State of Illinois
2021 and 2022


Introduced 1/21/2022, by Rep. Theresa Mah


See Index

    Amends the Regulatory Sunset Act. Provides that the Wholesale Drug Distribution Licensing Act is repealed on January 1, 2028 (instead of January 1, 2023). Amends the Wholesale Drug Distribution Licensing Act. Defines "address of record", "email address of record", and "suspicious order". Changes the definition of "wholesale drug distributor". Provides that applicants and licensees must provide a valid address and email address to the Department of Financial and Professional Regulation and must inform the Department of any change of these within 14 days. Provides that each licensee required to report suspicious orders shall submit such report to the Department. Provides that an individual taxpayer identification number can be included on the application for an original license, the application can be made in writing or electronically, and the application shall be accompanied by the required, nonrefundable fee. Provides that any licensee who engages in the licensed practice while the license is expired shall be considered to be practicing without a license which is grounds for discipline. Removes provisions that provide that: the Department shall present to the State Board of Pharmacy of the Department for review all appropriation requests from the Illinois State Pharmacy Disciplinary Fund; the Department shall maintain a roster of the names and addresses of all registrants and all persons whose licenses have been suspended or revoked; and rules that set detailed standards for meeting each license prerequisite requirements shall be adopted no later than September 14, 1992. Provides that the written notice of disciplinary hearing may be served by email or physical mail to the respondent's email of record or address of record. Provides that the Department may subpoena and compel the relevant documents in connection with any hearing. Provides that if the Secretary of Financial and Professional Regulation disagrees with the recommendation of the Board or hearing officer, the Secretary may issue an order in contravention of the recommendation. Provides that the sanctions imposed upon the accused by the Department shall remain in full force and effect in order to protect the public pending final resolution of the proceedings. Repeals a provision concerning references to the Department or Director of Professional Regulation. Makes corresponding and other changes. Section 5 and Section 99 take effect upon becoming law.

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HB4664LRB102 24218 AMQ 33447 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 Regulatory Sunset Act is amended by
5changing Sections 4.33 and 4.38 as follows:
6    (5 ILCS 80/4.33)
7    Sec. 4.33. Acts repealed on January 1, 2023. The following
8Acts are repealed on January 1, 2023:
9    The Dietitian Nutritionist Practice Act.
10    The Elevator Safety and Regulation Act.
11    The Fire Equipment Distributor and Employee Regulation Act
12of 2011.
13    The Funeral Directors and Embalmers Licensing Code.
14    The Naprapathic Practice Act.
15    The Pharmacy Practice Act.
16    The Professional Counselor and Clinical Professional
17Counselor Licensing and Practice Act.
18    The Wholesale Drug Distribution Licensing Act.
19(Source: P.A. 101-621, eff. 12-20-19.)
20    (5 ILCS 80/4.38)
21    Sec. 4.38. Acts repealed on January 1, 2028. The following
22Acts are repealed on January 1, 2028:



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1    The Acupuncture Practice Act.
2    The Clinical Social Work and Social Work Practice Act.
3    The Home Medical Equipment and Services Provider License
5    The Illinois Petroleum Education and Marketing Act.
6    The Illinois Speech-Language Pathology and Audiology
7Practice Act.
8    The Interpreter for the Deaf Licensure Act of 2007.
9    The Nurse Practice Act.
10    The Nursing Home Administrators Licensing and Disciplinary
12    The Physician Assistant Practice Act of 1987.
13    The Podiatric Medical Practice Act of 1987.
14    The Wholesale Drug Distribution Licensing Act.
15(Source: P.A. 100-220, eff. 8-18-17; 100-375, eff. 8-25-17;
16100-398, eff. 8-25-17; 100-414, eff. 8-25-17; 100-453, eff.
178-25-17; 100-513, eff. 9-20-17; 100-525, eff. 9-22-17;
18100-530, eff. 9-22-17; 100-560, eff. 12-8-17.)
19    Section 10. The Wholesale Drug Distribution Licensing Act
20is amended by changing Sections 15, 27, 30, 35, 40, 50, 57, 70,
2175, 80, 85, 100, 105, 110, 115, 120, 125, 135, 140, 155, 165,
22and 200 and by adding Sections 15.5, 21, and 31 as follows:
23    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
24    (Section scheduled to be repealed on January 1, 2023)



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1    Sec. 15. Definitions. As used in this Act:
2    "Address of record" means the designated address recorded
3by the Department in the applicant's application file or
4licensee's license file maintained by the Department's
5licensure maintenance unit.
6    "Authentication" means the affirmative verification,
7before any wholesale distribution of a prescription drug
8occurs, that each transaction listed on the pedigree has
10    "Authorized distributor of record" means a wholesale
11distributor with whom a manufacturer has established an
12ongoing relationship to distribute the manufacturer's
13prescription drug. An ongoing relationship is deemed to exist
14between a wholesale distributor and a manufacturer when the
15wholesale distributor, including any affiliated group of the
16wholesale distributor, as defined in Section 1504 of the
17Internal Revenue Code, complies with the following:
18        (1) The wholesale distributor has a written agreement
19    currently in effect with the manufacturer evidencing the
20    ongoing relationship; and
21        (2) The wholesale distributor is listed on the
22    manufacturer's current list of authorized distributors of
23    record, which is updated by the manufacturer on no less
24    than a monthly basis.
25    "Blood" means whole blood collected from a single donor
26and processed either for transfusion or further manufacturing.



