage, or with the frequency or duration prescribed,
recommended, or suggested in the labeling of the drug or
device.
(15) Under the conditions described in section 6 of this chapter.
As added by P.L.2-1993, SEC.25. Amended by P.L.17-2001, SEC.3.
IC 16-42-3-5
Exemption of drugs or devices in transit for further processing,
labeling, or repackaging
Sec. 5. A drug or device that, in accordance with the practice of
the trade, is to be processed, labeled, or repacked in substantial
quantities at an establishment other than the establishment where the
drug or device was originally processed or packed, is exempt from
the labeling and packaging requirements of IC 16-42-1 through
IC 16-42-4 while the drug or device is in transit in intrastate
commerce from one (1) establishment to the other if the transit is
made in good faith for completion purposes only. However, the drug
or device is otherwise subject to the applicable provisions of
IC 16-42-1 through IC 16-42-4.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-6
Drugs dispensed on prescription
Sec. 6. (a) This section applies to a drug intended for use by
humans that:
(1) is a habit forming drug to which section 4(4) of this chapter
applies;
(2) because of:
(A) the drug's toxicity or other potential for harmful effect;
(B) the method of the drug's use; or
(C) the collateral measures necessary to the drug's use;
is not safe for use except under the supervision of a practitioner
licensed by law to administer the drug; or
(3) is limited by an approved application under Section 505 of
the Federal Act or section 7 or 8 of this chapter to use under the
professional supervision of a practitioner licensed by law to
administer the drug.
(b) A drug described in subsection (a) may be dispensed only:
(1) upon a written or an electronically transmitted prescription
of a practitioner licensed by law to administer the drug;
(2) upon an oral prescription of the practitioner that is reduced
promptly to writing and filed by the pharmacist or pharmacist
intern (as defined in IC 25-26-13-2); or
(3) by refilling a prescription if the refilling is authorized by the
prescriber either in the original prescription, by an
electronically transmitted order that is recorded in an electronic
format, or by oral order that is reduced promptly to writing or
is entered into an electronic format and filed by the pharmacist
or pharmacist intern (as defined in IC 25-26-13-2).
(c) If a prescription for a drug described in subsection (a) does not
indicate how many times the prescription may be refilled, if any, the
prescription may not be refilled unless the pharmacist is
subsequently authorized to do so by the practitioner.
(d) The act of dispensing a drug contrary to subsection (a), (b), or
(c) is considered to be an act that results in a drug being misbranded
while held for sale.
(e) A drug dispensed by filling or refilling a prescription of a
practitioner licensed by law to administer the drug is exempt from
the requirements of section 4(2), 4(3), 4(4), 4(5), 4(6), 4(7), 4(8), and
4(9) of this chapter if the drug bears a label containing the following:
(1) The name and address of the dispenser.
(2) The serial number and date of the prescription or of the
prescription's filling.
(3) The name of the drug's prescriber and, if stated in the
prescription, the name of the patient.
(4) The directions for use and cautionary statements, if any,
contained in the prescription.
This exemption does not apply to any drugs dispensed in the course
of the conduct of a business of dispensing drugs pursuant to
diagnosis by mail or to a drug dispensed in violation of subsection
(a), (b), (c), or (d).
(f) The state department may adopt rules to remove drugs subject
to section 4(4) of this chapter, section 7 of this chapter, or section 8
of this chapter from the requirements of subsections (a) through (d)
when the requirements are not necessary for the protection of public
health. Drugs removed from the prescription requirements of the
Federal Act by regulations issued under the Federal Act may also, by
rules adopted by the state department, be removed from the
requirement of subsections (a) through (d).
(g) A drug that is subject to subsections (a) through (d) is
considered to be misbranded if at any time before dispensing the
drug's label fails to bear the statement "Caution: Federal Law
Prohibits Dispensing Without Prescription" or "Caution: State Law
Prohibits Dispensing Without Prescription". A drug to which
subsections (a) through (d) do not apply is considered to be
misbranded if, at any time before dispensing, the drug's label bears
the caution statement described in this subsection.
(h) This section does not relieve a person from a requirement
prescribed by or under authority of law with respect to drugs
included within the classifications of narcotic drugs or marijuana as
defined in the applicable federal and state laws relating to narcotic
drugs and marijuana.
(i) A drug may be dispensed under subsection (b) upon an
electronically transmitted prescription only to the extent permitted by
federal law.
As added by P.L.2-1993, SEC.25. Amended by P.L.144-1996,
SEC.12; P.L.204-2005, SEC.4.
IC 16-42-3-7
New drugs; federal qualification; testing; application to introduce
drug
Sec. 7. (a) This section does not apply under the circumstances
described in section 9 of this chapter.
(b) A person may not sell, deliver, offer for sale, hold for sale,
give away, or introduce into intrastate commerce any new drug
unless:
(1) an application to sell, deliver, offer for sale, hold for sale,
give away, or introduce into intrastate commerce a new drug
has been approved and the approval has not been withdrawn
under Section 505 of the Federal Act; or
(2) if not subject to the Federal Act the drug has been tested and
has been found to be safe for use and effective in use under the
conditions prescribed, recommended, or suggested in the
labeling of the drug.
(c) Before selling or offering for sale the new drug, there must be
filed with the state department an application setting forth the
following:
(1) Full reports of investigations that have been made to show
whether or not the drug is safe for use and whether the drug is
effective in use.
(2) A full list of the articles used as components of the drug.
(3) A full statement of the composition of the drug.
