State of Illinois
92nd General Assembly
Legislation

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[ Introduced ][ Engrossed ][ Senate Amendment 001 ]


92_SB1685enr

 
SB1685 Enrolled                                LRB9215594ACcd

 1        AN ACT concerning the regulation of professions.

 2        Be it enacted by the People of  the  State  of  Illinois,
 3    represented in the General Assembly:

 4        Section  5.  The  Regulatory  Sunset  Act  is  amended by
 5    changing Section 4.13 and adding Section 4.23 as follows:

 6        (5 ILCS 80/4.13) (from Ch. 127, par. 1904.13)
 7        Sec. 4.13.  Acts repealed  on  December  31,  2002.   The
 8    following Acts are repealed on December 31, 2002:
 9        The Environmental Health Practitioner Licensing Act.
10        The Naprapathic Practice Act.
11        The Wholesale Drug Distribution Licensing Act.
12        The Dietetic and Nutrition Services Practice Act.
13        The Funeral Directors and Embalmers Licensing Code.
14        The  Professional  Counselor  and  Clinical  Professional
15    Counselor Licensing Act.
16    (Source: P.A. 88-45; 89-61, eff. 6-30-95; revised 8-22-01.)

17        (5 ILCS 80/4.23 new)
18        Sec.  4.23.   Act  repealed  on  January  1,  2013.   The
19    following Act is repealed on January 1, 2013:
20        The Wholesale Drug Distribution Licensing Act.

21        Section  10.   The  Wholesale Drug Distribution Licensing
22    Act is amended by changing Sections 25 and 35 as follows:

23        (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
24        (Section scheduled to be repealed on December 31, 2002)
25        Sec.   25.    Wholesale   drug   distributor    licensing
26    requirements.    All   wholesale  distributors  and  pharmacy
27    distributors,  wherever  located,  who  engage  in  wholesale
28    distribution into, out of,  or  within  the  State  shall  be
 
SB1685 Enrolled             -2-                LRB9215594ACcd
 1    subject to the following requirements:
 2        (a)  No  person  or  distribution  outlet  shall act as a
 3    wholesale drug distributor without first obtaining a  license
 4    to  do  so  from the Department and paying any reasonable fee
 5    required by the Department, the fee not to  exceed  $200  per
 6    year.
 7        (b)  The  Department may grant a temporary license when a
 8    wholesale drug distributor first applies  for  a  license  to
 9    operate  within this State.  A temporary license shall remain
10    valid until the Department finds that the applicant meets  or
11    fails   to  meet  the  requirements  for  regular  licensure.
12    Nevertheless, no temporary license shall be  valid  for  more
13    than  90  days  from  the  date  of  issuance.  Any temporary
14    license issued under this subsection shall be renewable for a
15    similar period of time not to exceed 90 days  under  policies
16    and procedures prescribed by the Department.
17        (c)  No   license  shall  be  issued  or  renewed  for  a
18    wholesale drug distributor to operate  unless  the  wholesale
19    drug  distributor shall operate in a manner prescribed by law
20    and according to the rules and regulations promulgated by the
21    Department.
22        (d)  The Department may require a  separate  license  for
23    each facility directly or indirectly owned or operated by the
24    same  business  entity  within  this  State,  or for a parent
25    entity with divisions, subsidiaries, and affiliate  companies
26    within  this State when operations are conducted at more than
27    one location and there exists  joint  ownership  and  control
28    among all the entities.
29        (e)  As  a  condition  for  receiving  and  renewing  any
30    wholesale  drug  distributor  license  issued under this Act,
31    each applicant shall satisfy the Department that it  has  and
32    will continuously maintain:
33             (1)  acceptable storage and handling conditions plus
34        facilities standards;
 