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1    "Blood component" means that part of blood separated by
2physical or mechanical means.
3    "Board" means the State Board of Pharmacy of the
4Department of Professional Regulation.
5    "Chain pharmacy warehouse" means a physical location for
6prescription drugs that acts as a central warehouse and
7performs intracompany sales or transfers of the drugs to a
8group of chain or mail order pharmacies that have the same
9common ownership and control. Notwithstanding any other
10provision of this Act, a chain pharmacy warehouse shall be
11considered part of the normal distribution channel.
12    "Co-licensed partner or product" means an instance where
13one or more parties have the right to engage in the
14manufacturing or marketing of a prescription drug, consistent
15with the FDA's implementation of the Prescription Drug
16Marketing Act.
17    "Department" means the Department of Financial and
18Professional Regulation.
19    "Drop shipment" means the sale of a prescription drug to a
20wholesale distributor by the manufacturer of the prescription
21drug or that manufacturer's co-licensed product partner, that
22manufacturer's third-party third party logistics provider, or
23that manufacturer's exclusive distributor or by an authorized
24distributor of record that purchased the product directly from
25the manufacturer or one of these entities whereby the
26wholesale distributor or chain pharmacy warehouse takes title



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1but not physical possession of such prescription drug and the
2wholesale distributor invoices the pharmacy, chain pharmacy
3warehouse, or other person authorized by law to dispense or
4administer such drug to a patient and the pharmacy, chain
5pharmacy warehouse, or other authorized person receives
6delivery of the prescription drug directly from the
7manufacturer, that manufacturer's third-party third party
8logistics provider, or that manufacturer's exclusive
9distributor or from an authorized distributor of record that
10purchased the product directly from the manufacturer or one of
11these entities.
12    "Drug sample" means a unit of a prescription drug that is
13not intended to be sold and is intended to promote the sale of
14the drug.
15    "Email address of record" means the designated email
16address recorded by the Department in the applicant's
17application file or the licensee's license file, as maintained
18by the Department's licensure maintenance unit.
19    "Facility" means a facility of a wholesale distributor
20where prescription drugs are stored, handled, repackaged, or
21offered for sale, or a facility of a third-party logistics
22provider where prescription drugs are stored or handled.
23    "FDA" means the United States Food and Drug
25    "Manufacturer" means a person licensed or approved by the
26FDA to engage in the manufacture of drugs or devices,



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1consistent with the definition of "manufacturer" set forth in
2the FDA's regulations and guidances implementing the
3Prescription Drug Marketing Act. "Manufacturer" does not
4include anyone who is engaged in the packaging, repackaging,
5or labeling of drugs only to the extent permitted under the
6Illinois Drug Reuse Opportunity Program Act.
7    "Manufacturer's exclusive distributor" means anyone who
8contracts with a manufacturer to provide or coordinate
9warehousing, distribution, or other services on behalf of a
10manufacturer and who takes title to that manufacturer's
11prescription drug, but who does not have general
12responsibility to direct the sale or disposition of the
13manufacturer's prescription drug. A manufacturer's exclusive
14distributor must be licensed as a wholesale distributor under
15this Act and, in order to be considered part of the normal
16distribution channel, must also be an authorized distributor
17of record.
18    "Normal distribution channel" means a chain of custody for
19a prescription drug that goes, directly or by drop shipment,
20from (i) a manufacturer of the prescription drug, (ii) that
21manufacturer to that manufacturer's co-licensed partner, (iii)
22that manufacturer to that manufacturer's third-party third
23party logistics provider, or (iv) that manufacturer to that
24manufacturer's exclusive distributor to:
25        (1) a pharmacy or to other designated persons
26    authorized by law to dispense or administer the drug to a



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1    patient;
2        (2) a wholesale distributor to a pharmacy or other
3    designated persons authorized by law to dispense or
4    administer the drug to a patient;
5        (3) a wholesale distributor to a chain pharmacy
6    warehouse to that chain pharmacy warehouse's intracompany
7    pharmacy to a patient or other designated persons
8    authorized by law to dispense or administer the drug to a
9    patient;
10        (4) a chain pharmacy warehouse to the chain pharmacy
11    warehouse's intracompany pharmacy or other designated
12    persons authorized by law to dispense or administer the
13    drug to the patient;
14        (5) an authorized distributor of record to one other
15    authorized distributor of record to an office-based health
16    care practitioner authorized by law to dispense or
17    administer the drug to the patient; or
18        (6) an authorized distributor to a pharmacy or other
19    persons licensed to dispense or administer the drug.
20    "Pedigree" means a document or electronic file containing
21information that records each wholesale distribution of any
22given prescription drug from the point of origin to the final
23wholesale distribution point of any given prescription drug.
24    "Person" means and includes a natural person, partnership,
25association, corporation, or any other legal business entity.
26    "Pharmacy distributor" means any pharmacy licensed in this



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1State or hospital pharmacy that is engaged in the delivery or
2distribution of prescription drugs either to any other
3pharmacy licensed in this State or to any other person or
4entity including, but not limited to, a wholesale drug
5distributor engaged in the delivery or distribution of
6prescription drugs who is involved in the actual,
7constructive, or attempted transfer of a drug in this State to
8other than the ultimate consumer except as otherwise provided
9for by law.
10    "Prescription drug" means any human drug, including any
11biological product (except for blood and blood components
12intended for transfusion or biological products that are also
13medical devices), required by federal law or regulation to be
14dispensed only by a prescription, including finished dosage
15forms and bulk drug substances subject to Section 503 of the
16Federal Food, Drug and Cosmetic Act.
17    "Repackage" means repackaging or otherwise changing the
18container, wrapper, or labeling to further the distribution of
19a prescription drug, excluding that completed by the
20pharmacist responsible for dispensing the product to a
22    "Secretary" means the Secretary of the Department of
23Financial and Professional Regulation.
24    "Suspicious order" includes, but is not limited to, an
25order of a controlled substance of unusual size, an order of a
26controlled substance deviating substantially from a normal



