Illinois General Assembly - Full Text of Public Act 097-0804
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Public Act 097-0804


 

Public Act 0804 97TH GENERAL ASSEMBLY

  
  
  

 


 
Public Act 097-0804
 
SB2935 EnrolledLRB097 16822 CEL 62004 b

    AN ACT concerning regulation.
 
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
 
    Section 1. The Regulatory Sunset Act is amended by changing
Section 4.23 and by adding Section 4.33 as follows:
 
    (5 ILCS 80/4.23)
    Sec. 4.23. Acts and Sections repealed on January 1, 2013.
The following Acts and Sections of Acts are repealed on January
1, 2013:
    The Dietetic and Nutrition Services Practice Act.
    The Elevator Safety and Regulation Act.
    The Fire Equipment Distributor and Employee Regulation Act
of 2011.
    The Funeral Directors and Embalmers Licensing Code.
    The Naprapathic Practice Act.
    The Professional Counselor and Clinical Professional
Counselor Licensing Act.
    The Wholesale Drug Distribution Licensing Act.
    Section 2.5 of the Illinois Plumbing License Law.
(Source: P.A. 95-331, eff. 8-21-07; 96-1499, eff. 1-18-11.)
 
    (5 ILCS 80/4.33 new)
    Sec. 4.33. Act repealed on January 1, 2023. The following
Act is repealed on January 1, 2023:
    The Wholesale Drug Distribution Licensing Act.
 
    Section 5. The Wholesale Drug Distribution Licensing Act is
amended by changing Sections 15, 20, 25, 26, 50, 55, and 59 and
by adding Section 173 as follows:
 
