Illinois General Assembly - Full Text of SB2935
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Full Text of SB2935  97th General Assembly

SB2935 97TH GENERAL ASSEMBLY

  
  

 


 
97TH GENERAL ASSEMBLY
State of Illinois
2011 and 2012
SB2935

 

Introduced 2/1/2012, by Sen. Iris Y. Martinez

 

SYNOPSIS AS INTRODUCED:
 
See Index

    Amends the Wholesale Drug Distribution Licensing Act. Provides that 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 under the Act shall pay a civil penalty to the Department of Financial and Professional Regulation in an amount not to exceed $10,000 (instead of $5,000) per violation for each offense. Provides that any pharmacy investigator authorized by the Department has the right of entry that includes the business premises of a person licensed pursuant to the Act. Permits the authorized pharmacy investigator unfettered access to the entire business premises. Provides that the most recent 12 months of record must be kept on the premises where the drugs are stored. Allows the Department to take action, including imposing fines not to exceed $10,000 per violation, if the individual meets the requirements for grounds for disciplinary action. Provides that if any person violates the provisions of the Act, the Secretary may petition for an order enjoining the violation or for an order enforcing compliance with the Act. Provides that the Department may issue a rule to show cause why an order to cease and desist shall not be entered against that person. Makes other changes. Amends the Regulatory Sunset Act to extend the repeal of the Wholesale Drug Distribution Licensing Act from January 1, 2013 to January 1, 2023. Effective immediately.


LRB097 16822 CEL 62004 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

SB2935LRB097 16822 CEL 62004 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 1. The Regulatory Sunset Act is amended by changing
5Section 4.23 and by adding Section 4.33 as follows:
 
6    (5 ILCS 80/4.23)
7    Sec. 4.23. Acts and Sections repealed on January 1, 2013.
8The following Acts and Sections of Acts are repealed on January
91, 2013:
10    The Dietetic and Nutrition Services Practice Act.
11    The Elevator Safety and Regulation Act.
12    The Fire Equipment Distributor and Employee Regulation Act
13of 2011.
14    The Funeral Directors and Embalmers Licensing Code.
15    The Naprapathic Practice Act.
16    The Professional Counselor and Clinical Professional
17Counselor Licensing Act.
18    The Wholesale Drug Distribution Licensing Act.
19    Section 2.5 of the Illinois Plumbing License Law.
20(Source: P.A. 95-331, eff. 8-21-07; 96-1499, eff. 1-18-11.)
 
21    (5 ILCS 80/4.33 new)
22    Sec. 4.33. Act repealed on January 1, 2023. The following

 

 

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1Act is repealed on January 1, 2023:
2    The Wholesale Drug Distribution Licensing Act.
 
3    Section 5. The Wholesale Drug Distribution Licensing Act is
4amended by changing Sections 15, 20, 25, 26, 50, 55, and 59 and
5by adding Section 173 as follows:
 
6    (225 ILCS 120/15)  (from Ch. 111, par. 8301-15)
7    (Section scheduled to be repealed on January 1, 2013)
8    Sec. 15. Definitions. As used in this Act:
9    "Authentication" means the affirmative verification,
10before any wholesale distribution of a prescription drug
11occurs, that each transaction listed on the pedigree has
12occurred.
13    "Authorized distributor of record" means a wholesale
14distributor with whom a manufacturer has established an ongoing
15relationship to distribute the manufacturer's prescription
16drug. An ongoing relationship is deemed to exist between a
17wholesale distributor and a manufacturer when the wholesale
18distributor, including any affiliated group of the wholesale
19distributor, as defined in Section 1504 of the Internal Revenue
20Code, complies with the following:
21        (1) The wholesale distributor has a written agreement
22    currently in effect with the manufacturer evidencing the
23    ongoing relationship; and
24        (2) The wholesale distributor is listed on the

 

 

