SB 3896

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Full Text of SB3896
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	SB3896 - 104th General Assembly
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		SB3896 Enrolled		LRB104 20398 AAS 33859 b
1    AN ACT concerning regulation.
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
4    Section 5. The Wholesale Drug Distribution Licensing Act
5is amended by changing Sections 15, 26, 31, 40, 50, 56, 60, 80,
6155, 185, and 200 and by adding Section 25.7 as follows:
7    (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8    (Section scheduled to be repealed on January 1, 2028)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
11by the Department in the applicant's application file or
12licensee's license file maintained by the Department's
13licensure maintenance unit.
14    "Authentication" means the affirmative verification,
15before any wholesale distribution of a prescription drug
16occurs, that each transaction listed on the pedigree has
17occurred.
18    "Authorized distributor of record" means a wholesale
19distributor or virtual wholesale distributor with whom a
20manufacturer has established an ongoing relationship to
21distribute the manufacturer's prescription drug. An ongoing
22relationship is deemed to exist between a wholesale
23distributor or virtual wholesale distributor and a
		SB3896 Enrolled	- 2 -	LRB104 20398 AAS 33859 b
1manufacturer when the wholesale distributor or virtual 
2wholesale distributor, including any affiliated group of the
3wholesale distributor or virtual wholesale distributor, as
4defined in Section 1504 of the Internal Revenue Code, complies
5with 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
15and processed either for transfusion or further manufacturing.
16    "Blood component" means that part of blood separated by
17physical or mechanical means.
18    "Board" means the State Board of Pharmacy of the
19Department of Financial and Professional Regulation.
20    "Chain pharmacy warehouse" means a physical location for
21prescription drugs that acts as a central warehouse and
22performs intracompany sales or transfers of the drugs to a
23group of chain or mail order pharmacies that have the same
24common ownership and control. Notwithstanding any other
25provision of this Act, a chain pharmacy warehouse shall be
26considered part of the normal distribution channel.
		SB3896 Enrolled	- 3 -	LRB104 20398 AAS 33859 b
1    "Co-licensed partner or product" means an instance where
2one or more parties have the right to engage in the
3manufacturing or marketing of a prescription drug, consistent
4with the FDA's implementation of the Prescription Drug
5Marketing Act.
6    "Department" means the Department of Financial and
7Professional Regulation.
8    "Drop shipment" means the sale of a prescription drug to a
9wholesale distributor or virtual wholesale distributor by the
10manufacturer of the prescription drug or that manufacturer's
11co-licensed product partner, that manufacturer's third-party
12logistics provider, or that manufacturer's exclusive
13distributor or by an authorized distributor of record that
14purchased the product directly from the manufacturer or one of
15these entities whereby the wholesale distributor, virtual 
16wholesale distributor, or chain pharmacy warehouse takes title
17but not physical possession of such prescription drug and the
18wholesale distributor or virtual wholesale distributor
19invoices the pharmacy, chain pharmacy warehouse, or other
20person authorized by law to dispense or administer such drug
21to a patient and the pharmacy, chain pharmacy warehouse, or
22other authorized person receives delivery of the prescription
23drug directly from the manufacturer, that manufacturer's
24third-party logistics provider, or that manufacturer's
25exclusive distributor or from an authorized distributor of
26record that purchased the product directly from the
		SB3896 Enrolled	- 4 -	LRB104 20398 AAS 33859 b
1manufacturer or one of these entities.
2    "Drug sample" means a unit of a prescription drug that is
3not intended to be sold and is intended to promote the sale of
4the drug.
5    "Email address of record" means the designated email
6address recorded by the Department in the applicant's
7application file or the licensee's license file, as maintained
8by the Department's licensure maintenance unit.
9    "Facility" means a facility of a wholesale distributor
10where prescription drugs are stored, handled, repackaged, or
11offered for sale, or a facility of a third-party logistics
12provider where prescription drugs are stored or handled.
13    "FDA" means the United States Food and Drug
14Administration.
