MISCELLANEOUS LAWS
370
IC 16-42-4, means the following:
(1) Articles recognized in the official
United States Pharmacopoeia, official
Homeopathic Pharmacopoeia of the United
States, or official National Formulary, or
any supplement to any of them.
(2) Articles intended for use in the diag-
nosis, cure, mitigation, treatment, or pre-
vention of disease in man or other animals.
(3) Articles other than food intended to
affect the structure or any function of the
body of man or other animals.
(4) Articles intended for use as a compo-
nent of any article specified in subdivi-
sion (1), (2), or (3).
The term does not include devices or their com-
ponents, parts, or accessories.
(b) “Drug,” for purposes of IC 16-42-19, has
the meaning set forth in IC 16-42-19-2.
16-18-2-102. “Drug order” defined.
“Drug order,” for purposes of IC 16-42-19, has
the meaning set forth in IC 16-42-19-3.
16-18-2-103. “Drug sample” defined.
“Drug sample,” for purposes of IC 16-42-21,
has the meaning set forth in IC 16-42-21-2.
16-18-2-128.5. “Fetal stem cell” defined.
(a) “Fetal stem cell” means any of the fol-
lowing types of stem cells taken from a fetus that
was either miscarried or stillborn from any of the
following sources:
(1) Placenta.
(2) Umbilical cord.
(3) Amniotic fluid.
(4) Fetal tissue.
(b) The term does not include any cells that are
taken as the result of an abortion.
16-18-2-183.5. “Human embryo” defined.
“Human embryo” means a human egg cell
with a full genetic composition capable of differ-
entiating and maturing into a complete human
being.
16-18-2-194. “Investigational or new drug”
defined.
“Investigational or new drug,” for purposes of
IC 16-42-19, has the meaning set forth in IC 16-
42-19-4.
16-18-2-199. “Legend drug” defined.
“Legend drug,” for purposes of IC 16-42,
means a drug that is:
(1) Subject to 21 U.S.C. 353(b)(1);
(2) Listed in the Prescription Drug Product
List as:
(A) Published in United States
Department of Health and Human
ServicesApproved Drug Products with
Therapeutic Equivalence Evaluations,
Tenth Edition, (1990); and
(B) Revised in United [States]
Department of Health and Human
Services,Approved Drug Products with
Therapeutic Equivalence Evaluations,
Cumulative Supplement to the Tenth
Edition, Number 10 (1990).
(3) Insulin.
16-18-2-216. “Manufacturer” defined.
(a) “Manufacturer,” for purposes of IC 16-
42-19 and IC 16-42-21, means a person who by
compounding, cultivating, harvesting, mixing, or
other process produces or prepares legend drugs.
The term includes a person who:
(1) Prepares legend drugs in dosage forms
by mixing, compounding, encapsulating,
entableting, or other process; or
(2) Packages or repackages legend drugs.
(b) The term does not include pharmacists or
practitioners (as defined in section 288(a) and
288(c) of this chapter) in the practice of their pro-
fession.
16-18-2-223. “Mechanical device” defined.
“Mechanical device,” for purposes of IC 16-
42-19-23, has the meaning set forth in IC 16-42-
19-23(a).
16-18-2-281. “Pharmacist” defined.
“Pharmacist” means a person licensed by law
to practice pharmacy in Indiana.
16-18-2-288. “Practitioner” defined.
(a) “Practitioner,” for purposes of IC 16-42-19,
has the meaning set forth in IC 16-42-19-5.
(b) “Practitioner,” for purposes of IC 16-41-14,
has the meaning set forth in IC 16-41-14-4.