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1pattern, and orders of controlled substances of unusual
2frequency as defined by 21 USC 802.
3    "Third-party logistics provider" means anyone who
4contracts with a prescription drug manufacturer to provide or
5coordinate warehousing, distribution, or other services on
6behalf of a manufacturer, but does not take title to the
7prescription drug or have general responsibility to direct the
8prescription drug's sale or disposition.
9    "Wholesale distribution" means the distribution of
10prescription drugs to persons other than a consumer or
11patient, but does not include any of the following:
12        (1) Intracompany sales of prescription drugs, meaning
13    (i) any transaction or transfer between any division,
14    subsidiary, parent, or affiliated or related company under
15    the common ownership and control of a corporate entity or
16    (ii) any transaction or transfer between co-licensees of a
17    co-licensed product.
18        (2) The sale, purchase, distribution, trade, or
19    transfer of a prescription drug or offer to sell,
20    purchase, distribute, trade, or transfer a prescription
21    drug for emergency medical reasons.
22        (3) The distribution of prescription drug samples by
23    manufacturers' representatives.
24        (4) Drug returns, when conducted by a hospital, health
25    care entity, or charitable institution in accordance with
26    federal regulation.



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1        (5) The sale of minimal quantities of prescription
2    drugs by licensed pharmacies to licensed practitioners for
3    office use or other licensed pharmacies.
4        (6) The sale, purchase, or trade of a drug, an offer to
5    sell, purchase, or trade a drug, or the dispensing of a
6    drug pursuant to a prescription.
7        (7) The sale, transfer, merger, or consolidation of
8    all or part of the business of a pharmacy or pharmacies
9    from or with another pharmacy or pharmacies, whether
10    accomplished as a purchase and sale of stock or business
11    assets.
12        (8) The sale, purchase, distribution, trade, or
13    transfer of a prescription drug from one authorized
14    distributor of record to one additional authorized
15    distributor of record when the manufacturer has stated in
16    writing to the receiving authorized distributor of record
17    that the manufacturer is unable to supply the prescription
18    drug and the supplying authorized distributor of record
19    states in writing that the prescription drug being
20    supplied had until that time been exclusively in the
21    normal distribution channel.
22        (9) The delivery of or the offer to deliver a
23    prescription drug by a common carrier solely in the common
24    carrier's usual course of business of transporting
25    prescription drugs when the common carrier does not store,
26    warehouse, or take legal ownership of the prescription



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1    drug.
2        (10) The sale or transfer from a retail pharmacy, mail
3    order pharmacy, or chain pharmacy warehouse of expired,
4    damaged, returned, or recalled prescription drugs to the
5    original manufacturer, the originating wholesale
6    distributor, or a third party returns processor.
7        (11) The donation of drugs to the extent permitted
8    under the Illinois Drug Reuse Opportunity Program Act.
9    "Wholesale drug distributor" means anyone engaged in the
10wholesale distribution of prescription drugs into, out of, or
11within the State, including without limitation manufacturers;
12repackers; own label distributors; jobbers; private label
13distributors; brokers; virtual wholesalers or virtual
14distributors; warehouses, including manufacturers' and
15distributors' warehouses; manufacturer's exclusive
16distributors; and authorized distributors of record; drug
17wholesalers or distributors; independent wholesale drug
18traders; specialty wholesale distributors; and retail
19pharmacies that conduct wholesale distribution; and chain
20pharmacy warehouses that conduct wholesale distribution. In
21order to be considered part of the normal distribution
22channel, a wholesale distributor must also be an authorized
23distributor of record.
24(Source: P.A. 101-420, eff. 8-16-19; 102-389, eff. 1-1-22.)
25    (225 ILCS 120/15.5 new)



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1    Sec. 15.5. Address of record; email address of record. All
2applicants and licensees shall:
3        (1) provide a valid address and email address to the
4    Department, which shall serve as the address of record and
5    email address of record, respectively, at the time of
6    application for licensure or renewal of a license; and
7        (2) inform the Department of any change of address of
8    record or email address of record within 14 days after
9    such change either through the Department's website or by
10    contacting the Department's licensure maintenance unit.
11    (225 ILCS 120/21 new)
12    Sec. 21. Reports to Department. Each licensee that is
13required to report suspicious orders under 21 USC 832 shall
14also submit such suspicions order reports to the Department.
15    (225 ILCS 120/27)
16    (Section scheduled to be repealed on January 1, 2023)
17    Sec. 27. Social security number, individual taxpayer
18identification number, or unique identifying number Security
19Number on license application. In addition to any other
20information required to be contained in the application, every
21application for an original license under this Act shall
22include the applicant's social security number, individual
23taxpayer identification number, or other unique identifying
24number deemed appropriate by the Department, Social Security



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1Number, which shall be retained in the agency's records
2pertaining to the license. As soon as practical, the
3Department shall assign a customer's identification number to
4each applicant for a license.
5    Every application for a renewal or restored license shall
6require the applicant's customer identification number.
7(Source: P.A. 97-400, eff. 1-1-12.)
8    (225 ILCS 120/30)  (from Ch. 111, par. 8301-30)
9    (Section scheduled to be repealed on January 1, 2023)
10    Sec. 30. License applications; renewal renewal application
11procedures. An application for an original license or renewal
12shall be made to the Department in writing or electronically
13on forms prescribed by the Department and shall be accompanied
14by the required fee, which shall not be refundable. Any such
15application shall require such information as in the judgment
16of the Department will enable the Board and Department to pass
17on the qualifications of the applicant for a license.
18Application for renewal of any license required by this Act
19shall be mailed or emailed to each licensee at least 60 days
20before the license expires. If the application for renewal
21with the required fee is not received by the Department before
22the expiration date, the existing license shall lapse and
23become null and void. Failure to renew before the expiration
24date is cause for a late payment penalty, discipline, or both.
25(Source: P.A. 101-420, eff. 8-16-19.)



