093_HB3898

 
                                     LRB093 13353 AMC 18639 b

 1        AN ACT concerning drugs.

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

 4        Section 5.  The Wholesale Drug Distribution Licensing Act
 5    is amended by changing Sections 15, 25, and 55 as follows:

 6        (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
 7        (Section scheduled to be repealed on January 1, 2013)
 8        Sec. 15.  Definitions.  As used in this Act:
 9        "Blood" means whole blood collected from a  single  donor
10    and    processed    either   for   transfusion   or   further
11    manufacturing.
12        "Blood component" means that part of blood  separated  by
13    physical or mechanical means.
14        "Board"   means  the  State  Board  of  Pharmacy  of  the
15    Department of Professional Regulation.
16        "Department"  means  the   Department   of   Professional
17    Regulation.
18        "Director" means the Director of Professional Regulation.
19        "Drug sample" means a unit of a prescription drug that is
20    not  intended  to be sold and is intended to promote the sale
21    of the drug.
22        "Manufacturer"  means  anyone  who  is  engaged  in   the
23    manufacturing,     preparing,    propagating,    compounding,
24    processing,  packaging,  repackaging,  or   labeling   of   a
25    prescription drug.
26        "Pedigree  papers"  means  that  term  as  defined in the
27    Illinois Food, Drug and Cosmetic Act.
28        "Person"   means   and   includes   a   natural   person,
29    partnership, association or corporation.
30        "Pharmacy distributor" means  any  pharmacy  licensed  in
31    this  State  or  hospital  pharmacy  that  is  engaged in the
 
                            -2-      LRB093 13353 AMC 18639 b
 1    delivery or distribution of prescription drugs either to  any
 2    other  pharmacy licensed in this State or to any other person
 3    or entity including, but not limited  to,  a  wholesale  drug
 4    distributor  engaged  in  the  delivery  or  distribution  of
 5    prescription   drugs   who   is   involved   in  the  actual,
 6    constructive, or attempted transfer of a drug in  this  State
 7    to  other  than  the  ultimate  consumer  except as otherwise
 8    provided for by law.
 9        "Prescription drug" means  any  human  drug  required  by
10    federal   law  or  regulation  to  be  dispensed  only  by  a
11    prescription, including  finished  dosage  forms  and  active
12    ingredients  subject  to subsection (b) of Section 503 of the
13    Federal Food, Drug and Cosmetic Act.
14        "Wholesale  distribution"  or  "wholesale  distributions"
15    means distribution of prescription  drugs  to  persons  other
16    than  a  consumer or patient, but does not include any of the
17    following:
18             (a)  Intracompany sales, defined as any  transaction
19        or  transfer between any division, subsidiary, parent, or
20        affiliated or related company under the common  ownership
21        and control of a corporate entity.
22             (b)  The purchase or other acquisition by a hospital
23        or  other  health care entity that is a member of a group
24        purchasing organization of a drug for its  own  use  from
25        the group purchasing organization or from other hospitals
26        or  health  care  entities  that  are  members of a group
27        organization.
28             (c)  The sale, purchase, or trade of a  drug  or  an
29        offer  to sell, purchase, or trade a drug by a charitable
30        organization described in subsection  (c)(3)  of  Section
31        501  of  the  U.S.  Internal  Revenue  Code  of 1954 to a
32        nonprofit affiliate of the  organization  to  the  extent
33        otherwise permitted by law.
34             (d)  The  sale,  purchase,  or trade of a drug or an
 
