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Senate
File
2158
-
Introduced
SENATE
FILE
2158
BY
CAMPBELL
A
BILL
FOR
An
Act
relating
to
the
inspection
of
compounding
pharmacies,
1
and
making
penalties
applicable.
2
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
3
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(2)
91
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S.F.
2158
Section
1.
Section
22.7,
Code
2026,
is
amended
by
adding
the
1
following
new
subsection:
2
NEW
SUBSECTION
.
78.
Records
relating
to
the
investigation
3
and
remediation
of
an
infraction
at
a
compounding
facility
4
engaging
in
the
compounding
of
nonsterile
preparations
as
5
provided
in
section
155A.15A.
6
Sec.
2.
NEW
SECTION
.
155A.15A
Compounding
facilities
——
7
inspections
——
penalties.
8
1.
a.
If
an
inspector
employed
by
the
board
discovers
9
during
the
course
of
an
inspection
that
a
compounding
facility
10
engaging
in
the
compounding
of
nonsterile
preparations
is
11
out
of
compliance
with
the
requirements
of
United
States
12
pharmacopeia
general
chapter
795,
the
inspector
shall
notify
13
the
pharmacist
in
charge
of
the
compounding
facility
of
the
14
infraction
that
the
pharmacist
in
charge
must
correct.
15
b.
If
an
inspector
employed
by
the
board
discovers
16
during
the
course
of
an
inspection
conducted
not
less
than
17
thirty
days,
or
more
than
ninety
days,
after
the
date
of
an
18
inspection
described
in
paragraph
“a”
that
the
infraction
19
identified
pursuant
to
paragraph
“a”
has
not
been
corrected,
20
the
inspector
shall
provide
comprehensive
instruction
regarding
21
the
infraction
and
the
correction
of
the
infraction
to
the
22
pharmacist
in
charge.
23
c.
If
an
inspector
employed
by
the
board
discovers
during
24
the
course
of
an
inspection
conducted
not
less
than
thirty
25
days,
or
more
than
ninety
days,
after
an
inspection
described
26
in
paragraph
“b”
that
the
infraction
identified
pursuant
to
27
paragraph
“a”
has
not
been
corrected,
the
inspector
shall
28
prescribe
mandatory
education
for
the
pharmacist
in
charge
for
29
the
correction
of
the
infraction.
30
2.
If
a
compounding
facility
engaging
in
the
compounding
31
of
nonsterile
preparations
does
not
correct
an
infraction
as
32
provided
in
subsection
1,
the
board
may
impose
a
single
fine
33
not
to
exceed
five
hundred
dollars,
which
shall
be
adjusted
for
34
inflation,
as
that
term
is
defined
in
section
668.15A,
by
the
35
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5293XS
(2)
91
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1/
2
S.F.
2158
board
by
rule
on
January
1
of
each
even-numbered
year.
The
1
board
shall
not
impose
any
other
fine
or
remedy
for
a
violation
2
of
this
section.
This
subsection
shall
not
affect
damages
3
available
in
tort,
contract,
or
otherwise
for
a
violation
of
4
this
section.
5
EXPLANATION
6
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
7
the
explanation’s
substance
by
the
members
of
the
general
assembly.
8
This
bill
relates
to
the
investigation
and
remediation
of
9
infractions
at
compounding
facilities
(facility)
engaging
in
10
the
compounding
of
nonsterile
preparations.
The
bill
requires
11
an
inspector
employed
by
the
board
of
pharmacy
(board)
who
12
discovers
during
the
course
of
an
inspection
that
a
facility
13
engaging
in
the
compounding
of
nonsterile
preparations
14
is
out
of
compliance
with
the
United
States
pharmacopeia
15
general
chapter
795
to
notify
the
pharmacist
in
charge
of
16
the
infraction.
If
an
inspector
discovers
at
a
subsequent
17
inspection
that
the
infraction
has
not
been
corrected,
the
bill
18
requires
the
inspector
to
provide
comprehensive
instruction
19
regarding
the
infraction
and
the
correction
of
the
infraction
20
to
the
pharmacist
in
charge.
If
an
inspector
discovers
at
a
21
third
inspection
that
an
infraction
has
not
been
corrected,
the
22
bill
requires
the
inspector
to
prescribe
mandatory
education
23
for
the
correction
of
the
infraction
to
the
pharmacist
in
24
charge.
25
The
bill
allows
the
board
to
impose
a
single
fee
of
not
more
26
than
$500,
adjusted
for
inflation,
on
a
facility
that
fails
27
to
correct
an
infraction
as
provided
in
the
bill.
The
bill
28
makes
records
relating
to
the
investigation
and
remediation
of
29
infractions
pursuant
to
the
bill
confidential
records
that
are
30
not
subject
to
examination
by
the
public.
31
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