SB3896 WHOLESALE DRUG DISTRIBUTORS | Illinois Bill

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SB3896 Enrolled
LRB104 20398 AAS 33859 b
1

AN ACT concerning regulation.

Be it enacted by the People of the State of Illinois,
3
represented in the General Assembly:

Section 5.
The Wholesale Drug Distribution Licensing Act
5
is amended by changing Sections 15, 26, 31, 40, 50, 56, 60, 80,
6
155, 185, and 200 and by adding Section 25.7 as follows:

(225 ILCS 120/15)

(from Ch. 111, par. 8301-15)
8

(Section scheduled to be repealed on January 1, 2028)
9

Sec. 15.
Definitions.
As used in this Act:
10

"Address of record" means the designated address recorded
11
by the Department in the applicant's application file or
12
licensee's license file maintained by the Department's
13
licensure maintenance unit.
14

"Authentication" means the affirmative verification,
15
before any wholesale distribution of a prescription drug
16
occurs, that each transaction listed on the pedigree has
17
occurred.
18

"Authorized distributor of record" means a wholesale
19
distributor
or virtual wholesale distributor
with whom a
20
manufacturer has established an ongoing relationship to
21
distribute the manufacturer's prescription drug. An ongoing
22
relationship is deemed to exist between a wholesale
23
distributor
or virtual wholesale distributor
and a

SB3896 Enrolled
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1
manufacturer when the wholesale distributor
or virtual
2
wholesale distributor
, including any affiliated group of the
3
wholesale distributor
or virtual wholesale distributor
, as
4
defined in Section 1504 of the Internal Revenue Code, complies
5
with the following:
6

(1) The wholesale distributor
or virtual wholesale
7

distributor
has a written agreement currently in effect
8

with the manufacturer evidencing the ongoing relationship;
9

and
10

(2) The wholesale distributor
or virtual wholesale
11

distributor
is listed on the manufacturer's current list
12

of authorized distributors of record, which is updated by
13

the manufacturer on no less than a monthly basis.
14

"Blood" means whole blood collected from a single donor
15
and processed either for transfusion or further manufacturing.
16

"Blood component" means that part of blood separated by
17
physical or mechanical means.
18

"Board" means the State Board of Pharmacy of the
19
Department of Financial and Professional Regulation.
20

"Chain pharmacy warehouse" means a physical location for
21
prescription drugs that acts as a central warehouse and
22
performs intracompany sales or transfers of the drugs to a
23
group of chain or mail order pharmacies that have the same
24
common ownership and control. Notwithstanding any other
25
provision of this Act, a chain pharmacy warehouse shall be
26
considered part of the normal distribution channel.

SB3896 Enrolled
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LRB104 20398 AAS 33859 b
1

"Co-licensed partner or product" means an instance where
2
one or more parties have the right to engage in the
3
manufacturing or marketing of a prescription drug, consistent
4
with the FDA's implementation of the Prescription Drug
5
Marketing Act.
6

"Department" means the Department of Financial and
7
Professional Regulation.
8

"Drop shipment" means the sale of a prescription drug to a
9
wholesale distributor
or virtual wholesale distributor
by the
10
manufacturer of the prescription drug or that manufacturer's
11
co-licensed product partner, that manufacturer's third-party
12
logistics provider, or that manufacturer's exclusive
13
distributor or by an authorized distributor of record that
14
purchased the product directly from the manufacturer or one of
15
these entities whereby the wholesale distributor
, virtual
16
wholesale distributor,
or chain pharmacy warehouse takes title
17
but not physical possession of such prescription drug and the
18
wholesale distributor
or virtual wholesale distributor

19
invoices the pharmacy, chain pharmacy warehouse, or other
20
person authorized by law to dispense or administer such drug
21
to a patient and the pharmacy, chain pharmacy warehouse, or
22
other authorized person receives delivery of the prescription
23
drug directly from the manufacturer, that manufacturer's
24
third-party logistics provider, or that manufacturer's
25
exclusive distributor or from an authorized distributor of
26
record that purchased the product directly from the

SB3896 Enrolled
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1
manufacturer or one of these entities.
2