                            -3-      LRB093 13353 AMC 18639 b
 1        offer to sell, purchase, or trade a drug among  hospitals
 2        or  other  health  care  entities  that  are under common
 3        control.  For purposes  of  this  Act,  "common  control"
 4        means  the  power to direct or cause the direction of the
 5        management and policies of a person or  an  organization,
 6        whether  by  ownership of stock, voting rights, contract,
 7        or otherwise.
 8             (e)  The sale, purchase, or trade of a  drug  or  an
 9        offer  to  sell,  purchase, or trade a drug for emergency
10        medical reasons. For purposes  of  this  Act,  "emergency
11        medical  reasons" include transfers of prescription drugs
12        by a  retail  pharmacy  to  another  retail  pharmacy  to
13        alleviate a temporary shortage.
14             (f)  The  sale,  purchase,  or  trade  of a drug, an
15        offer  to  sell,  purchase,  or  trade  a  drug,  or  the
16        dispensing of a drug pursuant to a prescription.
17             (g)  The   distribution   of   drug    samples    by
18        manufacturers'     representatives    or    distributors'
19        representatives.
20             (h)  The sale, purchase, or trade of blood and blood
21        components intended for transfusion.
22        "Wholesale drug distributor" means any person  or  entity
23    engaged  in    wholesale  distribution of prescription drugs,
24    including, but not limited to, manufacturers; repackers;  own
25    label  distributors;  jobbers;  private  label  distributors;
26    brokers;    warehouses,    including    manufacturers'    and
27    distributors'   warehouses,   chain   drug   warehouses,  and
28    wholesale  drug  warehouses;   independent   wholesale   drug
29    traders;   and   retail  pharmacies  that  conduct  wholesale
30    distributions, including, but not limited  to,  any  pharmacy
31    distributor  as  defined  in  this Section.  A wholesale drug
32    distributor shall not include any for hire carrier or  person
33    or entity hired solely to transport prescription drugs.
34    (Source: P.A. 87-594.)
 
                            -4-      LRB093 13353 AMC 18639 b
 1        (225 ILCS 120/25) (from Ch. 111, par. 8301-25)
 2        (Section scheduled to be repealed on January 1, 2013)
 3        Sec.    25.    Wholesale   drug   distributor   licensing
 4    requirements.   All  wholesale  distributors   and   pharmacy
 5    distributors,  wherever  located,  who  engage  in  wholesale
 6    distribution  into,  out  of,  or  within  the State shall be
 7    subject to the following requirements:
 8        (a)  No person or distribution  outlet  shall  act  as  a
 9    wholesale  drug distributor without first obtaining a license
10    to do so from the Department and paying  any  reasonable  fee
11    required by the Department.
12        (b)  The  Department may grant a temporary license when a
13    wholesale drug distributor first applies  for  a  license  to
14    operate  within this State.  A temporary license shall remain
15    valid until the Department finds that the applicant meets  or
16    fails   to  meet  the  requirements  for  regular  licensure.
17    Nevertheless, no temporary license shall be  valid  for  more
18    than  90  days  from  the  date  of  issuance.  Any temporary
19    license issued under this subsection shall be renewable for a
20    similar period of time not to exceed 90 days  under  policies
21    and procedures prescribed by the Department.
22        (c)  No   license  shall  be  issued  or  renewed  for  a
23    wholesale drug distributor to operate  unless  the  wholesale
24    drug  distributor shall operate in a manner prescribed by law
25    and according to the rules and regulations promulgated by the
26    Department.
27        (d)  The Department may require a  separate  license  for
28    each facility directly or indirectly owned or operated by the
29    same  business  entity  within  this  State,  or for a parent
30    entity with divisions, subsidiaries, and affiliate  companies
31    within  this State when operations are conducted at more than
32    one location and there exists  joint  ownership  and  control
33    among all the entities.
34        (e)  As  a  condition  for  receiving  and  renewing  any
 
                            -5-      LRB093 13353 AMC 18639 b
 1    wholesale  drug  distributor  license  issued under this Act,
 2    each applicant shall satisfy the Department that it  has  and
 3    will continuously maintain:
 4             (1)  acceptable storage and handling conditions plus
 5        facilities standards;
 6             (2)  minimum liability and other insurance as may be
 7        required under any applicable federal or State law;
 8             (3)  a  security  system  that includes after hours,
 9        central alarm or comparable entry  detection  capability;
10        restricted  premises  access;  adequate outside perimeter
11        lighting; comprehensive employment  applicant  screening;
12        and safeguards against employee theft;
13             (4)  an  electronic, manual, or any other reasonable
14        system of records, describing all  wholesale  distributor
15        activities  governed  by  this  Act for the 2 year period
16        following disposition  of  each  product  and  reasonably
17        accessible  during  regular  business hours as defined by
18        the Department's rules in any  inspection  authorized  by
19        the Department;
20             (5)  officers,   directors,   managers,   and  other
21        persons  in  charge  of  wholesale   drug   distribution,
22        storage,  and  handling who must at all times demonstrate
23        and maintain  their  capability  of  conducting  business
24        according  to  sound financial practices as well as State
25        and federal law;
26             (6)  complete, updated information, to  be  provided
27        the  Department as a condition for obtaining and renewing
28        a  license,  about  each  wholesale  distributor  to   be
29        licensed under this Act, including all pertinent licensee
30        ownership   and   other   key  personnel  and  facilities
31        information deemed necessary for enforcement of this Act.
32        Any changes in this information shall be submitted at the
33        time of license renewal or within 45 days from  the  date
34        of the change;
 