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1    manufacturer's current list of authorized distributors of
2    record, which is updated by the manufacturer on no less
3    than a monthly basis.
4    "Blood" means whole blood collected from a single donor and
5processed either for transfusion or further manufacturing.
6    "Blood component" means that part of blood separated by
7physical or mechanical means.
8    "Board" means the State Board of Pharmacy of the Department
9of Professional Regulation.
10    "Chain pharmacy warehouse" means a physical location for
11prescription drugs that acts as a central warehouse and
12performs intracompany sales or transfers of the drugs to a
13group of chain or mail order pharmacies that have the same
14common ownership and control. Notwithstanding any other
15provision of this Act, a chain pharmacy warehouse shall be
16considered part of the normal distribution channel.
17    "Co-licensed partner or product" means an instance where
18one or more parties have the right to engage in the
19manufacturing or marketing of a prescription drug, consistent
20with the FDA's implementation of the Prescription Drug
21Marketing Act.
22    "Department" means the Department of Financial and
23Professional Regulation.
24    "Drop shipment" means the sale of a prescription drug to a
25wholesale distributor by the manufacturer of the prescription
26drug or that manufacturer's co-licensed product partner, that

 

 

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1manufacturer's third party logistics provider, or that
2manufacturer's exclusive distributor or by an authorized
3distributor of record that purchased the product directly from
4the manufacturer or one of these entities whereby the wholesale
5distributor or chain pharmacy warehouse takes title but not
6physical possession of such prescription drug and the wholesale
7distributor invoices the pharmacy, chain pharmacy warehouse,
8or other person authorized by law to dispense or administer
9such drug to a patient and the pharmacy, chain pharmacy
10warehouse, or other authorized person receives delivery of the
11prescription drug directly from the manufacturer, that
12manufacturer's third party logistics provider, or that
13manufacturer's exclusive distributor or from an authorized
14distributor of record that purchased the product directly from
15the manufacturer or one of these entities.
16    "Drug sample" means a unit of a prescription drug that is
17not intended to be sold and is intended to promote the sale of
18the drug.
19    "Facility" means a facility of a wholesale distributor
20where prescription drugs are stored, handled, repackaged, or
21offered for sale.
22    "FDA" means the United States Food and Drug Administration.
23    "Manufacturer" means a person licensed or approved by the
24FDA to engage in the manufacture of drugs or devices,
25consistent with the definition of "manufacturer" set forth in
26the FDA's regulations and guidances implementing the

 

 

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

 

 

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1    pharmacy to a patient or other designated persons
2    authorized by law to dispense or administer the drug to a
3    patient;
4        (4) a chain pharmacy warehouse to the chain pharmacy
5    warehouse's intracompany pharmacy or other designated
6    persons authorized by law to dispense or administer the
7    drug to the patient;
8        (5) an authorized distributor of record to one other
9    authorized distributor of record to an office-based health
10    care practitioner authorized by law to dispense or
11    administer the drug to the patient; or
12        (6) an authorized distributor to a pharmacy or other
13    persons licensed to dispense or administer the drug.
14    "Pedigree" means a document or electronic file containing
15information that records each wholesale distribution of any
16given prescription drug from the point of origin to the final
17wholesale distribution point of any given prescription drug.
18    "Person" means and includes a natural person, partnership,
19association, or corporation, or any other legal business
20entity.
21    "Pharmacy distributor" means any pharmacy licensed in this
22State or hospital pharmacy that is engaged in the delivery or
23distribution of prescription drugs either to any other pharmacy
24licensed in this State or to any other person or entity
25including, but not limited to, a wholesale drug distributor
26engaged in the delivery or distribution of prescription drugs

 

 

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1who is involved in the actual, constructive, or attempted
2transfer of a drug in this State to other than the ultimate
3consumer except as otherwise provided for by law.
4    "Prescription drug" means any human drug, including any
5biological product (except for blood and blood components
6intended for transfusion or biological products that are also
7medical devices), required by federal law or regulation to be
8dispensed only by a prescription, including finished dosage
9forms and bulk drug substances subject to Section 503 of the
10Federal Food, Drug and Cosmetic Act.
11    "Repackage" means repackaging or otherwise changing the
12container, wrapper, or labeling to further the distribution of
13a prescription drug, excluding that completed by the pharmacist
14responsible for dispensing the product to a patient.
15    "Secretary" means the Secretary of Financial and
16Professional Regulation.
17    "Third party logistics provider" means anyone who
18contracts with a prescription drug manufacturer to provide or
19coordinate warehousing, distribution, or other services on
20behalf of a manufacturer, but does not take title to the
21prescription drug or have general responsibility to direct the
22prescription drug's sale or disposition. A third party
23logistics provider must be licensed as a wholesale distributor
24under this Act and, in order to be considered part of the
25normal distribution channel, must also be an authorized
26distributor of record.

