Illinois General Assembly - Full Text of Public Act 094-0942
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Public Act 094-0942




Public Act 094-0942
SB2909 Enrolled LRB094 18023 RAS 53328 b

    AN ACT concerning regulation.
    Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
    Section 5. The Wholesale Drug Distribution Licensing Act is
amended by changing Sections 25 and 50 as follows:
    (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    (Section scheduled to be repealed on January 1, 2013)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. 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:
    (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.
    (b) The Department may grant a temporary license when a
wholesale drug distributor first applies for a license to
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
shall be renewable for a similar period of time not to exceed
90 days under policies and procedures prescribed by the
    (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
    (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
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
    (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
        (1) acceptable storage and handling conditions plus
    facilities standards;
        (2) minimum liability and other insurance as may be
    required under any applicable federal or State law;
        (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;
    and safeguards against employee theft;
        (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
    Department's rules in any inspection authorized by the
        (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;
        (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
    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;
        (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
        (8) sufficient inspection procedures for all incoming
    and outgoing product shipments; and
        (9) operations in compliance with all federal legal
    requirements applicable to wholesale drug distribution.
    (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:
        (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
        (2) any felony convictions of the applicant under
    federal, State, or local laws;
        (3) the applicant's past experience in the manufacture
    or distribution of prescription drugs, including
    controlled substances;
        (4) the furnishing by the applicant of false or
    fraudulent material in any application made in connection
    with drug manufacturing or distribution;
        (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;
        (6) compliance with licensing requirements under
    previously granted licenses, if any;
        (7) compliance with requirements to maintain and make
    available to the Department or to federal, State, or local
    law enforcement officials those records required by this
    Act; and
        (8) any other factors or qualifications the Department
    considers relevant to and consistent with the public health
    and safety, including whether the granting of the license
    would not be in the public interest.
        (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
    Department and any FDA wholesale drug distributor
    licensing guideline, the FDA guideline shall control.
    (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
    (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.
    (i) A license issued under this Act shall not be sold,
transferred, or assigned in any manner.
(Source: P.A. 92-586, eff. 6-26-02.)
    (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. 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
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) 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
Department. The records may be kept in any form permissible
under federal law applicable to prescription drugs record
    (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.
(Source: P.A. 87-594.)

Effective Date: 1/1/2007