Bill Text: IA SSB3072 | 2017-2018 | 87th General Assembly | Introduced
Bill Title: A bill for an act relating to pharmacy regulation, including the composition of the board of pharmacy and the wholesale distribution of prescription drugs and devices, and including penalties.
Spectrum: Committee Bill
Status: (N/A - Dead) 2018-01-30 - Subcommittee recommends passage. [SSB3072 Detail]
Download: Iowa-2017-SSB3072-Introduced.html
Senate
Study
Bill
3072
-
Introduced
SENATE/HOUSE
FILE
_____
BY
(PROPOSED
BOARD
OF
PHARMACY
BILL)
A
BILL
FOR
An
Act
relating
to
pharmacy
regulation,
including
the
1
composition
of
the
board
of
pharmacy
and
the
wholesale
2
distribution
of
prescription
drugs
and
devices,
and
3
including
penalties.
4
BE
IT
ENACTED
BY
THE
GENERAL
ASSEMBLY
OF
THE
STATE
OF
IOWA:
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Section
1.
Section
147.14,
subsection
1,
paragraph
e,
Code
1
2018,
is
amended
to
read
as
follows:
2
e.
For
pharmacy,
five
members
licensed
to
practice
pharmacy
,
3
one
member
registered
as
a
certified
pharmacy
technician
as
4
defined
by
the
board
by
rule,
and
two
members
who
are
not
5
licensed
to
practice
pharmacy
or
registered
as
a
certified
6
pharmacy
technician
and
who
shall
represent
the
general
public.
7
Sec.
2.
Section
155A.3,
subsection
11,
Code
2018,
is
amended
8
to
read
as
follows:
9
11.
“Device”
means
an
instrument,
apparatus,
implement,
10
machine,
contrivance,
implant,
in
vitro
reagent,
or
other
11
similar
or
related
article,
including
any
component
part
or
12
accessory,
a
medical
device,
as
classified
by
the
United
States
13
food
and
drug
administration,
intended
for
use
by
a
patient
14
that
is
required
under
federal
or
state
law
by
the
United
15
States
food
and
drug
administration
to
be
ordered
or
prescribed
16
for
a
patient
by
a
practitioner.
17
Sec.
3.
Section
155A.3,
subsection
14,
Code
2018,
is
amended
18
by
striking
the
subsection.
19
Sec.
4.
Section
155A.3,
subsection
25,
Code
2018,
is
amended
20
to
read
as
follows:
21
25.
“Limited
drug
and
device
distributor”
means
a
person
22
operating
or
maintaining
,
either
within
or
outside
this
state,
23
a
location
at
which
limited
noncontrolled
,
regardless
of
the
24
location,
where
prescription
drugs
,
prescription
or
devices
,
25
and
medical
gases,
are
distributed
to
patients
in
this
state
26
pursuant
to
a
prescription
drug
order;
or
a
person
operating
or
27
maintaining
a
location
at
which
limited
quantities
of
drugs,
28
devices,
or
medical
gases
are
distributed
at
wholesale
in
this
29
state
or
to
a
patient
pursuant
to
a
prescription
drug
order,
30
who
is
not
eligible
for
a
wholesale
distributer
license
or
31
pharmacy
license
.
A
“limited
drug
and
device
distributor”
does
32
not
include
a
pharmacy
licensed
pursuant
to
this
chapter
or
a
33
drug
wholesaler
providing
prescription
drugs
to
patients
in
34
this
state
pursuant
to
a
drug
manufacturer’s
prescription
drug
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assistance
program.
1
Sec.
5.
Section
155A.3,
subsection
26,
Code
2018,
is
amended
2
by
striking
the
subsection.
3
Sec.
6.
Section
155A.3,
Code
2018,
is
amended
by
adding
the
4
following
new
subsections:
5
NEW
SUBSECTION
.
27A.
“Manufacturer”
means
manufacturer
6
as
defined
by
the
federal
Drug
Supply
Chain
Security
Act,
21
7
U.S.C.
§360eee
et
seq.
8
NEW
SUBSECTION
.
27B.
“Medical
convenience
kit”
means
9
a
collection
of
devices,
which
may
include
a
product
or
10
biological
product,
assembled
in
kit
form
strictly
for
the
11
convenience
of
the
purchaser
or
ultimate
user.