15    "Manufacturer" means a person licensed or approved by the
16FDA to engage in the manufacture of drugs or devices,
17consistent with the definition of "manufacturer" set forth in
18the FDA's regulations and guidances implementing the
19Prescription Drug Marketing Act. "Manufacturer" does not
20include anyone who is engaged in the packaging, repackaging,
21or labeling of drugs only to the extent permitted under the
22Illinois Drug Reuse Opportunity Program Act.
23    "Manufacturer's exclusive distributor" means anyone who
24contracts with a manufacturer to provide or coordinate
25warehousing, distribution, or other services on behalf of a
26manufacturer and who takes title to that manufacturer's
		SB3896 Enrolled	- 5 -	LRB104 20398 AAS 33859 b
1prescription drug, but who does not have general
2responsibility to direct the sale or disposition of the
3manufacturer's prescription drug. A manufacturer's exclusive
4distributor must be licensed as a wholesale distributor under
5this Act and, in order to be considered part of the normal
6distribution channel, must also be an authorized distributor
7of record.
8    "Normal distribution channel" means a chain of custody for
9a prescription drug that goes, directly or by drop shipment,
10from (i) a manufacturer of the prescription drug, (ii) that
11manufacturer to that manufacturer's co-licensed partner, (iii)
12that manufacturer to that manufacturer's virtual wholesale 
13distributor [third-party logistics provider], or (iv) that
14manufacturer to that manufacturer's exclusive distributor or 
15third-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;
		SB3896 Enrolled	- 6 -	LRB104 20398 AAS 33859 b
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
12information that records each wholesale distribution of any
13given prescription drug from the point of origin to the final
14wholesale distribution point of any given prescription drug.
15    "Person" means and includes a natural person, partnership,
16association, corporation, or any other legal business entity.
17    "Pharmacy distributor" means any pharmacy licensed in this
18State or hospital pharmacy that is engaged in the delivery or
19distribution of prescription drugs either to any other
20pharmacy licensed in this State or to any other person or
21entity including, but not limited to, a wholesale drug
22distributor engaged in the delivery or distribution of
23prescription drugs who is involved in the actual,
24constructive, or attempted transfer of a drug in this State to
25other than the ultimate consumer except as otherwise provided
26for by law.
		SB3896 Enrolled	- 7 -	LRB104 20398 AAS 33859 b
1    "Prescription drug" means any human drug, including any
2biological product (except for blood and blood components
3intended for transfusion or biological products that are also
4medical devices), required by federal law or regulation to be
5dispensed only by a prescription, including finished dosage
6forms and bulk drug substances subject to Section 503 of the
7Federal Food, Drug and Cosmetic Act.
8    "Repackage" means repackaging or otherwise changing the
9container, wrapper, or labeling to further the distribution of
10a prescription drug, excluding that completed by the
11pharmacist responsible for dispensing the product to a
12patient.
13    "Secretary" means the Secretary of the Department of
14Financial and Professional Regulation.
15    "Suspicious order" includes, but is not limited to, an
16order of a controlled substance of unusual size, an order of a
17controlled substance deviating substantially from a normal
18pattern, and orders of controlled substances of unusual
19frequency as defined by 21 U.S.C. 802.
20    "Third-party logistics provider" means anyone who
21contracts with a prescription drug manufacturer or virtual 
22wholesale distributor to provide or coordinate warehousing,
23distribution, or other services on behalf of a manufacturer or 
24virtual wholesale distributor, but does not take title to the
25prescription drug or have general responsibility to direct the
26prescription drug's sale or disposition.
		SB3896 Enrolled	- 8 -	LRB104 20398 AAS 33859 b
1    "Wholesale distribution" means the distribution of
2prescription drugs to persons other than a consumer or
3patient, 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
		SB3896 Enrolled	- 9 -	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	- 10 -	LRB104 20398 AAS 33859 b
1    "Wholesale drug distributor" means anyone engaged in the
2wholesale distribution of prescription drugs into, out of, or
3within the State, including, without limitation,
4manufacturers; repackers; own label distributors; jobbers;
5private label distributors; brokers; warehouses, including
6manufacturers' and distributors' warehouses; manufacturer's
7exclusive distributors; and authorized distributors of record;
8drug wholesalers or distributors; independent wholesale drug
9traders; specialty wholesale distributors; retail pharmacies
10that conduct wholesale distribution; and chain pharmacy
11warehouses that conduct wholesale distribution. In order to be
12considered part of the normal distribution channel, a
13wholesale distributor must also be an authorized distributor
14of record.
