Full Text of SB1739 94th General Assembly
SB1739eng 94TH GENERAL ASSEMBLY
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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 Freedom of Information Act is amended by | 5 |
| changing Section 7 as follows: | 6 |
| (5 ILCS 140/7) (from Ch. 116, par. 207) | 7 |
| Sec. 7. Exemptions.
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| (1) The following shall be exempt from inspection and | 9 |
| copying:
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| (a) Information specifically prohibited from | 11 |
| disclosure by federal or
State law or rules and regulations | 12 |
| adopted under federal or State law.
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| (b) Information that, if disclosed, would constitute a | 14 |
| clearly
unwarranted invasion of personal privacy, unless | 15 |
| the disclosure is
consented to in writing by the individual | 16 |
| subjects of the information. The
disclosure of information | 17 |
| that bears on the public duties of public
employees and | 18 |
| officials shall not be considered an invasion of personal
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| privacy. Information exempted under this subsection (b) | 20 |
| shall include but
is not limited to:
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| (i) files and personal information maintained with | 22 |
| respect to
clients, patients, residents, students or | 23 |
| other individuals receiving
social, medical, | 24 |
| educational, vocational, financial, supervisory or
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| custodial care or services directly or indirectly from | 26 |
| federal agencies
or public bodies;
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| (ii) personnel files and personal information | 28 |
| maintained with
respect to employees, appointees or | 29 |
| elected officials of any public body or
applicants for | 30 |
| those positions;
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| (iii) files and personal information maintained | 32 |
| with respect to any
applicant, registrant or licensee |
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| by any public body cooperating with or
engaged in | 2 |
| professional or occupational registration, licensure | 3 |
| or discipline;
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| (iv) information required of any taxpayer in | 5 |
| connection with the
assessment or collection of any tax | 6 |
| unless disclosure is otherwise required
by State | 7 |
| statute;
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| (v) information revealing the identity of persons | 9 |
| who file complaints
with or provide information to | 10 |
| administrative, investigative, law enforcement
or | 11 |
| penal agencies; provided, however, that identification | 12 |
| of witnesses to
traffic accidents, traffic accident | 13 |
| reports, and rescue reports may be provided
by agencies | 14 |
| of local government, except in a case for which a | 15 |
| criminal
investigation is ongoing, without | 16 |
| constituting a clearly unwarranted per se
invasion of | 17 |
| personal privacy under this subsection; and
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| (vi) the names, addresses, or other personal | 19 |
| information of
participants and registrants in park | 20 |
| district, forest preserve district, and
conservation | 21 |
| district programs.
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| (c) Records compiled by any public body for | 23 |
| administrative enforcement
proceedings and any law | 24 |
| enforcement or correctional agency for
law enforcement | 25 |
| purposes or for internal matters of a public body,
but only | 26 |
| to the extent that disclosure would:
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| (i) interfere with pending or actually and | 28 |
| reasonably contemplated
law enforcement proceedings | 29 |
| conducted by any law enforcement or correctional
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| agency;
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| (ii) interfere with pending administrative | 32 |
| enforcement proceedings
conducted by any public body;
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| (iii) deprive a person of a fair trial or an | 34 |
| impartial hearing;
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| (iv) unavoidably disclose the identity of a | 36 |
| confidential source or
confidential information |
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| furnished only by the confidential source;
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| (v) disclose unique or specialized investigative | 3 |
| techniques other than
those generally used and known or | 4 |
| disclose internal documents of
correctional agencies | 5 |
| related to detection, observation or investigation of
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| incidents of crime or misconduct;
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| (vi) constitute an invasion of personal privacy | 8 |
| under subsection (b) of
this Section;
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| (vii) endanger the life or physical safety of law | 10 |
| enforcement personnel
or any other person; or
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| (viii) obstruct an ongoing criminal investigation.
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| (d) Criminal history record information maintained by | 13 |
| State or local
criminal justice agencies, except the | 14 |
| following which shall be open for
public inspection and | 15 |
| copying:
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| (i) chronologically maintained arrest information, | 17 |
| such as traditional
arrest logs or blotters;
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| (ii) the name of a person in the custody of a law | 19 |
| enforcement agency and
the charges for which that | 20 |
| person is being held;
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| (iii) court records that are public;
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| (iv) records that are otherwise available under | 23 |
| State or local law; or
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| (v) records in which the requesting party is the | 25 |
| individual
identified, except as provided under part | 26 |
| (vii) of
paragraph (c) of subsection (1) of this | 27 |
| Section.
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| "Criminal history record information" means data | 29 |
| identifiable to an
individual and consisting of | 30 |
| descriptions or notations of arrests,
detentions, | 31 |
| indictments, informations, pre-trial proceedings, trials, | 32 |
| or
other formal events in the criminal justice system or | 33 |
| descriptions or
notations of criminal charges (including | 34 |
| criminal violations of local
municipal ordinances) and the | 35 |
| nature of any disposition arising therefrom,
including | 36 |
| sentencing, court or correctional supervision, |
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| rehabilitation and
release. The term does not apply to | 2 |
| statistical records and reports in
which individuals are | 3 |
| not identified and from which
their identities are not | 4 |
| ascertainable, or to information that is for
criminal | 5 |
| investigative or intelligence purposes.
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| (e) Records that relate to or affect the security of | 7 |
| correctional
institutions and detention facilities.
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| (f) Preliminary drafts, notes, recommendations, | 9 |
| memoranda and other
records in which opinions are | 10 |
| expressed, or policies or actions are
formulated, except | 11 |
| that a specific record or relevant portion of a
record | 12 |
| shall not be exempt when the record is publicly cited
and | 13 |
| identified by the head of the public body. The exemption | 14 |
| provided in
this paragraph (f) extends to all those records | 15 |
| of officers and agencies
of the General Assembly that | 16 |
| pertain to the preparation of legislative
documents.
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| (g) Trade secrets and commercial or financial | 18 |
| information obtained from
a person or business where the | 19 |
| trade secrets or information are
proprietary, privileged | 20 |
| or confidential, or where disclosure of the trade
secrets | 21 |
| or information may cause competitive harm, including all
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| information determined to be confidential under Section | 23 |
| 4002 of the
Technology Advancement and Development Act. | 24 |
| Nothing contained in this
paragraph (g) shall be construed | 25 |
| to prevent a person or business from
consenting to | 26 |
| disclosure.
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| (h) Proposals and bids for any contract, grant, or | 28 |
| agreement, including
information which if it were | 29 |
| disclosed would frustrate procurement or give
an advantage | 30 |
| to any person proposing to enter into a contractor | 31 |
| agreement
with the body, until an award or final selection | 32 |
| is made. Information
prepared by or for the body in | 33 |
| preparation of a bid solicitation shall be
exempt until an | 34 |
| award or final selection is made.
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| (i) Valuable formulae,
computer geographic systems,
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| designs, drawings and research data obtained or
produced by |
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| any public body when disclosure could reasonably be | 2 |
| expected to
produce private gain or public loss.
The | 3 |
| exemption for "computer geographic systems" provided in | 4 |
| this paragraph
(i) does not extend to requests made by news | 5 |
| media as defined in Section 2 of
this Act when the | 6 |
| requested information is not otherwise exempt and the only
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| purpose of the request is to access and disseminate | 8 |
| information regarding the
health, safety, welfare, or | 9 |
| legal rights of the general public.
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| (j) Test questions, scoring keys and other examination | 11 |
| data used to
administer an academic examination or | 12 |
| determined the qualifications of an
applicant for a license | 13 |
| or employment.
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| (k) Architects' plans, engineers' technical | 15 |
| submissions, and
other
construction related technical | 16 |
| documents for
projects not constructed or developed in | 17 |
| whole or in part with public funds
and the same for | 18 |
| projects constructed or developed with public funds, but
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| only to the extent
that disclosure would compromise | 20 |
| security, including but not limited to water
treatment | 21 |
| facilities, airport facilities, sport stadiums, convention | 22 |
| centers,
and all government owned, operated, or occupied | 23 |
| buildings.