12
NEW
SUBSECTION
.
41A.
“Product”
means
the
same
as
defined
in
13
21
U.S.C.
§360eee.
14
NEW
SUBSECTION
.
42A.
“Repackager”
means
a
person
who
owns
15
or
operates
an
establishment
that
repackages
or
relabels
a
16
product
or
package
for
further
sale
or
for
distribution
without
17
a
further
transaction.
18
NEW
SUBSECTION
.
45A.
“Third-party
logistics
provider”
means
19
an
entity
that
provides
or
coordinates
warehousing
or
other
20
logistics
services
of
a
product
in
interstate
commerce
on
21
behalf
of
a
manufacturer,
wholesale
distributor,
or
dispenser
22
of
a
product,
but
does
not
take
ownership
of
the
product
nor
23
have
responsibility
to
direct
the
sale
or
other
disposition
of
24
the
product.
25
Sec.
7.
Section
155A.3,
subsection
40,
Code
2018,
is
amended
26
by
striking
the
subsection
and
inserting
in
lieu
thereof
the
27
following:
28
40.
“Prescription
drug”
or
“drug”
means
a
drug,
as
29
classified
by
the
United
States
food
and
drug
administration,
30
that
is
required
by
the
United
States
food
and
drug
31
administration
to
be
prescribed
or
administered
to
a
patient
by
32
a
practitioner
prior
to
dispensation.
33
Sec.
8.
Section
155A.3,
subsection
48,
Code
2018,
is
amended
34
by
striking
the
subsection
and
inserting
in
lieu
thereof
the
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following:
1
48.
“Wholesale
distribution”
means
the
distribution
of
2
a
drug
to
a
person
other
than
a
consumer
or
patient,
or
the
3
receipt
of
a
drug
by
a
person
other
than
a
consumer
or
patient,
4
but
does
not
include
any
of
the
following:
5
a.
Intracompany
distribution
of
any
drug
between
members
6
of
an
affiliate,
as
defined
in
21
U.S.C.
§360eee,
or
within
a
7
manufacturer.
8
b.
The
distribution
of
a
drug,
or
an
offer
to
distribute
a
9
drug
among
hospitals
or
other
health
care
entities
under
common
10
control.
11
c.
The
distribution
of
a
drug
or
an
offer
to
distribute
a
12
drug
for
emergency
medical
reasons,
including
a
public
health
13
emergency
declaration
as
defined
in
42
U.S.C.
§247d,
except
14
that
for
purposes
of
this
paragraph
a
drug
shortage
not
caused
15
by
a
public
health
emergency
shall
not
constitute
an
emergency
16
medical
reason.
17
d.
The
dispensing
of
a
drug
pursuant
to
a
prescription
drug
18
order.
19
e.
The
distribution
of
minimal
quantities
of
a
drug
by
a
20
pharmacy
to
a
practitioner
for
office
use.
21
f.
The
distribution
of
a
drug
or
an
offer
to
distribute
a
22
drug
by
a
charitable
organization
to
an
affiliate,
as
defined
23
in
21
U.S.C.
§360eee,
of
the
organization
that
is
a
nonprofit,
24
to
the
extent
otherwise
permitted
by
law.
25
g.
The
purchase
or
other
acquisition
of
a
drug
by
a
26
dispenser,
as
defined
in
21
U.S.C.
§360eee,
hospital,
or
other
27
health
care
entity
for
use
by
such
dispenser,
hospital,
or
28
other
health
care
entity.
29
h.
The
distribution
of
a
drug
by
the
manufacturer
of
such
30
drug.
31
i.
The
receipt
or
transfer
of
a
drug
by
a
third-party
32
logistics
provider,
provided
that
such
third-party
logistics
33
provider
does
not
take
ownership
of
the
drug.
34
j.
A
common
carrier
that
transports
a
drug,
provided
that
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the
common
carrier
does
not
take
ownership
of
the
drug.
1
k.
The
distribution
of
a
drug
or
an
offer
to
distribute
a
2
drug
by
a
repackager
that
has
taken
ownership
or
possession
of
3
the
drug
and
repackages
it.
4
l.
The
return
of
a
saleable
product
when
conducted
by
a
5
dispenser.
6
m.