 

 

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1    "Wholesale distribution" means the distribution of
2prescription drugs to persons other than a consumer or patient,
3but does not include any of the following:
4        (1) Intracompany sales of prescription drugs, meaning
5    (i) any transaction or transfer between any division,
6    subsidiary, parent, or affiliated or related company under
7    the common ownership and control of a corporate entity or
8    (ii) any transaction or transfer between co-licensees of a
9    co-licensed product.
10        (2) The sale, purchase, distribution, trade, or
11    transfer of a prescription drug or offer to sell, purchase,
12    distribute, trade, or transfer a prescription drug for
13    emergency medical reasons.
14        (3) The distribution of prescription drug samples by
15    manufacturers' representatives.
16        (4) Drug returns, when conducted by a hospital, health
17    care entity, or charitable institution in accordance with
18    federal regulation.
19        (5) The sale of minimal quantities of prescription
20    drugs by licensed retail pharmacies to licensed
21    practitioners for office use or other licensed pharmacies.
22        (6) The sale, purchase, or trade of a drug, an offer to
23    sell, purchase, or trade a drug, or the dispensing of a
24    drug pursuant to a prescription.
25        (7) The sale, transfer, merger, or consolidation of all
26    or part of the business of a pharmacy or pharmacies from or

 

 

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1    with another pharmacy or pharmacies, whether accomplished
2    as a purchase and sale of stock or business assets.
3        (8) The sale, purchase, distribution, trade, or
4    transfer of a prescription drug from one authorized
5    distributor of record to one additional authorized
6    distributor of record when the manufacturer has stated in
7    writing to the receiving authorized distributor of record
8    that the manufacturer is unable to supply the prescription
9    drug and the supplying authorized distributor of record
10    states in writing that the prescription drug being supplied
11    had until that time been exclusively in the normal
12    distribution channel.
13        (9) The delivery of or the offer to deliver a
14    prescription drug by a common carrier solely in the common
15    carrier's usual course of business of transporting
16    prescription drugs when the common carrier does not store,
17    warehouse, or take legal ownership of the prescription
18    drug.
19        (10) The sale or transfer from a retail pharmacy, mail
20    order pharmacy, or chain pharmacy warehouse of expired,
21    damaged, returned, or recalled prescription drugs to the
22    original manufacturer, the originating wholesale
23    distributor, or a third party returns processor.
24    "Wholesale drug distributor" means anyone engaged in the
25wholesale distribution of prescription drugs into, out of, or
26within the State, including without limitation manufacturers;

 

 

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1repackers; own label distributors; jobbers; private label
2distributors; brokers; warehouses, including manufacturers'
3and distributors' warehouses; manufacturer's exclusive
4distributors; and authorized distributors of record; drug
5wholesalers or distributors; independent wholesale drug
6traders; specialty wholesale distributors; third party
7logistics providers; and retail pharmacies that conduct
8wholesale distribution; and chain pharmacy warehouses that
9conduct wholesale distribution. In order to be considered part
10of the normal distribution channel, a wholesale distributor
11must also be an authorized distributor of record.
12(Source: P.A. 95-689, eff. 10-29-07.)
 
13    (225 ILCS 120/20)  (from Ch. 111, par. 8301-20)
14    (Section scheduled to be repealed on January 1, 2013)
15    Sec. 20. Prohibited drug purchases or receipt. It shall be
16unlawful for any person or entity located in this State to
17knowingly purchase or receive any prescription drug from any
18source other than a person or entity licensed under the laws of
19this State or the state of domicile except where otherwise
20provided. A person or entity licensed under the laws of this
21State shall include, but is not limited to, a wholesale
22distributor, manufacturer, pharmacy distributor, or pharmacy.
23Any person violating this Section shall, upon conviction, be
24adjudged guilty of a Class C misdemeanor. A second violation
25shall constitute a Class 4 felony.

 

 

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1(Source: P.A. 87-594.)
 