"Drug sample" means a unit of a prescription drug that is
3
not intended to be sold and is intended to promote the sale of
4
the drug.
5

"Email address of record" means the designated email
6
address recorded by the Department in the applicant's
7
application file or the licensee's license file, as maintained
8
by the Department's licensure maintenance unit.
9

"Facility" means a facility of a wholesale distributor
10
where prescription drugs are stored, handled, repackaged, or
11
offered for sale, or a facility of a third-party logistics
12
provider where prescription drugs are stored or handled.
13

"FDA" means the United States Food and Drug
14
Administration.
15

"Manufacturer" means a person licensed or approved by the
16
FDA to engage in the manufacture of drugs or devices,
17
consistent with the definition of "manufacturer" set forth in
18
the FDA's regulations and guidances implementing the
19
Prescription Drug Marketing Act. "Manufacturer" does not
20
include anyone who is engaged in the packaging, repackaging,
21
or labeling of drugs only to the extent permitted under the
22
Illinois Drug Reuse Opportunity Program Act.
23

"Manufacturer's exclusive distributor" means anyone who
24
contracts with a manufacturer to provide or coordinate
25
warehousing, distribution, or other services on behalf of a
26
manufacturer and who takes title to that manufacturer's

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1
prescription drug, but who does not have general
2
responsibility to direct the sale or disposition of the
3
manufacturer's prescription drug. A manufacturer's exclusive
4
distributor must be licensed as a wholesale distributor under
5
this Act and, in order to be considered part of the normal
6
distribution channel, must also be an authorized distributor
7
of record.
8

"Normal distribution channel" means a chain of custody for
9
a prescription drug that goes, directly or by drop shipment,
10
from (i) a manufacturer of the prescription drug, (ii) that
11
manufacturer to that manufacturer's co-licensed partner, (iii)
12
that manufacturer to that manufacturer's
virtual wholesale
13
distributor

third-party logistics provider
, or (iv) that
14
manufacturer to that manufacturer's exclusive distributor
or
15
third-party logistics provider
to:
16

(1) a pharmacy or to other designated persons
17

authorized by law to dispense or administer the drug to a
18

patient;
19

(2) a wholesale distributor to a pharmacy or other
20

designated persons authorized by law to dispense or
21

administer the drug to a patient;
22

(3) a wholesale distributor to a chain pharmacy
23

warehouse to that chain pharmacy warehouse's intracompany
24

pharmacy to a patient or other designated persons
25

authorized by law to dispense or administer the drug to a
26

patient;

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1

(4) a chain pharmacy warehouse to the chain pharmacy
2

warehouse's intracompany pharmacy or other designated
3

persons authorized by law to dispense or administer the
4

drug to the patient;
5

(5) an authorized distributor of record to one other
6

authorized distributor of record to an office-based health
7

care practitioner authorized by law to dispense or
8

administer the drug to the patient; or
9

(6) an authorized distributor to a pharmacy or other
10

persons licensed to dispense or administer the drug.
11

"Pedigree" means a document or electronic file containing
12
information that records each wholesale distribution of any
13
given prescription drug from the point of origin to the final
14
wholesale distribution point of any given prescription drug.
15

"Person" means and includes a natural person, partnership,
16
association, corporation, or any other legal business entity.
17

"Pharmacy distributor" means any pharmacy licensed in this
18
State or hospital pharmacy that is engaged in the delivery or
19
distribution of prescription drugs either to any other
20
pharmacy licensed in this State or to any other person or
21
entity including, but not limited to, a wholesale drug
22
distributor engaged in the delivery or distribution of
23
prescription drugs who is involved in the actual,
24
constructive, or attempted transfer of a drug in this State to
25
other than the ultimate consumer except as otherwise provided
26
for by law.