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| (l) Library circulation and order records identifying | 25 |
| library users with
specific materials.
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| (m) Minutes of meetings of public bodies closed to the
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| public as provided in the Open Meetings Act until the | 28 |
| public body
makes the minutes available to the public under | 29 |
| Section 2.06 of the Open
Meetings Act.
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| (n) Communications between a public body and an | 31 |
| attorney or auditor
representing the public body that would | 32 |
| not be subject to discovery in
litigation, and materials | 33 |
| prepared or compiled by or for a public body in
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| anticipation of a criminal, civil or administrative | 35 |
| proceeding upon the
request of an attorney advising the | 36 |
| public body, and materials prepared or
compiled with |
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| respect to internal audits of public bodies.
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| (o) Information received by a primary or secondary | 3 |
| school, college or
university under its procedures for the | 4 |
| evaluation of faculty members by
their academic peers.
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| (p) Administrative or technical information associated | 6 |
| with automated
data processing operations, including but | 7 |
| not limited to software,
operating protocols, computer | 8 |
| program abstracts, file layouts, source
listings, object | 9 |
| modules, load modules, user guides, documentation
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| pertaining to all logical and physical design of | 11 |
| computerized systems,
employee manuals, and any other | 12 |
| information that, if disclosed, would
jeopardize the | 13 |
| security of the system or its data or the security of
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| materials exempt under this Section.
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| (q) Documents or materials relating to collective | 16 |
| negotiating matters
between public bodies and their | 17 |
| employees or representatives, except that
any final | 18 |
| contract or agreement shall be subject to inspection and | 19 |
| copying.
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| (r) Drafts, notes, recommendations and memoranda | 21 |
| pertaining to the
financing and marketing transactions of | 22 |
| the public body. The records of
ownership, registration, | 23 |
| transfer, and exchange of municipal debt
obligations, and | 24 |
| of persons to whom payment with respect to these | 25 |
| obligations
is made.
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| (s) The records, documents and information relating to | 27 |
| real estate
purchase negotiations until those negotiations | 28 |
| have been completed or
otherwise terminated. With regard to | 29 |
| a parcel involved in a pending or
actually and reasonably | 30 |
| contemplated eminent domain proceeding under
Article VII | 31 |
| of the Code of Civil Procedure, records, documents and
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| information relating to that parcel shall be exempt except | 33 |
| as may be
allowed under discovery rules adopted by the | 34 |
| Illinois Supreme Court. The
records, documents and | 35 |
| information relating to a real estate sale shall be
exempt | 36 |
| until a sale is consummated.
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| (t) Any and all proprietary information and records | 2 |
| related to the
operation of an intergovernmental risk | 3 |
| management association or
self-insurance pool or jointly | 4 |
| self-administered health and accident
cooperative or pool.
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| (u) Information concerning a university's adjudication | 6 |
| of student or
employee grievance or disciplinary cases, to | 7 |
| the extent that disclosure
would reveal the identity of the | 8 |
| student or employee and information
concerning any public | 9 |
| body's adjudication of student or employee grievances
or | 10 |
| disciplinary cases, except for the final outcome of the | 11 |
| cases.
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| (v) Course materials or research materials used by | 13 |
| faculty members.
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| (w) Information related solely to the internal | 15 |
| personnel rules and
practices of a public body.
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| (x) Information contained in or related to | 17 |
| examination, operating, or
condition reports prepared by, | 18 |
| on behalf of, or for the use of a public
body responsible | 19 |
| for the regulation or supervision of financial
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| institutions or insurance companies, unless disclosure is | 21 |
| otherwise
required by State law.
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| (y) Information the disclosure of which is restricted | 23 |
| under Section
5-108 of the Public Utilities Act.
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| (z) Manuals or instruction to staff that relate to | 25 |
| establishment or
collection of liability for any State tax | 26 |
| or that relate to investigations
by a public body to | 27 |
| determine violation of any criminal law.
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| (aa) Applications, related documents, and medical | 29 |
| records received by
the Experimental Organ Transplantation | 30 |
| Procedures Board and any and all
documents or other records | 31 |
| prepared by the Experimental Organ
Transplantation | 32 |
| Procedures Board or its staff relating to applications
it | 33 |
| has received.
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| (bb) Insurance or self insurance (including any | 35 |
| intergovernmental risk
management association or self | 36 |
| insurance pool) claims, loss or risk
management |
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| information, records, data, advice or communications.
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| (cc) Information and records held by the Department of | 3 |
| Public Health and
its authorized representatives relating | 4 |
| to known or suspected cases of
sexually transmissible | 5 |
| disease or any information the disclosure of which
is | 6 |
| restricted under the Illinois Sexually Transmissible | 7 |
| Disease Control Act.
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| (dd) Information the disclosure of which is exempted | 9 |
| under Section 30
of the Radon Industry Licensing Act.
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| (ee) Firm performance evaluations under Section 55 of | 11 |
| the
Architectural, Engineering, and Land Surveying | 12 |
| Qualifications Based
Selection Act.
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| (ff) Security portions of system safety program plans, | 14 |
| investigation
reports, surveys, schedules, lists, data, or | 15 |
| information compiled, collected,
or prepared by or for the | 16 |
| Regional Transportation Authority under Section 2.11
of | 17 |
| the Regional Transportation Authority Act or the St. Clair | 18 |
| County Transit
District under the
Bi-State Transit Safety | 19 |
| Act.
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| (gg) Information the disclosure of which is restricted | 21 |
| and
exempted under Section 50 of the Illinois Prepaid | 22 |
| Tuition Act.
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| (hh) Information the disclosure of which is
exempted | 24 |
| under the State Officials and Employees Ethics Act.
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| (ii) Beginning July 1, 1999, information that would | 26 |
| disclose
or might lead to the disclosure of
secret or | 27 |
| confidential information, codes, algorithms, programs, or | 28 |
| private
keys intended to be used to create electronic or | 29 |
| digital signatures under the
Electronic Commerce Security | 30 |
| Act.
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| (jj) Information contained in a local emergency energy | 32 |
| plan submitted to
a municipality in accordance with a local | 33 |
| emergency energy plan ordinance that
is adopted under | 34 |
| Section 11-21.5-5 of the Illinois Municipal Code.
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| (kk) Information and data concerning the distribution | 36 |
| of
surcharge moneys collected and remitted by wireless |
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| carriers under the Wireless
Emergency Telephone Safety | 2 |
| Act.
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| (ll) Vulnerability assessments, security measures, and | 4 |
| response policies
or plans that are designed to identify, | 5 |
| prevent, or respond to potential
attacks upon a community's | 6 |
| population or systems, facilities, or installations,
the | 7 |
| destruction or contamination of which would constitute a | 8 |
| clear and present
danger to the health or safety of the | 9 |
| community, but only to the extent that
disclosure could | 10 |
| reasonably be expected to jeopardize the effectiveness of | 11 |
| the
measures or the safety of the personnel who implement | 12 |
| them or the public.
Information exempt under this item may | 13 |
| include such things as details
pertaining to the | 14 |
| mobilization or deployment of personnel or equipment, to | 15 |
| the
operation of communication systems or protocols, or to | 16 |
| tactical operations.
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| (mm) Maps and other records regarding the location or | 18 |
| security of a
utility's generation, transmission, | 19 |
| distribution, storage, gathering,
treatment, or switching | 20 |
| facilities.
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| (nn) Law enforcement officer identification | 22 |
| information or
driver
identification
information compiled | 23 |
| by a law enforcement agency or the Department of
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| Transportation
under Section 11-212 of the Illinois | 25 |
| Vehicle Code.