2    (225 ILCS 120/25)  (from Ch. 111, par. 8301-25)
3    (Section scheduled to be repealed on January 1, 2013)
4    Sec. 25. Wholesale drug distributor licensing
5requirements.
6    (a) Every resident wholesale distributor who engages in the
7wholesale distribution of prescription drugs must be licensed
8by the Department, and every non-resident wholesale
9distributor must be licensed in this State if it ships
10prescription drugs into this State, in accordance with this
11Act, before engaging in wholesale distributions of wholesale
12prescription drugs.
13    (b) The Department shall require without limitation all of
14the following information from each applicant for licensure
15under this Act:
16        (1) The name, full business address, and telephone
17    number of the licensee.
18        (2) All trade or business names used by the licensee.
19        (3) Addresses, telephone numbers, and the names of
20    contact persons for all facilities used by the licensee for
21    the storage, handling, and distribution of prescription
22    drugs.
23        (4) The type of ownership or operation, such as a
24    partnership, corporation, or sole proprietorship.
25        (5) The name of the owner or operator of the wholesale

 

 

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1    distributor, including:
2            (A) if a natural person, the name of the natural
3        person;
4            (B) if a partnership, the name of each partner and
5        the name of the partnership;
6            (C) if a corporation, the name and title of each
7        corporate officer and director, the corporate names,
8        and the name of the state of incorporation; and
9            (D) if a sole proprietorship, the full name of the
10        sole proprietor and the name of the business entity.
11        (6) A list of all licenses and permits issued to the
12    applicant by any other state that authorizes the applicant
13    to purchase or possess prescription drugs.
14        (7) The name of the designated representative for the
15    wholesale distributor, together with the personal
16    information statement and fingerprints, as required under
17    subsection (c) of this Section.
18        (8) Minimum liability insurance and other insurance as
19    defined by rule.
20        (9) Any additional information required by the
21    Department.
22    (c) Each wholesale distributor must designate an
23individual representative who shall serve as the contact person
24for the Department. This representative must provide the
25Department with all of the following information:
26        (1) Information concerning whether the person has been

 

 

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1    enjoined, either temporarily or permanently, by a court of
2    competent jurisdiction from violating any federal or State
3    law regulating the possession, control, or distribution of
4    prescription drugs or criminal violations, together with
5    details concerning any such event.
6        (2) A description of any involvement by the person with
7    any business, including any investments, other than the
8    ownership of stock in a publicly traded company or mutual
9    fund which manufactured, administered, prescribed,
10    distributed, or stored pharmaceutical products and any
11    lawsuits in which such businesses were named as a party.
12        (3) A description of any misdemeanor or felony criminal
13    offense of which the person, as an adult, was found guilty,
14    regardless of whether adjudication of guilt was withheld or
15    whether the person pled guilty or nolo contendere. If the
16    person indicates that a criminal conviction is under appeal
17    and submits a copy of the notice of appeal of that criminal
18    offense, the applicant must, within 15 days after the
19    disposition of the appeal, submit to the Department a copy
20    of the final written order of disposition.
21        (4) The designated representative of an applicant for
22    licensure as a wholesale drug distributor shall have his or
23    her fingerprints submitted to the Department of State
24    Police in an electronic format that complies with the form
25    and manner for requesting and furnishing criminal history
26    record information as prescribed by the Department of State

 

 

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1    Police. These fingerprints shall be checked against the
2    Department of State Police and Federal Bureau of
3    Investigation criminal history record databases now and
4    hereafter filed. The Department of State Police shall
5    charge applicants a fee for conducting the criminal history
6    records check, which shall be deposited into the State
7    Police Services Fund and shall not exceed the actual cost
8    of the records check. The Department of State Police shall
9    furnish, pursuant to positive identification, records of
10    Illinois convictions to the Department. The Department may
11    require applicants to pay a separate fingerprinting fee,
12    either to the Department or to a vendor. The Department, in
13    its discretion, may allow an applicant who does not have
14    reasonable access to a designated vendor to provide his or
15    her fingerprints in an alternative manner. The Department
16    may adopt any rules necessary to implement this Section.
17        The designated representative of a licensee shall
18    receive and complete continuing training in applicable
19    federal and State laws governing the wholesale
20    distribution of prescription drugs.
21    (d) The Department may not issue a wholesale distributor
22license to an applicant, unless the Department first:
23        (1) ensures that a physical inspection of the facility
24    satisfactory to the Department has occurred at the address
25    provided by the applicant, as required under item (1) of
26    subsection (b) of this Section; and

 

 