                            -6-      LRB093 13353 AMC 18639 b
 1             (7)  written  policies  and  procedures  that assure
 2        reasonable   wholesale   distributor   preparation   for,
 3        protection against and handling of any facility  security
 4        or  operation  problems,  including,  but not limited to,
 5        those caused by natural disaster or government emergency;
 6        inventory inaccuracies or product shipping and receiving;
 7        outdated product or other unauthorized  product  control;
 8        appropriate  disposition  of  returned goods; and product
 9        recalls;
10             (8)  sufficient  inspection   procedures   for   all
11        incoming and outgoing product shipments; and
12             (8.5)  pedigree   papers  as  provided  for  in  the
13        Illinois Food, Drug and Cosmetic Act; and
14             (9)  operations in compliance with all federal legal
15        requirements applicable to wholesale drug distribution.
16        (f)  The Department shall consider,  at  a  minimum,  the
17    following  factors in reviewing the qualifications of persons
18    who engage in wholesale distribution of prescription drugs in
19    this State:
20             (1)  any  conviction  of  the  applicant  under  any
21        federal, State, or local laws relating to  drug  samples,
22        wholesale or retail drug distribution, or distribution of
23        controlled substances;
24             (2)  any  felony  convictions of the applicant under
25        federal, State, or local laws;
26             (3)  the  applicant's   past   experience   in   the
27        manufacture   or   distribution  of  prescription  drugs,
28        including controlled substances;
29             (4)  the furnishing by the  applicant  of  false  or
30        fraudulent material in any application made in connection
31        with drug manufacturing or distribution;
32             (5)  suspension  or revocation by federal, State, or
33        local government of any license currently  or  previously
34        held by the applicant for the manufacture or distribution
 
                            -7-      LRB093 13353 AMC 18639 b
 1        of any drug, including controlled substances;
 2             (6)  compliance  with  licensing  requirements under
 3        previously granted licenses, if any;
 4             (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             (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
11        of the license would not be in the public interest.
12             (9)  All requirements set forth in  this  subsection
13        shall  conform  to  wholesale  drug distributor licensing
14        guidelines formally adopted by the  U.S.  Food  and  Drug
15        Administration  (FDA).   In  case of conflict between any
16        wholesale drug distributor licensing requirement  imposed
17        by  the Department and any FDA wholesale drug distributor
18        licensing guideline, the FDA guideline shall control.
19        (g)  An agent or employee of any licensed wholesale  drug
20    distributor  need  not  seek licensure under this Section and
21    may lawfully possess pharmaceutical drugs when the  agent  or
22    employee  is  acting  in  the  usual  course  of  business or
23    employment.
24        (h)  The issuance of a license under this Act  shall  not
25    change  or  affect  tax liability imposed by the State on any
26    wholesale drug distributor.
27        (i)  A license issued under this Act shall not  be  sold,
28    transferred, or assigned in any manner.
29    (Source: P.A. 92-586, eff. 6-26-02.)

30        (225 ILCS 120/55) (from Ch. 111, par. 8301-55)
31        (Section scheduled to be repealed on January 1, 2013)
32        Sec. 55.  Discipline; grounds.
33        (a)  The  Department  may  refuse  to  issue, restore, or
 
                            -8-      LRB093 13353 AMC 18639 b
 1    renew, or may revoke, suspend, place on probation,  reprimand
 2    or  take other disciplinary action as the Department may deem
 3    proper for any of the following reasons:
 4             (1)  Violation of this Act or its rules.
 5             (2)  Aiding or assisting another person in violating
 6        any provision of this Act or its rules.
 7             (3)  Failing,  within  60  days,  to  respond  to  a
 8        written  requirement   made   by   the   Department   for
 9        information.
10             (4)  Engaging   in   dishonorable,   unethical,   or
11        unprofessional  conduct of a character likely to deceive,
12        defraud, or harm the public. This includes violations  of
13        "good  faith"  as  defined  by  the  Illinois  Controlled
14        Substances Act and applies to all prescription drugs.
15             (5)  Discipline  by  another  U.S.  jurisdiction  or
16        foreign  nation,  if  at least one of the grounds for the
17        discipline is the same  or  substantially  equivalent  to
18        those set forth in this Act.
19             (6)  Selling or engaging in the sale of drug samples
20        provided at no cost by drug manufacturers.
21             (7)  Conviction of the applicant or licensee, or any
22        officer,  director,  manager or shareholder who owns more
23        than 5% of stock, in State or federal court of any  crime
24        that is a felony.
25             (8)  Habitual  or  excessive  use  or  addiction  to
26        alcohol,  narcotics,  stimulants,  or  any other chemical
27        agent or drug that results in the inability  to  function
28        with reasonable judgment, skill, or safety.
29             (9)  Violation   of  the  Illinois  Food,  Drug  and
30        Cosmetic Act.
31        (b)  The Department may  refuse  to  issue,  restore,  or
32    renew,  or may revoke, suspend, place on probation, reprimand
33    or take other disciplinary action as the Department may  deem
34    property  including  fines not to exceed $1,500 $1000 for any
 