SB3896 Enrolled
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LRB104 20398 AAS 33859 b
1

"Prescription drug" means any human drug, including any
2
biological product (except for blood and blood components
3
intended for transfusion or biological products that are also
4
medical devices), required by federal law or regulation to be
5
dispensed only by a prescription, including finished dosage
6
forms and bulk drug substances subject to Section 503 of the
7
Federal Food, Drug and Cosmetic Act.
8

"Repackage" means repackaging or otherwise changing the
9
container, wrapper, or labeling to further the distribution of
10
a prescription drug, excluding that completed by the
11
pharmacist responsible for dispensing the product to a
12
patient.
13

"Secretary" means the Secretary of the Department of
14
Financial and Professional Regulation.
15

"Suspicious order" includes, but is not limited to, an
16
order of a controlled substance of unusual size, an order of a
17
controlled substance deviating substantially from a normal
18
pattern, and orders of controlled substances of unusual
19
frequency as defined by 21 U.S.C. 802.
20

"Third-party logistics provider" means anyone who
21
contracts with a prescription drug manufacturer
or virtual
22
wholesale distributor
to provide or coordinate warehousing,
23
distribution, or other services on behalf of a manufacturer
or
24
virtual wholesale distributor
, but does not take title to the
25
prescription drug or have general responsibility to direct the
26
prescription drug's sale or disposition.

SB3896 Enrolled
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LRB104 20398 AAS 33859 b
1

"Wholesale distribution" means the distribution of
2
prescription drugs to persons other than a consumer or
3
patient, but does not include any of the following:
4

(1) Intracompany sales of prescription drugs, meaning
5

(i) any transaction or transfer between any division,
6

subsidiary, parent, or affiliated or related company under
7

the common ownership and control of a corporate entity or
8

(ii) any transaction or transfer between co-licensees of a
9

co-licensed product.
10

(2) The sale, purchase, distribution, trade, or
11

transfer of a prescription drug or offer to sell,
12

purchase, distribute, trade, or transfer a prescription
13

drug for emergency medical reasons.
14

(3) The distribution of prescription drug samples by
15

manufacturers' representatives.
16

(4) Drug returns, when conducted by a hospital, health
17

care entity, or charitable institution in accordance with
18

federal regulation.
19

(5) The sale of minimal quantities of prescription
20

drugs by licensed pharmacies to licensed practitioners for
21

office use or other licensed pharmacies.
22

(6) The sale, purchase, or trade of a drug, an offer to
23

sell, purchase, or trade a drug, or the dispensing of a
24

drug pursuant to a prescription.
25

(7) The sale, transfer, merger, or consolidation of
26

all or part of the business of a pharmacy or pharmacies

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LRB104 20398 AAS 33859 b
1

from or with another pharmacy or pharmacies, whether
2

accomplished as a purchase and sale of stock or business
3

assets.
4

(8) The sale, purchase, distribution, trade, or
5

transfer of a prescription drug from one authorized
6

distributor of record to one additional authorized
7

distributor of record when the manufacturer has stated in
8

writing to the receiving authorized distributor of record
9

that the manufacturer is unable to supply the prescription
10

drug and the supplying authorized distributor of record
11

states in writing that the prescription drug being
12

supplied had until that time been exclusively in the
13

normal distribution channel.
14

(9) The delivery of or the offer to deliver a
15

prescription drug by a common carrier solely in the common
16

carrier's usual course of business of transporting
17

prescription drugs when the common carrier does not store,
18

warehouse, or take legal ownership of the prescription
19

drug.
20

(10) The sale or transfer from a retail pharmacy, mail
21

order pharmacy, or chain pharmacy warehouse of expired,
22

damaged, returned, or recalled prescription drugs to the
23

original manufacturer, the originating wholesale
24

distributor, or a third party returns processor.
25

(11) The donation of drugs to the extent permitted
26

under the Illinois Drug Reuse Opportunity Program Act.

SB3896 Enrolled
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LRB104 20398 AAS 33859 b
1

"Wholesale drug distributor" means anyone engaged in the
2
wholesale distribution of prescription drugs into, out of, or
3
within the State, including, without limitation,
4
manufacturers; repackers; own label distributors; jobbers;
5
private label distributors; brokers; warehouses, including
6
manufacturers' and distributors' warehouses; manufacturer's
7
exclusive distributors; and authorized distributors of record;
8
drug wholesalers or distributors; independent wholesale drug
9
traders; specialty wholesale distributors; retail pharmacies
10
that conduct wholesale distribution; and chain pharmacy
11
warehouses that conduct wholesale distribution. In order to be
12
considered part of the normal distribution channel, a
13
wholesale distributor must also be an authorized distributor
14
of record.
15

"Virtual wholesale distributor" means any person engaged
16
in the wholesale distribution of prescription drugs into, out
17
of, or within the State who holds title to, but does not take
18
physical possession of, prescription drugs.