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1        (2) determines that the designated representative
2    meets each of the following qualifications:
3            (A) He or she is at least 21 years of age.
4            (B) He or she has been employed full-time for at
5        least 3 years in a pharmacy or with a wholesale
6        distributor in a capacity related to the dispensing and
7        distribution of, and recordkeeping relating to,
8        prescription drugs.
9            (C) He or she is employed by the applicant full
10        time in a managerial level position.
11            (D) He or she is actively involved in and aware of
12        the actual daily operation of the wholesale
13        distributor.
14            (E) He or she is physically present at the facility
15        of the applicant during regular business hours, except
16        when the absence of the designated representative is
17        authorized, including without limitation sick leave
18        and vacation leave.
19            (F) He or she is serving in the capacity of a
20        designated representative for only one applicant at a
21        time, except where more than one licensed wholesale
22        distributor is co-located in the same facility and such
23        wholesale distributors are members of an affiliated
24        group, as defined in Section 1504 of the Internal
25        Revenue Code.
26    (e) If a wholesale distributor distributes prescription

 

 

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1drugs from more than one facility, the wholesale distributor
2shall obtain a license for each facility.
3    (f) The information provided under this Section may not be
4disclosed to any person or entity other than the Department or
5another government entity in need of such information for
6licensing or monitoring purposes.
7(Source: P.A. 94-942, eff. 1-1-07; 95-689, eff. 10-29-07.)
 
8    (225 ILCS 120/26)
9    (Section scheduled to be repealed on January 1, 2013)
10    Sec. 26. Unlicensed practice; violation; civil penalty.
11    (a) Any person who practices, offers to practice, attempts
12to practice, or holds oneself out to practice as a wholesale
13drug distributor or pharmacy distributor without being
14licensed under this Act shall, in addition to any other penalty
15provided by law, pay a civil penalty to the Department in an
16amount not to exceed $10,000 $5,000 for each offense as
17determined by the Department. The civil penalty shall be
18assessed by the Department after a hearing is held in
19accordance with the provisions set forth in this Act regarding
20the provision of a hearing for the discipline of a licensee.
21    (b) The Department has the authority and power to
22investigate any and all unlicensed activity.
23    (c) The civil penalty shall be paid within 60 days after
24the effective date of the order imposing the civil penalty. The
25order shall constitute a judgment and may be filed and

 

 

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1execution had thereon in the same manner as any judgment from
2any court of record.
3(Source: P.A. 89-474, eff. 6-18-96.)
 
4    (225 ILCS 120/50)  (from Ch. 111, par. 8301-50)
5    (Section scheduled to be repealed on January 1, 2013)
6    Sec. 50. Inspection powers; access to records.
7    (a) Any pharmacy investigator authorized by the Department
8has the right of entry for inspection during normal business
9hours of premises purporting or appearing to be used by a
10wholesale drug distributor in this State, including the
11business premises of a person licensed pursuant to this Act.
12This right of entry shall permit the authorized pharmacy
13investigator unfettered access to the entire business
14premises. Any attempt to hinder an authorized pharmacy
15investigator from inspecting the business premises and
16documenting the inspection shall be a violation of this Act.
17The duly authorized investigators shall be required to show
18appropriate identification before being given access to a
19wholesale drug distributor's premises and delivery vehicles.
20Any wholesale drug distributor providing adequate
21documentation of the most recent satisfactory inspection less
22than 3 years old of the distributor's wholesale drug
23distribution activities and facilities by either the U.S. FDA,
24a State agency, or any person or entity lawfully designated by
25a State agency to perform an inspection determined to be

 

 

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1comparable by the Department shall be exempt from further
2inspection for a period of time to be determined by the
3Department. The exemption shall not bar the Department from
4initiating an investigation of a public or governmental
5complaint received by the Department regarding a wholesale drug
6distributor. Wholesale drug distributors shall be given an
7opportunity to correct minor violations determined by these
8investigations.
9    (b) With the exception of the most recent 12 months of
10records that must be kept on the premises where the drugs are
11stored, wholesale Wholesale drug distributors may keep records
12regarding purchase and sales transactions at a central location
13apart from the principal office of the wholesale drug
14distributor or the location at which the drugs were stored and
15from which they were shipped, provided that the records shall
16be made available for inspection within 2 working days of a
17request by the Department. The records may be kept in any form
18permissible under federal law applicable to prescription drugs
19record keeping.
20    (c) (Blank).
21(Source: P.A. 94-942, eff. 1-1-07.)
 