                            -9-      LRB093 13353 AMC 18639 b
 1    of the following reasons:
 2             (1)  Material misstatement in furnishing information
 3        to the Department.
 4             (2)  Making any misrepresentation for the purpose of
 5        obtaining a license.
 6             (3)  A finding by the Department that the  licensee,
 7        after  having  his  or her license placed on probationary
 8        status, has violated the terms of probation.
 9             (4)  A finding that licensure  or  registration  has
10        been applied for or obtained by fraudulent means.
11             (5)  Willfully  making  or  filing  false records or
12        reports.
13             (6)  A finding of a  substantial  discrepancy  in  a
14        Department  audit  of  a  prescription  drug, including a
15        controlled substance as that term is defined in this  Act
16        or in the Illinois Controlled Substances Act.
17        (c)  The  Department  may  refuse to issue or may suspend
18    the license or registration of any person who fails to file a
19    return, or to pay the tax, penalty or  interest  shown  in  a
20    filed  return, or to pay any final assessment of tax, penalty
21    or interest, as required by any tax Act administered  by  the
22    Illinois   Department   of   Revenue,   until  the  time  the
23    requirements of the tax Act are satisfied.
24        (d)  The  Department  shall   revoke   the   license   or
25    certificate  of  registration  issued  under  this Act or any
26    prior Act of this State of any person who has been  convicted
27    a  second  time  of  committing any felony under the Illinois
28    Controlled Substances Act or who has been convicted a  second
29    time  of  committing a Class 1 felony under Sections 8A-3 and
30    8A-6 of the Illinois Public Aid Code.  A person whose license
31    or certificate of registration issued under this Act  or  any
32    prior  Act of this State is revoked under this subsection (c)
33    shall be prohibited from engaging in the practice of pharmacy
34    in this State.
 
                            -10-     LRB093 13353 AMC 18639 b
 1    (Source: P.A. 87-594.)

 2        Section 10.  The Illinois Food, Drug and Cosmetic Act  is
 3    amended  by changing Sections 2, 3, 3.7, 5, and 14 and adding
 4    Sections 2.40, 2.41, 2.42, 2.43, 2.44, 3.21a,  3.21b,  3.21c,
 5    3.21d, 3.23, 3.24, 3.25, 3.26, and 14.5 as follows:

 6        (410 ILCS 620/2) (from Ch. 56 1/2, par. 502)
 7        Sec.   2.  In  this  Act  unless  the  context  otherwise
 8    requires, the words  and  phrases  defined  in  the  Sections
 9    following  this  Section  and  preceding  Section  3 have the
10    meanings ascribed to them in those Sections 2.1 through 2.37,
11    have the meanings set forth therein.
12    (Source: P.A. 84-891.)

13        (410 ILCS 620/2.40 new)
14        Sec.   2.40.  Authenticate.   "Authenticate"   means   to
15    affirmatively verify before any distribution of a legend drug
16    occurs that each transaction listed on the pedigree paper has
17    occurred.

18        (410 ILCS 620/2.41 new)
19        Sec. 2.41.  Contraband legend  drug.  "Contraband  legend
20    drug"  means  (i) any adulterated drug, as defined in Section
21    14, (ii) any counterfeit drug, and (iii) any legend drug  for
22    which a pedigree paper does not exist, for which the pedigree
23    paper  in  existence  has been forged, counterfeited, falsely
24    created,  or   that   contains   any   altered,   false,   or
25    misrepresented matter.

