State of Illinois
92nd General Assembly
Legislation

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92_SB1685sam001











                                             LRB9215594ACpkam

 1                    AMENDMENT TO SENATE BILL 1685

 2        AMENDMENT NO.     .  Amend Senate Bill 1685  on  page  1,
 3    immediately below line 20, by inserting the following:

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

 6        (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
 7        (Section scheduled to be repealed on December 31, 2002)
 8        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
12    subject to the following requirements:
13        (a)  No  person  or  distribution  outlet  shall act as a
14    wholesale drug distributor without first obtaining a  license
15    to  do  so  from the Department and paying any reasonable fee
16    required by the Department, the fee not to  exceed  $200  per
17    year.
18        (b)  The  Department may grant a temporary license when a
19    wholesale drug distributor first applies  for  a  license  to
20    operate  within this State.  A temporary license shall remain
21    valid until the Department finds that the applicant meets  or
22    fails   to  meet  the  requirements  for  regular  licensure.
 
                            -2-              LRB9215594ACpkam
 1    Nevertheless, no temporary license shall be  valid  for  more
 2    than  90  days  from  the  date  of  issuance.  Any temporary
 3    license issued under this subsection shall be renewable for a
 4    similar period of time not to exceed 90 days  under  policies
 5    and procedures prescribed by the Department.
 6        (c)  No   license  shall  be  issued  or  renewed  for  a
 7    wholesale drug distributor to operate  unless  the  wholesale
 8    drug  distributor shall operate in a manner prescribed by law
 9    and according to the rules and regulations promulgated by the
10    Department.
11        (d)  The Department may require a  separate  license  for
12    each facility directly or indirectly owned or operated by the
13    same  business  entity  within  this  State,  or for a parent
14    entity with divisions, subsidiaries, and affiliate  companies
15    within  this State when operations are conducted at more than
16    one location and there exists  joint  ownership  and  control
17    among all the entities.
18        (e)  As  a  condition  for  receiving  and  renewing  any
19    wholesale  drug  distributor  license  issued under this Act,
20    each applicant shall satisfy the Department that it  has  and
21    will continuously maintain:
22             (1)  acceptable storage and handling conditions plus
23        facilities standards;
24             (2)  minimum liability and other insurance as may be
25        required under any applicable federal or State law;
26             (3)  a  security  system  that includes after hours,
27        central alarm or comparable entry  detection  capability;
28        restricted  premises  access;  adequate outside perimeter
29        lighting; comprehensive employment  applicant  screening;
30        and safeguards against employee theft;
31             (4)  an  electronic, manual, or any other reasonable
32        system of records, describing all  wholesale  distributor
33        activities  governed  by  this  Act for the 2 year period
34        following disposition  of  each  product  and  reasonably
 
                            -3-              LRB9215594ACpkam
 1        accessible  during  regular  business hours as defined by
 2        the Department's rules in any  inspection  authorized  by
 3        the Department;
 4             (5)  officers,   directors,   managers,   and  other
 5        persons  in  charge  of  wholesale   drug   distribution,
 6        storage,  and  handling who must at all times demonstrate
 7        and maintain  their  capability  of  conducting  business
 8        according  to  sound financial practices as well as State
 9        and federal law;
10             (6)  complete, updated information, to  be  provided
11        the  Department as a condition for obtaining and renewing
12        a  license,  about  each  wholesale  distributor  to   be
13        licensed under this Act, including all pertinent licensee
14        ownership   and   other   key  personnel  and  facilities
15        information deemed necessary for enforcement of this Act.
16        Any changes in this information shall be submitted at the
17        time of license renewal or within 45 days from  the  date
18        of the change;
19             (7)  written  policies  and  procedures  that assure
20        reasonable   wholesale   distributor   preparation   for,
21        protection against and handling of any facility  security
22        or  operation  problems,  including,  but not limited to,
23        those caused by natural disaster or government emergency;
24        inventory inaccuracies or product shipping and receiving;
25        outdated product or other unauthorized  product  control;
26        appropriate  disposition  of  returned goods; and product
27        recalls;
28             (8)  sufficient  inspection   procedures   for   all
29        incoming and outgoing product shipments; and
30             (9)  operations in compliance with all federal legal
31        requirements applicable to wholesale drug distribution.
32        (f)  The  Department  shall  consider,  at a minimum, the
33    following factors in reviewing the qualifications of  persons
34    who engage in wholesale distribution of prescription drugs in
 
                            -4-              LRB9215594ACpkam
 1    this State:
 2             (1)  any  conviction  of  the  applicant  under  any
 3        federal,  State,  or local laws relating to drug samples,
 4        wholesale or retail drug distribution, or distribution of
 5        controlled substances;
 6             (2)  any felony convictions of the  applicant  under
 7        federal, State, or local laws;
 8             (3)  the   applicant's   past   experience   in  the
 9        manufacture  or  distribution  of   prescription   drugs,
10        including controlled substances;
11             (4)  the  furnishing  by  the  applicant of false or
12        fraudulent material in any application made in connection
13        with drug manufacturing or distribution;
14             (5)  suspension or revocation by federal, State,  or
15        local  government  of any license currently or previously
16        held by the applicant for the manufacture or distribution
17        of any drug, including controlled substances;
18             (6)  compliance with  licensing  requirements  under
19        previously granted licenses, if any;
20             (7)  compliance  with  requirements  to maintain and
21        make available to the Department or to federal, State, or
22        local law enforcement officials those records required by
23        this Act; and
24             (8)  any  other  factors   or   qualifications   the
25        Department  considers relevant to and consistent with the
26        public health and safety, including whether the  granting
27        of the license would not be in the public interest.
28             (9)  All  requirements  set forth in this subsection
29        shall conform to  wholesale  drug  distributor  licensing
30        guidelines  formally  adopted  by  the U.S. Food and Drug
31        Administration (FDA).  In case of  conflict  between  any
32        wholesale  drug distributor licensing requirement imposed
33        by the Department and any FDA wholesale drug  distributor
34        licensing guideline, the FDA guideline shall control.
 