22    (225 ILCS 120/55)  (from Ch. 111, par. 8301-55)
23    (Section scheduled to be repealed on January 1, 2013)
24    Sec. 55. Discipline; grounds.
25    (a) The Department may refuse to issue, restore, or renew,

 

 

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1or may revoke, suspend, place on probation, reprimand or take
2other disciplinary or non-disciplinary action as the
3Department may deem appropriate, including imposing fines not
4to exceed $10,000 for each violation, with regard to any
5applicant or licensee or any officer, director, manager, or
6shareholder who owns 5% or more interest in the business that
7holds the license proper for any one or a combination of the
8following reasons:
9        (1) Violation of this Act or of the its rules adopted
10    under this Act.
11        (2) Aiding or assisting another person in violating any
12    provision of this Act or the its rules adopted under this
13    Act.
14        (3) Failing, within 60 days, to provide information in
15    response respond to a written requirement made by the
16    Department for information.
17        (4) Engaging in dishonorable, unethical, or
18    unprofessional conduct of a character likely to deceive,
19    defraud, or harm the public. This includes violations of
20    "good faith" as defined by the Illinois Controlled
21    Substances Act and applies to all prescription drugs.
22        (5) Discipline by another U.S. jurisdiction or foreign
23    nation, if at least one of the grounds for the discipline
24    is the same or substantially equivalent to those set forth
25    in this Act.
26        (6) Selling or engaging in the sale of drug samples

 

 

SB2935- 20 -LRB097 16822 CEL 62004 b

1    provided at no cost by drug manufacturers.
2        (7) Conviction by of or entry of a plea of guilty or
3    nolo contendere, finding of guilt, jury verdict, or entry
4    of judgment or by sentencing of any crime, including, but
5    not limited to, convictions, preceding sentences of
6    supervision, conditional discharge, or first offender
7    probation, under the laws of any jurisdiction of the United
8    States (i) by the applicant or licensee, or any officer,
9    director, manager or shareholder who owns more than 5% of
10    stock, to any crime under the laws of the United States or
11    any state or territory of the United States that is a
12    felony or (ii) a misdemeanor, of which an essential element
13    of which is dishonesty, or any crime that is directly
14    related to the practice of this profession.
15        (8) Habitual or excessive use or addiction to alcohol,
16    narcotics, stimulants, or any other chemical agent or drug
17    by the designated representative, as provided for in item
18    (7) of subsection (b) of Section 25 of this Act, any
19    officer, or director that results in the inability to
20    function with reasonable judgment, skill, or safety.
21    (b) The Department may refuse to issue, restore, or renew,
22or may revoke, suspend, place on probation, reprimand or take
23other disciplinary action as the Department may deem property
24including fines not to exceed $10,000 per offense for any of
25the following reasons:
26        (9) (1) Material misstatement in furnishing

 

 

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1    information to the Department.
2        (2) Making any misrepresentation for the purpose of
3    obtaining a license.
4        (10) (3) A finding by the Department that the licensee,
5    after having his or her license placed on probationary
6    status, has violated the terms of probation.
7        (11) Fraud or misrepresentation in applying for, or
8    procuring, a license under this Act or in connection with
9    applying for renewal of a license under this Act. (4) A
10    finding that licensure or registration has been applied for
11    or obtained by fraudulent means.
12        (12) (5) Willfully making or filing false records or
13    reports.
14        (13) (6) A finding of a substantial discrepancy in a
15    Department audit of a prescription drug, including a
16    controlled substance as that term is defined in this Act or
17    in the Illinois Controlled Substances Act.
18        (14) Falsifying a pedigree or selling, distributing,
19    transferring, manufacturing, repackaging, handling, or
20    holding a counterfeit prescription drug intended for human
21    use.
22        (15) Interfering with a Department investigation.
23        (16) Failing to adequately secure controlled
24    substances or other prescription drugs from diversion.
25        (17) Acquiring or distributing prescription drugs not
26    obtained from a licensed source.

 

 

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1        (18) Failing to properly store drugs.
2        (19) Failing to maintain the licensed premises with
3    proper storage and security controls.
4    (b) (c) The Department may refuse to issue or may suspend
5the license or registration of any person who fails to file a
6return, or to pay the tax, penalty or interest shown in a filed
7return, or to pay any final assessment of tax, penalty or
8interest, as required by any tax Act administered by the
9Illinois Department of Revenue, until the time the requirements
10of the tax Act are satisfied.
11    (c) (d) The Department shall revoke the license or
12certificate of registration issued under this Act or any prior
13Act of this State of any person who has been convicted a second
14time of committing any felony under the Illinois Controlled
15Substances Act or the Methamphetamine Control and Community
16Protection Act or who has been convicted a second time of
17committing a Class 1 felony under Sections 8A-3 and 8A-6 of the
18Illinois Public Aid Code. A person whose license or certificate
19of registration issued under this Act or any prior Act of this
20State is revoked under this subsection (b) (c) shall be
21prohibited from engaging in the practice of pharmacy in this
22State.
23(Source: P.A. 94-556, eff. 9-11-05; 95-689, eff. 10-29-07;
24revised 11-18-11.)
 