26        (410 ILCS 620/2.42 new)
27        Sec.  2.42.  Legend drug label. "Legend drug label" means
28    any display of written, printed, or graphic matter  upon  the
29    immediate   container   of  any  legend  drug  prior  to  its
 
                            -11-     LRB093 13353 AMC 18639 b
 1    dispensing  to  an   individual   patient   pursuant   to   a
 2    prescription   of   a   practitioner  authorized  by  law  to
 3    prescribe.

 4        (410 ILCS 620/2.43 new)
 5        Sec. 2.43.  Pedigree  paper.  "Pedigree  paper"  means  a
 6    document  in  a  form  approved  by  the Department of Public
 7    Health  and  containing   information   that   records   each
 8    distribution  of  any  given  legend  drug,  from  sale  by a
 9    pharmaceutical manufacturer, through acquisition and sale  by
10    any  wholesaler,  until  final  sale  to  a pharmacy or other
11    person administering or dispensing the drug.

12        (410 ILCS 620/2.44 new)
13        Sec.  2.44.  Prescription  label.  "Prescription   label"
14    means any display of written, printed, or graphic matter upon
15    the immediate container of any legend drug dispensed pursuant
16    to  a  prescription  of  a  practitioner authorized by law to
17    prescribe.

18        (410 ILCS 620/3) (from Ch. 56 1/2, par. 503)
19        Sec. 3.  The enumerated  acts  in  Sections  3.1  through
20    3.21d  3.21  and  the  causing thereof are prohibited in this
21    State.
22    (Source: P.A. 84-891.)

23        (410 ILCS 620/3.7) (from Ch. 56 1/2, par. 503.7)
24        Sec. 3.7.  The purchase or sale of prescription drugs for
25    wholesale  distribution  except  in   accordance   with   the
26    Wholesale  Drug  Distribution  Licensing Act. The giving of a
27    guaranty or undertaking which is false, except  by  a  person
28    who  relied  on  a guaranty or undertaking to the same effect
29    signed by and containing the name and address of  the  person
30    residing  in  the  State of Illinois from whom he received in
 
                            -12-     LRB093 13353 AMC 18639 b
 1    good faith the food, drug, device or cosmetic.
 2    (Source: Laws 1967, p. 959.)

 3        (410 ILCS 620/3.21a new)
 4        Sec. 3.21a.  Removing a pharmacy's dispensing label  from
 5    a  dispensed  prescription  drug  with  the intent to further
 6    distribute the prescription drug.

 7        (410 ILCS 620/3.21b new)
 8        Sec. 3.21b.  Distributing a prescription  drug  that  was
 9    previously  dispensed  by  a  licensed  pharmacy, unless such
10    distribution was authorized by the Pharmacy Practice  Act  of
11    1987.

12        (410 ILCS 620/3.21c new)
13        Sec.  3.21c.  Failure  to  obtain  or  pass on a pedigree
14    paper.

15        (410 ILCS 620/3.21d new)
16        Sec. 3.21d.  The receipt of a prescription drug  pursuant
17    to   a  wholesale  distribution  without  first  receiving  a
18    pedigree paper that was attested to as accurate and  complete
19    by the wholesale distributor.

20        (410 ILCS 620/3.23 new)
21        Sec.   3.23.  Criminal   acts   involving  contraband  or
22    adulterated drugs.
23        (a)  A person, other than a manufacturer, engaged in  the
24    wholesale  distribution  of legend drugs who fails to deliver
25    to another  person  complete  and  accurate  pedigree  papers
26    concerning  a  legend drug or contraband legend drug prior to
27    transferring the legend drug or  contraband  legend  drug  to
28    another person commits a Class 3 felony.
29        (b)  A  person  engaged  in the wholesale distribution of
 