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1    (225 ILCS 120/31 new)
2    Sec. 31. Expiration of license; renewal.
3    (a) The expiration date and renewal period for each
4license issued under this Act shall be set by rule.
5    (b) Any licensee who shall engage in the practice for
6which the license was issued while the license is expired or on
7inactive status shall be considered to be practicing without a
8license which shall be grounds for discipline under this Act.
9    (c) A wholesale drug distributor or third-party logistics
10provider whose license has been expired for one year or more
11may not have its license restored but must apply for a new
12license and meet all requirements for licensure. Any wholesale
13drug distributor or third-party logistics provider whose
14license has been expired for less than one year may apply for
15restoration of its license and shall have its license
17    (d) Anyone operating on an expired license is engaged in
18unlawful practice and subject to discipline under this Act.
19    (225 ILCS 120/35)  (from Ch. 111, par. 8301-35)
20    (Section scheduled to be repealed on January 1, 2023)
21    Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
22    (a) The Department shall provide by rule for a schedule of
23fees for the administration and enforcement of this Act,
24including but not limited to original licensure, renewal, and



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1restoration. The fees shall be nonrefundable.
2    (b) All fees collected under this Act shall be deposited
3into the Illinois State Pharmacy Disciplinary Fund and shall
4be appropriated to the Department for the ordinary and
5contingent expenses of the Department in the administration of
6this Act. Moneys in the Fund may be transferred to the
7Professions Indirect Cost Fund as authorized by Section
82105-300 of the Department of Financial and Professional
9Regulation Law (20 ILCS 2105/2105-300).
10    The moneys deposited into the Illinois State Pharmacy
11Disciplinary Fund shall be invested to earn interest which
12shall accrue to the Fund.
13    The Department shall present to the Board for its review
14and comment all appropriation requests from the Illinois State
15Pharmacy Disciplinary Fund. The Department shall give due
16consideration to any comments of the Board in making
17appropriation requests.
18    (c) Any person who delivers a check or other payment to the
19Department that is returned to the Department unpaid by the
20financial institution upon which it is drawn shall pay to the
21Department, in addition to the amount already owed to the
22Department, a fine of $50. The fines imposed by this Section
23are in addition to any other discipline provided under this
24Act for unlicensed practice or practice on a nonrenewed
25license. The Department shall notify the person that payment
26of fees and fines shall be paid to the Department by certified



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1check or money order within 30 calendar days of the
2notification. If, after the expiration of 30 days from the
3date of the notification, the person has failed to submit the
4necessary remittance, the Department shall automatically
5terminate the license or certificate or deny the application,
6without hearing. If, after termination or denial, the person
7seeks a license or certificate, he or she shall apply to the
8Department for restoration or issuance of the license or
9certificate and pay all fees and fines due to the Department.
10The Department may establish a fee for the processing of an
11application for restoration of a license or certificate to pay
12all expenses of processing this application. The Secretary
13Director may waive the fines due under this Section in
14individual cases where the Secretary Director finds that the
15fines would be unreasonable or unnecessarily burdensome.
16    (d) (Blank). The Department shall maintain a roster of the
17names and addresses of all registrants and of all persons
18whose licenses have been suspended or revoked. This roster
19shall be available upon written request and payment of the
20required fee.
21    (e) A manufacturer of controlled substances, wholesale
22distributor of controlled substances, or third-party logistics
23provider that is licensed under this Act and owned and
24operated by the State is exempt from licensure, registration,
25renewal, and other fees required under this Act. Nothing in
26this subsection (e) shall be construed to prohibit the



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1Department from imposing any fine or other penalty allowed
2under this Act.
3(Source: P.A. 101-420, eff. 8-16-19.)
4    (225 ILCS 120/40)  (from Ch. 111, par. 8301-40)
5    (Section scheduled to be repealed on January 1, 2023)
6    Sec. 40. Rules and regulations. The Department shall make
7any rules and regulations, not inconsistent with law, as may
8be necessary to carry out the purposes and enforce the
9provisions of this Act. Rules and regulations that incorporate
10and set detailed standards for meeting each of the license
11prerequisites set forth in Section 25 of this Act shall be
12adopted no later than September 14, 1992. All rules and
13regulations promulgated under this Section shall conform to
14wholesale drug distributor licensing guidelines formally
15adopted by the FDA at 21 C.F.R. Part 205. In case of conflict
16between any rule or regulation adopted by the Department and
17any FDA wholesale drug distributor or third-party logistics
18provider guideline, the FDA guideline shall control.
19(Source: P.A. 101-420, eff. 8-16-19.)
20    (225 ILCS 120/50)  (from Ch. 111, par. 8301-50)
21    (Section scheduled to be repealed on January 1, 2023)
22    Sec. 50. Inspection powers; access to records.
23    (a) Any pharmacy investigator authorized by the Department
24has the right of entry for inspection during normal business



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1hours of premises purporting or appearing to be used by a
2wholesale drug distributor in this State, including the
3business premises of a person licensed pursuant to this Act.
4This right of entry shall permit the authorized pharmacy
5investigator unfettered access to the entire business
6premises. Any attempt to hinder an authorized pharmacy
7investigator from inspecting the business premises and
8documenting the inspection shall be a violation of this Act.
9The duly authorized investigators shall be required to show
10appropriate identification before being given access to a
11wholesale drug distributor's premises and delivery vehicles.
12    (b) With the exception of the most recent 12 months of
13records that must be kept on the premises where the drugs are
14stored, wholesale drug distributors may keep records regarding
15purchase and sales transactions electronically at a central
16location apart from the principal office of the wholesale drug
17distributor or the location at which the drugs were stored and
18from which they were shipped, provided that the records shall
19be made readily available for inspection within 2 working days
20of a request by the Department. The records may be kept in any
21form permissible under federal law applicable to prescription
22drugs record keeping.
23    (c) (Blank).
24(Source: P.A. 97-804, eff. 1-1-13.)
25    (225 ILCS 120/57)