    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 15. Definitions. As used in this Act:
    "Authentication" means the affirmative verification,
before any wholesale distribution of a prescription drug
occurs, that each transaction listed on the pedigree has
occurred.
    "Authorized distributor of record" means a wholesale
distributor with whom a manufacturer has established an ongoing
relationship to distribute the manufacturer's prescription
drug. An ongoing relationship is deemed to exist between a
wholesale distributor and a manufacturer when the wholesale
distributor, including any affiliated group of the wholesale
distributor, as defined in Section 1504 of the Internal Revenue
Code, complies with the following:
        (1) The wholesale distributor has a written agreement
    currently in effect with the manufacturer evidencing the
    ongoing relationship; and
        (2) The wholesale distributor is listed on the
    manufacturer's current list of authorized distributors of
    record, which is updated by the manufacturer on no less
    than a monthly basis.
    "Blood" means whole blood collected from a single donor and
processed either for transfusion or further manufacturing.
    "Blood component" means that part of blood separated by
physical or mechanical means.
    "Board" means the State Board of Pharmacy of the Department
of Professional Regulation.
    "Chain pharmacy warehouse" means a physical location for
prescription drugs that acts as a central warehouse and
performs intracompany sales or transfers of the drugs to a
group of chain or mail order pharmacies that have the same
common ownership and control. Notwithstanding any other
provision of this Act, a chain pharmacy warehouse shall be
considered part of the normal distribution channel.
    "Co-licensed partner or product" means an instance where
one or more parties have the right to engage in the
manufacturing or marketing of a prescription drug, consistent
with the FDA's implementation of the Prescription Drug
Marketing Act.
    "Department" means the Department of Financial and
Professional Regulation.
    "Drop shipment" means the sale of a prescription drug to a
wholesale distributor by the manufacturer of the prescription
drug or that manufacturer's co-licensed product partner, that
manufacturer's third party logistics provider, or that
manufacturer's exclusive distributor or by an authorized
distributor of record that purchased the product directly from
the manufacturer or one of these entities whereby the wholesale
distributor or chain pharmacy warehouse takes title but not
physical possession of such prescription drug and the wholesale
distributor invoices the pharmacy, chain pharmacy warehouse,
or other person authorized by law to dispense or administer
such drug to a patient and the pharmacy, chain pharmacy
warehouse, or other authorized person receives delivery of the
prescription drug directly from the manufacturer, that
manufacturer's third party logistics provider, or that
manufacturer's exclusive distributor or from an authorized
distributor of record that purchased the product directly from
the manufacturer or one of these entities.
    "Drug sample" means a unit of a prescription drug that is
not intended to be sold and is intended to promote the sale of
the drug.
    "Facility" means a facility of a wholesale distributor
where prescription drugs are stored, handled, repackaged, or
offered for sale.
    "FDA" means the United States Food and Drug Administration.
    "Manufacturer" means a person licensed or approved by the
FDA to engage in the manufacture of drugs or devices,
consistent with the definition of "manufacturer" set forth in
the FDA's regulations and guidances implementing the
Prescription Drug Marketing Act.
    "Manufacturer's exclusive distributor" means anyone who
contracts with a manufacturer to provide or coordinate
warehousing, distribution, or other services on behalf of a
manufacturer and who takes title to that manufacturer's
prescription drug, but who does not have general responsibility
to direct the sale or disposition of the manufacturer's
prescription drug. A manufacturer's exclusive distributor must
be licensed as a wholesale distributor under this Act and, in
order to be considered part of the normal distribution channel,
must also be an authorized distributor of record.
    "Normal distribution channel" means a chain of custody for
a prescription drug that goes, directly or by drop shipment,
from (i) a manufacturer of the prescription drug, (ii) that
manufacturer to that manufacturer's co-licensed partner, (iii)
that manufacturer to that manufacturer's third party logistics
provider, or (iv) that manufacturer to that manufacturer's
exclusive distributor to:
        (1) a pharmacy or to other designated persons
    authorized by law to dispense or administer the drug to a
    patient;
        (2) a wholesale distributor to a pharmacy or other
    designated persons authorized by law to dispense or
    administer the drug to a patient;
        (3) a wholesale distributor to a chain pharmacy
    warehouse to that chain pharmacy warehouse's intracompany
    pharmacy to a patient or other designated persons
    authorized by law to dispense or administer the drug to a
    patient;
        (4) a chain pharmacy warehouse to the chain pharmacy
    warehouse's intracompany pharmacy or other designated
    persons authorized by law to dispense or administer the
    drug to the patient;
        (5) an authorized distributor of record to one other
    authorized distributor of record to an office-based health
    care practitioner authorized by law to dispense or
    administer the drug to the patient; or
        (6) an authorized distributor to a pharmacy or other