19
(Source: P.A. 102-389, eff. 1-1-22; 102-879, eff. 1-1-23;
20
103-154, eff. 6-30-23.)

(225 ILCS 120/25.7 new)
22

Sec. 25.7.
Virtual wholesale distributor licensing
23
requirements.
24

(a) Every virtual wholesale distributor that engages in
25
virtual drug distribution of prescription drugs shall be

SB3896 Enrolled
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LRB104 20398 AAS 33859 b
1
licensed by the Department. A virtual wholesale distributor
2
shall only contract with entities licensed under this Act to
3
take physical possession of prescription drugs if the
4
prescription drugs are being shipped into the State.
5

(b) Each applicant for licensure as a virtual wholesale
6
distributor under this Act shall submit the following
7
information to the Department:
8

(1) the name, full business address, and telephone
9

number of the applicant;
10

(2) all trade or business names used by the applicant;
11

(3) addresses, email addresses, telephone numbers, and
12

the names of contact persons for all facilities used by
13

the applicant for the storage, handling, and distribution
14

of prescription drugs;
15

(4) the applicant's type of ownership or operation,
16

such as a partnership, corporation, or sole
17

proprietorship;
18

(5) the name of each person with an ownership or
19

operation interest in the applicant, including the
20

following:
21

(A) if the applicant is a natural person, the name
22

of the person;
23

(B) if the applicant is a partnership, the name of
24

each partner and the name of the partnership;
25

and title of each person who owns 5% or more of its

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1

stock and each corporate officer and director and the
2

name of the state of incorporation;
3

(D) if the applicant is a sole proprietorship, the
4

full name of the sole proprietor and the name of the
5

business entity and the state of organization;
6

(E) if the applicant is a limited liability
7

company, the name and title of each member or manager
8

and the name of the business entity and the state of
9

organization;
10

(F) if the applicant is a limited liability
11

partnership, the name and title of each partner and
12

the name of the partnership and the state of
13

organization; and
14

(G) if the applicant is a limited partnership, the
15

name and title of each partner and the name of the
16

partnership and the state of organization;
17

(6) a list of all licenses and permits issued to the
18

applicant by any other state that authorizes the applicant
19

to purchase or facilitate the distribution of prescription
20

drugs;
21

(7) minimum liability insurance and other insurance as
22

defined by rule;
23

(8) the name and license number of the third-party
24

logistics provider who provides warehouse and shipping
25

services to the applicant; and
26

(9) any additional information required by the

SB3896 Enrolled
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LRB104 20398 AAS 33859 b
1

Department.
2

(c) A virtual wholesale distributor shall ensure that any
3
licensed entity providing distribution services to the virtual
4
wholesale distributor complies with the following:
5

(1) the licensed entity is in compliance with all
6

rules related to storage and distribution of prescription
7

drugs;
8

(2) the licensed entity has designated a
9

representative who is at least 21 years of age and who has
10

adequate education, experience, and training to be
11

employed by the licensed entity full time in a managerial
12

level position and to be actively involved in and aware of
13

the actual daily operation of the virtual wholesale
14

distributor;
15

(3) the licensed entity contracts with carriers that
16

provide adequate security to guard against in-transit
17

losses; and
18

(4) the licensed entity is compliant with Title II of
19

the federal Drug Quality and Security Act.
20

(d) A virtual wholesale distributor shall not operate out
21
of a location that is a residence or personal dwelling.

