093_HB0409

 
                                     LRB093 04118 DRJ 04158 b

 1        AN ACT in relation to public aid.

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

 4        Section  5.  The Pharmacy Practice Act of 1987 is amended
 5    by changing Section 4 as follows:

 6        (225 ILCS 85/4) (from Ch. 111, par. 4124)
 7        (Section scheduled to be repealed on January 1, 2008)
 8        Sec. 4.  Exemptions. Nothing contained in any Section  of
 9    this  Act shall apply to, or in any manner interfere with any
10    of the following:
11        (a)  The lawful practice of  any  physician  licensed  to
12    practice   medicine   in   all   of  its  branches,  dentist,
13    podiatrist,    veterinarian,    or     therapeutically     or
14    diagnostically certified optometrist within the limits of his
15    or  her  license, or prevent him or her from supplying to his
16    or her bona fide patients such drugs, medicines,  or  poisons
17    as may seem to him appropriate.;
18        (b)  The sale of compressed gases.;
19        (c)  The  sale  of  patent  or  proprietary medicines and
20    household  remedies  when  sold  in  original  and   unbroken
21    packages  only,  if  such patent or proprietary medicines and
22    household remedies be properly and adequately labeled  as  to
23    content  and  usage  and generally considered and accepted as
24    harmless  and  nonpoisonous  when  used  according   to   the
25    directions  on  the  label,  and also do not contain opium or
26    coca leaves, or any compound, salt or derivative thereof,  or
27    any  drug  which,  according  to  the  latest editions of the
28    following   authoritative   pharmaceutical   treatises    and
29    standards,  namely,  The United States Pharmacopoeia/National
30    Formulary (USP/NF), the United States Dispensatory,  and  the
31    Accepted   Dental   Remedies   of   the   Council  of  Dental
 
                            -2-      LRB093 04118 DRJ 04158 b
 1    Therapeutics of the American Dental  Association  or  any  or
 2    either  of them, in use on the effective date of this Act, or
 3    according to the existing provisions  of  the  Federal  Food,
 4    Drug,  and  Cosmetic Act and Regulations of the Department of
 5    Health and Human  Services,  Food  and  Drug  Administration,
 6    promulgated   thereunder   now   in  effect,  is  designated,
 7    described  or  considered  as  a  narcotic,  hypnotic,  habit
 8    forming, dangerous, or poisonous drug.;
 9        (d)  The  sale  of  poultry  and  livestock  remedies  in
10    original and unbroken packages only, labeled for poultry  and
11    livestock medication.;
12        (e)  The  sale  of  poisonous  substances  or  mixture of
13    poisonous substances, in unbroken packages, for  nonmedicinal
14    use  in  the  arts or industries or for insecticide purposes;
15    provided, they are properly  and  adequately  labeled  as  to
16    content  and  such nonmedicinal usage, in conformity with the
17    provisions of all applicable federal, state  and  local  laws
18    and regulations promulgated thereunder now in effect relating
19    thereto  and governing the same, and those which are required
20    under such applicable laws and regulations to be labeled with
21    the word "Poison", are also labeled with  the  word  "Poison"
22    printed  thereon  in prominent type and the name of a readily
23    obtainable antidote with directions for its administration.;
24        (f)  The delegation of limited prescriptive authority  by
25    a physician licensed to practice medicine in all its branches
26    to  a  physician assistant under Section 7.5 of the Physician
27    Assistant Practice Act of 1987. This delegated authority  may
28    but  is not required to include prescription of Schedule III,
29    IV, or V controlled substances, as defined in Article  II  of
30    the  Illinois  Controlled  Substances Act, in accordance with
31    written  guidelines  under  Section  7.5  of  the   Physician
32    Assistant Practice Act of 1987.; and
33        (g)  The  delegation of limited prescriptive authority by
34    a physician licensed to practice medicine in all its branches
 
                            -3-      LRB093 04118 DRJ 04158 b
 1    to an advanced practice nurse in accordance  with  a  written
 2    collaborative agreement under Sections 15-15 and 15-20 of the
 3    Nursing  and  Advanced  Practice Nursing Act.  This delegated
 4    authority may but is not required to include the prescription
 5    of Schedule III, IV, or V controlled substances as defined in
 6    Article II of the Illinois Controlled Substances Act.
 7        (h)  The return and packaging, repackaging, and  labeling
 8    of  prescription  drugs  to the extent required under Section
 9    12-4.25d of the Illinois Public Aid Code.
10    (Source: P.A. 90-116, eff.  7-14-97;  90-253,  eff.  7-29-97;
11    90-655, eff. 7-30-98; 90-742, eff. 8-13-98.)

