Illinois General Assembly - Full Text of SB4014
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Full Text of SB4014  102nd General Assembly

SB4014enr 102ND GENERAL ASSEMBLY

  
  
  

 


 
SB4014 EnrolledLRB102 24215 AMQ 33444 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 Acts repealed on January 1, 2023.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8Acts are repealed on January 1, 2023: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 Acts repealed on January 1, 2028.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22Acts are repealed on January 1, 2028:

 

 

SB4014 Enrolled- 2 -LRB102 24215 AMQ 33444 b

1    The Acupuncture Practice Act.
2    The Clinical Social Work and Social Work Practice Act.
3    The Home Medical Equipment and Services Provider License
4Act.
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
11Act.
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24    (Section scheduled to be repealed on January 1, 2023)

 

 

SB4014 Enrolled- 3 -LRB102 24215 AMQ 33444 b

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
9occurred.
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.

 

 

SB4014 Enrolled- 4 -LRB102 24215 AMQ 33444 b

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
24Administration.
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

 

 

SB4014 Enrolled- 8 -LRB102 24215 AMQ 33444 b

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
21patient.
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

 

 

SB4014 Enrolled- 9 -LRB102 24215 AMQ 33444 b

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; warehouses, including manufacturers'
14and distributors' warehouses; manufacturer's exclusive
15distributors; and authorized distributors of record; drug
16wholesalers or distributors; independent wholesale drug
17traders; specialty wholesale distributors; and retail
18pharmacies that conduct wholesale distribution; and chain
19pharmacy warehouses that conduct wholesale distribution. In
20order to be considered part of the normal distribution
21channel, a wholesale distributor must also be an authorized
22distributor of record.
23(Source: P.A. 101-420, eff. 8-16-19; 102-389, eff. 1-1-22.)
 
24    (225 ILCS 120/15.5 new)
25    Sec. 15.5. Address of record; email address of record. All

 

 

SB4014 Enrolled- 12 -LRB102 24215 AMQ 33444 b

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

 

 

SB4014 Enrolled- 13 -LRB102 24215 AMQ 33444 b

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

 

 

SB4014 Enrolled- 14 -LRB102 24215 AMQ 33444 b

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
16restored.
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
25restoration. The fees shall be nonrefundable.

 

 

SB4014 Enrolled- 15 -LRB102 24215 AMQ 33444 b

1    (b) All fees collected under this Act shall be deposited
2into the Illinois State Pharmacy Disciplinary Fund and shall
3be appropriated to the Department for the ordinary and
4contingent expenses of the Department in the administration of
5this Act. Moneys in the Fund may be transferred to the
6Professions Indirect Cost Fund as authorized by Section
72105-300 of the Department of Financial and Professional
8Regulation Law (20 ILCS 2105/2105-300).
9    The moneys deposited into the Illinois State Pharmacy
10Disciplinary Fund shall be invested to earn interest which
11shall accrue to the Fund.
12    The Department shall present to the Board for its review
13and comment all appropriation requests from the Illinois State
14Pharmacy Disciplinary Fund. The Department shall give due
15consideration to any comments of the Board in making
16appropriation requests.
17    (c) Any person who delivers a check or other payment to the
18Department that is returned to the Department unpaid by the
19financial institution upon which it is drawn shall pay to the
20Department, in addition to the amount already owed to the
21Department, a fine of $50. The fines imposed by this Section
22are in addition to any other discipline provided under this
23Act for unlicensed practice or practice on a nonrenewed
24license. The Department shall notify the person that payment
25of fees and fines shall be paid to the Department by certified
26check or money order within 30 calendar days of the

 

 

SB4014 Enrolled- 16 -LRB102 24215 AMQ 33444 b

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

 

 

SB4014 Enrolled- 17 -LRB102 24215 AMQ 33444 b

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

 

 

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1wholesale drug distributor in this State, including the
2business premises of a person licensed pursuant to this Act.
3This right of entry shall permit the authorized pharmacy
4investigator unfettered access to the entire business
5premises. Any attempt to hinder an authorized pharmacy
6investigator from inspecting the business premises and
7documenting the inspection shall be a violation of this Act.
8The duly authorized investigators shall be required to show
9appropriate identification before being given access to a
10wholesale drug distributor's premises and delivery vehicles.
11    (b) With the exception of the most recent 12 months of
12records that must be kept on the premises where the drugs are
13stored, wholesale drug distributors may keep records regarding
14purchase and sales transactions electronically at a central
15location apart from the principal office of the wholesale drug
16distributor or the location at which the drugs were stored and
17from which they were shipped, provided that the records shall
18be made readily available for inspection within 2 working days
19of a request by the Department. The records may be kept in any
20form permissible under federal law applicable to prescription
21drugs record keeping.
22    (c) (Blank).
23(Source: P.A. 97-804, eff. 1-1-13.)
 
