Full Text of SB2909 94th General Assembly
SB2909 94TH GENERAL ASSEMBLY
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94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006 SB2909
Introduced 1/20/2006, by Sen. Ira I. Silverstein SYNOPSIS AS INTRODUCED: |
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225 ILCS 120/25 |
from Ch. 111, par. 8301-25 |
225 ILCS 120/50 |
from Ch. 111, par. 8301-50 |
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Amends the Wholesale Drug Distribution Act. Provides that an applicant for temporary licensure must meet the inspection requirements for regular licensure before the temporary license shall be granted. Removes a provision that requires the Department of Financial and Professional Regulation to employ an Assistant Drug Compliance Coordinator to assist the Drug Compliance
Coordinator in administering and enforcing the Act.
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A BILL FOR
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SB2909 |
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LRB094 18023 RAS 53328 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 5. The Wholesale Drug Distribution Licensing Act is | 5 |
| 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| (Section scheduled to be repealed on January 1, 2013)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 | 9 |
| requirements. All
wholesale distributors and pharmacy | 10 |
| distributors, wherever located, who
engage in wholesale | 11 |
| distribution into, out of, or within the State shall be
subject | 12 |
| to the following requirements:
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| (a) No person or distribution outlet shall act as a | 14 |
| wholesale drug
distributor without first obtaining a license to | 15 |
| do so from the Department
and paying any reasonable fee | 16 |
| required by the Department.
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| (b) The Department may grant a temporary
license when a | 18 |
| wholesale drug distributor first applies for a license to
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| operate within this State. A temporary license shall only be | 20 |
| granted after the applicant meets the inspection requirements | 21 |
| for regular licensure and shall remain valid
until the | 22 |
| Department finds that the applicant
meets or fails to meet the | 23 |
| requirements for regular licensure. Nevertheless,
no temporary | 24 |
| license shall be valid for more than 90 days from the
date of | 25 |
| issuance. Any temporary license issued under this subsection
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| shall be renewable for a similar period of time not to exceed | 27 |
| 90 days
under policies and procedures prescribed by the | 28 |
| Department.
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| (c) No license shall be issued or renewed for a wholesale | 30 |
| drug
distributor to operate unless the wholesale drug | 31 |
| distributor shall operate
in a manner prescribed by law and | 32 |
| according to the rules and regulations
promulgated by the |
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SB2909 |
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LRB094 18023 RAS 53328 b |
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| Department.
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| (d) The Department may require a separate
license for each | 3 |
| facility directly or indirectly owned or operated by the
same | 4 |
| business entity within this State, or for a parent entity with
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| divisions, subsidiaries, and affiliate companies within this | 6 |
| State when
operations are conducted at more than one location | 7 |
| and there exists joint
ownership and control among all the | 8 |
| entities.
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| (e) As a condition for receiving and renewing any wholesale | 10 |
| drug
distributor license issued under this Act, each applicant | 11 |
| shall satisfy the
Department that it has and will continuously | 12 |
| maintain:
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| (1) acceptable storage and handling conditions plus | 14 |
| facilities standards;
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| (2) minimum liability and other insurance as may be | 16 |
| required under
any applicable federal or State law;
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| (3) a security system that includes after hours, | 18 |
| central alarm or
comparable entry detection capability; | 19 |
| restricted premises access; adequate
outside perimeter | 20 |
| 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 | 23 |
| system of
records, describing all wholesale distributor | 24 |
| activities governed by this
Act for the 2 year period | 25 |
| following disposition of each product and
reasonably | 26 |
| accessible during regular business hours as defined by the
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| Department's rules in any inspection authorized by the | 28 |
| Department;
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| (5) officers, directors, managers, and other persons | 30 |
| in charge of
wholesale drug distribution, storage, and | 31 |
| handling who must at all times
demonstrate and maintain | 32 |
| their capability of conducting business according
to sound | 33 |
| financial practices as well as State and federal law;
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| (6) complete, updated information, to be provided the | 35 |
| Department
as a condition for obtaining and renewing a | 36 |
| license, about each wholesale
distributor to be licensed |
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SB2909 |
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LRB094 18023 RAS 53328 b |
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| under this Act, including all pertinent licensee
ownership | 2 |
| and other key personnel and facilities information deemed
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| necessary for enforcement of this Act. Any changes in this | 4 |
| information
shall be submitted at the time of license | 5 |
| renewal or within 45 days from
the date of the change;
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| (7) written policies and procedures that assure | 7 |
| reasonable
wholesale distributor preparation for, | 8 |
| protection against and handling of
any facility security or | 9 |
| operation problems, including, but not limited to,
those | 10 |
| caused by natural disaster or government emergency; | 11 |
| inventory
inaccuracies or product shipping and receiving; | 12 |
| outdated product or other
unauthorized product control; | 13 |
| appropriate disposition of returned goods;
and product | 14 |
| recalls;
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| (8) sufficient inspection procedures for all incoming | 16 |
| and outgoing
product shipments; and
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| (9) operations in compliance with all federal legal | 18 |
| requirements
applicable to wholesale drug distribution.