                            -5-              LRB9215594ACpkam
 1        (g)  An  agent or employee of any licensed wholesale drug
 2    distributor need not seek licensure under  this  Section  and
 3    may  lawfully  possess pharmaceutical drugs when the agent or
 4    employee is  acting  in  the  usual  course  of  business  or
 5    employment.
 6        (h)  The  issuance  of a license under this Act shall not
 7    change or affect tax liability imposed by the  State  on  any
 8    wholesale drug distributor.
 9        (i)  A  license  issued under this Act shall not be sold,
10    transferred, or assigned in any manner.
11    (Source: P.A. 87-594.)

12        (225 ILCS 120/35) (from Ch. 111, par. 8301-35)
13        (Section scheduled to be repealed on December 31, 2002)
14        Sec. 35. Fees; Illinois State Pharmacy Disciplinary Fund.
15        (a)  The Department shall provide by rule for a  schedule
16    of  fees  for the administration and enforcement of this Act,
17    including but not limited to original licensure, renewal, and
18    restoration. The fees shall be nonrefundable.  The  following
19    fees   shall  be  imposed  by  the  Department  and  are  not
20    refundable.
21             (1)  The fee for application for  a  certificate  of
22        registration as a wholesale drug distributor is $200.
23             (2)  The  fee  for  the  renewal of a certificate of
24        registration as a wholesale drug distributor is $200  per
25        year.
26             (3)  The  fee  for  the change of person responsible
27        for drugs is $50.
28             (4)  The fee for the issuance of a duplicate license
29        to replace a license that has been lost or  destroyed  is
30        $25.
31             (5)  The  fee  for  certification  of a registrant's
32        record for any purpose is $25.
33             (6)  The fee for a roster of licensed wholesale drug
 
                            -6-              LRB9215594ACpkam
 1        distributors shall be the actual cost  of  producing  the
 2        roster.
 3             (7)  The   fee   for   wholesale   drug  distributor
 4        licensing,   disciplinary,   or   investigative   records
 5        obtained under subpoena is $1 per page.
 6        (b)  All fees collected under this Act shall be deposited
 7    into the Illinois State Pharmacy Disciplinary Fund and  shall
 8    be  appropriated  to  the  Department  for  the  ordinary and
 9    contingent expenses of the Department in  the  administration
10    of this Act. All moneys received by the Department under this
11    Act  shall  be  deposited  into  the  Illinois State Pharmacy
12    Disciplinary Fund in the State Treasury  and  shall  be  used
13    only  for  the  following purposes: (i) by the State Board of
14    Pharmacy in the exercise of its powers and performance of its
15    duties, as such use  is  made  by  the  Department  upon  the
16    recommendations  of  the  State  Board  of Pharmacy, (ii) for
17    costs directly related to license renewal of persons licensed
18    under this Act, and (iii) for direct and  allocable  indirect
19    costs  related  to  the  public purposes of the Department of
20    Professional  Regulation.   Moneys  in  the   Fund   may   be
21    transferred   to   the  Professions  Indirect  Cost  Fund  as
22    authorized  by  Section  2105-300  of   the   Department   of
23    Professional Regulation Law (20 ILCS 2105/2105-300).
24        The  moneys  deposited  into  the Illinois State Pharmacy
25    Disciplinary Fund shall be invested to  earn  interest  which
26    shall accrue to the Fund.
27        The  Department shall present to the Board for its review
28    and comment all  appropriation  requests  from  the  Illinois
29    State  Pharmacy Disciplinary Fund.  The Department shall give
30    due consideration to any comments  of  the  Board  in  making
31    appropriation requests.
32        (c)  Any  person who delivers a check or other payment to
33    the Department that is returned to the Department  unpaid  by
34    the financial institution upon which it is drawn shall pay to
 
                            -7-              LRB9215594ACpkam
 1    the Department, in addition to the amount already owed to the
 2    Department,  a  fine  of  $50.    The  fines  imposed by this
 3    Section are in addition  to  any  other  discipline  provided
 4    under  this  Act  for  unlicensed  practice  or practice on a
 5    nonrenewed license.  The Department shall notify  the  person
 6    that  payment  of  fees  and  fines  shall  be  paid  to  the
 7    Department  by  certified  check  or  money  order  within 30
 8    calendar days of the notification.  If, after the  expiration
 9    of  30 days from the date of the notification, the person has
10    failed to submit the  necessary  remittance,  the  Department
11    shall  automatically  terminate the license or certificate or
12    deny the application, without hearing.  If, after termination
13    or denial, the person seeks a license or certificate,  he  or
14    she shall apply to the Department for restoration or issuance
15    of  the license or certificate and pay all fees and fines due
16    to the Department.  The Department may establish  a  fee  for
17    the processing of an application for restoration of a license
18    or  certificate  to  pay  all  expenses  of  processing  this
19    application.  The Director may waive the fines due under this
20    Section in individual cases where the Director finds that the
21    fines would be unreasonable or unnecessarily burdensome.
22        (d)  The  Department shall maintain a roster of the names
23    and addresses of all registrants and  of  all  persons  whose
24    licenses  have  been suspended or revoked.  This roster shall
25    be available upon written request and payment of the required
26    fee.
27    (Source: P.A. 91-239, eff. 1-1-00; 92-146, eff. 1-1-02.)".

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