12        Section  10.  The  Wholesale  Drug Distribution Licensing
13    Act is amended by changing Section 15 as follows:

14        (225 ILCS 120/15) (from Ch. 111, par. 8301-15)
15        (Section scheduled to be repealed on January 1, 2013)
16        Sec. 15.  Definitions.  As used in this Act:
17        "Blood" means whole blood collected from a  single  donor
18    and    processed    either   for   transfusion   or   further
19    manufacturing.
20        "Blood component" means that part of blood  separated  by
21    physical or mechanical means.
22        "Board"   means  the  State  Board  of  Pharmacy  of  the
23    Department of Professional Regulation.
24        "Department"  means  the   Department   of   Professional
25    Regulation.
26        "Director" means the Director of Professional Regulation.
27        "Drug sample" means a unit of a prescription drug that is
28    not  intended  to be sold and is intended to promote the sale
29    of the drug.
30        "Manufacturer"  means  anyone  who  is  engaged  in   the
31    manufacturing,     preparing,    propagating,    compounding,
32    processing,  packaging,  repackaging,  or   labeling   of   a
 
                            -4-      LRB093 04118 DRJ 04158 b
 1    prescription drug. "Manufacturer" does not include anyone who
 2    is  engaged  in  the packaging, repackaging, or labeling of a
 3    prescription drug only to the extent required  under  Section
 4    12-4.25d of the Illinois Public Aid Code.
 5        "Person"   means   and   includes   a   natural   person,
 6    partnership, association or corporation.
 7        "Pharmacy  distributor"  means  any  pharmacy licensed in
 8    this State or  hospital  pharmacy  that  is  engaged  in  the
 9    delivery  or distribution of prescription drugs either to any
10    other pharmacy licensed in this State or to any other  person
11    or  entity  including,  but  not limited to, a wholesale drug
12    distributor  engaged  in  the  delivery  or  distribution  of
13    prescription  drugs  who   is   involved   in   the   actual,
14    constructive,  or  attempted transfer of a drug in this State
15    to other than  the  ultimate  consumer  except  as  otherwise
16    provided for by law.
17        "Prescription  drug"  means  any  human  drug required by
18    federal  law  or  regulation  to  be  dispensed  only  by   a
19    prescription,  including  finished  dosage  forms  and active
20    ingredients subject to subsection (b) of Section 503  of  the
21    Federal Food, Drug and Cosmetic Act.
22        "Wholesale  distribution"  or  "wholesale  distributions"
23    means  distribution  of  prescription  drugs to persons other
24    than a consumer or patient, but does not include any  of  the
25    following:
26             (a)  Intracompany  sales, defined as any transaction
27        or transfer between any division, subsidiary, parent,  or
28        affiliated  or related company under the common ownership
29        and control of a corporate entity.
30             (b)  The purchase or other acquisition by a hospital
31        or other health care entity that is a member of  a  group
32        purchasing  organization  of  a drug for its own use from
33        the group purchasing organization or from other hospitals
34        or health care entities  that  are  members  of  a  group
 
                            -5-      LRB093 04118 DRJ 04158 b
 1        organization.
 2             (c)  The  sale,  purchase,  or trade of a drug or an
 3        offer to sell, purchase, or trade a drug by a  charitable
 4        organization  described  in  subsection (c)(3) of Section
 5        501 of the U.S.  Internal  Revenue  Code  of  1954  to  a
 6        nonprofit  affiliate  of  the  organization to the extent
 7        otherwise permitted by law.
 8             (d)  The sale, purchase, or trade of a  drug  or  an
 9        offer  to sell, purchase, or trade a drug among hospitals
10        or other health  care  entities  that  are  under  common
11        control.   For  purposes  of  this  Act, "common control"
12        means the power to direct or cause the direction  of  the
13        management  and  policies of a person or an organization,
14        whether by ownership of stock, voting  rights,  contract,
15        or otherwise.
16             (e)  The  sale,  purchase,  or trade of a drug or an
17        offer to sell, purchase, or trade a  drug  for  emergency
18        medical  reasons.  For  purposes  of this Act, "emergency
19        medical reasons" include transfers of prescription  drugs
20        by  a  retail  pharmacy  to  another  retail  pharmacy to
21        alleviate a temporary shortage.
22             (f)  The sale, purchase, or  trade  of  a  drug,  an
23        offer  to  sell,  purchase,  or  trade  a  drug,  or  the
24        dispensing of a drug pursuant to a prescription.
25             (g)  The    distribution    of   drug   samples   by
26        manufacturers'    representatives    or     distributors'
27        representatives.
28             (h)  The sale, purchase, or trade of blood and blood
29        components intended for transfusion.
30        "Wholesale  drug  distributor" means any person or entity
31    engaged in  wholesale  distribution  of  prescription  drugs,
32    including,  but not limited to, manufacturers; repackers; own
33    label  distributors;  jobbers;  private  label  distributors;
34    brokers;    warehouses,    including    manufacturers'    and
 