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| (oo) Records and information provided to a residential
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| health care
facility resident sexual assault
and death | 28 |
| review team or the Residential Health Care Facility | 29 |
| Resident Sexual
Assault and Death Review Teams Executive | 30 |
| Council under the Residential Health
Care Facility | 31 |
| Resident Sexual Assault and Death Review Team Act.
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| (pp) Information the disclosure of which is exempted | 33 |
| under Sections 25 and 25a of the Wholesale Prescription | 34 |
| Drug Distribution Protection and Licensing Act of 2005.
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| (2) This Section does not authorize withholding of | 36 |
| information or limit the
availability of records to the public, |
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| except as stated in this Section or
otherwise provided in this | 2 |
| Act.
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| (Source: P.A. 92-16, eff. 6-28-01; 92-241, eff. 8-3-01; 92-281, | 4 |
| eff. 8-7-01; 92-645, eff. 7-11-02; 92-651, eff. 7-11-02; 93-43, | 5 |
| eff. 7-1-03; 93-209, eff. 7-18-03; 93-237, eff. 7-22-03; | 6 |
| 93-325, eff. 7-23-03, 93-422, eff. 8-5-03; 93-577, eff. | 7 |
| 8-21-03; 93-617, eff. 12-9-03.)
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| Section 10. The Regulatory Sunset Act is amended by | 9 |
| changing Section 4.23 as follows:
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| (5 ILCS 80/4.23)
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| Sec. 4.23. Acts and Sections
Act Section repealed on | 12 |
| January 1,
2013. The following Acts and Sections of Acts are
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| Act Section is
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 Funeral Directors and Embalmers Licensing Code.
| 17 |
| The Naprapathic Practice Act.
| 18 |
| The Professional Counselor and Clinical Professional | 19 |
| Counselor
Licensing Act.
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| The Wholesale Prescription Drug Distribution Protection | 21 |
| and Licensing Act of 2005 .
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| Section 2.5 of the Illinois Plumbing License Law.
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| (Source: P.A. 92-586, eff. 6-26-02; 92-641, eff. 7-11-02; | 24 |
| 92-642, eff.
7-11-02; 92-655, eff. 7-16-02; 92-719, eff. | 25 |
| 7-25-02; 92-778, eff. 8-6-02;
92-873, eff. 6-1-03; revised | 26 |
| 1-18-03.)
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| Section 15. The Wholesale Drug Distribution Licensing Act | 28 |
| is amended by changing Sections 1, 10, 15, 20, 25, 50, 55, and | 29 |
| 170 and by adding Sections 25a, 25b, 25c, 25d, 25e, and 25f as | 30 |
| follows:
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| (225 ILCS 120/1) (from Ch. 111, par. 8301-1)
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| (Section scheduled to be repealed on January 1, 2013)
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| Sec. 1. Short title. This Act may be cited as the Wholesale | 2 |
| Prescription Drug Distribution Protection and Licensing Act of | 3 |
| 2005 .
| 4 |
| (Source: P.A. 87-594.)
| 5 |
| (225 ILCS 120/10) (from Ch. 111, par. 8301-10)
| 6 |
| (Section scheduled to be repealed on January 1, 2013)
| 7 |
| Sec. 10. Purpose. The purpose of this Act is to implement | 8 |
| the
Federal Prescription Drug Marketing Act of 1987 (PDMA), | 9 |
| U.S. Pub. L.
100-293, 102 Stat. 95, codified at U.S.C. Sec. 321 | 10 |
| et seq.; and
particularly PDMA requirements that no person or | 11 |
| entity may engage in the
wholesale distribution of human | 12 |
| prescription drugs in any state unless the
person or entity is | 13 |
| licensed by that state in accordance with federally
prescribed | 14 |
| minimum standards, terms, and conditions as set forth in
| 15 |
| guidelines issued by United States Food and Drug Administration | 16 |
| (FDA)
regulations.
| 17 |
| The purpose of this amendatory Act of the 94th General | 18 |
| Assembly is to strengthen existing State requirements | 19 |
| governing the distribution of prescription drugs in order to | 20 |
| protect the drug supply and consumer safety.
| 21 |
| (Source: P.A. 87-594.)
| 22 |
| (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
| 23 |
| (Section scheduled to be repealed on January 1, 2013)
| 24 |
| Sec. 15. Definitions. As used in this Act:
| 25 |
| "Authorized distributor of record" means a wholesale drug | 26 |
| distributor with whom a manufacturer has established an ongoing | 27 |
| relationship to distribute that manufacturer's product. An | 28 |
| ongoing relationship is deemed to exist when a wholesale drug | 29 |
| distributor, including any affiliated group, as defined in | 30 |
| Section 1504 of the Internal Revenue Code, of which the | 31 |
| wholesale distributor is a member:
| 32 |
| (1) is listed on the manufacturer's list and the list | 33 |
| is updated monthly;
| 34 |
| (2) has a written agreement currently in effect with |
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| the manufacturer; or
| 2 |
| (3) has a verifiable account with a line of credit with | 3 |
| the manufacturer and minimal transaction or volume | 4 |
| requirement thresholds as follows: (i) 5,000 sales units | 5 |
| per company within 12 months or (ii) 12 purchases or | 6 |
| invoices from the manufacturer at the manufacturer's | 7 |
| minimum purchasing requirements per invoice within 12 | 8 |
| months.
| 9 |
| "Blood" means whole blood collected from a single donor and | 10 |
| processed
either for transfusion or further manufacturing.
| 11 |
| "Blood component" means that part of blood separated by | 12 |
| physical or
mechanical means.
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| "Board" means the State Board of Pharmacy of the Department | 14 |
| of
Professional Regulation.
| 15 |
| "Department" means the Department of Professional | 16 |
| Regulation.
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| "Director" means the Director of Professional Regulation.
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| "Drug sample" means a unit of a prescription drug that is | 19 |
| not intended to
be sold and is intended to promote the sale of | 20 |
| the drug.
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| "Manufacturer" means anyone who is engaged in the | 22 |
| manufacturing, preparing,
propagating, compounding, | 23 |
| processing, packaging, repackaging, or labeling
of a | 24 |
| prescription drug.
| 25 |
| "Person" means and includes a natural person, partnership, | 26 |
| association or
corporation.
| 27 |
| "Pharmacy distributor" means any pharmacy licensed in this | 28 |
| State or
hospital pharmacy that is engaged in the delivery or | 29 |
| distribution of
prescription drugs either to any other pharmacy | 30 |
| licensed in this State or
to any other person or entity | 31 |
| including, but not limited to, a wholesale
drug distributor | 32 |
| engaged in the delivery or distribution of prescription
drugs | 33 |
| who is involved in the actual, constructive, or attempted | 34 |
| transfer of
a drug in this State to other than the ultimate | 35 |
| consumer except as
otherwise provided for by law.
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| "Prescription drug" means any human drug required by |
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| federal law or
regulation to be dispensed only by a | 2 |
| prescription, including finished
dosage forms and active | 3 |
| ingredients subject to subsection (b) of Section
503 of the | 4 |
| Federal Food, Drug and Cosmetic Act.
