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| Public Act 097-0804
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| SB2935 Enrolled | LRB097 16822 CEL 62004 b |
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AN ACT concerning regulation.
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Be it enacted by the People of the State of Illinois,
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represented in the General Assembly:
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Section 1. The Regulatory Sunset Act is amended by changing |
Section 4.23 and by adding Section 4.33 as follows:
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(5 ILCS 80/4.23)
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Sec. 4.23. Acts and Sections repealed on January 1,
2013. |
The following Acts and Sections of Acts are
repealed on January |
1, 2013:
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The Dietetic and Nutrition Services Practice Act.
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The Elevator Safety and Regulation Act.
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The Fire Equipment Distributor and Employee Regulation Act |
of 2011. |
The Funeral Directors and Embalmers Licensing Code.
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The Naprapathic Practice Act.
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The Professional Counselor and Clinical Professional |
Counselor
Licensing Act.
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The Wholesale Drug Distribution Licensing Act.
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Section 2.5 of the Illinois Plumbing License Law.
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(Source: P.A. 95-331, eff. 8-21-07; 96-1499, eff. 1-18-11.)
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(5 ILCS 80/4.33 new) |
Sec. 4.33. Act repealed on January 1,
2023. The following |
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Act is
repealed on January 1, 2023: |
The Wholesale Drug Distribution Licensing Act.
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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:
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(225 ILCS 120/15) (from Ch. 111, par. 8301-15)
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(Section scheduled to be repealed on January 1, 2013)
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Sec. 15. Definitions. As used in this Act:
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"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 |
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manufacturer's current list of authorized distributors of |
record, which is updated by the manufacturer on no less |
than a monthly basis.
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"Blood" means whole blood collected from a single donor and |
processed
either for transfusion or further manufacturing.
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"Blood component" means that part of blood separated by |
physical or
mechanical means.
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"Board" means the State Board of Pharmacy of the Department |
of
Professional Regulation.
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"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.
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"Department" means the Department of Financial and
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Professional Regulation.
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"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 |
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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.
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"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.
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"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.
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"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 |
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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.
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"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 |
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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.
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"Person" means and includes a natural person, partnership, |
association, or
corporation, or any other legal business |
entity.
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"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 |
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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.
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"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.
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"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. |
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"Wholesale distribution"
means the distribution
of |
prescription drugs to persons other than a consumer or patient, |
but does
not include any of the following:
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(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.
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(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.
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(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 |
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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.
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"Wholesale drug distributor" means anyone
engaged in the
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wholesale distribution of prescription drugs into, out of, or |
within the State, including without limitation
manufacturers; |
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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.
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(Source: P.A. 95-689, eff. 10-29-07.)
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(225 ILCS 120/20) (from Ch. 111, par. 8301-20)
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(Section scheduled to be repealed on January 1, 2013)
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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
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misdemeanor. A second violation shall constitute a Class 4 |
felony.
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(Source: P.A. 87-594.)
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(225 ILCS 120/25) (from Ch. 111, par. 8301-25)
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(Section scheduled to be repealed on January 1, 2013)
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Sec. 25. Wholesale drug distributor licensing |
requirements.
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(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.
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(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 |
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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
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subsection (c) of this Section. |
(8) Minimum liability insurance and other insurance as |
defined by rule. |
(9) Any additional information required by the |
Department.
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(c) Each wholesale distributor must designate an |
individual representative who shall serve as the contact person |
for the Department. This representative must provide the
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Department with all of the following information:
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(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 |
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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.
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(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 |
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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 |
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Revenue Code.
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(e) If a wholesale distributor distributes prescription |
drugs from more than one facility, the wholesale distributor |
shall obtain a license for each facility.
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(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.
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(Source: P.A. 94-942, eff. 1-1-07; 95-689, eff. 10-29-07.)
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(225 ILCS 120/26)
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(Section scheduled to be repealed on January 1, 2013)
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Sec. 26. Unlicensed practice; violation; civil penalty.
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(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.
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(b) The Department has the authority and power to |
investigate any and all
unlicensed activity.
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(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.
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(Source: P.A. 89-474, eff. 6-18-96.)
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(225 ILCS 120/50) (from Ch. 111, par. 8301-50)
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(Section scheduled to be repealed on January 1, 2013)
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Sec. 50. Inspection powers; access to records.
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(a) Any pharmacy investigator authorized by the Department
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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
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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 |
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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
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complaint received by the Department regarding a wholesale drug
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distributor. Wholesale drug distributors shall be given an |
opportunity to
correct minor violations determined by these |
investigations.
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(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.
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(c) (Blank).
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(Source: P.A. 94-942, eff. 1-1-07.)
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(225 ILCS 120/55) (from Ch. 111, par. 8301-55)
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(Section scheduled to be repealed on January 1, 2013)
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Sec. 55. Discipline; grounds.
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(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:
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(1) Violation of this Act or of the its rules adopted |
under this Act.
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(2) Aiding or assisting another person in violating any |
provision of
this Act or the its rules adopted under this |
Act.
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(3) Failing, within 60 days, to provide information in |
response respond to a written requirement made by
the |
Department for information.
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(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.
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(5) Discipline by another U.S. jurisdiction or foreign |
nation, if at
least one of the grounds for the discipline |
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is the same or substantially
equivalent to those set forth |
in this Act.
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(6) Selling or engaging in the sale of drug samples |
provided at no cost
by drug manufacturers.
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(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.
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(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.
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(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 |
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including fines not to exceed
$10,000 per offense
for any of |
the following reasons:
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(9) (1) Material misstatement in furnishing |
information to the Department.
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(2) Making any misrepresentation for the purpose of |
obtaining a license.
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(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.
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(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.
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(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 |
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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.
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(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.
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(Source: P.A. 94-556, eff. 9-11-05; 95-689, eff. 10-29-07; |
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revised 11-18-11.)
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(225 ILCS 120/59)
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(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, |
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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.
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(Source: P.A. 95-689, eff. 10-29-07.)
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(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.
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Section 99. Effective date. This Act takes effect on |
January 1, 2013.
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INDEX
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Statutes amended in order of appearance
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