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1    (Section scheduled to be repealed on January 1, 2023)
2    Sec. 57. Pedigree.
3    (a) Each person who is engaged in the wholesale
4distribution of prescription drugs, including repackagers, but
5excluding the original manufacturer of the finished form of
6the prescription drug, that leave or have ever left the normal
7distribution channel shall, before each wholesale distribution
8of the drug, provide a pedigree to the person who receives the
9drug. A retail pharmacy, mail order pharmacy, or chain
10pharmacy warehouse must comply with the requirements of this
11Section only if the pharmacy or chain pharmacy warehouse
12engages in the wholesale distribution of prescription drugs.
13On or before July 1, 2009, the Department shall determine a
14targeted implementation date for electronic track and trace
15pedigree technology. This targeted implementation date shall
16not be sooner than July 1, 2010. Beginning on the date
17established by the Department, pedigrees may be implemented
18through an approved and readily available system that
19electronically tracks and traces the wholesale distribution of
20each prescription drug starting with the sale by the
21manufacturer through acquisition and sale by any wholesale
22distributor and until final sale to a pharmacy or other
23authorized person administering or dispensing the prescription
24drug. This electronic tracking system shall be deemed to be
25readily available only upon there being available a
26standardized system originating with the manufacturers and



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1capable of being used on a wide scale across the entire
2pharmaceutical chain, including manufacturers, wholesale
3distributors, third-party logistics providers, and pharmacies.
4Consideration must also be given to the large-scale
5implementation of this technology across the supply chain and
6the technology must be proven to have no negative impact on the
7safety and efficacy of the pharmaceutical product.
8    (b) Each person who is engaged in the wholesale
9distribution of a prescription drug who is provided a pedigree
10for a prescription drug and attempts to further distribute
11that prescription drug, including repackagers, but excluding
12the original manufacturer of the finished form of the
13prescription drug, must affirmatively verify before any
14distribution of a prescription drug occurs that each
15transaction listed on the pedigree has occurred.
16    (c) The pedigree must include all necessary identifying
17information concerning each sale in the chain of distribution
18of the product from the manufacturer or the manufacturer's
19third-party third party logistics provider, co-licensed
20product partner, or exclusive distributor through acquisition
21and sale by any wholesale distributor or repackager, until
22final sale to a pharmacy or other person dispensing or
23administering the drug. This necessary chain of distribution
24information shall include, without limitation all of the
26        (1) The name, address, telephone number and, if



HB4664- 21 -LRB102 24218 AMQ 33447 b

1    available, the e-mail address of each owner of the
2    prescription drug and each wholesale distributor of the
3    prescription drug.
4        (2) The name and address of each location from which
5    the product was shipped, if different from the owner's.
6        (3) Transaction dates.
7        (4) Certification that each recipient has
8    authenticated the pedigree.
9    (d) The pedigree must also include without limitation all
10of the following information concerning the prescription drug:
11        (1) The name and national drug code number of the
12    prescription drug.
13        (2) The dosage form and strength of the prescription
14    drug.
15        (3) The size of the container.
16        (4) The number of containers.
17        (5) The lot number of the prescription drug.
18        (6) The name of the manufacturer of the finished
19    dosage form.
20    (e) Each pedigree or electronic file shall be maintained
21by the purchaser and the wholesale distributor for at least 3
22years from the date of sale or transfer and made available for
23inspection or use within 5 business days upon a request of the
25(Source: P.A. 101-420, eff. 8-16-19.)



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1    (225 ILCS 120/70)  (from Ch. 111, par. 8301-70)
2    (Section scheduled to be repealed on January 1, 2023)
3    Sec. 70. Immediate suspension of license or registration;
4hearing. The Secretary Director may, upon receipt of a
5written communication from the Secretary of Human Services or
6the Director of Public Health that continuation of practice of
7a person licensed or registered under this Act constitutes an
8immediate danger to the public, immediately suspend the
9license or registration of that person without a hearing. In
10instances in which the Secretary Director immediately suspends
11a license or registration under this Section, a hearing upon
12the person's license must be convened by the Board within 15
13days after the suspension and completed without appreciable
14delay. The hearing shall be held to determine whether to
15recommend to the Secretary Director that the person's license
16be revoked, suspended, placed on probationary status, or
17reinstated, or that the person be subject to other
18disciplinary action. In the hearing, the written communication
19and any other evidence submitted with the communication may be
20introduced as evidence against the person. The person or his
21or her counsel shall have the opportunity to discredit or
22impeach such evidence and submit rebuttal evidence.
23(Source: P.A. 89-507, eff. 7-1-97.)
24    (225 ILCS 120/75)  (from Ch. 111, par. 8301-75)
25    (Section scheduled to be repealed on January 1, 2023)