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| "Sales unit" means the unit of measure the manufacturer | 6 |
| uses to invoice its customer for the particular product. | 7 |
| "Verifiable account" means: | 8 |
| (1) an account that the manufacturer confirms, in | 9 |
| written or oral form, is assigned to the wholesaler; or | 10 |
| (2) copies of the manufacturer's invoices containing a | 11 |
| printed account number and the name and address of the | 12 |
| wholesaler.
| 13 |
| "Wholesale distribution" or "wholesale distributions" | 14 |
| means distribution
of prescription drugs to persons other than | 15 |
| a consumer or patient, but does
not include any of the | 16 |
| following:
| 17 |
| (a) Intracompany sales, defined as any transaction or | 18 |
| transfer
between any division, subsidiary, parent, or | 19 |
| affiliated or related company
under the common ownership | 20 |
| and control of a corporate entity.
| 21 |
| (b) The purchase or other acquisition by a hospital or | 22 |
| other health
care entity that is a member of a group | 23 |
| purchasing organization of a drug
for its own use from the | 24 |
| group purchasing organization or from other
hospitals or | 25 |
| health care entities that are members of a group | 26 |
| organization.
| 27 |
| (c) The sale, purchase, or trade of a drug or an offer | 28 |
| to sell,
purchase, or trade a drug by a charitable | 29 |
| organization described in
subsection (c)(3) of Section 501 | 30 |
| of the U.S. Internal Revenue Code of 1954
to a nonprofit | 31 |
| affiliate of the organization to the extent otherwise
| 32 |
| permitted by law.
| 33 |
| (d) The sale, purchase, or trade of a drug or an offer | 34 |
| to sell,
purchase, or trade a drug among hospitals or other | 35 |
| health care entities
that are under common control. For | 36 |
| purposes of this Act, "common control"
means the power to |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| direct or cause the direction of the management and
| 2 |
| policies of a person or an organization, whether by | 3 |
| ownership of stock,
voting rights, contract, or otherwise.
| 4 |
| (e) The sale, purchase, or trade of a drug or an offer | 5 |
| to sell,
purchase, or trade a drug for emergency medical | 6 |
| reasons. For purposes of
this Act, "emergency medical | 7 |
| reasons" include transfers of prescription
drugs by a | 8 |
| retail pharmacy to another retail pharmacy to alleviate a
| 9 |
| temporary shortage.
| 10 |
| (f) The sale, purchase, or trade of a drug, an offer to | 11 |
| sell, purchase,
or trade a drug, or the dispensing of a | 12 |
| drug pursuant to a prescription.
| 13 |
| (g) The distribution of drug samples by manufacturers' | 14 |
| representatives
or authorized distributors' | 15 |
| representatives.
| 16 |
| (h) The sale, purchase, or trade of blood and blood | 17 |
| components
intended for transfusion. | 18 |
| (i) Drug returns, when conducted by a hospital, health | 19 |
| care entity, or charitable institution in accordance with | 20 |
| Department rules.
| 21 |
| (j) The sale of minimal quantities of drugs by retail | 22 |
| pharmacies to licensed practitioners for office use.
| 23 |
| "Wholesale drug distributor" means any person or entity | 24 |
| engaged in
wholesale distribution of prescription drugs, | 25 |
| including, but not limited
to, manufacturers; repackers; own | 26 |
| label distributors; jobbers; private
label distributors; | 27 |
| brokers; warehouses, including manufacturers' and
| 28 |
| distributors' warehouses, chain drug warehouses, and wholesale | 29 |
| drug
warehouses; independent wholesale drug traders; and | 30 |
| retail
pharmacies that conduct wholesale distributions, | 31 |
| including, but
not limited to, any pharmacy distributor as | 32 |
| defined in this Section. A
wholesale drug distributor shall not | 33 |
| include any for hire carrier or person
or entity hired solely | 34 |
| to transport prescription drugs.
| 35 |
| (Source: P.A. 87-594.)
|
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| (225 ILCS 120/20) (from Ch. 111, par. 8301-20)
| 2 |
| (Section scheduled to be repealed on January 1, 2013)
| 3 |
| Sec. 20. Prohibited acts.
drug purchases or receipt.
| 4 |
| (a) It shall be unlawful to knowingly tamper with, | 5 |
| counterfeit, adulterate, misbrand, or divert prescription drug | 6 |
| products. Violation of this subsection (a) shall constitute a | 7 |
| Class 4 felony. | 8 |
| (b) It shall be unlawful to knowingly purchase, transfer, | 9 |
| sell, or distribute prescription drugs from or to persons not | 10 |
| authorized to possess such prescription drugs. Violation of | 11 |
| this subsection (b) shall constitute a Class 4 felony. | 12 |
| (c) It shall be unlawful to knowingly purchase, transfer, | 13 |
| sell, or distribute prescription drugs that have been tampered | 14 |
| with, counterfeited, adulterated, misbranded, or diverted. | 15 |
| Violation of this subsection (c) shall constitute a Class 4 | 16 |
| felony. | 17 |
| (d) It shall be unlawful to knowingly forge, counterfeit, | 18 |
| or tamper with any pedigree documentation or other | 19 |
| transactional documentation associated with the purchase, | 20 |
| transfer, delivery, or sale of prescription drugs that is | 21 |
| required by federal or State laws and rules. Violation of this | 22 |
| subsection (d) shall constitute a Class 4 felony.
| 23 |
| It shall be unlawful
for any person or entity to knowingly | 24 |
| purchase or receive any prescription
drug from any source other | 25 |
| than a person or entity licensed under the
laws of this State | 26 |
| or the state of domicile except where otherwise
provided. A | 27 |
| person or entity licensed under the laws of this State shall
| 28 |
| include, but is not limited to, a wholesale distributor, | 29 |
| manufacturer,
pharmacy distributor, or pharmacy. Any person | 30 |
| violating
this Section shall, upon conviction, be adjudged | 31 |
| guilty of a Class C
misdemeanor. A second violation shall | 32 |
| constitute a Class 4 felony.
| 33 |
| (Source: P.A. 87-594.)
| 34 |
| (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
| 35 |
| (Section scheduled to be repealed on January 1, 2013)
|
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| Sec. 25. Wholesale drug distributor licensing | 2 |
| requirements. All
wholesale distributors and pharmacy | 3 |
| distributors, wherever located, who
engage in wholesale | 4 |
| distribution into, out of, or within the State shall be
subject | 5 |
| to the following requirements:
| 6 |
| (a) No person or distribution outlet shall act as a | 7 |
| wholesale drug
distributor without first obtaining a license to | 8 |
| do so from the Department
and paying any reasonable fee | 9 |
| required by the Department.
| 10 |
| (b) The Department may grant a temporary
license when a | 11 |
| wholesale drug distributor first applies for a license to
| 12 |
| operate within this State. A temporary license shall remain | 13 |
| valid
until the Department finds that the applicant
meets or | 14 |
| fails to meet the requirements for regular licensure. | 15 |
| Nevertheless,
no temporary license shall be valid for more than | 16 |
| 90 days from the
date of issuance. Any temporary license issued | 17 |
| under this subsection
shall be renewable for a similar period | 18 |
| of time not to exceed 90 days
under policies and procedures | 19 |
| prescribed by the Department.
| 20 |
| (c) No license shall be issued or renewed for a wholesale | 21 |
| drug
distributor to operate unless the wholesale drug | 22 |
| distributor shall operate
in a manner prescribed by law and | 23 |
| according to the rules and regulations
promulgated by the | 24 |
| Department.
| 25 |
| (d) The Department may require a separate
license for each | 26 |
| facility directly or indirectly owned or operated by the
same | 27 |
| business entity within this State, or for a parent entity with
| 28 |
| divisions, subsidiaries, and affiliate companies within this | 29 |
| State when
operations are conducted at more than one location | 30 |
| and there exists joint
ownership and control among all the | 31 |
| entities.