                            -6-      LRB093 04118 DRJ 04158 b
 1    distributors'  warehouses,   chain   drug   warehouses,   and
 2    wholesale   drug   warehouses;   independent  wholesale  drug
 3    traders;  and  retail  pharmacies  that   conduct   wholesale
 4    distributions,  including,  but  not limited to, any pharmacy
 5    distributor as defined in this  Section.   A  wholesale  drug
 6    distributor  shall not include any for hire carrier or person
 7    or entity hired solely to transport prescription drugs.
 8    (Source: P.A. 87-594.)

 9        Section 15.  The Illinois Public Aid Code is  amended  by
10    adding Section 12-4.25d as follows:

11        (305 ILCS 5/12-4.25d new)
12        Sec.   12-4.25d.  Nursing   homes;   return   of   unused
13    prescription drugs.
14        (a)  Every provider of long-term care services under this
15    Code  shall return to the vendor pharmacy from which the drug
16    product was purchased, for repackaging and  reimbursement  to
17    the Department of Public Aid, every drug product that (i) was
18    dispensed  to  a  resident  of  the provider's long-term care
19    facility and not used and (ii) meets  all  of  the  following
20    criteria:
21             (1)  It is a prescription drug product that is not a
22        controlled substance.
23             (2)  It is sealed in an individually packaged unit.
24             (3)  It  is  returned  to the vendor pharmacy within
25        the recommended period of shelf life for the  purpose  of
26        redispensing the drug product.
27             (4)  It  is determined to be of acceptable integrity
28        by a licensed pharmacist.
29             (5)  It  consists  of   (i)   oral   or   parenteral
30        medication  in a single-dose sealed container approved by
31        the federal Food and Drug Administration, (ii) a  topical
32        or  inhalant  drug  product  in  a  unit-of-use container
 
                            -7-      LRB093 04118 DRJ 04158 b
 1        approved by the federal Food and Drug Administration,  or
 2        (iii)  a  parenteral medication in a multiple-dose sealed
 3        container  approved  by  the  federal   Food   and   Drug
 4        Administration.
 5             (6)  No doses have been withdrawn from the container
 6        in which the drug product is packaged.
 7        If  a provider of long-term care services under this Code
 8    returns a drug product  under  this  Section  to  the  vendor
 9    pharmacy  from  which  the  drug  product  was purchased, the
10    pharmacy must accept the returned product.
11        (b)  Notwithstanding the provisions of subsection (a):
12             (1)  If  a  drug  product   is   packaged   in   the
13        manufacturer's  unit-dose package, the drug product shall
14        be returned to the vendor pharmacy for  redispensing  and
15        reimbursement to the Department of Public Aid if the drug
16        may be redispensed for use before the expiration date, if
17        any, indicated on the package.
18             (2)  If  the  drug  product  is  repackaged  in  the
19        manufacturer's  unit-dose  or multiple-dose blister pack,
20        the drug product shall be returned to the vendor pharmacy
21        for redispensing and reimbursement to the  Department  of
22        Public Aid if:
23                  (A)  the  date  on  which  the drug product was
24             repackaged and the drug  product's  lot  number  and
25             expiration date are indicated clearly on the package
26             of the repackaged drug product;
27                  (B)  ninety days or fewer have elapsed from the
28             date the drug product was repackaged; and
29                  (C)  a  repackaging  log  is  maintained by the
30             pharmacy in the case of drug products repackaged  in
31             advance of immediate needs.
32             (3)  A  drug  product dispensed in a bulk dispensing
33        container may not be returned to the vendor pharmacy.
34        (c)  Every provider of long term-care services under this
 
