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Public Act 094-0942 |
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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 5. The Wholesale Drug Distribution Licensing Act is | ||||
amended by changing Sections 25 and 50 as follows:
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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(Section scheduled to be repealed on January 1, 2013)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. All
wholesale distributors and pharmacy | ||||
distributors, wherever located, who
engage in wholesale | ||||
distribution into, out of, or within the State shall be
subject | ||||
to the following requirements:
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(a) No person or distribution outlet shall act as a | ||||
wholesale drug
distributor without first obtaining a license to | ||||
do so from the Department
and paying any reasonable fee | ||||
required by the Department.
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(b) The Department may grant a temporary
license when a | ||||
wholesale drug distributor first applies for a license to
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operate within this State. A temporary license shall only be | ||||
granted after the applicant meets the inspection requirements | ||||
for regular licensure and shall remain valid
until the | ||||
Department finds that the applicant
meets or fails to meet the | ||||
requirements for regular licensure. Nevertheless,
no temporary | ||||
license shall be valid for more than 90 days from the
date of | ||||
issuance. Any temporary license issued under this subsection
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shall be renewable for a similar period of time not to exceed | ||||
90 days
under policies and procedures prescribed by the | ||||
Department.
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(c) No license shall be issued or renewed for a wholesale | ||||
drug
distributor to operate unless the wholesale drug | ||||
distributor shall operate
in a manner prescribed by law and | ||||
according to the rules and regulations
promulgated by the |
Department.
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(d) The Department may require a separate
license for each | ||
facility directly or indirectly owned or operated by the
same | ||
business entity within this State, or for a parent entity with
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divisions, subsidiaries, and affiliate companies within this | ||
State when
operations are conducted at more than one location | ||
and there exists joint
ownership and control among all the | ||
entities.
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(e) As a condition for receiving and renewing any wholesale | ||
drug
distributor license issued under this Act, each applicant | ||
shall satisfy the
Department that it has and will continuously | ||
maintain:
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(1) acceptable storage and handling conditions plus | ||
facilities standards;
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(2) minimum liability and other insurance as may be | ||
required under
any applicable federal or State law;
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(3) a security system that includes after hours, | ||
central alarm or
comparable entry detection capability; | ||
restricted premises access; adequate
outside perimeter | ||
lighting; comprehensive employment applicant screening;
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and safeguards against employee theft;
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(4) an electronic, manual, or any other reasonable | ||
system of
records, describing all wholesale distributor | ||
activities governed by this
Act for the 2 year period | ||
following disposition of each product and
reasonably | ||
accessible during regular business hours as defined by the
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Department's rules in any inspection authorized by the | ||
Department;
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(5) officers, directors, managers, and other persons | ||
in charge of
wholesale drug distribution, storage, and | ||
handling who must at all times
demonstrate and maintain | ||
their capability of conducting business according
to sound | ||
financial practices as well as State and federal law;
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(6) complete, updated information, to be provided the | ||
Department
as a condition for obtaining and renewing a | ||
license, about each wholesale
distributor to be licensed |
under this Act, including all pertinent licensee
ownership | ||
and other key personnel and facilities information deemed
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necessary for enforcement of this Act. Any changes in this | ||
information
shall be submitted at the time of license | ||
renewal or within 45 days from
the date of the change;
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(7) written policies and procedures that assure | ||
reasonable
wholesale distributor preparation for, | ||
protection against and handling of
any facility security or | ||
operation problems, including, but not limited to,
those | ||
caused by natural disaster or government emergency; | ||
inventory
inaccuracies or product shipping and receiving; | ||
outdated product or other
unauthorized product control; | ||
appropriate disposition of returned goods;
and product | ||
recalls;
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(8) sufficient inspection procedures for all incoming | ||
and outgoing
product shipments; and
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(9) operations in compliance with all federal legal | ||
requirements
applicable to wholesale drug distribution.
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(f) The Department shall consider, at a minimum, the | ||
following factors
in reviewing the qualifications of persons | ||
who engage in wholesale
distribution of prescription drugs in | ||
this State:
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(1) any conviction of the applicant under any federal, | ||
State, or
local laws relating to drug samples, wholesale or | ||
retail drug distribution,
or distribution of controlled | ||
substances;
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(2) any felony convictions of the applicant under | ||
federal, State,
or local laws;
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(3) the applicant's past experience in the manufacture | ||
or
distribution of prescription drugs, including | ||
controlled substances;
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(4) the furnishing by the applicant of false or | ||
fraudulent material
in any application made in connection | ||
with drug manufacturing or distribution;
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(5) suspension or revocation by federal, State, or | ||
local government
of any license currently or previously |
held by the applicant for the
manufacture or distribution | ||
of any drug, including controlled substances;
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(6) compliance with licensing requirements under | ||
previously granted
licenses, if any;
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(7) compliance with requirements to maintain and make | ||
available to
the Department or to federal, State, or local
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law enforcement officials those records required by this | ||
Act; and
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(8) any other factors or qualifications the Department
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considers relevant to and consistent with the
public health | ||
and safety, including whether the granting of the license
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would not be in the public interest.
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(9) All requirements set forth in this subsection shall | ||
conform to
wholesale drug distributor licensing guidelines | ||
formally adopted by the
U.S. Food and Drug Administration | ||
(FDA). In case of conflict between
any wholesale drug | ||
distributor licensing requirement imposed by the
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Department and any FDA wholesale drug distributor | ||
licensing guideline, the
FDA guideline shall control.
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(g) An agent or employee of any licensed wholesale drug | ||
distributor need
not seek licensure under this Section and may | ||
lawfully possess
pharmaceutical drugs when the agent or | ||
employee is acting in the usual
course of business or | ||
employment.
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(h) The issuance of a license under this Act shall not | ||
change or
affect tax liability imposed by the State on any | ||
wholesale drug distributor.
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(i) A license issued under this Act shall not be sold, | ||
transferred, or
assigned in any manner.
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(Source: P.A. 92-586, eff. 6-26-02.)
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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. The duly authorized | ||
investigators shall be
required to show appropriate | ||
identification before given access to a
wholesale drug | ||
distributor's premises and delivery vehicles. Any wholesale
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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
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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.
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(b) Wholesale drug distributors may keep records regarding | ||
purchase and
sales transactions 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 available | ||
for inspection within 2 working days of a request by the
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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).
The Department shall employ a person whose | ||
title shall be
Assistant Drug Compliance Coordinator to assist | ||
the Drug Compliance
Coordinator in administering and enforcing | ||
this Act.
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(Source: P.A. 87-594.)
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