(225 ILCS 120/26)
23

(Section scheduled to be repealed on January 1, 2028)
24

Sec. 26.
Unlicensed practice; violation; civil penalty.
25

(a) Any person who practices, offers to practice, attempts

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LRB104 20398 AAS 33859 b
1
to practice, or holds oneself out to practice as a wholesale
2
drug distributor, pharmacy distributor,
virtual wholesale
3
distributor,
or third-party logistics provider without being
4
licensed to ship into, out of, or within the State under this
5
Act shall, in addition to any other penalty provided by law,
6
pay a civil penalty to the Department in an amount not to
7
exceed $10,000 for each offense as determined by the
8
Department. The civil penalty shall be assessed by the
9
Department after a hearing is held in accordance with the
10
provisions set forth in this Act regarding the provision of a
11
hearing for the discipline of a licensee.
12

(b) The Department has the authority and power to
13
investigate any and all unlicensed activity.
14

(c) The civil penalty shall be paid within 60 days after
15
the effective date of the order imposing the civil penalty.
16
The order shall constitute a judgment and may be filed and
17
execution had thereon in the same manner as any judgment from
18
any court of record.
19
(Source: P.A. 101-420, eff. 8-16-19
.)

(225 ILCS 120/31)
21

(Section scheduled to be repealed on January 1, 2028)
22

Sec. 31.
Expiration of license; renewal.
23

(a) The expiration date and renewal period for each
24
license issued under this Act shall be set by rule.
25

(b) Any licensee who shall engage in the practice for

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LRB104 20398 AAS 33859 b
1
which the license was issued while the license is expired or on
2
inactive status shall be considered to be practicing without a
3
license which shall be grounds for discipline under this Act.
4

(c) A wholesale drug distributor
, virtual wholesale
5
distributor,
or third-party logistics provider whose license
6
has been expired for one year or more may not have its license
7
restored but must apply for a new license and meet all
8
requirements for licensure. Any wholesale drug distributor
,
9
virtual wholesale distributor,
or third-party logistics
10
provider whose license has been expired for less than one year
11
may apply for restoration of its license and shall have its
12
license restored.
13

(d) Anyone operating on an expired license is engaged in
14
unlawful practice and subject to discipline under this Act.
15
(Source: P.A. 102-879, eff. 1-1-23
.)

(225 ILCS 120/40)

(from Ch. 111, par. 8301-40)
17

(Section scheduled to be repealed on January 1, 2028)
18

Sec. 40.
Rules and regulations.
The Department shall make
19
any rules and regulations, not inconsistent with law, as may
20
be necessary to carry out the purposes and enforce the
21
provisions of this Act. All rules and regulations promulgated
22
under this Section shall conform to wholesale drug distributor
23
licensing guidelines formally adopted by the FDA at 21 C.F.R.
24
Part 205. In case of conflict between any rule or regulation
25
adopted by the Department and any FDA wholesale drug

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LRB104 20398 AAS 33859 b
1
distributor
, virtual wholesale distributor,
or third-party
2
logistics provider guideline, the FDA guideline shall control.
3
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23
.)

(225 ILCS 120/50)

(from Ch. 111, par. 8301-50)
5

(Section scheduled to be repealed on January 1, 2028)
6

Sec. 50.
Inspection powers; access to records.
7

(a) Any pharmacy investigator authorized by the Department
8
has the right of entry for inspection of premises purporting
9
or appearing to be used by a wholesale drug distributor
,
10
virtual wholesale distributor, or third-party logistics
11
provider
in this State, including the business premises of a
12
person licensed pursuant to this Act. This right of entry
13
shall permit the authorized pharmacy investigator unfettered
14
access to the entire business premises. Any attempt to hinder
15
an authorized pharmacy investigator from inspecting the
16
business premises and documenting the inspection shall be a
17
violation of this Act. The duly authorized investigators shall
18
be required to show appropriate identification before being
19
given access to
the

a wholesale drug distributor's
premises
20
and delivery vehicles.
21

(b) With the exception of the most recent 12 months of
22
records that must be kept on the premises where the drugs are
23
stored, wholesale drug distributors
, virtual wholesale
24
distributors, and third-party logistics providers
may keep
25
records regarding purchase and sales transactions

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1
electronically at a central location apart from the principal
2
office of the wholesale drug distributor or the location at
3
which the drugs were stored and from which they were shipped,
4
provided that the records shall be made readily available for
5
inspection within 2 working days of a request by the
6
Department. The records may be kept in any form permissible
7
under federal law applicable to prescription drugs record
8
keeping.
9