| 32 |
| (e) As a condition for receiving and renewing any wholesale | 33 |
| drug
distributor license issued under this Act, each applicant | 34 |
| shall satisfy the
Department that it has and will continuously | 35 |
| maintain:
| 36 |
| (1) acceptable storage and handling conditions plus |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| facilities standards;
| 2 |
| (2) minimum liability and other insurance as may be | 3 |
| required under
any applicable federal or State law;
| 4 |
| (3) a security system that includes after hours, | 5 |
| central alarm or
comparable entry detection capability; | 6 |
| restricted premises access; adequate
outside perimeter | 7 |
| lighting; comprehensive employment applicant screening;
| 8 |
| and safeguards against employee theft;
| 9 |
| (4) an electronic, manual, or any other reasonable | 10 |
| system of
records, describing all wholesale distributor | 11 |
| activities governed by this
Act for the 2 year period | 12 |
| following disposition of each product and
reasonably | 13 |
| accessible during regular business hours as defined by the
| 14 |
| Department's rules in any inspection authorized by the | 15 |
| Department;
| 16 |
| (5) officers, directors, managers, and other persons | 17 |
| in charge of
wholesale drug distribution, storage, and | 18 |
| handling who must at all times
demonstrate and maintain | 19 |
| their capability of conducting business according
to sound | 20 |
| financial practices as well as State and federal law;
| 21 |
| (6) complete, updated information, to be provided the | 22 |
| Department
as a condition for obtaining and renewing a | 23 |
| license, about each wholesale
distributor to be licensed | 24 |
| under this Act, including all pertinent licensee
ownership | 25 |
| and other key personnel and facilities information deemed
| 26 |
| necessary for enforcement of this Act. Any changes in this | 27 |
| information
shall be submitted at the time of license | 28 |
| renewal or within 45 days from
the date of the change;
| 29 |
| (7) written policies and procedures that assure | 30 |
| reasonable
wholesale distributor preparation for, | 31 |
| protection against and handling of
any facility security or | 32 |
| operation problems, including, but not limited to,
those | 33 |
| caused by natural disaster or government emergency; | 34 |
| inventory
inaccuracies or product shipping and receiving; | 35 |
| outdated product or other
unauthorized product control; | 36 |
| appropriate disposition of returned goods;
and product |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| recalls;
| 2 |
| (8) sufficient inspection procedures for all incoming | 3 |
| and outgoing
product shipments; and
| 4 |
| (9) operations in compliance with all federal legal | 5 |
| requirements
applicable to wholesale drug distribution.
| 6 |
| (f) The Department shall consider, at a minimum, the | 7 |
| following factors
in reviewing the qualifications of persons | 8 |
| who engage in wholesale
distribution of prescription drugs in | 9 |
| this State:
| 10 |
| (1) any conviction of the applicant under any federal, | 11 |
| State, or
local laws relating to drug samples, wholesale or | 12 |
| retail drug distribution,
or distribution of controlled | 13 |
| substances;
| 14 |
| (2) any felony convictions of the applicant under | 15 |
| federal, State,
or local laws;
| 16 |
| (3) the applicant's past experience in the manufacture | 17 |
| or
distribution of prescription drugs, including | 18 |
| controlled substances;
| 19 |
| (4) the furnishing by the applicant of false or | 20 |
| fraudulent material
in any application made in connection | 21 |
| with drug manufacturing or distribution;
| 22 |
| (5) suspension or revocation by federal, State, or | 23 |
| local government
of any license currently or previously | 24 |
| held by the applicant for the
manufacture or distribution | 25 |
| of any drug, including controlled substances; | 26 |
| (6) any findings of a criminal background and civil | 27 |
| litigation check, which the Department shall be authorized | 28 |
| to conduct in conjunction with the Department of State | 29 |
| Police or an independent 3rd party company or organization | 30 |
| authorized to conduct such searches, of all company | 31 |
| officers, key management, principals, and owners with 10% | 32 |
| or greater interest in the company, the latter applying to | 33 |
| non-publicly held companies only; | 34 |
| (7) any findings of a financial background check, | 35 |
| including a credit history of the company and its key | 36 |
| officers, maintained by an independent 3rd party |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| evaluation organization;
| 2 |
| (8)
(6) compliance with licensing requirements under | 3 |
| previously granted
licenses, if any;
| 4 |
| (9)
(7) compliance with requirements to maintain and | 5 |
| make available to
the Department or to federal, State, or | 6 |
| local
law enforcement officials those records required by | 7 |
| this Act; and
| 8 |
| (10)
(8) any other factors or qualifications the | 9 |
| Department
considers relevant to and consistent with the
| 10 |
| public health and safety, including whether the granting of | 11 |
| the license
would not be in the public interest ; . | 12 |
| (11) The information collected by the Department as | 13 |
| part of the background checks authorized in this subsection | 14 |
| (f) is exempt from the Freedom of Information Act; and
| 15 |
| (12)
(9) All requirements set forth in this subsection | 16 |
| shall conform to
wholesale drug distributor licensing | 17 |
| guidelines formally adopted by the
U.S. Food and Drug | 18 |
| Administration (FDA). In case of conflict between
any | 19 |
| wholesale drug distributor licensing requirement imposed | 20 |
| by the
Department and any FDA wholesale drug distributor | 21 |
| licensing guideline, the
FDA guideline shall control.
| 22 |
| (g) An agent or employee of any licensed wholesale drug | 23 |
| distributor need
not seek licensure under this Section and may | 24 |
| lawfully possess
pharmaceutical drugs when the agent or | 25 |
| employee is acting in the usual
course of business or | 26 |
| employment.
| 27 |
| (h) The issuance of a license under this Act shall not | 28 |
| change or
affect tax liability imposed by the State on any | 29 |
| wholesale drug distributor.
| 30 |
| (i) A license issued under this Act shall not be sold, | 31 |
| transferred, or
assigned in any manner.
| 32 |
| (Source: P.A. 92-586, eff. 6-26-02.)
| 33 |
| (225 ILCS 120/25a new) | 34 |
| (Section scheduled to be repealed on January 1, 2013) | 35 |
| Sec. 25a. Application requirements. |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| (a) An application for licensure or renewal as a wholesale | 2 |
| distributor or an out-of-state wholesale distributor submitted | 3 |
| to the Department must include all of the following:
| 4 |
| (1) The name, full business address, and telephone | 5 |
| number of the applicant. | 6 |
| (2) All trade or business names used by the applicant, | 7 |
| including all affiliated
businesses. | 8 |
| (3) The name, address, and telephone number of a | 9 |
| contact person for each facility used by the applicant for | 10 |
| the storage, handling, and distribution of prescription | 11 |
| drugs. Companies with multiple facilities may designate | 12 |
| one person to serve as the contact person for all of its | 13 |
| facilities, including those of its affiliates. | 14 |
| (4) The type of ownership or operation, such as a | 15 |
| partnership, corporation, or sole proprietorship. | 16 |
| (5) The names of the owner and the operator of the | 17 |
| establishment, including the following: | 18 |
| (A) if an individual, the name of the individual; | 19 |
| (B) if a partnership, the name of each partner and | 20 |
| the name of the partnership; | 21 |
| (C) if a corporation: | 22 |
| (i) the name, address, and title of each | 23 |
| corporate officer and director; | 24 |
| (ii) the name and address of the corporation, | 25 |
| the name and address of the resident agent of the | 26 |
| corporation, and the corporation's state of | 27 |
| incorporation; and | 28 |
| (iii) for non-publicly held companies only, | 29 |
| the name and address of each shareholder that owns | 30 |
| 10% or more of the outstanding stock of the | 31 |
| corporation; | 32 |
| (D) if a sole proprietorship, the full name of the | 33 |
| sole proprietor and the name of the business entity; | 34 |
| and | 35 |
| (E) if a limited liability company: | 36 |
| (i) the name and address of each principal; |
|
|
|
SB1739 Engrossed |
- 21 - |
LRB094 11222 RAS 41944 b |
|
| 1 |
| (ii) the name and address of each manager; and | 2 |
| (iii) the name and address of the limited | 3 |
| liability company, the name and address of the | 4 |
| resident agent of the limited liability company, | 5 |
| and the name of the state in which the limited | 6 |
| liability company was organized.