(4) A full description of the methods used in and the facilities
and controls used for the manufacture, processing, and packing
of the drug.
(5) Such samples of the drug and of the articles used as
components of the drug that the state department requires.
(6) Specimens of the labeling proposed to be used for the drug.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-8
New drugs; time for application to take effect
Sec. 8. (a) This section does not apply under the circumstances
described in section 9 of this chapter.
(b) An application provided for under section 7 of this chapter
becomes effective on the one hundred eightieth day after the filing
of the application. However, if the state department finds, after due
notice to the applicant and giving the applicant an opportunity for a
hearing that:
(1) the drug is not safe or not effective for use under the
conditions prescribed, recommended, or suggested in the
proposed labeling of the drug;
(2) the methods used in and the facilities and controls used for
the manufacture, processing, and packing of the drugs are
inadequate to preserve the drug's identity, strength, quality, and
purity; or
(3) based on a fair evaluation of all material facts, that the
labeling is false or misleading in any particular;
the state department shall, before the effective date of the
application, issue an order refusing to permit the application to
become effective.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-9
New drugs; exemption
Sec. 9. (a) Sections 7 and 8 of this chapter do not apply to the
following:
(1) To a drug dispensed on a written or an electronically
transmitted prescription signed by or with an electronic
signature of a physician, dentist, or veterinarian (except a drug
dispensed in the course of the conduct of a business of
dispensing drugs pursuant to diagnosis by mail) if the physician,
dentist, or veterinarian is licensed by law to administer the drug,
and the drug bears a label containing the name and place of
business of the dispenser, the serial number and date of the
prescription, and the name of the physician, dentist, or
veterinarian.
(2) To a drug exempted by rule of the state department and that
is intended solely for investigational use by experts qualified by
scientific training and experience to investigate the safety and
effectiveness of drugs.
(3) To a drug sold in Indiana or introduced into intrastate
commerce at any time before the enactment of the Federal Act,
if the drug's labeling contained the same representations
concerning the conditions of the drug's use.
(4) To any drug that is licensed under the Public Health Service
Act of July 1, 1944 (58 Stat. 682, as amended; 42 U.S.C. 201 et
seq.) or under the Animal Virus-Serum Toxin Act of March 4,
1913 (13 Stat. 832; 21 U.S.C. 151 et seq.).
(5) To a drug subject to section 4(10) of this chapter.
(b) Rules exempting drugs intended for investigational use under
subsection (a)(2) may, within the discretion of the state department
among other conditions relating to the protection of the public health,
provide for conditioning the exemption upon the following:
(1) The submission to the state department, before any clinical
testing of a new drug is undertaken, of reports by the
manufacturer or the sponsor of the investigation of the drug or
preclinical tests, including tests on animals, of the drug
adequate to justify the proposed clinical testing.
(2) The manufacturer or the sponsor of the investigation of a
new drug proposed to be distributed to investigators for clinical
testing obtaining a signed agreement from each of the
investigators that patients to whom the drug is administered will
be under the manufacturer's or sponsor's personal supervision
or under the supervision of investigators responsible to the
manufacturer or sponsor and that the manufacturer or sponsor
will not supply the drug to any other investigator or to clinics
for administration to human beings.
(3) The establishment and maintenance of the records and the
making of the reports to the state department by the
manufacturer or the sponsor of the investigation of the drug of
data (including analytical reports by investigators) obtained as
the result of the investigational use of the drug that the state
department finds will enable the state department to evaluate
the safety and effectiveness of the drug if an application is filed
under section 8 of this chapter.
(c) Rules exempting drugs intended for investigational use under
subsection (a)(2) must provide that the exemption is conditioned
upon the manufacturer or the sponsor of the investigation requiring
that experts using the drugs for investigational purposes certify to the
manufacturer or sponsor that the experts will inform any human
beings to whom the drugs or any controls used in connection with the
drugs are being administered that the drugs are being used for
investigational purposes and will obtain the consent of the human
beings or their representatives, except where they consider it not
feasible or, in their professional judgment, contrary to the best
interests of the human beings.
(d) This section does not require a clinical investigator to submit
directly to the state department reports on the investigational use of
drugs. The regulations adopted under Section 505(i) of the Federal
Act are the rules in Indiana. The state may adopt rules, whether or
not in accordance with regulations promulgated under the Federal
Act.
As added by P.L.2-1993, SEC.25. Amended by P.L.204-2005, SEC.5.
IC 16-42-3-10
New drugs; revocation of order refusing application to take effect;
revocation of approved application
Sec. 10. (a) An order refusing to permit an application under
section 7 or 8 of this chapter to become effective may be revoked by
the state department.
(b) The state department may, after affording an opportunity for
public hearing and judicial appeal, revoke an application approved
under section 7 or 8 of this chapter if the state department finds any
of the following:
(1) That the drug, based on evidence acquired after approval,
may not be safe or effective for the intended use.
(2) That the facilities or controls used in the manufacture,
processing, or labeling of the drug may present a hazard to the
public health.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-11
Representation of antiseptic
Sec. 11. The representation of a drug in the labeling or
advertisement as an antiseptic is considered to be a representation
that the drug is a germicide, except if a drug purporting to be or
represented as an antiseptic for inhibitory use as a wet dressing,
ointment, dusting powder, or other use involves prolonged contact
with the body.
As added by P.L.2-1993, SEC.25.
IC 16-42-3-12
Violation of chapter; offenses
Sec. 12. (a) Except as otherwise provided, a person 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.