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1    Sec. 75. Automatic suspension. The determination by a
2circuit court that a licensee is subject to involuntary
3admission or judicial admission as provided in the Mental
4Health and Developmental Disabilities Code operates as an
5automatic suspension. The suspension shall end only upon (i) a
6finding by a court that the patient is no longer subject to
7involuntary admission or judicial admission and the issuance
8of an order so finding and discharging the patient and (ii) the
9recommendation of the Board to the Secretary Director that the
10licensee be allowed to resume his or her practice.
11(Source: P.A. 91-357, eff. 7-29-99.)
12    (225 ILCS 120/80)  (from Ch. 111, par. 8301-80)
13    (Section scheduled to be repealed on January 1, 2023)
14    Sec. 80. Violations of Act.
15    (a) If any person violates the provisions of this Act, the
16Secretary Director may, in the name of the People of the State
17of Illinois through the Attorney General of the State of
18Illinois or the State's Attorney of any county in which the
19action is brought, petition for an order enjoining the
20violation or for an order enforcing compliance with this Act.
21Upon the filing of a verified petition in the court, the court
22may issue a temporary restraining order, without notice or
23bond, and may preliminarily and permanently enjoin the
24violation. If it is established that the person has violated
25or is violating the injunction, the Court may punish the



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1offender for contempt of court. Proceedings under this Section
2shall be in addition to, and not in lieu of, all other remedies
3and penalties provided by this Act.
4    (b) Whoever knowingly conducts business as a wholesale
5drug distributor or third-party logistics provider in this
6State without being appropriately licensed under this Act
7shall be guilty of a Class A misdemeanor for a first violation
8and for each subsequent conviction shall be guilty of a Class 4
10    (c) Whenever in the opinion of the Department any person
11not licensed in good standing under this Act violates any
12provision of this Act, the Department may issue a rule to show
13cause why an order to cease and desist should not be entered
14against him. The rule shall clearly set forth the grounds
15relied upon by the Department and shall provide a period of 7
16days from the date of the rule to file an answer to the
17satisfaction of the Department. Failure to answer to the
18satisfaction of the Department shall cause an order to cease
19and desist to be issued immediately.
20(Source: P.A. 101-420, eff. 8-16-19.)
21    (225 ILCS 120/85)  (from Ch. 111, par. 8301-85)
22    (Section scheduled to be repealed on January 1, 2023)
23    Sec. 85. Investigations; notice of disciplinary hearing.
24The Department may investigate the actions of any applicant or
25of any person or persons holding or claiming to hold a license



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1or registration. Before suspending, revoking, placing on
2probationary status, or taking any other disciplinary action
3as the Department may deem proper with regard to any license or
4certificate, at least 30 days before the date set for the
5hearing, the Department shall (i) notify the accused in
6writing of any charges made and the time and place for a
7hearing of the charges before the Board, (ii) direct him or her
8to file a written answer to the charges with the Board under
9oath within 20 days after the service of the notice, and (iii)
10inform the accused that if he or she fails to file an answer
11default will be taken against him or her and his or her license
12or certificate may be suspended, revoked, placed on
13probationary status, or have other disciplinary action,
14including limiting the scope, nature or extent of business, as
15provided for in this Act. The written notice may be served by
16personal delivery, email to the respondent's email address of
17record, or mail to the respondent's address of record or
18certified or registered mail to the respondent at the address
19of last notification to the Department. At the time and place
20fixed in the notice, the Board shall proceed to hear the
21charges and the parties or their counsel shall be accorded
22ample opportunity to present any statements, testimony,
23evidence and argument that may be pertinent to the charges or
24to their defense. The hearing may be continued from time to
25time. In case the accused person, after receiving notice,
26fails to file an answer, his or her license or certificate may



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1in the discretion of the Secretary Director, having received
2first the recommendation of the Board, be suspended, revoked,
3placed on probationary status, or the Secretary Director may
4take whatever disciplinary action as he or she may deem proper
5as provided in this Act, including limiting the scope, nature,
6or extent of the person's practice, without a hearing, if the
7act or acts charged constitute sufficient grounds for such
8action under this Act.
9(Source: P.A. 87-594.)
10    (225 ILCS 120/100)  (from Ch. 111, par. 8301-100)
11    (Section scheduled to be repealed on January 1, 2023)
12    Sec. 100. Subpoena power; administration of oaths. The
13Department shall have power to subpoena and bring before it
14any person in this State and to take testimony, either orally
15or by deposition or both, with the same fees and mileage and in
16the same manner as prescribed by law in judicial proceedings
17in civil cases in circuit courts of this State. The Department
18may subpoena and compel the production of documents, papers,
19files, books, and records in connection with any hearing or
21    The Secretary, hearing officer, and Director and any
22member of the Board shall each have power to administer oaths
23to witnesses at any hearing which the Department is authorized
24to conduct under this Act, and any other oaths required or
25authorized to be administered by the Department under this



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2(Source: P.A. 87-594.)
3    (225 ILCS 120/105)  (from Ch. 111, par. 8301-105)
4    (Section scheduled to be repealed on January 1, 2023)
5    Sec. 105. Report of findings and recommendation. At the
6conclusion of the hearing, the Board shall present to the
7Secretary Director a written report of its findings of fact,
8conclusions of law, and recommendations. The report shall
9contain a finding whether or not the accused person violated
10this Act or failed to comply with the conditions required in
11this Act. The Board shall specify the nature of the violation
12or failure to comply and shall make its recommendations to the
13Secretary Director.
14    The report of findings of fact, conclusion of law, and
15recommendations of the Board shall be the basis for the
16Department's order for refusal or for the granting of a
17license or registration. The finding is not admissible in
18evidence against the person in a criminal prosecution brought
19for the violation of this Act, but the hearing and finding are
20not a bar to a criminal prosecution brought for the violation
21of this Act.
22(Source: P.A. 87-594.)
23    (225 ILCS 120/110)  (from Ch. 111, par. 8301-110)
24    (Section scheduled to be repealed on January 1, 2023)