| 7 |
| (6) A list of all state licenses, registrations, or | 8 |
| permits, including the license, registration, or permit | 9 |
| numbers, issued to the applicant by any other state | 10 |
| licensing authority that authorizes the applicant to | 11 |
| purchase, possess, and distribute prescription drugs. | 12 |
| (7) A list of all disciplinary actions by state and | 13 |
| federal agencies against the company, as well as any | 14 |
| actions against principals, owners, directors, or officers | 15 |
| over the last 7 years. | 16 |
| (8) The number of employees at each facility and | 17 |
| screening procedures for hiring. | 18 |
| (9) The minimum liability insurance limits the company | 19 |
| maintains, including general as well as product liability | 20 |
| insurance. | 21 |
| (10) A full description of each facility or warehouse, | 22 |
| including all locations utilized for prescription drug | 23 |
| storage or distribution. The description should include | 24 |
| the following: | 25 |
| (A) square footage; | 26 |
| (B) security and alarm system description; | 27 |
| (C) terms of lease or ownership; | 28 |
| (D) address; and | 29 |
| (E) temperature and humidity controls. | 30 |
| (11) The tax year of the applicant. | 31 |
| (12) A copy of the deed for the property on which the | 32 |
| applicant's establishment is located, if the establishment | 33 |
| is owned by the applicant, or a copy of the applicant's | 34 |
| lease for the property on which the applicant's | 35 |
| establishment is located that has an original term of not | 36 |
| less than one calendar year, if the establishment is not |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| owned by the applicant. | 2 |
| (13) A description of the applicant's prescription | 3 |
| drug import and export activities. | 4 |
| (14) A description of the applicant's written | 5 |
| procedures as required under Section 25 of this Act.
| 6 |
| (b) The portions of the information required under this | 7 |
| Section that are personally identifiable or are a trade secret, | 8 |
| as defined by the Freedom of Information Act, shall be | 9 |
| maintained by the Department as a trade secret or as | 10 |
| proprietary information and shall be exempt from public | 11 |
| disclosure.
| 12 |
| (225 ILCS 120/25b new) | 13 |
| (Section scheduled to be repealed on January 1, 2013) | 14 |
| Sec. 25b. Required information from drug manufacturer. | 15 |
| Each manufacturer of a prescription drug sold in this State | 16 |
| shall file with the Department a written list of all of the | 17 |
| manufacturer's authorized distributors of record. A | 18 |
| manufacturer shall notify the Department not later than 10 days | 19 |
| after any change to the list. The Department shall publish a | 20 |
| list of all authorized distributors of record on its website. | 21 |
| The Department shall update this list on at least a monthly | 22 |
| basis. | 23 |
| (225 ILCS 120/25c new) | 24 |
| (Section scheduled to be repealed on January 1, 2013) | 25 |
| Sec. 25c. Surety bond. | 26 |
| (a) An applicant for a wholesale distributor license or an | 27 |
| applicant for the renewal of an existing wholesale distributor | 28 |
| license must submit a surety bond of $100,000 or evidence of | 29 |
| other equivalent means of security acceptable to the | 30 |
| Department, such as insurance, an irrevocable letter of credit, | 31 |
| or funds deposited in a trust account or financial institution. | 32 |
| A separate surety bond or other equivalent means of security is | 33 |
| not required for each company's separate locations or for | 34 |
| affiliated companies or groups when these separate locations or |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| affiliated companies or groups are required to apply for or | 2 |
| renew their wholesale distributor license with the Department. | 3 |
| (b) The purpose of the bond or other equivalent means of | 4 |
| security is to secure payment of any administrative penalties | 5 |
| imposed by the Department and any fees or costs incurred by the | 6 |
| Department regarding that license, when those penalties, fees, | 7 |
| or costs are authorized under State law and the licensee fails | 8 |
| to pay within 30 days after the penalty, fee, or cost becomes | 9 |
| final. | 10 |
| (c) The Department may make a claim against the surety bond | 11 |
| or other equivalent means of security until one year after the | 12 |
| wholesale distributor's license ceases to be valid or until 60 | 13 |
| days after any administrative or legal proceeding as authorized | 14 |
| by law that involves the licensee is concluded, including any | 15 |
| appeal, whichever occurs later. The surety bond or other | 16 |
| equivalent means of security must remain in place or in effect | 17 |
| for at least one year after the wholesale distributor's license | 18 |
| ceases to be valid or 60 days after any administrative or legal | 19 |
| proceeding authorized in this Act against the licensee is | 20 |
| concluded, including any appeal, whichever occurs later. | 21 |
| (d) The surety bond requirement may be waived, at the | 22 |
| discretion of the Department, if the wholesale distributor | 23 |
| previously has obtained a comparable surety bond or other | 24 |
| equivalent means of security for the purpose of licensure in | 25 |
| another state where the wholesale distributor possesses a valid | 26 |
| license in good standing. | 27 |
| (e) The Department may accept a surety bond of $25,000 if | 28 |
| the annual gross receipts of the previous tax year for the | 29 |
| wholesale distributor is $10,000,000 or less.
| 30 |
| (225 ILCS 120/25d new) | 31 |
| (Section scheduled to be repealed on January 1, 2013) | 32 |
| Sec. 25d. Wholesale distributor designated representative. | 33 |
| (a) Each wholesale distributor licensed by the Department | 34 |
| must identify a designated representative who is responsible | 35 |
| for the company's compliance with applicable State and federal |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| laws. A designated representative may be a corporate employee | 2 |
| or officer, outside counsel, or outside consulting specialist | 3 |
| with the authority to help ensure compliance and may have | 4 |
| responsibility for multiple licensed facilities. A designated | 5 |
| representative shall not be required to be physically present | 6 |
| at the facility. | 7 |
| (b) A wholesale distributor must notify the Department | 8 |
| within 10 business days of changing its designated | 9 |
| representative. A wholesale distributor may not operate for | 10 |
| more than 30 business days without a designated representative | 11 |
| under a wholesale distributor's license without appointing | 12 |
| another designated representative and notifying the Department | 13 |
| of the identity of the new designated representative.
| 14 |
| (225 ILCS 120/25e new) | 15 |
| (Section scheduled to be repealed on January 1, 2013) | 16 |
| Sec. 25e. Pedigree. | 17 |
| (a) Each person who is engaged in the wholesale | 18 |
| distribution of a drug subject to this Act and who is not the | 19 |
| manufacturer or an authorized distributor of record of the drug | 20 |
| shall provide to each wholesale distributor of the drug, | 21 |
| including each distribution to an authorized distributor of | 22 |
| record or to a retail pharmacy, before the sale is made to the | 23 |
| wholesale distributor, a statement or record that identifies by | 24 |
| date each previous sale of the drug starting with the last | 25 |
| authorized distributor of record or the manufacturer if the | 26 |
| drug has not been purchased previously by an authorized | 27 |
| distributor of record, the proprietary and established name of | 28 |
| the drug, dosage, container size, number of containers, the lot | 29 |
| or control number of the drug, and the business name and | 30 |
| address of all parties identified in the statement. | 31 |
| (b) Notwithstanding subsection (a) of this Section, a | 32 |
| repackager or a manufacturer that repackages a drug subject to | 33 |
| the provisions of this Act and who is not an authorized | 34 |
| distributor of record, shall be subject to the requirements of | 35 |
| that subsection (a). |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| (c) Notwithstanding subsection (a) of this Section, each | 2 |
| person who is engaged in the wholesale distribution of a | 3 |
| specified drug who did not purchase the specified drug directly | 4 |
| from the manufacturer must provide to each wholesale | 5 |
| distributor of the specified drug, including each distribution | 6 |
| to an authorized distributor of record or to a retail pharmacy, | 7 |
| a statement or record that identifies by date each previous | 8 |
| sale of the specific unit of specified drug back to the | 9 |
| manufacturer of the specified drug, the proprietary and | 10 |
| established name of the drug, dosage, container size, number of | 11 |
| containers, the lot or control numbers of the specific unit of | 12 |
| the specified drug, and the business name and address of all | 13 |
| parties identified in the statement. | 14 |
| (d) For each drug specified on the list, a distributor must | 15 |
| provide to each wholesale distributor, including each | 16 |
| distribution to an authorized distributor of record or to a | 17 |
| retail pharmacy, to whom it sells the specified drug a written | 18 |
| statement on the invoice that states the following: | 19 |
| (1) if the establishment is not a member of an | 20 |
| affiliated group, "This establishment purchased the | 21 |
| specific unit of the specified drug directly from the | 22 |
| manufacturer."; or | 23 |
| (2) if the establishment is a member of an affiliated | 24 |
| group, "This establishment or a member of my affiliated | 25 |
| group purchased the specific unit of the specified drug | 26 |
| directly from the manufacturer.".