                            -13-     LRB093 13353 AMC 18639 b
 1    legend drugs who  fails  to  acquire  complete  and  accurate
 2    pedigree papers concerning a legend drug or contraband legend
 3    drug  prior to obtaining the legend drug or contraband legend
 4    drug from another person commits a Class 3 felony.
 5        (c)  A person who knowingly destroys,  alters,  conceals,
 6    or  fails  to  maintain complete and accurate pedigree papers
 7    concerning any legend drug or contraband legend drug  in  his
 8    or her possession commits a Class 3 felony.
 9        (d)  A  person  engaged  in the wholesale distribution of
10    legend  drugs  who  is  in  possession  of  pedigree   papers
11    concerning  legend  drugs  or contraband legend drugs and who
12    fails to authenticate the matters contained in  the  pedigree
13    papers  and  who  nevertheless attempts to further distribute
14    legend drugs or contraband legend  drug  commits  a  Class  3
15    felony.
16        (e)  A person in possession of pedigree papers concerning
17    legend drugs or contraband legend drugs who falsely swears or
18    certifies  that  he  or  she  has  authenticated  the matters
19    contained in the pedigree papers commits a Class 3 felony.
20        (f)  A person  who  knowingly  forges,  counterfeits,  or
21    falsely  creates  any  pedigree paper; who falsely represents
22    any factual matter contained on any pedigree  paper;  or  who
23    knowingly omits to record material information required to be
24    recorded in a pedigree paper, commits a Class 1 felony.
25        (g)  A  person who knowingly purchases or receives from a
26    person not authorized to distribute legend drugs  under  this
27    Act  a  legend  drug  in a wholesale distribution transaction
28    commits a Class 1 felony.
29        (h)  A person who  knowingly  sells  or  transfers  to  a
30    person  not  authorized  to  purchase or possess legend drug,
31    under the  law  of  the  jurisdiction  in  which  the  person
32    receives  the drug, a legend drug in a wholesale distribution
33    transaction commits a Class 1 felony.
34        (i)  A person who is knowingly in actual or  constructive
 
                            -14-     LRB093 13353 AMC 18639 b
 1    possession  of  any  amount  of  contraband legend drugs, who
 2    knowingly sells or delivers, or who possesses with intent  to
 3    sell  or  deliver  any  amount  of  contraband  legend drugs,
 4    commits a Class 1 felony.
 5        (j)  A person  who  knowingly  forges,  counterfeits,  or
 6    falsely  creates any prescription label or legend drug label,
 7    or who falsely represents any factual matter contained on any
 8    prescription label or legend drug label, commits  a  Class  X
 9    felony.

10        (410 ILCS 620/3.24 new)
11        Sec. 3.24.  Trafficking in contraband legend drugs.
12        (a)  A    person    who   knowingly   sells,   purchases,
13    manufactures, delivers, or brings into this State, or who  is
14    knowingly  in actual or constructive possession of any amount
15    of contraband legend drugs valued at $25,000 or more  commits
16    a  Class  X  felony. Upon conviction, each defendant shall be
17    ordered to pay a mandatory fine according  to  the  following
18    schedule:
19             (1)  If   the   value  of  contraband  legend  drugs
20        involved is $25,000 or more, but less than $100,000,  the
21        defendant  shall  pay a mandatory fine of $25,000. If the
22        defendant is a corporation or other person that is not  a
23        natural person, it shall pay a mandatory fine of $75,000.
24             (2)  If   the   value  of  contraband  legend  drugs
25        involved is $100,000 or more, but less than $250,000, the
26        defendant shall pay a mandatory fine of $100,000. If  the
27        defendant  is a corporation or other person that is not a
28        natural  person,  it  shall  pay  a  mandatory  fine   of
29        $300,000.
30             (3)  If   the   value  of  contraband  legend  drugs
31        involved is $250,000 or more, the defendant shall  pay  a
32        mandatory  fine  of  $200,000.  If  the  defendant  is  a
33        corporation or other person that is not a natural person,
 
                            -15-     LRB093 13353 AMC 18639 b
 1        it shall pay a mandatory fine of $600,000.
 2        (b)  As  used  in  this Section, "value" means the market
 3    value of the property at the time and place  of  the  offense
 4    or, if the market value cannot be satisfactorily ascertained,
 5    the  cost  of replacement of the property within a reasonable
 6    time after the offense.
 7        (c)  Amounts of value of separate contraband legend drugs
 8    involved in distinct transactions for the distribution of the
 9    contraband legend drugs committed pursuant to one  scheme  or
10    course  of  conduct,  whether  involving  the  same person or
11    several  persons,  may  be  aggregated  in  determining   the
12    punishment of the offense.

13        (410 ILCS 620/3.25 new)
14        Sec.  3.25.  Sale  or purchase of contraband legend drugs
15    resulting in great bodily harm. A person who knowingly sells,
16    purchases, manufactures, delivers, or brings into this State,
17    or who is knowingly in actual or constructive  possession  of
18    any  amount  of  contraband  legend  drugs, and whose acts in
19    violation of this Section result in great bodily  harm  to  a
20    person, commits a Class X felony.