SB1685 Enrolled             -3-                LRB9215594ACcd
 1             (2)  minimum liability and other insurance as may be
 2        required under any applicable federal or State law;
 3             (3)  a  security  system  that includes after hours,
 4        central alarm or comparable entry  detection  capability;
 5        restricted  premises  access;  adequate outside perimeter
 6        lighting; comprehensive employment  applicant  screening;
 7        and safeguards against employee theft;
 8             (4)  an  electronic, manual, or any other reasonable
 9        system of records, describing all  wholesale  distributor
10        activities  governed  by  this  Act for the 2 year period
11        following disposition  of  each  product  and  reasonably
12        accessible  during  regular  business hours as defined by
13        the Department's rules in any  inspection  authorized  by
14        the Department;
15             (5)  officers,   directors,   managers,   and  other
16        persons  in  charge  of  wholesale   drug   distribution,
17        storage,  and  handling who must at all times demonstrate
18        and maintain  their  capability  of  conducting  business
19        according  to  sound financial practices as well as State
20        and federal law;
21             (6)  complete, updated information, to  be  provided
22        the  Department as a condition for obtaining and renewing
23        a  license,  about  each  wholesale  distributor  to   be
24        licensed under this Act, including all pertinent licensee
25        ownership   and   other   key  personnel  and  facilities
26        information deemed necessary for enforcement of this Act.
27        Any changes in this information shall be submitted at the
28        time of license renewal or within 45 days from  the  date
29        of the change;
30             (7)  written  policies  and  procedures  that assure
31        reasonable   wholesale   distributor   preparation   for,
32        protection against and handling of any facility  security
33        or  operation  problems,  including,  but not limited to,
34        those caused by natural disaster or government emergency;
 
SB1685 Enrolled             -4-                LRB9215594ACcd
 1        inventory inaccuracies or product shipping and receiving;
 2        outdated product or other unauthorized  product  control;
 3        appropriate  disposition  of  returned goods; and product
 4        recalls;
 5             (8)  sufficient  inspection   procedures   for   all
 6        incoming and outgoing product shipments; and
 7             (9)  operations in compliance with all federal legal
 8        requirements applicable to wholesale drug distribution.
 9        (f)  The  Department  shall  consider,  at a minimum, the
10    following factors in reviewing the qualifications of  persons
11    who engage in wholesale distribution of prescription drugs in
12    this State:
13             (1)  any  conviction  of  the  applicant  under  any
14        federal,  State,  or local laws relating to drug samples,
15        wholesale or retail drug distribution, or distribution of
16        controlled substances;
17             (2)  any felony convictions of the  applicant  under
18        federal, State, or local laws;
19             (3)  the   applicant's   past   experience   in  the
20        manufacture  or  distribution  of   prescription   drugs,
21        including controlled substances;
22             (4)  the  furnishing  by  the  applicant of false or
23        fraudulent material in any application made in connection
24        with drug manufacturing or distribution;
25             (5)  suspension or revocation by federal, State,  or
26        local  government  of any license currently or previously
27        held by the applicant for the manufacture or distribution
28        of any drug, including controlled substances;
29             (6)  compliance with  licensing  requirements  under
30        previously granted licenses, if any;
31             (7)  compliance  with  requirements  to maintain and
32        make available to the Department or to federal, State, or
33        local law enforcement officials those records required by
34        this Act; and
 
SB1685 Enrolled             -5-                LRB9215594ACcd
 1             (8)  any  other  factors   or   qualifications   the
 2        Department  considers relevant to and consistent with the
 3        public health and safety, including whether the  granting
 4        of the license would not be in the public interest.
 5             (9)  All  requirements  set forth in this subsection
 6        shall conform to  wholesale  drug  distributor  licensing
 7        guidelines  formally  adopted  by  the U.S. Food and Drug
 8        Administration (FDA).  In case of  conflict  between  any
 9        wholesale  drug distributor licensing requirement imposed
10        by the Department and any FDA wholesale drug  distributor
11        licensing guideline, the FDA guideline shall control.
12        (g)  An  agent or employee of any licensed wholesale drug
13    distributor need not seek licensure under  this  Section  and
14    may  lawfully  possess pharmaceutical drugs when the agent or
15    employee is  acting  in  the  usual  course  of  business  or
16    employment.
17        (h)  The  issuance  of a license under this Act shall not
18    change or affect tax liability imposed by the  State  on  any
19    wholesale drug distributor.
20        (i)  A  license  issued under this Act shall not be sold,
21    transferred, or assigned in any manner.
22    (Source: P.A. 87-594.)

23        (225 ILCS 120/35) (from Ch. 111, par. 8301-35)
24        (Section scheduled to be repealed on December 31, 2002)
25        Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
26        (a)  The Department shall provide by rule for a  schedule
27    of  fees  for the administration and enforcement of this Act,
28    including but not limited to original licensure, renewal, and
29    restoration. The fees shall be nonrefundable.  The  following
30    fees   shall  be  imposed  by  the  Department  and  are  not
31    refundable.
32             (1)  The fee for application for  a  certificate  of
33        registration as a wholesale drug distributor is $200.
 