24    (225 ILCS 120/57)
25    (Section scheduled to be repealed on January 1, 2023)

 

 

SB4014 Enrolled- 19 -LRB102 24215 AMQ 33444 b

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

 

 

SB4014 Enrolled- 20 -LRB102 24215 AMQ 33444 b

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

 

 

SB4014 Enrolled- 21 -LRB102 24215 AMQ 33444 b

1    prescription drug and each wholesale distributor of the
2    prescription drug.
3        (2) The name and address of each location from which
4    the product was shipped, if different from the owner's.
5        (3) Transaction dates.
6        (4) Certification that each recipient has
7    authenticated the pedigree.
8    (d) The pedigree must also include without limitation all
9of the following information concerning the prescription drug:
10        (1) The name and national drug code number of the
11    prescription drug.
12        (2) The dosage form and strength of the prescription
13    drug.
14        (3) The size of the container.
15        (4) The number of containers.
16        (5) The lot number of the prescription drug.
17        (6) The name of the manufacturer of the finished
18    dosage form.
19    (e) Each pedigree or electronic file shall be maintained
20by the purchaser and the wholesale distributor for at least 3
21years from the date of sale or transfer and made available for
22inspection or use within 5 business days upon a request of the
23Department.
24(Source: P.A. 101-420, eff. 8-16-19.)
 
25    (225 ILCS 120/70)  (from Ch. 111, par. 8301-70)

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1any other provision of this Act, the Secretary Director shall
2have the authority to appoint any attorney duly licensed to
3practice law in the State of Illinois to serve as the hearing
4officer in any action before the Board for refusal to issue or
5renew a license, or the discipline of a licensee. The Director
6shall notify the Board of any such appointment. The hearing
7officer shall have full authority to conduct the hearing.
8There shall be present at least one member of the Board at any
9such hearing. The hearing officer shall report his findings of
10fact, conclusions of law, and recommendations to the Board and
11the Secretary Director. The Board shall have 60 days from
12receipt of the report to review the report of the hearing
13officer and present its findings of fact, conclusions of law,
14and recommendations to the Secretary Director. If the Board
15fails to present its report within the 60 day period, the
16Secretary Director may issue an order based on report of the
17hearing officer and the record of the proceedings or issue an
18order remanding the matter back to the hearing officer for
19additional proceedings in accordance with the order. If the
20Secretary disagrees with the recommendation of the Board or
21the hearing officer, the Secretary may issue an order in
22contravention of the recommendation. However, if the Board
23does present its report within the specified 60 days, the
24Director's order shall be based upon the report of the Board.
25(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
25justice has not been done in the revocation, suspension, or

 

 

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1refusal to issue or renew a license or registration, the
2Secretary Director may order a rehearing by the same hearing
3office or Board.
4(Source: P.A. 87-594.)
 
5    (225 ILCS 120/125)  (from Ch. 111, par. 8301-125)
6    (Section scheduled to be repealed on January 1, 2023)
7    Sec. 125. Duties of the Board Board recommendations to
8Director; disagreement. The Board shall exercise the rights,
9powers, and duties which have been vested in the Board under
10this Act, and any other duties conferred upon the Board by law.
11None of the disciplinary functions, powers, and duties
12enumerated in this Act shall be exercised by the Department
13except upon the action and report in writing of the Board,
14except as otherwise provided in this Act.
15    In all instances under this Act in which the Board has
16rendered a recommendation to the Director with respect to a
17particular license or certificate, the Director shall, in the
18event that he or she disagrees with or takes action contrary to
19the recommendation of the Board, file with the Board and
20Secretary of State his or her specific written reasons for
21disagreement with the Board. These reasons shall be filed
22within 30 days after the Director taking the contrary
23position.
24    The action and report in writing of a majority of the Board
25is sufficient authority upon which the Director may act.

 

 

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

 

 

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

 

 

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1Department has received from the plaintiff payment of the
2costs of furnishing and certifying the record, which costs
3shall be determined by the Department. Failure on the part of
4the plaintiff to file a receipt in court shall be grounds for
5dismissal of the action. During the pendency and hearing of
6any and all judicial proceedings incident to the disciplinary
7action, the sanctions imposed upon the accused by the
8Department because of acts or omissions related to the
9delivery of direct patient care as specified in the
10Department's final administrative decision, shall, as a matter
11of public policy, remain in full force and effect in order to
12protect the public pending final resolution of any of the
13proceedings.
14The Department shall not be required to certify any record to
15the court or file any answer in court or otherwise appear in
16any court in a judicial review proceeding, unless there is
17filed in the court, with the complaint, a receipt from the
18Department acknowledging payment of the costs of furnishing
19and certifying the record, which costs shall be computed at
20the rate of 25 cents per page of such record. Failure on the
21part of the plaintiff to file a receipt in court shall be
22grounds for dismissal of the action.
23(Source: P.A. 87-594.)
 
24    (225 ILCS 120/200)
25    (Section scheduled to be repealed on January 1, 2023)

 

 

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

 

 

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

 

 

SB4014 Enrolled- 36 -LRB102 24215 AMQ 33444 b

1 INDEX
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

 

 

SB4014 Enrolled- 37 -LRB102 24215 AMQ 33444 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.