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1    Sec. 110. Hearing officers; appointment. Notwithstanding
2any other provision of this Act, the Secretary Director shall
3have the authority to appoint any attorney duly licensed to
4practice law in the State of Illinois to serve as the hearing
5officer in any action before the Board for refusal to issue or
6renew a license, or the discipline of a licensee. The Director
7shall notify the Board of any such appointment. The hearing
8officer shall have full authority to conduct the hearing.
9There shall be present at least one member of the Board at any
10such hearing. The hearing officer shall report his findings of
11fact, conclusions of law, and recommendations to the Board and
12the Secretary Director. The Board shall have 60 days from
13receipt of the report to review the report of the hearing
14officer and present its findings of fact, conclusions of law,
15and recommendations to the Secretary Director. If the Board
16fails to present its report within the 60 day period, the
17Secretary Director may issue an order based on report of the
18hearing officer and the record of the proceedings or issue an
19order remanding the matter back to the hearing officer for
20additional proceedings in accordance with the order. If the
21Secretary disagrees with the recommendation of the Board or
22the hearing officer, the Secretary may issue an order in
23contravention of the recommendation. However, if the Board
24does present its report within the specified 60 days, the
25Director's order shall be based upon the report of the Board.
26(Source: P.A. 87-594.)



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1    (225 ILCS 120/115)  (from Ch. 111, par. 8301-115)
2    (Section scheduled to be repealed on January 1, 2023)
3    Sec. 115. Motion for rehearing. In any case involving the
4refusal to issue, renew, or discipline of a license or
5registration, a copy of the Board's report shall be served
6upon the respondent by the Department, either personally or as
7provided in this Act for the service of the notice of hearing.
8Within 20 days after service, the respondent may present to
9the Department a motion in writing for a rehearing, which
10shall specify the particular grounds for rehearing. If no
11motion for rehearing is filed, then upon the expiration of the
12time specified for filing a motion, or if a motion for
13rehearing is denied, then upon denial the Secretary Director
14may enter an order in accordance with recommendations of the
15Board. If the respondent orders from the reporting service and
16pays for a transcript of the record within the time for filing
17a motion for rehearing, the 20-day 20 day period within which a
18motion may be filed shall commence upon the delivery of the
19transcript to the respondent.
20(Source: P.A. 87-594.)
21    (225 ILCS 120/120)  (from Ch. 111, par. 8301-120)
22    (Section scheduled to be repealed on January 1, 2023)
23    Sec. 120. Rehearing by order of Secretary Director.
24Whenever the Secretary Director is satisfied that substantial



HB4664- 30 -LRB102 24218 AMQ 33447 b

1justice has not been done in the revocation, suspension, or
2refusal to issue or renew a license or registration, the
3Secretary Director may order a rehearing by the same hearing
4office or Board.
5(Source: P.A. 87-594.)
6    (225 ILCS 120/125)  (from Ch. 111, par. 8301-125)
7    (Section scheduled to be repealed on January 1, 2023)
8    Sec. 125. Duties of the Board Board recommendations to
9Director; disagreement. The Board shall exercise the rights,
10powers, and duties which have been vested in the Board under
11this Act, and any other duties conferred upon the Board by law.
12None of the disciplinary functions, powers, and duties
13enumerated in this Act shall be exercised by the Department
14except upon the action and report in writing of the Board,
15except as otherwise provided in this Act.
16    In all instances under this Act in which the Board has
17rendered a recommendation to the Director with respect to a
18particular license or certificate, the Director shall, in the
19event that he or she disagrees with or takes action contrary to
20the recommendation of the Board, file with the Board and
21Secretary of State his or her specific written reasons for
22disagreement with the Board. These reasons shall be filed
23within 30 days after the Director taking the contrary
25    The action and report in writing of a majority of the Board



HB4664- 31 -LRB102 24218 AMQ 33447 b

1is sufficient authority upon which the Director may act.
2(Source: P.A. 87-594.)
3    (225 ILCS 120/135)  (from Ch. 111, par. 8301-135)
4    (Section scheduled to be repealed on January 1, 2023)
5    Sec. 135. Disciplinary consent orders. Notwithstanding the
6provisions of this Act concerning the conduct of hearings and
7recommendations for disciplinary actions, the Secretary
8Director shall have the authority to negotiate agreements with
9licensees and registrants resulting in disciplinary consent
10orders. Consent orders may provide for any of the forms of
11discipline otherwise provided in this Act. Consent orders
12shall provide that they were not entered into a result of any
13coercion by the Department. The Director shall forward copies
14of all final consent orders to the Board within 30 days after
15their entry.
16(Source: P.A. 87-594.)
17    (225 ILCS 120/140)  (from Ch. 111, par. 8301-140)
18    (Section scheduled to be repealed on January 1, 2023)
19    Sec. 140. Orders; prima facie proof. An order or a
20certified copy thereof, over the seal of the Department and
21purporting to be signed by the Secretary Director, shall be
22prima facie proof that:
23        (a) the signature is the genuine signature of the
24    Secretary Director;



HB4664- 32 -LRB102 24218 AMQ 33447 b

1        (b) the Secretary Director is duly appointed and
2    qualified; and
3        (c) the Board and its members are qualified to act.
4(Source: P.A. 91-357, eff. 7-29-99.)
5    (225 ILCS 120/155)  (from Ch. 111, par. 8301-155)
6    (Section scheduled to be repealed on January 1, 2023)
7    Sec. 155. Temporary suspension of license; hearing. The
8Secretary Director may temporarily suspend licensure as a
9wholesale drug distributor or third-party logistics provider,
10without a hearing, simultaneously with the institution of
11proceedings for a hearing provided for in Section 85 of this
12Act, if the Secretary Director finds that evidence in his or
13her possession indicates that a continuation in business would
14constitute an imminent danger to the public. In the event that
15the Secretary Director temporarily suspends a license or
16certificate without a hearing, a hearing by the Department
17must be held within 10 days after the suspension has occurred
18and be concluded without appreciable delay.
19(Source: P.A. 101-420, eff. 8-16-19.)
20    (225 ILCS 120/165)  (from Ch. 111, par. 8301-165)
21    (Section scheduled to be repealed on January 1, 2023)
22    Sec. 165. Certification of record; receipt for costs. The
23Department shall not be required to certify any record to the
24court, to file an answer in court, or to otherwise appear in