(225 ILCS 120/56)
12

(Section scheduled to be repealed on January 1, 2028)
13

Sec. 56.
Restrictions on transactions.
14

(a) A licensee shall receive prescription drug returns or
15
exchanges from a pharmacy or other persons authorized to
16
administer or dispense drugs or a chain pharmacy warehouse
17
pursuant to the terms and conditions of the agreement between
18
the wholesale distributor
, virtual wholesale distributor, or
19
third-party logistics provider
and the pharmacy or chain
20
pharmacy warehouse. Returns of expired, damaged, recalled, or
21
otherwise non-saleable pharmaceutical products shall be
22
distributed by the receiving wholesale distributor
or
23
third-party logistics provider
only to either the original
24
manufacturer or a third party returns processor. Returns or
25
exchanges of prescription drugs, saleable or otherwise,

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LRB104 20398 AAS 33859 b
1
including any redistribution by a receiving wholesaler, shall
2
not be subject to the pedigree requirements of Section 57 of
3
this Act, so long as they are exempt from the pedigree
4
requirement of the FDA's currently applicable Prescription
5
Drug Marketing Act guidance. Both licensees under this Act and
6
pharmacies or other persons authorized to administer or
7
dispense drugs shall be accountable for administering their
8
returns process and ensuring that the aspects of this
9
operation are secure and do not permit the entry of
10
adulterated and counterfeit product.
11

(b) A manufacturer
,

or
wholesale distributor
, virtual
12
wholesale distributor, or third-party logistics provider

13
licensed under this Act may furnish prescription drugs only to
14
a person licensed by the appropriate state licensing
15
authorities. Before furnishing prescription drugs to a person
16
not known to the manufacturer or
licensee

wholesale
17
distributor
, the manufacturer or
licensee

wholesale
18
distributor
must affirmatively verify that the person is
19
legally authorized to receive the prescription drugs by
20
contacting the appropriate state licensing authorities.
21

22
wholesale distributor
, virtual wholesale distributor, or
23
third-party logistics provider
licensed under this Act may be
24
delivered only to the premises listed on the license, provided
25
that the manufacturer or
licensee

wholesale distributor
may
26
furnish prescription drugs to an authorized person or agent of

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1
that person at the premises of the manufacturer or
licensee

2
wholesale distributor
if:
3

(1) the identity and authorization of the recipient is
4

properly established; and
5

(2) this method of receipt is employed only to meet
6

the immediate needs of a particular patient of the
7

authorized person.
8

(d) Prescription drugs may be furnished to a hospital
9
pharmacy receiving area, provided that a pharmacist or
10
authorized receiving personnel signs, at the time of delivery,
11
a receipt showing the type and quantity of the prescription
12
drug received. Any discrepancy between the receipt and the
13
type and quantity of the prescription drug actually received
14
shall be reported to the delivering manufacturer
,

or
wholesale
15
distributor
, or third-party logistics provider
by the next
16
business day after the delivery to the pharmacy receiving
17
area.
18

(e) A manufacturer
,

or
wholesale distributor
, or virtual
19
wholesale distributor
licensed under this Act may not accept
20
payment for, or allow the use of, a person or entity's credit
21
to establish an account for the purchase of prescription drugs
22
from any person other than the owner of record, the chief
23
executive officer, or the chief financial officer listed on
24
the license of a person or entity legally authorized to
25
receive the prescription drugs. Any account established for
26
the purchase of prescription drugs must bear the name of the

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1
licensee. This subsection (e) shall not be construed to
2
prohibit a pharmacy or chain pharmacy warehouse from receiving
3
prescription drugs if payment for the prescription drugs is
4
processed through the pharmacy's or chain pharmacy warehouse's
5
contractual drug manufacturer or wholesale distributor.
6
(Source: P.A. 95-689, eff. 10-29-07
.)