    persons licensed to dispense or administer the drug.
    "Pedigree" means a document or electronic file containing
information that records each wholesale distribution of any
given prescription drug from the point of origin to the final
wholesale distribution point of any given prescription drug.
    "Person" means and includes a natural person, partnership,
association, or corporation, or any other legal business
entity.
    "Pharmacy distributor" means any pharmacy licensed in this
State or hospital pharmacy that is engaged in the delivery or
distribution of prescription drugs either to any other pharmacy
licensed in this State or to any other person or entity
including, but not limited to, a wholesale drug distributor
engaged in the delivery or distribution of prescription drugs
who is involved in the actual, constructive, or attempted
transfer of a drug in this State to other than the ultimate
consumer except as otherwise provided for by law.
    "Prescription drug" means any human drug, including any
biological product (except for blood and blood components
intended for transfusion or biological products that are also
medical devices), required by federal law or regulation to be
dispensed only by a prescription, including finished dosage
forms and bulk drug substances subject to Section 503 of the
Federal Food, Drug and Cosmetic Act.
    "Repackage" means repackaging or otherwise changing the
container, wrapper, or labeling to further the distribution of
a prescription drug, excluding that completed by the pharmacist
responsible for dispensing the product to a patient.
    "Secretary" means the Secretary of Financial and
Professional Regulation.
    "Third party logistics provider" means anyone who
contracts with a prescription drug manufacturer to provide or
coordinate warehousing, distribution, or other services on
behalf of a manufacturer, but does not take title to the
prescription drug or have general responsibility to direct the
prescription drug's sale or disposition. A third party
logistics provider must be licensed as a wholesale distributor
under this Act and, in order to be considered part of the
normal distribution channel, must also be an authorized
distributor of record.
    "Wholesale distribution" means the distribution of
prescription drugs to persons other than a consumer or patient,
but does not include any of the following:
        (1) Intracompany sales of prescription drugs, meaning
    (i) any transaction or transfer between any division,
    subsidiary, parent, or affiliated or related company under
    the common ownership and control of a corporate entity or
    (ii) any transaction or transfer between co-licensees of a
    co-licensed product.
        (2) The sale, purchase, distribution, trade, or
    transfer of a prescription drug or offer to sell, purchase,
    distribute, trade, or transfer a prescription drug for
    emergency medical reasons.
        (3) The distribution of prescription drug samples by
    manufacturers' representatives.
        (4) Drug returns, when conducted by a hospital, health
    care entity, or charitable institution in accordance with
    federal regulation.
        (5) The sale of minimal quantities of prescription
    drugs by licensed retail pharmacies to licensed
    practitioners for office use or other licensed pharmacies.
        (6) The sale, purchase, or trade of a drug, an offer to
    sell, purchase, or trade a drug, or the dispensing of a
    drug pursuant to a prescription.
        (7) The sale, transfer, merger, or consolidation of all
    or part of the business of a pharmacy or pharmacies from or
    with another pharmacy or pharmacies, whether accomplished
    as a purchase and sale of stock or business assets.
        (8) The sale, purchase, distribution, trade, or
    transfer of a prescription drug from one authorized
    distributor of record to one additional authorized
    distributor of record when the manufacturer has stated in
    writing to the receiving authorized distributor of record
    that the manufacturer is unable to supply the prescription
    drug and the supplying authorized distributor of record
    states in writing that the prescription drug being supplied
    had until that time been exclusively in the normal
    distribution channel.
        (9) The delivery of or the offer to deliver a
    prescription drug by a common carrier solely in the common
    carrier's usual course of business of transporting
    prescription drugs when the common carrier does not store,
    warehouse, or take legal ownership of the prescription
    drug.
        (10) The sale or transfer from a retail pharmacy, mail
    order pharmacy, or chain pharmacy warehouse of expired,
    damaged, returned, or recalled prescription drugs to the
    original manufacturer, the originating wholesale
    distributor, or a third party returns processor.
    "Wholesale drug distributor" means anyone engaged in the
wholesale distribution of prescription drugs into, out of, or
within the State, including without limitation manufacturers;
repackers; own label distributors; jobbers; private label
distributors; brokers; warehouses, including manufacturers'
and distributors' warehouses; manufacturer's exclusive
distributors; and authorized distributors of record; drug
wholesalers or distributors; independent wholesale drug
traders; specialty wholesale distributors; third party
logistics providers; and retail pharmacies that conduct
wholesale distribution; and chain pharmacy warehouses that
conduct wholesale distribution. In order to be considered part
of the normal distribution channel, a wholesale distributor
must also be an authorized distributor of record.
(Source: P.A. 95-689, eff. 10-29-07.)
 