HB4664- 33 -LRB102 24218 AMQ 33447 b

1any court in a judicial review proceeding unless and until the
2Department has received from the plaintiff payment of the
3costs of furnishing and certifying the record, which costs
4shall be determined by the Department. Failure on the part of
5the plaintiff to file a receipt in court shall be grounds for
6dismissal of the action. During the pendency and hearing of
7any and all judicial proceedings incident to the disciplinary
8action, the sanctions imposed upon the accused by the
9Department because of acts or omissions related to the
10delivery of direct patient care as specified in the
11Department's final administrative decision, shall, as a matter
12of public policy, remain in full force and effect in order to
13protect the public pending final resolution of any of the
15The Department shall not be required to certify any record to
16the court or file any answer in court or otherwise appear in
17any court in a judicial review proceeding, unless there is
18filed in the court, with the complaint, a receipt from the
19Department acknowledging payment of the costs of furnishing
20and certifying the record, which costs shall be computed at
21the rate of 25 cents per page of such record. Failure on the
22part of the plaintiff to file a receipt in court shall be
23grounds for dismissal of the action.
24(Source: P.A. 87-594.)
25    (225 ILCS 120/200)



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1    (Section scheduled to be repealed on January 1, 2023)
2    Sec. 200. Drugs in shortage.
3    (a) For the purpose of this Section, "drug in shortage"
4means a drug, as defined in Section 356c of the Federal Food,
5Drug, and Cosmetic Act, listed on the drug shortage list
6maintained by the U.S. Food and Drug Administration in
7accordance with Section 356e of the Federal Food, Drug, and
8Cosmetic Act.
9    (b) Any person engaged in the wholesale distribution of a
10drug in shortage in this State must be licensed by the
12    (c) It is unlawful for any person, other than a
13manufacturer, a manufacturer's exclusive distributor, a
14third-party third party logistics provider, or an authorized
15distributor of record, to purchase or receive a drug in
16shortage from any person not licensed by the Department. This
17subsection (c) does not apply to the return of drugs or the
18purchase or receipt of drugs pursuant to any of the
19distributions that are specifically excluded from the
20definition of "wholesale distribution" in Section 15 of the
21Wholesale Drug Distribution Licensing Act.
22    (d) A person found to have violated a provision of this
23Section shall be subject to administrative fines, orders for
24restitution, and orders for disgorgement.
25    (e) The Department shall create a centralized, searchable
26database of those entities licensed to engage in wholesale



HB4664- 35 -LRB102 24218 AMQ 33447 b

1distribution, including manufacturers, wholesale
2distributors, and pharmacy distributors, to enable purchasers
3of a drug in shortage to easily verify the licensing status of
4an entity offering such drugs.
5    (f) The Department shall establish a system for reporting
6the reasonable suspicion that a violation of this Act has been
7committed by a distributor of a drug in shortage. Reports made
8through this system shall be referred to the Office of the
9Attorney General and the appropriate State's Attorney's office
10for further investigation and prosecution.
11    (g) The Department shall adopt rules to carry out the
12provisions of this Section.
13    (h) Nothing in this Section prohibits one hospital
14pharmacy from purchasing or receiving a drug in shortage from
15another hospital pharmacy in the event of a medical emergency.
16(Source: P.A. 98-355, eff. 8-16-13.)
17    (225 ILCS 120/3 rep.)
18    Section 15. The Wholesale Drug Distribution Licensing Act
19is amended by repealing Section 3.
20    Section 99. Effective date. This Section and Section 5
21take effect upon becoming law.



HB4664- 36 -LRB102 24218 AMQ 33447 b

2 Statutes amended in order of appearance
3    5 ILCS 80/4.33
4    5 ILCS 80/4.38
5    225 ILCS 120/15from Ch. 111, par. 8301-15
6    225 ILCS 120/15.5 new
7    225 ILCS 120/21 new
8    225 ILCS 120/27
9    225 ILCS 120/30from Ch. 111, par. 8301-30
10    225 ILCS 120/31 new
11    225 ILCS 120/35from Ch. 111, par. 8301-35
12    225 ILCS 120/40from Ch. 111, par. 8301-40
13    225 ILCS 120/50from Ch. 111, par. 8301-50
14    225 ILCS 120/57
15    225 ILCS 120/70from Ch. 111, par. 8301-70
16    225 ILCS 120/75from Ch. 111, par. 8301-75
17    225 ILCS 120/80from Ch. 111, par. 8301-80
18    225 ILCS 120/85from Ch. 111, par. 8301-85
19    225 ILCS 120/100from Ch. 111, par. 8301-100
20    225 ILCS 120/105from Ch. 111, par. 8301-105
21    225 ILCS 120/110from Ch. 111, par. 8301-110
22    225 ILCS 120/115from Ch. 111, par. 8301-115
23    225 ILCS 120/120from Ch. 111, par. 8301-120
24    225 ILCS 120/125from Ch. 111, par. 8301-125
25    225 ILCS 120/135from Ch. 111, par. 8301-135



HB4664- 37 -LRB102 24218 AMQ 33447 b

1    225 ILCS 120/140from Ch. 111, par. 8301-140
2    225 ILCS 120/155from Ch. 111, par. 8301-155
3    225 ILCS 120/165from Ch. 111, par. 8301-165
4    225 ILCS 120/200
5    225 ILCS 120/3 rep.