| 27 |
| (e) As used in this Section, the term "specified drug" | 28 |
| means a prescription drug on a national list of prescription | 29 |
| drugs considered to be potential targets for adulteration, | 30 |
| counterfeiting, or diversion. This national list will be | 31 |
| created by a national drug advisory coalition in conjunction | 32 |
| with the U.S. Food and Drug Administration and other | 33 |
| stakeholders, including, but not limited to, wholesalers, | 34 |
| manufacturers, pharmacy, and appropriate state government | 35 |
| agencies responsible for regulating the sale or distribution of | 36 |
| prescription drugs. The Department shall notify and provide |
|
|
|
SB1739 Engrossed |
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LRB094 11222 RAS 41944 b |
|
| 1 |
| wholesale distributors with the national list of specified | 2 |
| drugs as prescription drugs are added to or removed from the | 3 |
| list. | 4 |
| (f) The Department shall allow for an effective, unique | 5 |
| electronic product identification tracking system for drugs | 6 |
| subject to this Act to be implemented by, among others, | 7 |
| manufacturers, repackagers, pharmacies, and wholesale | 8 |
| distributors of such products. The system shall be designed to | 9 |
| deter and detect counterfeiting and to provide a means for | 10 |
| prescription drug product manufacturers, repackagers, | 11 |
| distributors, and pharmacies to authenticate the product. The | 12 |
| tracking system shall be implemented by December 31, 2010 and, | 13 |
| once implemented, shall replace the requirements of this | 14 |
| Section. The tracking system shall be deemed to be readily | 15 |
| available and in place only upon the availability of a | 16 |
| standardized system capable of being used on a wide scale | 17 |
| across the entire healthcare industry, which includes | 18 |
| manufacturers, wholesale distributors, and pharmacies.
| 19 |
| (225 ILCS 120/25f new) | 20 |
| (Section scheduled to be repealed on January 1, 2013) | 21 |
| Sec. 25f. Due diligence review by purchasers.
Prior to | 22 |
| purchasing any prescription drugs from another wholesale | 23 |
| distributor, the purchasing wholesale distributor shall obtain | 24 |
| all of the following information from the selling wholesale | 25 |
| distributor: | 26 |
| (1) A listing of the states that the company is | 27 |
| domiciled in and shipping into and copies of all current | 28 |
| State and federal regulatory licenses and registrations | 29 |
| that authorize the selling wholesaler to purchase, | 30 |
| possess, and distribute prescription drugs. | 31 |
| (2) The company's most recent facility inspection | 32 |
| report. | 33 |
| (A) A wholesale distributor may rely upon the | 34 |
| licensure authority's most recent inspection report of | 35 |
| the selling wholesale distributor to satisfy the |
|
|
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| 1 |
| requirement of this paragraph (2). The licensure | 2 |
| authority, when requested, shall provide to a | 3 |
| purchasing wholesaler documentation that demonstrates | 4 |
| that the selling wholesaler had a satisfactory | 5 |
| inspection. | 6 |
| (B) If the Department has failed to conduct a | 7 |
| physical inspection of the selling wholesaler as | 8 |
| required under Section 25c, then the purchasing | 9 |
| wholesaler shall, before the initial purchase of any | 10 |
| drug from that selling wholesaler and at least once | 11 |
| every 3 years thereafter, inspect the selling | 12 |
| wholesale distributor's licensed establishment in | 13 |
| order to document that it has in place policies and | 14 |
| procedures relating to the distribution of drugs, the | 15 |
| appropriate temperature controlled environment for | 16 |
| drugs requiring temperature control, an alarm system, | 17 |
| appropriate access restrictions, and procedures to | 18 |
| ensure that records related to the wholesale | 19 |
| distribution of prescription drugs are maintained as | 20 |
| required by law. | 21 |
| (3) Information regarding the general and product | 22 |
| liability insurance the company maintains. | 23 |
| (4) A list of all corporate officers. | 24 |
| (5) A list of all owners of greater than 10% of the | 25 |
| company, unless it is a publicly held company. | 26 |
| (6) If the selling wholesale distributor claims to be | 27 |
| an authorized distributor of record, a written statement | 28 |
| from the company stating that it is an authorized | 29 |
| distributor of record and the basis on which this status | 30 |
| was given. | 31 |
| (7) A list of all disciplinary actions by State and | 32 |
| federal agencies against the company, as well as | 33 |
| principals, owners, and officers, over the last 7 years or | 34 |
| since the company was first licensed. | 35 |
| (8) A description, including the address, dimensions, | 36 |
| and other relevant information, of each facility or |
|
|
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| 1 |
| warehouse that the company uses for drug storage and | 2 |
| distribution. | 3 |
| (9) A description and listing of all drug import and | 4 |
| export activities of the company. | 5 |
| (10) A description of the process the company uses to | 6 |
| validate and certify its suppliers and purchases, | 7 |
| including the supplier's status as an authorized | 8 |
| distributor of record. | 9 |
| (11) A description of the company's systems and | 10 |
| procedures for prompt reporting to appropriate State and | 11 |
| federal authorities and manufacturers of any suspected | 12 |
| counterfeit, stolen, or otherwise unlawful prescription | 13 |
| drug products or buyers or sellers of the same.
| 14 |
| (225 ILCS 120/50) (from Ch. 111, par. 8301-50)
| 15 |
| (Section scheduled to be repealed on January 1, 2013)
| 16 |
| Sec. 50. Inspection powers; access to records.
| 17 |
| (a) The Department shall conduct a physical inspection of | 18 |
| each in-State applicant's facility prior to issuing a license | 19 |
| or, for a wholesale distributor with a valid license on the | 20 |
| effective date of this amendatory Act of the 94th General | 21 |
| Assembly, prior to issuing a renewal, with regular periodic | 22 |
| inspections conducted thereafter, no more than 3 years | 23 |
| following the last inspection. | 24 |
| Any pharmacy investigator authorized by the Department
has | 25 |
| the right of entry for inspection during normal business hours
| 26 |
| of premises purporting or appearing to be used by a wholesale
| 27 |
| drug distributor in this State. The duly authorized | 28 |
| investigators shall be
required to show appropriate | 29 |
| identification before given access to a
wholesale drug | 30 |
| distributor's premises and delivery vehicles. Any wholesale
| 31 |
| drug distributor providing adequate documentation of the most | 32 |
| recent
satisfactory inspection less than 3 years old of the | 33 |
| distributor's
wholesale drug distribution activities and | 34 |
| facilities by either the U.S.