The
distribution
of
a
medical
convenience
kit
under
any
7
of
the
following
circumstances:
8
(1)
The
medical
convenience
kit
is
assembled
in
an
9
establishment
registered
with
the
United
States
food
and
drug
10
administration
as
a
device
manufacturer.
11
(2)
The
medical
convenience
kit
does
not
contain
a
12
controlled
substance.
13
(3)
In
the
case
of
a
medical
convenience
kit
that
includes
14
a
product,
the
person
that
manufacturers
the
kit
does
all
of
15
the
following:
16
(a)
Purchases
the
product
directly
from
a
pharmaceutical
17
manufacturer
or
from
a
wholesale
distributor
that
purchased
the
18
product
directly
from
the
pharmaceutical
manufacturer.
19
(b)
Does
not
alter
the
primary
container
or
label
of
20
the
product
as
purchased
from
the
manufacturer
or
wholesale
21
distributor.
22
(4)
In
the
case
of
a
medical
convenience
kit
that
includes
a
23
product,
the
product
is
any
of
the
following:
24
(a)
An
intravenous
solution
intended
for
the
replenishment
25
of
fluids
and
electrolytes.
26
(b)
Intended
to
maintain
the
equilibrium
of
water
and
27
minerals
in
the
body.
28
(c)
Intended
for
irrigation
or
reconstitution.
29
(d)
An
anesthetic.
30
(e)
An
anticoagulant.
31
(f)
A
vasopressor.
32
(g)
A
sympathomimetic.
33
n.
The
distribution
of
an
intravenous
drug
that
by
its
34
formulation
is
intended
for
the
replenishment
of
fluids
and
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electrolytes
such
as
sodium,
chloride,
and
potassium,
or
1
calories
such
as
dextrose
and
amino
acids.
2
o.
The
distribution
of
an
intravenous
drug
used
to
maintain
3
the
equilibrium
of
water
and
minerals
in
the
body
such
as
a
4
dialysis
solution.
5
p.
The
distribution
of
a
drug
intended
for
irrigation
or
6
sterile
water
intended
for
irrigation
or
for
injection.
7
q.
The
distribution
of
a
medical
gas.
8
r.
The
facilitation
of
the
distribution
of
a
product
by
9
providing
administrative
services,
including
the
processing
of
10
orders
and
payments.
11
s.
The
transfer
of
a
product
by
a
hospital
or
other
health
12
care
entity,
or
by
a
wholesale
distributor
or
manufacturer
13
operating
at
the
direction
of
the
hospital
or
other
health
care
14
entity,
to
a
repackager
for
the
purpose
of
repackaging
the
15
product
for
use
by
that
hospital
or
other
health
care
entity
16
under
common
control,
if
the
ownership
of
the
product
remains
17
with
the
hospital
or
other
health
care
entity
at
all
times.
18
Sec.
9.
Section
155A.3,
subsection
49,
Code
2018,
is
amended
19
by
striking
the
subsection
and
inserting
in
lieu
thereof
the
20
following:
21
49.
“Wholesale
distributor”
means
a
person,
other
than
22
a
manufacturer,
a
manufacturer’s
co-licensed
partner,
a
23
third-party
logistics
provider,
or
repackager,
engaged
in
the
24
wholesale
distribution
of
a
drug.
25
Sec.
10.
Section
155A.4,
subsection
2,
paragraph
a,
Code
26
2018,
is
amended
to
read
as
follows:
27
a.
A
wholesaler
limited
distributor,
third-party
logistics
28
provider,
or
wholesale
distributor
to
distribute
prescription
29
drugs
or
devices
as
provided
by
state
or
federal
law.
30
Sec.
11.
Section
155A.4,
subsection
2,
paragraph
h,
Code
31
2018,
is
amended
by
striking
the
paragraph.
32
Sec.
12.
Section
155A.5,
Code
2018,
is
amended
to
read
as
33
follows:
34
155A.5
Injunction.
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Notwithstanding
the
existence
or
pursuit
of
any
other
remedy
1
the
board
may,
in
the
manner
provided
by
law,
maintain
an
2
action
in
the
name
of
the
state
for
injunction
or
other
process
3
against
any
person
to
restrain
or
prevent
the
establishment,
4
conduct,
management,
or
operation
of
a
pharmacy
or
wholesaler
,
5
limited
distributor,
third-party
logistics
provider,
or
6
wholesale
distributor
without
a
license,
or
to
prevent
the
7
violation
of
provisions
of
this
chapter
.