    (225 ILCS 120/20)  (from Ch. 111, par. 8301-20)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 20. Prohibited drug purchases or receipt. It shall be
unlawful for any person or entity located in this State to
knowingly purchase or receive any prescription drug from any
source other than a person or entity required by the laws of
this State to be licensed to ship into, out of, or within this
State licensed under the laws of this State or the state of
domicile except where otherwise provided. A person or entity
licensed under the laws of this State shall include, but is not
limited to, a wholesale distributor, manufacturer, pharmacy
distributor, or pharmacy. Any person violating this Section
shall, upon conviction, be adjudged guilty of a Class C
misdemeanor. A second violation shall constitute a Class 4
felony.
(Source: P.A. 87-594.)
 
    (225 ILCS 120/25)  (from Ch. 111, par. 8301-25)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 25. Wholesale drug distributor licensing
requirements.
    (a) Every resident wholesale distributor who engages in the
wholesale distribution of prescription drugs must be licensed
by the Department, and every non-resident wholesale
distributor must be licensed in this State if it ships
prescription drugs into this State, in accordance with this
Act, before engaging in wholesale distributions of wholesale
prescription drugs.
    (b) The Department shall require without limitation all of
the following information from each applicant for licensure
under this Act:
        (1) The name, full business address, and telephone
    number of the licensee.
        (2) All trade or business names used by the licensee.
        (3) Addresses, telephone numbers, and the names of
    contact persons for all facilities used by the licensee for
    the storage, handling, and distribution of prescription
    drugs.
        (4) The type of ownership or operation, such as a
    partnership, corporation, or sole proprietorship.
        (5) The name of the owner or operator of the wholesale
    distributor, including:
            (A) if a natural person, the name of the natural
        person;
            (B) if a partnership, the name of each partner and
        the name of the partnership;
            (C) if a corporation, the name and title of each
        corporate officer and director, the corporate names,
        and the name of the state of incorporation; and
            (D) if a sole proprietorship, the full name of the
        sole proprietor and the name of the business entity.
        (6) A list of all licenses and permits issued to the
    applicant by any other state that authorizes the applicant
    to purchase or possess prescription drugs.
        (7) The name of the designated representative for the
    wholesale distributor, together with the personal
    information statement and fingerprints, as required under
    subsection (c) of this Section.
        (8) Minimum liability insurance and other insurance as
    defined by rule.
        (9) Any additional information required by the
    Department.
    (c) Each wholesale distributor must designate an
individual representative who shall serve as the contact person
for the Department. This representative must provide the
Department with all of the following information:
        (1) Information concerning whether the person has been
    enjoined, either temporarily or permanently, by a court of
    competent jurisdiction from violating any federal or State
    law regulating the possession, control, or distribution of
    prescription drugs or criminal violations, together with
    details concerning any such event.
        (2) A description of any involvement by the person with
    any business, including any investments, other than the
    ownership of stock in a publicly traded company or mutual
    fund which manufactured, administered, prescribed,
    distributed, or stored pharmaceutical products and any
    lawsuits in which such businesses were named as a party.
        (3) A description of any misdemeanor or felony criminal
    offense of which the person, as an adult, was found guilty,
    regardless of whether adjudication of guilt was withheld or
    whether the person pled guilty or nolo contendere. If the
    person indicates that a criminal conviction is under appeal
    and submits a copy of the notice of appeal of that criminal
    offense, the applicant must, within 15 days after the
    disposition of the appeal, submit to the Department a copy
    of the final written order of disposition.
        (4) The designated representative of an applicant for
    licensure as a wholesale drug distributor shall have his or
    her fingerprints submitted to the Department of State
    Police in an electronic format that complies with the form
    and manner for requesting and furnishing criminal history
    record information as prescribed by the Department of State
    Police. These fingerprints shall be checked against the
    Department of State Police and Federal Bureau of
    Investigation criminal history record databases now and
    hereafter filed. The Department of State Police shall
    charge applicants a fee for conducting the criminal history
    records check, which shall be deposited into the State
    Police Services Fund and shall not exceed the actual cost
    of the records check. The Department of State Police shall
    furnish, pursuant to positive identification, records of
    Illinois convictions to the Department. The Department may
    require applicants to pay a separate fingerprinting fee,
    either to the Department or to a vendor. The Department, in
    its discretion, may allow an applicant who does not have
    reasonable access to a designated vendor to provide his or
    her fingerprints in an alternative manner. The Department
    may adopt any rules necessary to implement this Section.
        The designated representative of a licensee shall
    receive and complete continuing training in applicable
    federal and State laws governing the wholesale
    distribution of prescription drugs.
    (d) The Department may not issue a wholesale distributor
license to an applicant, unless the Department first:
        (1) ensures that a physical inspection of the facility
    satisfactory to the Department has occurred at the address
    provided by the applicant, as required under item (1) of
    subsection (b) of this Section; and
        (2) determines that the designated representative
    meets each of the following qualifications:
            (A) He or she is at least 21 years of age.
            (B) He or she has been employed full-time for at
        least 3 years in a pharmacy or with a wholesale
        distributor in a capacity related to the dispensing and
        distribution of, and recordkeeping relating to,
        prescription drugs.
            (C) He or she is employed by the applicant full
        time in a managerial level position.
            (D) He or she is actively involved in and aware of
        the actual daily operation of the wholesale
        distributor.
            (E) He or she is physically present at the facility
        of the applicant during regular business hours, except
        when the absence of the designated representative is
        authorized, including without limitation sick leave
        and vacation leave.
            (F) He or she is serving in the capacity of a
        designated representative for only one applicant at a
        time, except where more than one licensed wholesale
        distributor is co-located in the same facility and such
        wholesale distributors are members of an affiliated
        group, as defined in Section 1504 of the Internal
        Revenue Code.
    (e) If a wholesale distributor distributes prescription
drugs from more than one facility, the wholesale distributor
shall obtain a license for each facility.
    (f) The information provided under this Section may not be
disclosed to any person or entity other than the Department or
another government entity in need of such information for
licensing or monitoring purposes.
(Source: P.A. 94-942, eff. 1-1-07; 95-689, eff. 10-29-07.)
 