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| (f) The Department shall consider, at a minimum, the | 20 |
| following factors
in reviewing the qualifications of persons | 21 |
| who engage in wholesale
distribution of prescription drugs in | 22 |
| this State:
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| (1) any conviction of the applicant under any federal, | 24 |
| State, or
local laws relating to drug samples, wholesale or | 25 |
| retail drug distribution,
or distribution of controlled | 26 |
| substances;
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| (2) any felony convictions of the applicant under | 28 |
| federal, State,
or local laws;
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| (3) the applicant's past experience in the manufacture | 30 |
| or
distribution of prescription drugs, including | 31 |
| controlled substances;
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| (4) the furnishing by the applicant of false or | 33 |
| fraudulent material
in any application made in connection | 34 |
| with drug manufacturing or distribution;
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| (5) suspension or revocation by federal, State, or | 36 |
| local government
of any license currently or previously |
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LRB094 18023 RAS 53328 b |
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| held by the applicant for the
manufacture or distribution | 2 |
| of any drug, including controlled substances;
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| (6) compliance with licensing requirements under | 4 |
| previously granted
licenses, if any;
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| (7) compliance with requirements to maintain and make | 6 |
| available to
the Department or to federal, State, or local
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| law enforcement officials those records required by this | 8 |
| 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 | 11 |
| 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 | 14 |
| conform to
wholesale drug distributor licensing guidelines | 15 |
| formally adopted by the
U.S. Food and Drug Administration | 16 |
| (FDA). In case of conflict between
any wholesale drug | 17 |
| distributor licensing requirement imposed by the
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| Department and any FDA wholesale drug distributor | 19 |
| licensing guideline, the
FDA guideline shall control.
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| (g) An agent or employee of any licensed wholesale drug | 21 |
| distributor need
not seek licensure under this Section and may | 22 |
| lawfully possess
pharmaceutical drugs when the agent or | 23 |
| employee is acting in the usual
course of business or | 24 |
| employment.
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| (h) The issuance of a license under this Act shall not | 26 |
| change or
affect tax liability imposed by the State on any | 27 |
| wholesale drug distributor.
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| (i) A license issued under this Act shall not be sold, | 29 |
| 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 |
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LRB094 18023 RAS 53328 b |
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| hours
of premises purporting or appearing to be used by a | 2 |
| wholesale
drug distributor in this State. The duly authorized | 3 |
| investigators shall be
required to show appropriate | 4 |
| identification before given access to a
wholesale drug | 5 |
| distributor's premises and delivery vehicles. Any wholesale
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| drug distributor providing adequate documentation of the most | 7 |
| recent
satisfactory inspection less than 3 years old of the | 8 |
| distributor's
wholesale drug distribution activities and | 9 |
| facilities by either the U.S.
FDA, a State agency, or any | 10 |
| person or entity lawfully designated by a State
agency to | 11 |
| perform an inspection determined to be comparable by the
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| Department shall be exempt from further inspection for a period | 13 |
| of time to
be determined by the Department. The exemption shall | 14 |
| not bar the
Department from initiating an investigation of a | 15 |
| public or governmental
complaint received by the Department | 16 |
| regarding a wholesale drug
distributor. Wholesale drug | 17 |
| distributors shall be given an opportunity to
correct minor | 18 |
| violations determined by these investigations.
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| (b) Wholesale drug distributors may keep records regarding | 20 |
| purchase and
sales transactions at a central location apart | 21 |
| from the principal office of
the wholesale drug distributor or | 22 |
| the location at which the drugs were
stored and from which they | 23 |
| were shipped, provided that the records shall
be made available | 24 |
| 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 | 26 |
| under federal
law applicable to prescription drugs record | 27 |
| keeping.
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| (c) (Blank).
The Department shall employ a person whose | 29 |
| title shall be
Assistant Drug Compliance Coordinator to assist | 30 |
| the Drug Compliance
Coordinator in administering and enforcing | 31 |
| this Act.
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| (Source: P.A. 87-594.)
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