(225 ILCS 120/60)

(from Ch. 111, par. 8301-60)
8

(Section scheduled to be repealed on January 1, 2028)
9

Sec. 60.
Wholesaler licensing; complaints.
The Department
10
may refuse to issue a license to establish a new licensed
11
wholesale drug
distributor, virtual wholesale distributor, or
12
third-party logistics provider

distributorship
, if an owner of
13
the
entity

wholesale drug distributorship
applying for a
14
license was an owner of a wholesale drug
distributor, virtual
15
wholesale distributor, or third-party logistics provider

16
distributorship
that had its license revoked, unless the owner
17
presents sufficient evidence indicating rehabilitation. Once a
18
complaint has been filed by the Department against a wholesale
19
drug
distributor, virtual wholesale distributor, or
20
third-party logistics provider

distributorship
the Department
21
may refuse to issue a license to establish a new licensed
22
wholesale drug
distributor, virtual wholesale distributor, or
23
third-party logistics provider

distributorship
, until such
24
time as the Department issues a decision on the complaint if an
25
owner of the new wholesale drug
distributor, virtual wholesale

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1
distributor, or third-party logistics provider

distributorship

2
was also an owner of a wholesale drug
distributor, virtual
3
wholesale distributor, or third-party logistics provider

4
distributorship
against which the complaint was filed. Neither
5
an application for change of ownership nor for a change of
6
location for any such
entity

wholesale drug distributorship

7
shall be acted on by the Department until such time as the
8
Department issues a decision on the complaint. In the event
9
that the wholesale drug
distributor, virtual wholesale
10
distributor, or third-party logistics provider

distributorship

11
against which the complaint has been filed ceases to be
12
licensed by the Department, for any reason, before the
13
Department's decision on the complaint and an owner or that
14
wholesale drug
distributor, virtual wholesale distributor, or
15
third-party logistics provider

distributorship
applies for a
16
license to establish a new wholesale drug
distributor, virtual
17
wholesale distributor, or third-party logistics provider

18
distributorship
, the Department shall conduct a hearing on the
19
complaint earlier filed, regardless of whether that wholesale
20
drug
distributor, virtual wholesale distributor, or
21
third-party logistics provider

distributorship
is presently
22
licensed by the Department. If the conduct for which the
23
complaint was originally filed would have been sufficient to
24
result in a revocation of a license to operate a licensed
25
wholesale drug
distributor, virtual wholesale distributor, or
26
third-party logistics provider

distributorship
, then the

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1
conduct shall constitute sufficient grounds for denial of an
2
application for a license.
3
(Source: P.A. 87-594
.)

(225 ILCS 120/80)

(from Ch. 111, par. 8301-80)
5

(Section scheduled to be repealed on January 1, 2028)
6

Sec. 80.
Violations of Act.
7

(a) If any person violates the provisions of this Act, the
8
Secretary may, in the name of the People of the State of
9
Illinois through the Attorney General of the State of Illinois
10
or the State's Attorney of any county in which the action is
11
brought, petition for an order enjoining the violation or for
12
an order enforcing compliance with this Act. Upon the filing
13
of a verified petition in the court, the court may issue a
14
temporary restraining order, without notice or bond, and may
15
preliminarily and permanently enjoin the violation. If it is
16
established that the person has violated or is violating the
17
injunction, the Court may punish the offender for contempt of
18
court. Proceedings under this Section shall be in addition to,
19
and not in lieu of, all other remedies and penalties provided
20
by this Act.
21

(b) Whoever knowingly conducts business as a wholesale
22
drug distributor
, virtual wholesale distributor,
or
23
third-party logistics provider in this State without being
24
appropriately licensed under this Act shall be guilty of a
25
Class A misdemeanor for a first violation and for each

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1
subsequent conviction shall be guilty of a Class 4 felony.
2

(c) Whenever in the opinion of the Department any person
3
not licensed in good standing under this Act violates any
4
provision of this Act, the Department may issue a rule to show
5
cause why an order to cease and desist should not be entered
6
against him. The rule shall clearly set forth the grounds
7
relied upon by the Department and shall provide a period of 7
8
days from the date of the rule to file an answer to the
9
satisfaction of the Department. Failure to answer to the
10
satisfaction of the Department shall cause an order to cease
11
and desist to be issued immediately.
12
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23
.)