21        (410 ILCS 620/3.26 new)
22        Sec.  3.26.  Sale  or purchase of contraband legend drugs
23    resulting in death.  A  person  who  knowingly  manufactures,
24    sells, purchases, delivers, or brings into this State, or who
25    is  knowingly  in  actual  or  constructive possession of any
26    amount  of  contraband  legend  drugs,  and  whose  acts   in
27    violation  of  this  Section result in the death of a person,
28    commits a Class X felony.

29        (410 ILCS 620/5) (from Ch. 56 1/2, par. 505)
30        Sec. 5.  (a) A person who violates any of the  provisions
31    of  this  Act,  other  than  Sections 3.22, 3.23, 3.24, 3.25,
 
                            -16-     LRB093 13353 AMC 18639 b
 1    3.26, and 6, is guilty of a Class C misdemeanor; but  if  the
 2    violation  is  committed  after  a  conviction of such person
 3    under this Section has become  final,  the  person  shall  be
 4    guilty  of  a  Class A misdemeanor. A person who violates the
 5    provisions of Section 6 of this Act is guilty of  a  Class  A
 6    misdemeanor;  but  if  the  violation  is  committed  after a
 7    conviction of such  person  under  this  Section  has  become
 8    final, the person shall be guilty of a Class 4 felony.
 9        (b)  No  person is subject to the penalties of subsection
10    (a) of this Section for (1) violating Section 3.1 or  3.3  if
11    he  establishes  a  guaranty  or  undertaking  signed  by and
12    containing the name and address of the person residing in the
13    State of Illinois from whom he received the article  in  good
14    faith,  to  the effect that the article is not adulterated or
15    misbranded within the meaning of this Act,  designating  this
16    Act; or (2) for having violated clause (2) of Section 3.16 if
17    such  person acted in good faith and had no reason to believe
18    that the use of the punch, die, plate, stone or  other  thing
19    involved  would result in a drug being a counterfeit drug, or
20    for having violated clause (3) of Section 3.16 if the  person
21    doing  the  act  or causing it to be done acted in good faith
22    and had no reason to believe that the drug was a  counterfeit
23    drug.
24        (c)  No  publisher,  radio-broadcast  licensee, agency or
25    medium for the dissemination of an advertisement, except  the
26    manufacturer, packer, distributor or seller of the article to
27    which  a  false  advertisement  relates  is liable under this
28    Section for the dissemination  of  such  false  advertisement
29    unless  he  has  refused  on  the  request of the Director to
30    furnish the Director the name and post office address of  the
31    manufacturer,  packer,  distributor,  seller  or  advertising
32    agency  residing  in  the State of Illinois who causes him to
33    disseminate such advertisement.
34        (d)  No person shall  be  subject  to  the  penalties  of
 
                            -17-     LRB093 13353 AMC 18639 b
 1    subsection  (a)  of this Section for a violation of Section 3
 2    involving misbranded food  if  the  violation  exists  solely
 3    because  the  food  is  misbranded  under  subsection  (c) of
 4    Section 11 because of its advertising, and no person shall be
 5    subject to the penalties of subsection (a)  of  this  Section
 6    for  such  a violation unless the violation is committed with
 7    the intent to defraud or mislead.
 8    (Source: P.A. 86-704; 87-754.)

 9        (410 ILCS 620/14) (from Ch. 56 1/2, par. 514)
10        Sec. 14.  A drug or device is adulterated: (a) (1) If  it
11    consists  in  whole  or  in  part  of  any  filthy, putrid or
12    decomposed substance; or (2) (A) if  it  has  been  produced,
13    prepared,  packed or held under unsanitary conditions whereby
14    it may have been contaminated with filth or  whereby  it  may
15    have  been  rendered  injurious  to health; or (B) if it is a
16    drug and the methods used in, or the facilities  or  controls
17    used  for, its manufacture, processing, packing or holding do
18    not conform  to  or  are  not  operated  or  administered  in
19    conformity with current good manufacturing practice to assure
20    that such drug meets the requirements of the Act as to safety
21    and  has  the identity and strength and meets the quality and
22    purity characteristics which it purports or is represented to
23    possess; or (3)  if  it  is  a  drug  and  its  container  is
24    composed,   in   whole  or  in  part,  of  any  poisonous  or
25    deleterious substance which may render the contents injurious
26    to health; or (4) if (A)  it  is  a  drug  and  it  bears  or
27    contains,  for  purposes  of  coloring only, a color additive
28    which is unsafe within the meaning  of  Section  706  of  the
29    Federal  Act  or (B) it is a color additive, the intended use
30    of which in or  on  drugs  or  devices  is  for  purposes  of
31    coloring only and is unsafe within the meaning of Section 706
32    of  the  Federal Act; or (5) if it is a new animal drug which
33    is unsafe within the meaning of Section 512  of  the  Federal
 