    (225 ILCS 120/26)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 26. Unlicensed practice; violation; civil penalty.
    (a) Any person who practices, offers to practice, attempts
to practice, or holds oneself out to practice as a wholesale
drug distributor or pharmacy distributor without being
licensed to ship into, out of, or within the State under this
Act shall, in addition to any other penalty provided by law,
pay a civil penalty to the Department in an amount not to
exceed $10,000 $5,000 for each offense as determined by the
Department. The civil penalty shall be assessed by the
Department after a hearing is held in accordance with the
provisions set forth in this Act regarding the provision of a
hearing for the discipline of a licensee.
    (b) The Department has the authority and power to
investigate any and all unlicensed activity.
    (c) The civil penalty shall be paid within 60 days after
the effective date of the order imposing the civil penalty. The
order shall constitute a judgment and may be filed and
execution had thereon in the same manner as any judgment from
any court of record.
(Source: P.A. 89-474, eff. 6-18-96.)
 
    (225 ILCS 120/50)  (from Ch. 111, par. 8301-50)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 50. Inspection powers; access to records.
    (a) Any pharmacy investigator authorized by the Department
has the right of entry for inspection during normal business
hours of premises purporting or appearing to be used by a
wholesale drug distributor in this State, including the
business premises of a person licensed pursuant to this Act.
This right of entry shall permit the authorized pharmacy
investigator unfettered access to the entire business
premises. Any attempt to hinder an authorized pharmacy
investigator from inspecting the business premises and
documenting the inspection shall be a violation of this Act.
The duly authorized investigators shall be required to show
appropriate identification before being given access to a
wholesale drug distributor's premises and delivery vehicles.
Any wholesale drug distributor providing adequate
documentation of the most recent satisfactory inspection less
than 3 years old of the distributor's wholesale drug
distribution activities and facilities by either the U.S. FDA,
a State agency, or any person or entity lawfully designated by
a State agency to perform an inspection determined to be
comparable by the Department shall be exempt from further
inspection for a period of time to be determined by the
Department. The exemption shall not bar the Department from
initiating an investigation of a public or governmental
complaint received by the Department regarding a wholesale drug
distributor. Wholesale drug distributors shall be given an
opportunity to correct minor violations determined by these
investigations.
    (b) With the exception of the most recent 12 months of
records that must be kept on the premises where the drugs are
stored, wholesale Wholesale drug distributors may keep records
regarding purchase and sales transactions electronically at a
central location apart from the principal office of the
wholesale drug distributor or the location at which the drugs
were stored and from which they were shipped, provided that the
records shall be made readily available for inspection within 2
working days of a request by the Department. The records may be
kept in any form permissible under federal law applicable to
prescription drugs record keeping.
    (c) (Blank).
(Source: P.A. 94-942, eff. 1-1-07.)
 