Upon
request
of
8
the
board,
the
attorney
general
shall
institute
the
proper
9
proceedings
and
the
county
attorney,
at
the
request
of
the
10
attorney
general,
shall
appear
and
prosecute
the
action
when
11
brought
in
the
county
attorney’s
county.
12
Sec.
13.
Section
155A.17,
Code
2018,
is
amended
by
striking
13
the
section
and
inserting
in
lieu
thereof
the
following:
14
155A.17
Wholesale
distributor
license.
15
1.
A
person
shall
not
engage
in
wholesale
distribution
16
without
a
wholesale
distributor
license.
17
2.
Wholesale
distributors
shall
comply
with
the
national
18
standards
contained
in
the
federal
Drug
Supply
Chain
Security
19
Act,
21
U.S.C.
§360eee
et
seq.,
and
national
standards
20
promulgated
thereunder.
21
3.
The
board
shall
adopt
rules
establishing
requirements
22
for
wholesale
distributor
licenses,
licensure
fees,
and
other
23
relevant
matters
consistent
with
the
federal
Drug
Supply
Chain
24
Security
Act,
21
U.S.C.
§360eee
et
seq.
25
4.
The
board
may
deny,
suspend,
or
revoke
a
wholesale
26
distributor
license,
or
otherwise
discipline
a
wholesale
27
distributor,
for
failure
to
meet
the
applicable
standards
or
28
for
a
violation
of
the
laws
of
this
state,
another
state,
or
29
the
United
States,
or
for
a
violation
of
this
chapter,
chapter
30
124,
124B,
126,
or
205,
or
a
rule
of
the
board.
31
Sec.
14.
NEW
SECTION
.
155A.17A
Third-party
logistics
32
provider
license.
33
1.
A
person
shall
not
operate
as
a
third-party
logistics
34
provider
in
this
state
without
a
third-party
logistics
provider
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license.
1
2.
Third-party
logistics
providers
shall
comply
with
2
national
standards
contained
in
the
federal
Drug
Supply
Chain
3
Security
Act,
21
U.S.C.
§360eee
et
seq.,
and
national
standards
4
promulgated
thereunder.
5
3.
The
board
shall
adopt
rules
establishing
requirements
6
for
a
third-party
logistics
provider
license,
licensure
fees,
7
and
other
relevant
matters
consistent
with
the
federal
Drug
8
Supply
Chain
Security
Act,
21
U.S.C.
§360eee
et
seq.
9
4.
The
board
may
deny,
suspend,
or
revoke
a
third-party
10
logistics
provider
license,
or
otherwise
discipline
a
11
third-party
logistics
provider,
for
failure
to
meet
the
12
applicable
standards
or
for
a
violation
of
the
laws
of
this
13
state,
another
state,
or
the
United
States,
or
for
a
violation
14
of
this
chapter,
chapter
124,
124B,
126,
or
205,
or
a
rule
of
15
the
board.
16
Sec.
15.
Section
155A.42,
Code
2018,
is
amended
to
read
as
17
follows:
18
155A.42
Limited
drug
and
device
distributor
license.
19
1.
A
person
other
than
a
wholesale
distributor,
licensed
20
pharmacy,
or
practitioner,
shall
not
act
as
a
limited
drug
and
21
device
distributor
engage
in
any
of
the
following
activities
in
22
this
state
without
a
limited
distributor
license
.
The
license
23
shall
be
identified
as
a
limited
drug
and
device
distributor
24
license.
:
25
a.
Distribution
of
a
medical
gas
or
device
at
wholesale
or
26
to
a
patient
pursuant
to
a
prescription
drug
order.
27
b.
Wholesale
distribution
of
a
prescription
animal
drug.
28
c.
Wholesale
distribution
of
a
prescription
drug,
or
29
brokering
the
distribution
of
a
prescription
drug
at
wholesale,
30
by
a
manufacturer,
a
manufacturer’s
co-licensed
partner,
or
a
31
repackager.
32
d.
Intracompany
distribution
of
a
prescription
drug,
33
including
pharmacy
chain
distribution
centers.
34
e.
Distribution
at
wholesale
of
a
combination
product
as
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defined
by
the
United
States
food
and
drug
administration,
1
medical
convenience
kit,
intravenous
fluid
or
electrolyte,
2
dialysis
solution,
radioactive
drug,
or
irrigation
or
sterile
3
water
solution
to
be
dispensed
by
prescription
only.