SB1685 Enrolled             -6-                LRB9215594ACcd
 1             (2)  The  fee  for  the  renewal of a certificate of
 2        registration as a wholesale drug distributor is $200  per
 3        year.
 4             (3)  The  fee  for  the change of person responsible
 5        for drugs is $50.
 6             (4)  The fee for the issuance of a duplicate license
 7        to replace a license that has been lost or  destroyed  is
 8        $25.
 9             (5)  The  fee  for  certification  of a registrant's
10        record for any purpose is $25.
11             (6)  The fee for a roster of licensed wholesale drug
12        distributors shall be the actual cost  of  producing  the
13        roster.
14             (7)  The   fee   for   wholesale   drug  distributor
15        licensing,   disciplinary,   or   investigative   records
16        obtained under subpoena is $1 per page.
17        (b)  All fees collected under this Act shall be deposited
18    into the Illinois State Pharmacy Disciplinary Fund and  shall
19    be  appropriated  to  the  Department  for  the  ordinary and
20    contingent expenses of the Department in  the  administration
21    of this Act. All moneys received by the Department under this
22    Act  shall  be  deposited  into  the  Illinois State Pharmacy
23    Disciplinary Fund in the State Treasury  and  shall  be  used
24    only  for  the  following purposes: (i) by the State Board of
25    Pharmacy in the exercise of its powers and performance of its
26    duties, as such use  is  made  by  the  Department  upon  the
27    recommendations  of  the  State  Board  of Pharmacy, (ii) for
28    costs directly related to license renewal of persons licensed
29    under this Act, and (iii) for direct and  allocable  indirect
30    costs  related  to  the  public purposes of the Department of
31    Professional  Regulation.   Moneys  in  the   Fund   may   be
32    transferred   to   the  Professions  Indirect  Cost  Fund  as
33    authorized  by  Section  2105-300  of   the   Department   of
34    Professional Regulation Law (20 ILCS 2105/2105-300).
 
SB1685 Enrolled             -7-                LRB9215594ACcd
 1        The  moneys  deposited  into  the Illinois State Pharmacy
 2    Disciplinary Fund shall be invested to  earn  interest  which
 3    shall accrue to the Fund.
 4        The  Department shall present to the Board for its review
 5    and comment all  appropriation  requests  from  the  Illinois
 6    State  Pharmacy Disciplinary Fund.  The Department shall give
 7    due consideration to any comments  of  the  Board  in  making
 8    appropriation requests.
 9        (c)  Any  person who delivers a check or other payment to
10    the Department that is returned to the Department  unpaid  by
11    the financial institution upon which it is drawn shall pay to
12    the Department, in addition to the amount already owed to the
13    Department,  a  fine  of  $50.    The  fines  imposed by this
14    Section are in addition  to  any  other  discipline  provided
15    under  this  Act  for  unlicensed  practice  or practice on a
16    nonrenewed license.  The Department shall notify  the  person
17    that  payment  of  fees  and  fines  shall  be  paid  to  the
18    Department  by  certified  check  or  money  order  within 30
19    calendar days of the notification.  If, after the  expiration
20    of  30 days from the date of the notification, the person has
21    failed to submit the  necessary  remittance,  the  Department
22    shall  automatically  terminate the license or certificate or
23    deny the application, without hearing.  If, after termination
24    or denial, the person seeks a license or certificate,  he  or
25    she shall apply to the Department for restoration or issuance
26    of  the license or certificate and pay all fees and fines due
27    to the Department.  The Department may establish  a  fee  for
28    the processing of an application for restoration of a license
29    or  certificate  to  pay  all  expenses  of  processing  this
30    application.  The Director may waive the fines due under this
31    Section in individual cases where the Director finds that the
32    fines would be unreasonable or unnecessarily burdensome.
33        (d)  The  Department shall maintain a roster of the names
34    and addresses of all registrants and  of  all  persons  whose
 
SB1685 Enrolled             -8-                LRB9215594ACcd
 1    licenses  have  been suspended or revoked.  This roster shall
 2    be available upon written request and payment of the required
 3    fee.
 4    (Source: P.A. 91-239, eff. 1-1-00; 92-146, eff. 1-1-02.)

 5        Section 99.  Effective date.  This Act takes effect  upon
 6    becoming law.

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