25    (225 ILCS 120/59)

 

 

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1    (Section scheduled to be repealed on January 1, 2013)
2    Sec. 59. Injunctive action; cease and desist order.
3Enforcement; order to cease distribution of a drug.
4    (a) If any person violates the provisions of this Act, the
5Secretary, in the name of the People of the State of Illinois,
6through the Attorney General or the State's Attorney of the
7county where the violation is alleged to have occurred, may
8petition for an order enjoining the violation or for an order
9enforcing compliance with this Act. Upon the filing of a
10verified petition, the court with appropriate jurisdiction may
11issue a temporary restraining order, without notice or bond,
12and may preliminarily and permanently enjoin the violation. If
13it is established that the person has violated or is violating
14the injunction, then the court may punish the offender for
15contempt of court. Proceedings under this Section are in
16addition to, and not in lieu of, all other remedies and
17penalties provided by this Act. The Department shall issue an
18order requiring the appropriate person, including the
19distributors or retailers of a drug, to immediately cease
20distribution of the drug within this State, if the Department
21finds that there is a reasonable probability that:
22        (1) a wholesale distributor has (i) violated a
23    provision in this Act or (ii) falsified a pedigree or sold,
24    distributed, transferred, manufactured, repackaged,
25    handled, or held a counterfeit prescription drug intended
26    for human use;

 

 

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1        (2) the prescription drug at issue, as a result of a
2    violation in paragraph (1) of this subsection (a), could
3    cause serious, adverse health consequences or death; and
4        (3) other procedures would result in unreasonable
5    delay.
6    (b) Whenever, in the opinion of the Department, a person
7violates any provision of this Act, the Department may issue a
8rule to show cause why an order to cease and desist shall not
9be entered against that person. The rule shall clearly set
10forth the grounds relied upon by the Department and shall allow
11a person at least 7 days after the date of the rule to file an
12answer satisfactory to the Department. Failure to answer to the
13satisfaction of the Department shall cause an order to cease
14and desist to be issued. An order issued under this Section
15shall provide the person subject to the order with an
16opportunity for an informal hearing, to be held not later than
1710 days after the date of the issuance of the order, on the
18actions required by the order. If, after providing an
19opportunity for a hearing, the Department determines that
20inadequate grounds exist to support the actions required by the
21order, the Department shall vacate the order.
22(Source: P.A. 95-689, eff. 10-29-07.)
 
23    (225 ILCS 120/173 new)
24    Sec. 173. Confidentiality. All information collected by
25the Department in the course of an examination or investigation

 

 

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1of a licensee or applicant, including, but not limited to, any
2complaint against a licensee filed with the Department and
3information collected to investigate any such complaint, shall
4be maintained for the confidential use of the Department and
5shall not be disclosed. The Department may not disclose the
6information to anyone other than law enforcement officials,
7other regulatory agencies that have an appropriate regulatory
8interest as determined by the Secretary, or a party presenting
9a lawful subpoena to the Department. Information and documents
10disclosed to a federal, State, county, or local law enforcement
11agency shall not be disclosed by the agency for any purpose to
12any other agency or person. A formal complaint filed against a
13licensee by the Department or any order issued by the
14Department against a licensee or applicant shall be a public
15record, except as otherwise prohibited by law.
 
16    Section 99. Effective date. This Act takes effect upon
17becoming law.

 

 

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1 INDEX
2 Statutes amended in order of appearance
3    5 ILCS 80/4.23
4    5 ILCS 80/4.33 new
5    225 ILCS 120/15from Ch. 111, par. 8301-15
6    225 ILCS 120/20from Ch. 111, par. 8301-20
7    225 ILCS 120/25from Ch. 111, par. 8301-25
8    225 ILCS 120/26
9    225 ILCS 120/50from Ch. 111, par. 8301-50
10    225 ILCS 120/55from Ch. 111, par. 8301-55
11    225 ILCS 120/59
12    225 ILCS 120/173 new