[ Home ] [ ILCS ] [ Search ] [ Bottom ]
[ Other General Assemblies ]
Public Act 92-0586
SB1685 Enrolled LRB9215594ACcd
AN ACT concerning the regulation of professions.
Be it enacted by the People of the State of Illinois,
represented in the General Assembly:
Section 5. The Regulatory Sunset Act is amended by
changing Section 4.13 and adding Section 4.23 as follows:
(5 ILCS 80/4.13) (from Ch. 127, par. 1904.13)
Sec. 4.13. Acts repealed on December 31, 2002. The
following Acts are repealed on December 31, 2002:
The Environmental Health Practitioner Licensing Act.
The Naprapathic Practice Act.
The Wholesale Drug Distribution Licensing Act.
The Dietetic and Nutrition Services Practice Act.
The Funeral Directors and Embalmers Licensing Code.
The Professional Counselor and Clinical Professional
Counselor Licensing Act.
(Source: P.A. 88-45; 89-61, eff. 6-30-95; revised 8-22-01.)
(5 ILCS 80/4.23 new)
Sec. 4.23. Act repealed on January 1, 2013. The
following Act is repealed on January 1, 2013:
The Wholesale Drug Distribution Licensing Act.
Section 10. The Wholesale Drug Distribution Licensing
Act is amended by changing Sections 25 and 35 as follows:
(225 ILCS 120/25) (from Ch. 111, par. 8301-25)
(Section scheduled to be repealed on December 31, 2002)
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, the fee not to exceed $200 per
year.
(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 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 Department.
(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.
(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 entities.
(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:
(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 Department;
(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
recalls;
(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 substances;
(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
employment.
(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. 87-594.)
(225 ILCS 120/35) (from Ch. 111, par. 8301-35)
(Section scheduled to be repealed on December 31, 2002)
Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
(a) The Department shall provide by rule for a schedule
of fees for the administration and enforcement of this Act,
including but not limited to original licensure, renewal, and
restoration. The fees shall be nonrefundable. The following
fees shall be imposed by the Department and are not
refundable.
(1) The fee for application for a certificate of
registration as a wholesale drug distributor is $200.
(2) The fee for the renewal of a certificate of
registration as a wholesale drug distributor is $200 per
year.
(3) The fee for the change of person responsible
for drugs is $50.
(4) The fee for the issuance of a duplicate license
to replace a license that has been lost or destroyed is
$25.
(5) The fee for certification of a registrant's
record for any purpose is $25.
(6) The fee for a roster of licensed wholesale drug
distributors shall be the actual cost of producing the
roster.
(7) The fee for wholesale drug distributor
licensing, disciplinary, or investigative records
obtained under subpoena is $1 per page.
(b) All fees collected under this Act shall be deposited
into the Illinois State Pharmacy Disciplinary Fund and shall
be appropriated to the Department for the ordinary and
contingent expenses of the Department in the administration
of this Act. All moneys received by the Department under this
Act shall be deposited into the Illinois State Pharmacy
Disciplinary Fund in the State Treasury and shall be used
only for the following purposes: (i) by the State Board of
Pharmacy in the exercise of its powers and performance of its
duties, as such use is made by the Department upon the
recommendations of the State Board of Pharmacy, (ii) for
costs directly related to license renewal of persons licensed
under this Act, and (iii) for direct and allocable indirect
costs related to the public purposes of the Department of
Professional Regulation. Moneys in the Fund may be
transferred to the Professions Indirect Cost Fund as
authorized by Section 2105-300 of the Department of
Professional Regulation Law (20 ILCS 2105/2105-300).
The moneys deposited into the Illinois State Pharmacy
Disciplinary Fund shall be invested to earn interest which
shall accrue to the Fund.
The Department shall present to the Board for its review
and comment all appropriation requests from the Illinois
State Pharmacy Disciplinary Fund. The Department shall give
due consideration to any comments of the Board in making
appropriation requests.
(c) Any person who delivers a check or other payment to
the Department that is returned to the Department unpaid by
the financial institution upon which it is drawn shall pay to
the Department, in addition to the amount already owed to the
Department, a fine of $50. The fines imposed by this
Section are in addition to any other discipline provided
under this Act for unlicensed practice or practice on a
nonrenewed license. The Department shall notify the person
that payment of fees and fines shall be paid to the
Department by certified check or money order within 30
calendar days of the notification. If, after the expiration
of 30 days from the date of the notification, the person has
failed to submit the necessary remittance, the Department
shall automatically terminate the license or certificate or
deny the application, without hearing. If, after termination
or denial, the person seeks a license or certificate, he or
she shall apply to the Department for restoration or issuance
of the license or certificate and pay all fees and fines due
to the Department. The Department may establish a fee for
the processing of an application for restoration of a license
or certificate to pay all expenses of processing this
application. The Director may waive the fines due under this
Section in individual cases where the Director finds that the
fines would be unreasonable or unnecessarily burdensome.
(d) The Department shall maintain a roster of the names
and addresses of all registrants and of all persons whose
licenses have been suspended or revoked. This roster shall
be available upon written request and payment of the required
fee.
(Source: P.A. 91-239, eff. 1-1-00; 92-146, eff. 1-1-02.)
Section 99. Effective date. This Act takes effect upon
becoming law.
Passed in the General Assembly April 24, 2002.
Approved June 26, 2002.
Effective June 26, 2002.
[ Top ]