(225 ILCS 120/155)

(from Ch. 111, par. 8301-155)
14

(Section scheduled to be repealed on January 1, 2028)
15

Sec. 155.
Temporary suspension of license; hearing.
The
16
Secretary may temporarily suspend licensure as a wholesale
17
drug distributor
, virtual wholesale distributor,
or
18
third-party logistics provider, without a hearing,
19
simultaneously with the institution of proceedings for a
20
hearing provided for in Section 85 of this Act, if the
21
Secretary finds that evidence in his or her possession
22
indicates that a continuation in business would constitute an
23
imminent danger to the public. In the event that the Secretary
24
temporarily suspends a license or certificate without a
25
hearing, a hearing by the Department must be held within 10

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1
days after the suspension has occurred and be concluded
2
without appreciable delay.
3
(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23
.)

(225 ILCS 120/185)

(from Ch. 111, par. 8301-185)
5

(Section scheduled to be repealed on January 1, 2028)
6

Sec. 185.
Home rule preemption.
The regulation and
7
licensing of wholesale drug distributors
, virtual wholesale
8
distributors, and third-party logistics providers
are
9
exclusive powers and functions of the State. A home rule unit
10
may not regulate or license wholesale drug distributors
,
11
virtual wholesale distributors, and third-party logistics
12
providers
. This Section is a denial and limitation of home
13
rule powers and functions under subsection (h) of Section 6 of
14
Article VII of the Illinois Constitution.
15
(Source: P.A. 87-594
.)

(225 ILCS 120/200)
17

(Section scheduled to be repealed on January 1, 2028)
18

Sec. 200.
Drugs in shortage.
19

(a) For the purpose of this Section, "drug in shortage"
20
means a drug, as defined in Section 356c of the Federal Food,
21
Drug, and Cosmetic Act, listed on the drug shortage list
22
maintained by the U.S. Food and Drug Administration in
23
accordance with Section 356e of the Federal Food, Drug, and
24
Cosmetic Act.

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1

(b) Any person engaged in the wholesale distribution of a
2
drug in shortage in this State must be licensed by the
3
Department.
4

(c) It is unlawful for any person, other than a
5
manufacturer, a manufacturer's exclusive distributor,
a
6
virtual wholesale distributor,
a third-party logistics
7
provider, or an authorized distributor of record, to purchase
8
or receive a drug in shortage from any person not licensed by
9
the Department. This subsection (c) does not apply to the
10
return of drugs or the purchase or receipt of drugs pursuant to
11
any of the distributions that are specifically excluded from
12
the definition of "wholesale distribution" in Section 15 of
13
the Wholesale Drug Distribution Licensing Act.
14

(d) A person found to have violated a provision of this
15
Section shall be subject to administrative fines, orders for
16
restitution, and orders for disgorgement.
17

(e) The Department shall create a centralized, searchable
18
database of those entities licensed to engage in wholesale
19
distribution, including manufacturers, wholesale
20
distributors,
virtual wholesale distributors,
and pharmacy
21
distributors, to enable purchasers of a drug in shortage to
22
easily verify the licensing status of an entity offering such
23
drugs.
24

(f) The Department shall establish a system for reporting
25
the reasonable suspicion that a violation of this Act has been
26
committed by a distributor of a drug in shortage. Reports made

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1
through this system shall be referred to the Office of the
2
Attorney General and the appropriate State's Attorney's office
3
for further investigation and prosecution.
4

(g) The Department shall adopt rules to carry out the
5
provisions of this Section.
6

(h) Nothing in this Section prohibits one hospital
7
pharmacy from purchasing or receiving a drug in shortage from
8
another hospital pharmacy in the event of a medical emergency.
9
(Source: P.A. 102-879, eff. 1-1-23
.)

Section 99.
Effective date.
This Act takes effect upon
11
becoming law.

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WHOLESALE DRUG DISTRIBUTORS

Plain English Breakdown

WHOLESALE DRUG DISTRIBUTORS

What This Bill Does

Limits and Unknowns

Bill History

Official Summary Text

Current Bill Text