    (225 ILCS 120/55)  (from Ch. 111, par. 8301-55)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 55. Discipline; grounds.
    (a) The Department may refuse to issue, restore, or renew,
or may revoke, suspend, place on probation, reprimand or take
other disciplinary or non-disciplinary action as the
Department may deem appropriate, including imposing fines not
to exceed $10,000 for each violation, with regard to any
applicant or licensee or any officer, director, manager, or
shareholder who owns 5% or more interest in the business that
holds the license proper for any one or a combination of the
following reasons:
        (1) Violation of this Act or of the its rules adopted
    under this Act.
        (2) Aiding or assisting another person in violating any
    provision of this Act or the its rules adopted under this
    Act.
        (3) Failing, within 60 days, to provide information in
    response respond to a written requirement made by the
    Department for information.
        (4) Engaging in dishonorable, unethical, or
    unprofessional conduct of a character likely to deceive,
    defraud, or harm the public. This includes violations of
    "good faith" as defined by the Illinois Controlled
    Substances Act and applies to all prescription drugs.
        (5) Discipline by another U.S. jurisdiction or foreign
    nation, if at least one of the grounds for the discipline
    is the same or substantially equivalent to those set forth
    in this Act.
        (6) Selling or engaging in the sale of drug samples
    provided at no cost by drug manufacturers.
        (7) Conviction by of or entry of a plea of guilty or
    nolo contendere, finding of guilt, jury verdict, or entry
    of judgment or by sentencing of any crime, including, but
    not limited to, convictions, preceding sentences of
    supervision, conditional discharge, or first offender
    probation, under the laws of any jurisdiction of the United
    States (i) by the applicant or licensee, or any officer,
    director, manager or shareholder who owns more than 5% of
    stock, to any crime under the laws of the United States or
    any state or territory of the United States that is a
    felony or (ii) a misdemeanor, of which an essential element
    of which is dishonesty, or any crime that is directly
    related to the practice of this profession.
        (8) Habitual or excessive use or addiction to alcohol,
    narcotics, stimulants, or any other chemical agent or drug
    by the designated representative, as provided for in item
    (7) of subsection (b) of Section 25 of this Act, any
    officer, or director that results in the inability to
    function with reasonable judgment, skill, or safety.
    (b) The Department may refuse to issue, restore, or renew,
or may revoke, suspend, place on probation, reprimand or take
other disciplinary action as the Department may deem property
including fines not to exceed $10,000 per offense for any of
the following reasons:
        (9) (1) Material misstatement in furnishing
    information to the Department.
        (2) Making any misrepresentation for the purpose of
    obtaining a license.
        (10) (3) A finding by the Department that the licensee,
    after having his or her license placed on probationary
    status, has violated the terms of probation.
        (11) Fraud or misrepresentation in applying for, or
    procuring, a license under this Act or in connection with
    applying for renewal of a license under this Act. (4) A
    finding that licensure or registration has been applied for
    or obtained by fraudulent means.
        (12) (5) Willfully making or filing false records or
    reports.
        (13) (6) A finding of a substantial discrepancy in a
    Department audit of a prescription drug, including a
    controlled substance as that term is defined in this Act or
    in the Illinois Controlled Substances Act.
        (14) Falsifying a pedigree or selling, distributing,
    transferring, manufacturing, repackaging, handling, or
    holding a counterfeit prescription drug intended for human
    use.
        (15) Interfering with a Department investigation.
        (16) Failing to adequately secure controlled
    substances or other prescription drugs from diversion.
        (17) Acquiring or distributing prescription drugs not
    obtained from a source licensed by the Department.
        (18) Failing to properly store drugs.
        (19) Failing to maintain the licensed premises with
    proper storage and security controls.
    (b) (c) The Department may refuse to issue or may suspend
the license or registration of any person who fails to file a
return, or to pay the tax, penalty or interest shown in a filed
return, or to pay any final assessment of tax, penalty or
interest, as required by any tax Act administered by the
Illinois Department of Revenue, until the time the requirements
of the tax Act are satisfied.
    (c) (d) The Department shall revoke the license or
certificate of registration issued under this Act or any prior
Act of this State of any person who has been convicted a second
time of committing any felony under the Illinois Controlled
Substances Act or the Methamphetamine Control and Community
Protection Act or who has been convicted a second time of
committing a Class 1 felony under Sections 8A-3 and 8A-6 of the
Illinois Public Aid Code. A person whose license or certificate
of registration issued under this Act or any prior Act of this
State is revoked under this subsection (b) (c) shall be
prohibited from engaging in the practice of pharmacy in this
State.
(Source: P.A. 94-556, eff. 9-11-05; 95-689, eff. 10-29-07;
revised 11-18-11.)
 