                            -18-     LRB093 13353 AMC 18639 b
 1    Act;  or  (6) if it is an animal feed bearing or containing a
 2    new animal drug, and such animal feed is  unsafe  within  the
 3    meaning of Section 512 of the Federal Act.
 4        (b)  If it purports to be or is represented as a drug the
 5    name  of  which  is recognized in an official compendium, and
 6    its strength differs from or  its  quality  or  purity  falls
 7    below  the  standard  set  forth  in  such  compendium.  Such
 8    determination as to strength, quality or purity shall be made
 9    in accordance with the tests or methods of assay set forth in
10    such  compendium  or  in the absence of or inadequacy of such
11    tests or methods of assay, those prescribed  under  authority
12    of the Federal Act. No drug defined in an official compendium
13    is  adulterated under this subsection because it differs from
14    the standard of strength,  quality  or  purity  therefor  set
15    forth  in  such  compendium,  if  its difference in strength,
16    quality or purity from such standard is plainly stated on its
17    label. When a drug is recognized in both  the  United  States
18    Pharmacopoeia   -  National  Formulary  and  the  Homeopathic
19    Pharmacopoeia of the United States it shall be subject to the
20    requirements of the United States  Pharmacopoeia  -  National
21    Formulary  unless  it  is  labeled  and offered for sale as a
22    homeopathic drug, in which case it shall be  subject  to  the
23    provisions  of  the  Homeopathic  Pharmacopoeia of the United
24    States and not to those of the United States Pharmacopoeia  -
25    National Formulary.
26        (c)  If it is not subject to the provisions of subsection
27    (b)  of  this  Section  and  its strength differs from or its
28    purity or quality falls below that which it  purports  or  is
29    represented to possess.
30        (d)  If it is a drug and any substance has been (1) mixed
31    or  packed therewith so as to reduce its quality or strength;
32    or (2) substituted wholly or in part therefor.
33        (e)  If it is, or purports to be or is represented as,  a
34    device which is subject to a performance standard established
 
                            -19-     LRB093 13353 AMC 18639 b
 1    under  Section  514 of the Federal Act, unless such device is
 2    in all respects in conformity with such standard.
 3        (f)  If it is a device and the methods used  in,  or  the
 4    facilities  or  controls  used for, its manufacture, packing,
 5    storage,  or  installations  are  not  in   conformity   with
 6    applicable   requirements  under  Section  520(b)(1)  of  the
 7    Federal Act or an applicable condition as  prescribed  by  an
 8    order under Section 520(b)(2) of the Federal Act.
 9        (g)  If  it  is  a device for which an exemption has been
10    granted  under  Section  520(g)  of  the  Federal   Act   for
11    investigational  use  and  the  person  who  was granted such
12    exemption fails to comply with a requirement prescribed by or
13    under such Section.
14        (h)  If it is  a  legend  drug  for  which  the  required
15    pedigree  paper  is  nonexistent,  fraudulent,  or incomplete
16    under the requirements of this Act or the  applicable  rules,
17    or that has been purchased, held, sold, or distributed at any
18    time by a person not authorized under federal or state law to
19    do so.
20    (Source: P.A. 84-891.)

21        (410 ILCS 620/14.5 new)
22        Sec. 14.5. Pedigree papers; requirements. A legend drug's
23    pedigree   paper   must   at   least  contain  the  following
24    information: (i) the amount of  the  legend  drug,  (ii)  its
25    dosage  form  and  strength,  (iii) its lot numbers, (iv) the
26    name and address of each owner of the legend drug and his  or
27    her  signature,  (v)  its shipping information, including the
28    name and  address  of  each  person  certifying  delivery  or
29    receipt  of  the  legend  drug, (vi) a certification that the
30    recipient has authenticated the pedigree  papers,  and  (vii)
31    the  name,  address,  telephone  number,  and,  if available,
32    e-mail contact information of each wholesaler involved in the
33    chain of the legend drug's custody.
 
                            -20-     LRB093 13353 AMC 18639 b
 1        Section 99.  Effective date.  This Act  takes  effect  on
 2    January 1, 2006.