15    "Virtual wholesale distributor" means any person engaged 
16in the wholesale distribution of prescription drugs into, out 
17of, or within the State who holds title to, but does not take 
18physical possession of, prescription drugs.
19(Source: P.A. 102-389, eff. 1-1-22; 102-879, eff. 1-1-23;
20103-154, eff. 6-30-23.)
21    (225 ILCS 120/25.7 new)
22    Sec. 25.7. Virtual wholesale distributor licensing 
23requirements.
24    (a) Every virtual wholesale distributor that engages in 
25virtual drug distribution of prescription drugs shall be 
		SB3896 Enrolled	- 11 -	LRB104 20398 AAS 33859 b
1licensed by the Department. A virtual wholesale distributor 
2shall only contract with entities licensed under this Act to 
3take physical possession of prescription drugs if the 
4prescription drugs are being shipped into the State.
5    (b) Each applicant for licensure as a virtual wholesale 
6distributor under this Act shall submit the following 
7information 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            (C) if the applicant is a corporation, the name 
26        and title of each person who owns 5% or more of its 
		SB3896 Enrolled	- 12 -	LRB104 20398 AAS 33859 b
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	- 13 -	LRB104 20398 AAS 33859 b
1    Department.
2    (c) A virtual wholesale distributor shall ensure that any 
3licensed entity providing distribution services to the virtual 
4wholesale 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 
21of a location that is a residence or personal dwelling.
22    (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
		SB3896 Enrolled	- 14 -	LRB104 20398 AAS 33859 b
1to practice, or holds oneself out to practice as a wholesale
2drug distributor, pharmacy distributor, virtual wholesale 
3distributor, or third-party logistics provider without being
4licensed to ship into, out of, or within the State under this
5Act shall, in addition to any other penalty provided by law,
6pay a civil penalty to the Department in an amount not to
7exceed $10,000 for each offense as determined by the
8Department. The civil penalty shall be assessed by the
9Department after a hearing is held in accordance with the
10provisions set forth in this Act regarding the provision of a
11hearing for the discipline of a licensee.
12    (b) The Department has the authority and power to
13investigate any and all unlicensed activity.
14    (c) The civil penalty shall be paid within 60 days after
15the effective date of the order imposing the civil penalty.
16The order shall constitute a judgment and may be filed and
17execution had thereon in the same manner as any judgment from
18any court of record.
19(Source: P.A. 101-420, eff. 8-16-19.)
20    (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
24license issued under this Act shall be set by rule.
25    (b) Any licensee who shall engage in the practice for
		SB3896 Enrolled	- 15 -	LRB104 20398 AAS 33859 b
1which the license was issued while the license is expired or on
2inactive status shall be considered to be practicing without a
3license which shall be grounds for discipline under this Act.
4    (c) A wholesale drug distributor, virtual wholesale 
5distributor, or third-party logistics provider whose license
6has been expired for one year or more may not have its license
7restored but must apply for a new license and meet all
8requirements for licensure. Any wholesale drug distributor, 
9virtual wholesale distributor, or third-party logistics
10provider whose license has been expired for less than one year
11may apply for restoration of its license and shall have its
12license restored.
13    (d) Anyone operating on an expired license is engaged in
14unlawful practice and subject to discipline under this Act.
15(Source: P.A. 102-879, eff. 1-1-23.)
16    (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
19any rules and regulations, not inconsistent with law, as may
20be necessary to carry out the purposes and enforce the
21provisions of this Act. All rules and regulations promulgated
22under this Section shall conform to wholesale drug distributor
23licensing guidelines formally adopted by the FDA at 21 C.F.R.