    (225 ILCS 120/59)
    (Section scheduled to be repealed on January 1, 2013)
    Sec. 59. Injunctive action; cease and desist order.
Enforcement; order to cease distribution of a drug.
    (a) If any person violates the provisions of this Act, the
Secretary, in the name of the People of the State of Illinois,
through the Attorney General or the State's Attorney of the
county where the violation is alleged to have occurred, may
petition for an order enjoining the violation or for an order
enforcing compliance with this Act. Upon the filing of a
verified petition, the court with appropriate jurisdiction may
issue a temporary restraining order, without notice or bond,
and may preliminarily and permanently enjoin the violation. If
it is established that the person has violated or is violating
the injunction, then the court may punish the offender for
contempt of court. Proceedings under this Section are in
addition to, and not in lieu of, all other remedies and
penalties provided by this Act. The Department shall issue an
order requiring the appropriate person, including the
distributors or retailers of a drug, to immediately cease
distribution of the drug within this State, if the Department
finds that there is a reasonable probability that:
        (1) a wholesale distributor has (i) violated a
    provision in this Act or (ii) falsified a pedigree or sold,
    distributed, transferred, manufactured, repackaged,
    handled, or held a counterfeit prescription drug intended
    for human use;
        (2) the prescription drug at issue, as a result of a
    violation in paragraph (1) of this subsection (a), could
    cause serious, adverse health consequences or death; and
        (3) other procedures would result in unreasonable
    delay.
    (b) Whenever, in the opinion of the Department, a person
violates any provision of this Act, the Department may issue a
rule to show cause why an order to cease and desist shall not
be entered against that person. The rule shall clearly set
forth the grounds relied upon by the Department and shall allow
a person at least 7 days after the date of the rule to file an
answer satisfactory to the Department. Failure to answer to the
satisfaction of the Department shall cause an order to cease
and desist to be issued. An order issued under this Section
shall provide the person subject to the order with an
opportunity for an informal hearing, to be held not later than
10 days after the date of the issuance of the order, on the
actions required by the order. If, after providing an
opportunity for a hearing, the Department determines that
inadequate grounds exist to support the actions required by the
order, the Department shall vacate the order.
(Source: P.A. 95-689, eff. 10-29-07.)
 
    (225 ILCS 120/173 new)
    Sec. 173. Confidentiality. All information collected by
the Department in the course of an examination or investigation
of a licensee or applicant, including, but not limited to, any
complaint against a licensee filed with the Department and
information collected to investigate any such complaint, shall
be maintained for the confidential use of the Department and
shall not be disclosed. The Department may not disclose the
information to anyone other than law enforcement officials,
other regulatory agencies that have an appropriate regulatory
interest as determined by the Secretary, or a party presenting
a lawful subpoena to the Department. Information and documents
disclosed to a federal, State, county, or local law enforcement
agency shall not be disclosed by the agency for any purpose to
any other agency or person. A formal complaint filed against a
licensee by the Department or any order issued by the
Department against a licensee or applicant shall be a public
record, except as otherwise prohibited by law.
 
    Section 99. Effective date. This Act takes effect on
January 1, 2013.
INDEX
Statutes amended in order of appearance
    5 ILCS 80/4.23
    5 ILCS 80/4.33 new
    225 ILCS 120/15from Ch. 111, par. 8301-15
    225 ILCS 120/20from Ch. 111, par. 8301-20
    225 ILCS 120/25from Ch. 111, par. 8301-25
    225 ILCS 120/26
    225 ILCS 120/50from Ch. 111, par. 8301-50
    225 ILCS 120/55from Ch. 111, par. 8301-55
    225 ILCS 120/59
    225 ILCS 120/173 new

Effective Date: 1/1/2013