4
f.
Distribution
of
a
dialysis
solution
by
the
manufacturer
5
or
the
manufacturer’s
agent
to
a
patient
pursuant
to
a
6
prescription
drug
order,
provided
that
a
licensed
pharmacy
7
processes
the
prescription
drug
order.
8
2.
The
board
shall
establish,
by
rule,
adopt
rules
9
establishing
the
requirements
for
a
limited
distributor
10
license,
licensure
fees,
compliance
standards
for
limited
11
drug
and
device
distributors
and
may
define
specific
types
12
of
limited
drug
and
device
distributors
,
and
any
other
13
relevant
matters
.
The
board
may
identify,
by
rule,
specific
14
prescription
drugs
or
classes
of
noncontrolled
prescription
15
drugs,
which
may
be
distributed
by
a
limited
drug
and
device
16
distributor.
A
limited
distributor
shall
not
be
required
to
17
have
an
onsite
pharmacist.
18
3.
The
board
shall
adopt
rules
pursuant
to
chapter
19
17A
relating
to
the
issuance
of
a
limited
drug
and
device
20
distributor
license.
The
rules
shall
provide
for
conditions
of
21
licensure,
compliance
standards,
licensure
fees,
disciplinary
22
action,
and
other
relevant
matters.
23
4.
3.
The
board
may
deny,
suspend,
or
revoke
a
limited
24
drug
and
device
distributor’s
license
,
or
otherwise
discipline
25
a
limited
distributor,
for
failure
to
meet
the
applicable
26
standards
or
for
a
violation
of
the
laws
of
this
state,
another
27
state,
or
the
United
States
relating
to
prescription
drugs
or
28
controlled
substances
,
or
for
a
violation
of
this
chapter
,
29
chapter
124
,
124B
,
126
,
or
205
,
or
272C
,
or
a
rule
of
the
board.
30
EXPLANATION
31
The
inclusion
of
this
explanation
does
not
constitute
agreement
with
32
the
explanation’s
substance
by
the
members
of
the
general
assembly.
33
This
bill
relates
to
pharmacy
regulation
by
modifying
the
34
composition
of
the
board
of
pharmacy
and
altering
the
laws
35
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governing
the
wholesale
distribution
of
drugs.
1
The
bill
modifies
the
composition
of
the
board
of
pharmacy
by
2
adding
a
registered,
certified
pharmacy
technician
as
a
member
3
of
the
board.
4
The
bill
also
alters
the
laws
governing
the
wholesale
5
distribution
of
drugs.
Congress
enacted
the
federal
Drug
6
Quality
and
Security
Act
(DQSA)
in
2013.
Title
II
of
the
7
DQSA
included
the
federal
Drug
Supply
Chain
Security
Act
8
(DSCSA)
which
created
new
standards
for
the
distribution
of
9
prescription
drugs
and
devices,
including
prescription
drugs
10
defined
as
products
under
the
DSCSA,
to
ensure
prescription
11
drug
and
device
quality.
The
bill
updates
Code
chapter
155A
12
to
be
in
compliance
with
the
DSCSA,
which
also
contains
a
13
provision
that
prohibits
states
from
enacting
laws
that
are
14
more
or
less
strict
than
the
DSCSA.
15
The
board
of
pharmacy
currently
licenses
many
types
of
drug
16
distributors
under
a
single
wholesale
distributor
license.
17
Under
the
DSCSA,
entities
engaged
in
the
wholesale
distribution
18
of
prescription
drugs
are
held
to
a
higher
minimum
standard
19
than
entities
engaged
in
other
drug
distribution
activities.
20
The
bill
creates
specific
license
categories
for
third-party
21
logistics
providers,
limited
distributors,
and
wholesale
22
distributors
to
shield
entities
exempt
from
DSCSA
from
the
23
standards
required
of
wholesale
distributors
under
federal
24
law.
The
bill
grants
the
board
authority
to
deny,
suspend,
25
or
revoke
licenses
for
third-party
logistics
providers,
26
limited
distributors,
and
wholesale
distributors,
or
otherwise
27
discipline
such
providers,
limited
distributors,
and
wholesale
28
distributors.
29
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