24Part 205. In case of conflict between any rule or regulation
25adopted by the Department and any FDA wholesale drug
		SB3896 Enrolled	- 16 -	LRB104 20398 AAS 33859 b
1distributor, virtual wholesale distributor, or third-party
2logistics provider guideline, the FDA guideline shall control.
3(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)
4    (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
8has the right of entry for inspection of premises purporting
9or appearing to be used by a wholesale drug distributor, 
10virtual wholesale distributor, or third-party logistics 
11provider in this State, including the business premises of a
12person licensed pursuant to this Act. This right of entry
13shall permit the authorized pharmacy investigator unfettered
14access to the entire business premises. Any attempt to hinder
15an authorized pharmacy investigator from inspecting the
16business premises and documenting the inspection shall be a
17violation of this Act. The duly authorized investigators shall
18be required to show appropriate identification before being
19given access to the [a wholesale drug distributor's] premises
20and delivery vehicles.
21    (b) With the exception of the most recent 12 months of
22records that must be kept on the premises where the drugs are
23stored, wholesale drug distributors, virtual wholesale 
24distributors, and third-party logistics providers may keep
25records regarding purchase and sales transactions
		SB3896 Enrolled	- 17 -	LRB104 20398 AAS 33859 b
1electronically at a central location apart from the principal
2office of the wholesale drug distributor or the location at
3which the drugs were stored and from which they were shipped,
4provided that the records shall be made readily available for
5inspection within 2 working days of a request by the
6Department. The records may be kept in any form permissible
7under federal law applicable to prescription drugs record
8keeping.
9    (c) (Blank).
10(Source: P.A. 102-879, eff. 1-1-23.)
11    (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
15exchanges from a pharmacy or other persons authorized to
16administer or dispense drugs or a chain pharmacy warehouse
17pursuant to the terms and conditions of the agreement between
18the wholesale distributor, virtual wholesale distributor, or 
19third-party logistics provider and the pharmacy or chain
20pharmacy warehouse. Returns of expired, damaged, recalled, or
21otherwise non-saleable pharmaceutical products shall be
22distributed by the receiving wholesale distributor or 
23third-party logistics provider only to either the original
24manufacturer or a third party returns processor. Returns or
25exchanges of prescription drugs, saleable or otherwise,
		SB3896 Enrolled	- 18 -	LRB104 20398 AAS 33859 b
1including any redistribution by a receiving wholesaler, shall
2not be subject to the pedigree requirements of Section 57 of
3this Act, so long as they are exempt from the pedigree
4requirement of the FDA's currently applicable Prescription
5Drug Marketing Act guidance. Both licensees under this Act and
6pharmacies or other persons authorized to administer or
7dispense drugs shall be accountable for administering their
8returns process and ensuring that the aspects of this
9operation are secure and do not permit the entry of
10adulterated and counterfeit product.
11    (b) A manufacturer, [or] wholesale distributor, virtual 
12wholesale distributor, or third-party logistics provider
13licensed under this Act may furnish prescription drugs only to
14a person licensed by the appropriate state licensing
15authorities. Before furnishing prescription drugs to a person
16not known to the manufacturer or licensee [wholesale ]
17[distributor], the manufacturer or licensee [wholesale ]
18[distributor] must affirmatively verify that the person is
19legally authorized to receive the prescription drugs by
20contacting the appropriate state licensing authorities.
21    (c) Prescription drugs furnished by a manufacturer, [or]
22wholesale distributor, virtual wholesale distributor, or 
23third-party logistics provider licensed under this Act may be
24delivered only to the premises listed on the license, provided
25that the manufacturer or licensee [wholesale distributor] may
26furnish prescription drugs to an authorized person or agent of
		SB3896 Enrolled	- 19 -	LRB104 20398 AAS 33859 b
1that 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
9pharmacy receiving area, provided that a pharmacist or
10authorized receiving personnel signs, at the time of delivery,
11a receipt showing the type and quantity of the prescription
12drug received. Any discrepancy between the receipt and the
13type and quantity of the prescription drug actually received
14shall be reported to the delivering manufacturer, [or] wholesale
15distributor, or third-party logistics provider by the next
16business day after the delivery to the pharmacy receiving
17area.