FDA, a State agency, or any | 35 |
| person or entity lawfully designated by a State
agency to |
|
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| perform an inspection determined to be comparable by the
| 2 |
| Department shall be exempt from further inspection for a period | 3 |
| of time to
be determined by the Department. The exemption shall | 4 |
| not bar
| 5 |
| At any time, the
Department may initiate
from initiating an | 6 |
| investigation of a public or governmental
complaint received by | 7 |
| the Department regarding a wholesale drug
distributor. | 8 |
| Wholesale drug distributors shall be given an opportunity to
| 9 |
| correct minor violations determined by these investigations.
| 10 |
| (b) Wholesale drug distributors may keep records regarding | 11 |
| purchase and
sales transactions at a central location apart | 12 |
| from the principal office of
the wholesale drug distributor or | 13 |
| the location at which the drugs were
stored and from which they | 14 |
| were shipped, provided that the records shall
be made available | 15 |
| for inspection within 2 working days of a request by the
| 16 |
| Department. The records may be kept in any form permissible | 17 |
| under federal
law applicable to prescription drugs record | 18 |
| keeping.
| 19 |
| (c) The Department shall employ a person whose title shall | 20 |
| be
Assistant Drug Compliance Coordinator to assist the Drug | 21 |
| Compliance
Coordinator in administering and enforcing this | 22 |
| Act.
| 23 |
| (d) The Department must make publicly available on its | 24 |
| website the dates of the first and most recent inspections of | 25 |
| each wholesale distributor.
| 26 |
| (Source: P.A. 87-594.)
| 27 |
| (225 ILCS 120/55) (from Ch. 111, par. 8301-55)
| 28 |
| (Section scheduled to be repealed on January 1, 2013)
| 29 |
| Sec. 55. Discipline; grounds.
| 30 |
| (a) The Department may refuse to issue, restore, or renew, | 31 |
| or may revoke,
suspend, place on probation, reprimand or take | 32 |
| other disciplinary action as
the Department may deem proper for | 33 |
| any of the following reasons:
| 34 |
| (1) Violation of this Act or its rules.
| 35 |
| (2) Aiding or assisting another person in violating any |
|
|
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| 1 |
| provision of
this Act or its rules.
| 2 |
| (3) Failing, within 60 days, to respond to a written | 3 |
| requirement made by
the Department for information.
| 4 |
| (4) Engaging in dishonorable, unethical, or | 5 |
| unprofessional conduct of a
character likely to deceive, | 6 |
| defraud, or harm the public. This includes
violations of | 7 |
| "good faith" as defined by the Illinois Controlled | 8 |
| Substances
Act and applies to all prescription drugs.
| 9 |
| (5) Discipline by another U.S. jurisdiction or foreign | 10 |
| nation, if at
least one of the grounds for the discipline | 11 |
| is the same or substantially
equivalent to those set forth | 12 |
| in this Act.
| 13 |
| (6) Selling or engaging in the sale of drug samples | 14 |
| provided at no cost
by drug manufacturers.
| 15 |
| (7) Conviction of the applicant or licensee, or any | 16 |
| officer, director,
manager or shareholder who owns more | 17 |
| than 5% of stock, in State or federal
court of any crime | 18 |
| that is a felony.
| 19 |
| (8) Habitual or excessive use or addiction to alcohol, | 20 |
| narcotics,
stimulants, or any other chemical agent or drug | 21 |
| that results in the
inability to function with reasonable | 22 |
| judgment, skill, or safety.
| 23 |
| (b) The Department may refuse to issue, restore, or renew, | 24 |
| or may
revoke, suspend, place on probation, reprimand or take | 25 |
| other disciplinary
action as the Department may deem property | 26 |
| including fines not to exceed
$1000 for any of the following | 27 |
| reasons:
| 28 |
| (1) Material misstatement in furnishing information to | 29 |
| the Department.
| 30 |
| (2) Making any misrepresentation for the purpose of | 31 |
| obtaining a license.
| 32 |
| (3) A finding by the Department that the licensee, | 33 |
| after having his
or her license placed on probationary | 34 |
| status, has violated the terms of
probation.
| 35 |
| (4) A finding that licensure or registration has been | 36 |
| applied for or
obtained by fraudulent means.
|
|
|
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| 1 |
| (5) Willfully making or filing false records or | 2 |
| reports.
| 3 |
| (6) A finding of a substantial discrepancy in a | 4 |
| Department audit
of a prescription drug, including a | 5 |
| controlled substance as that term is
defined in this Act or | 6 |
| in the Illinois Controlled Substances Act.
| 7 |
| (c) The Department may refuse to issue or may suspend the | 8 |
| license or
registration of any person who fails to file a | 9 |
| return, or to pay the tax,
penalty or interest shown in a filed | 10 |
| return, or to pay any final assessment
of tax, penalty or | 11 |
| interest, as required by any tax Act administered by the
| 12 |
| Illinois Department of Revenue, until the time the requirements | 13 |
| of
the tax Act are satisfied.
| 14 |
| (d) The Department shall revoke the license or certificate | 15 |
| of
registration issued under this Act or any prior Act of
this | 16 |
| State of any person who has been convicted a second time of | 17 |
| committing
any felony under the Illinois Controlled Substances | 18 |
| Act or who
has been convicted a second time of committing a | 19 |
| Class 1 felony under
Sections 8A-3 and 8A-6 of the Illinois | 20 |
| Public Aid Code. A
person whose license or certificate of | 21 |
| registration issued under
this Act or any prior Act of this | 22 |
| State is revoked under this
subsection (c) shall be prohibited | 23 |
| from engaging in the practice of
pharmacy in this State.
| 24 |
| (e) The Department shall notify the appropriate person upon | 25 |
| license suspension, revocation, expiration, or other relevant | 26 |
| action and make such actions publicly available on its website | 27 |
| within 5 working days.
| 28 |
| (Source: P.A. 87-594.)
| 29 |
| (225 ILCS 120/170) (from Ch. 111, par. 8301-170)
| 30 |
| (Section scheduled to be repealed on January 1, 2013)
| 31 |
| Sec. 170. Penalties. Any person who is found to have | 32 |
| violated
any provision of this Act , except as provided in | 33 |
| Section 20, is guilty of a Class A misdemeanor. On
conviction | 34 |
| of a second or subsequent offense, the violator shall
be guilty | 35 |
| of a Class 4 felony. All criminal fines, monies, or
property |
|
|
|
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| 1 |
| collected or received by the Department under this Section
or | 2 |
| any other State or federal statute, including, but not limited
| 3 |
| to, property forfeited to the Department under Section 505 of | 4 |
| the
Illinois Controlled Substances Act, shall be deposited into | 5 |
| the
Professional Regulation Evidence Fund.
| 6 |
| (Source: P.A. 87-594.)
|
|
|
|
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| 1 |
|
INDEX
| 2 |
|
Statutes amended in order of appearance
|
| 3 |
| 5 ILCS 140/7 |
from Ch. 116, par. 207 |
| 4 |
| 5 ILCS 80/4.23 |
|
| 5 |
| 225 ILCS 120/1 |
from Ch. 111, par. 8301-1 |
| 6 |
| 225 ILCS 120/10 |
from Ch. 111, par. 8301-10 |
| 7 |
| 225 ILCS 120/15 |
from Ch. 111, par. 8301-15 |
| 8 |
| 225 ILCS 120/20 |
from Ch. 111, par. 8301-20 |
| 9 |
| 225 ILCS 120/25 |
from Ch. 111, par. 8301-25 |
| 10 |
| 225 ILCS 120/25a new |
|
| 11 |
| 225 ILCS 120/25b new |
|
| 12 |
| 225 ILCS 120/25c new |
|
| 13 |
| 225 ILCS 120/25d new |
|
| 14 |
| 225 ILCS 120/25e new |
|
| 15 |
| 225 ILCS 120/25f new |
|
| 16 |
| 225 ILCS 120/50 |
from Ch. 111, par. 8301-50 |
| 17 |
| 225 ILCS 120/55 |
from Ch. 111, par. 8301-55 |
| 18 |
| 225 ILCS 120/170 |
from Ch. 111, par. 8301-170 |
| |
|