18    (e) A manufacturer, [or] wholesale distributor, or virtual 
19wholesale distributor licensed under this Act may not accept
20payment for, or allow the use of, a person or entity's credit
21to establish an account for the purchase of prescription drugs
22from any person other than the owner of record, the chief
23executive officer, or the chief financial officer listed on
24the license of a person or entity legally authorized to
25receive the prescription drugs. Any account established for
26the purchase of prescription drugs must bear the name of the
		SB3896 Enrolled	- 20 -	LRB104 20398 AAS 33859 b
1licensee. This subsection (e) shall not be construed to
2prohibit a pharmacy or chain pharmacy warehouse from receiving
3prescription drugs if payment for the prescription drugs is
4processed through the pharmacy's or chain pharmacy warehouse's
5contractual drug manufacturer or wholesale distributor.
6(Source: P.A. 95-689, eff. 10-29-07.)
7    (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
10may refuse to issue a license to establish a new licensed
11wholesale drug distributor, virtual wholesale distributor, or 
12third-party logistics provider [distributorship], if an owner of
13the entity [wholesale drug distributorship] applying for a
14license was an owner of a wholesale drug distributor, virtual 
15wholesale distributor, or third-party logistics provider
16[distributorship] that had its license revoked, unless the owner
17presents sufficient evidence indicating rehabilitation. Once a
18complaint has been filed by the Department against a wholesale
19drug distributor, virtual wholesale distributor, or 
20third-party logistics provider [distributorship] the Department
21may refuse to issue a license to establish a new licensed
22wholesale drug distributor, virtual wholesale distributor, or 
23third-party logistics provider [distributorship], until such
24time as the Department issues a decision on the complaint if an
25owner of the new wholesale drug distributor, virtual wholesale 
		SB3896 Enrolled	- 21 -	LRB104 20398 AAS 33859 b
1distributor, or third-party logistics provider [distributorship]
2was also an owner of a wholesale drug distributor, virtual 
3wholesale distributor, or third-party logistics provider
4[distributorship] against which the complaint was filed. Neither
5an application for change of ownership nor for a change of
6location for any such entity [wholesale drug distributorship]
7shall be acted on by the Department until such time as the
8Department issues a decision on the complaint. In the event
9that the wholesale drug distributor, virtual wholesale 
10distributor, or third-party logistics provider [distributorship]
11against which the complaint has been filed ceases to be
12licensed by the Department, for any reason, before the
13Department's decision on the complaint and an owner or that
14wholesale drug distributor, virtual wholesale distributor, or 
15third-party logistics provider [distributorship] applies for a
16license to establish a new wholesale drug distributor, virtual 
17wholesale distributor, or third-party logistics provider
18[distributorship], the Department shall conduct a hearing on the
19complaint earlier filed, regardless of whether that wholesale
20drug distributor, virtual wholesale distributor, or 
21third-party logistics provider [distributorship] is presently
22licensed by the Department. If the conduct for which the
23complaint was originally filed would have been sufficient to
24result in a revocation of a license to operate a licensed
25wholesale drug distributor, virtual wholesale distributor, or 
26third-party logistics provider [distributorship], then the
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1conduct shall constitute sufficient grounds for denial of an
2application for a license.
3(Source: P.A. 87-594.)
4    (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
8Secretary may, in the name of the People of the State of
9Illinois through the Attorney General of the State of Illinois
10or the State's Attorney of any county in which the action is
11brought, petition for an order enjoining the violation or for
12an order enforcing compliance with this Act. Upon the filing
13of a verified petition in the court, the court may issue a
14temporary restraining order, without notice or bond, and may
15preliminarily and permanently enjoin the violation. If it is
16established that the person has violated or is violating the
17injunction, the Court may punish the offender for contempt of
18court. Proceedings under this Section shall be in addition to,
19and not in lieu of, all other remedies and penalties provided
20by this Act.
21    (b) Whoever knowingly conducts business as a wholesale
22drug distributor, virtual wholesale distributor, or
23third-party logistics provider in this State without being
24appropriately licensed under this Act shall be guilty of a
25Class A misdemeanor for a first violation and for each
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1subsequent conviction shall be guilty of a Class 4 felony.
2    (c) Whenever in the opinion of the Department any person
3not licensed in good standing under this Act violates any
4provision of this Act, the Department may issue a rule to show
5cause why an order to cease and desist should not be entered
6against him. The rule shall clearly set forth the grounds
7relied upon by the Department and shall provide a period of 7
8days from the date of the rule to file an answer to the
9satisfaction of the Department. Failure to answer to the
10satisfaction of the Department shall cause an order to cease
11and desist to be issued immediately.
12(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)
13    (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
16Secretary may temporarily suspend licensure as a wholesale
17drug distributor, virtual wholesale distributor, or
18third-party logistics provider, without a hearing,
19simultaneously with the institution of proceedings for a
20hearing provided for in Section 85 of this Act, if the
21Secretary finds that evidence in his or her possession
22indicates that a continuation in business would constitute an
23imminent danger to the public. In the event that the Secretary
24temporarily suspends a license or certificate without a
25hearing, a hearing by the Department must be held within 10
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1days after the suspension has occurred and be concluded
2without appreciable delay.
3(Source: P.A. 101-420, eff. 8-16-19; 102-879, eff. 1-1-23.)
4    (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
7licensing of wholesale drug distributors, virtual wholesale 
8distributors, and third-party logistics providers are
9exclusive powers and functions of the State. A home rule unit
10may not regulate or license wholesale drug distributors, 
11virtual wholesale distributors, and third-party logistics 
12providers. This Section is a denial and limitation of home
13rule powers and functions under subsection (h) of Section 6 of
14Article VII of the Illinois Constitution.
15(Source: P.A. 87-594.)
16    (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"
20means a drug, as defined in Section 356c of the Federal Food,
21Drug, and Cosmetic Act, listed on the drug shortage list
22maintained by the U.S. Food and Drug Administration in
23accordance with Section 356e of the Federal Food, Drug, and
24Cosmetic Act.
		SB3896 Enrolled	- 25 -	LRB104 20398 AAS 33859 b
1    (b) Any person engaged in the wholesale distribution of a
2drug in shortage in this State must be licensed by the
3Department.
4    (c) It is unlawful for any person, other than a
5manufacturer, a manufacturer's exclusive distributor, a 
6virtual wholesale distributor, a third-party logistics
7provider, or an authorized distributor of record, to purchase
8or receive a drug in shortage from any person not licensed by
9the Department. This subsection (c) does not apply to the
10return of drugs or the purchase or receipt of drugs pursuant to
11any of the distributions that are specifically excluded from
12the definition of "wholesale distribution" in Section 15 of
13the Wholesale Drug Distribution Licensing Act.
14    (d) A person found to have violated a provision of this
15Section shall be subject to administrative fines, orders for
16restitution, and orders for disgorgement.
17    (e) The Department shall create a centralized, searchable
18database of those entities licensed to engage in wholesale
19distribution, including manufacturers, wholesale
20distributors, virtual wholesale distributors, and pharmacy
21distributors, to enable purchasers of a drug in shortage to
22easily verify the licensing status of an entity offering such
23drugs.
24    (f) The Department shall establish a system for reporting
25the reasonable suspicion that a violation of this Act has been
26committed by a distributor of a drug in shortage. Reports made
		SB3896 Enrolled	- 26 -	LRB104 20398 AAS 33859 b
1through this system shall be referred to the Office of the
2Attorney General and the appropriate State's Attorney's office
3for further investigation and prosecution.
4    (g) The Department shall adopt rules to carry out the
5provisions of this Section.
6    (h) Nothing in this Section prohibits one hospital
7pharmacy from purchasing or receiving a drug in shortage from
8another hospital pharmacy in the event of a medical emergency.
9(Source: P.A. 102-879, eff. 1-1-23.)
10    Section 99. Effective date. This Act takes effect upon
11becoming law.