                            -8-      LRB093 04118 DRJ 04158 b
 1    Code shall establish procedures  for  the  return  of  unused
 2    drug  products  to  the vendor pharmacies from which the drug
 3    products were purchased.
 4        (d)  The Department of Public Aid:
 5             (1)  shall reimburse  to  the  vendor  pharmacy  the
 6        reasonable    cost    of   services   incurred   in   the
 7        implementation of this  Section,  as  determined  by  the
 8        Director of Public Aid; and
 9             (2)  may  establish  procedures,  if  feasible,  for
10        reimbursement  to  non-Medicaid  payors for drug products
11        returned under this Section.
12        (e)  The Department of Public Aid, in  consultation  with
13    the  Department of Professional Regulation, shall adopt rules
14    to govern the  repackaging  and  labeling  of  drug  products
15    returned  under  this Section. The rules must provide for the
16    following:
17             (1)  A  formulary  for  the  drug  products  to   be
18        returned for repackaging.
19             (2)  The protection of the privacy of the individual
20        for whom the drug product was originally prescribed.
21             (3)  The  integrity, safe storage, and safe transfer
22        of the drug product, which may include, but need  not  be
23        limited  to,  limiting  the  drugs  to  those  that  were
24        originally  dispensed  by  unit  dose  or an individually
25        sealed dose or that remain in intact packaging.
26             (4)  The tracking of and accountability for the drug
27        products.
28             (5)  Other matters necessary for  implementing  this
29        Section.
30        (f)  A  provider of long-term care services that fails to
31    comply with this Section is subject to  a  civil  penalty  of
32    $30,000  for  each  incident of noncompliance. The Department
33    may impose a civil penalty under this Section only  after  it
34    provides all of the following to the provider:
 
                            -9-      LRB093 04118 DRJ 04158 b
 1             (1)  Written notice of the alleged violation and the
 2        resulting penalty.
 3             (2)  Written  notice  of  the  provider's  right  to
 4        request  an administrative hearing on the question of the
 5        alleged violation.
 6             (3)  An opportunity to present evidence,  orally  or
 7        in  writing  or  both,  on  the  question  of the alleged
 8        violation before an impartial hearing examiner  appointed
 9        by the Director of Public Aid.
10             (4)  A  written decision from the Director of Public
11        Aid, based on the evidence introduced at the hearing  and
12        the  hearing examiner's recommendations, finding that the
13        provider violated this Section  and  imposing  the  civil
14        penalty.
15        A  provider  must request an administrative hearing under
16    this subsection within 15 days after receiving the notice  of
17    violation  from  the  Department.  If  a  provider requests a
18    hearing within that  time,  the  Department  shall  stay  the
19    imposition of a penalty pending the outcome of the hearing.
20        The  Department  of  Public Aid may impose a penalty on a
21    provider under this Section regardless of whether a change in
22    ownership of the provider has taken place since the  time  of
23    the  violation,  provided that (i) the Department sent notice
24    of the alleged violation and the  resulting  penalty  to  the
25    provider before the effective date of the change in ownership
26    and  (ii)  a  record  of the notice is readily available in a
27    central registry maintained by the Department.
28        (g)  The Attorney General may  bring  an  action  in  the
29    circuit court to enforce the collection of a monetary penalty
30    imposed under this Section. Alternatively, for the purpose of
31    collecting   a   penalty  imposed  under  this  Section,  the
32    Department may use all or part of the amount of  the  penalty
33    to  offset  payments  owed  by the Department to the provider
34    under this Code.
 
                            -10-     LRB093 04118 DRJ 04158 b
 1        (h)  All penalties collected under this Section shall  be
 2    deposited  into  the General Revenue Fund and credited to the
 3    Medicaid account.
 4        (i)  A licensed physician, pharmacist,  or  other  health
 5    care  professional is not subject to liability for compliance
 6    with this Section when acting within the scope of practice of
 7    his or her license and in  good  faith  compliance  with  the
 8    rules  adopted  by  the  Department  of Public Aid under this
 9    Section.

10        Section 20.  The Senior Pharmaceutical Assistance Act  is
11    amended by changing Section 10 as follows:

12        (320 ILCS 50/10)
13        Sec. 10.  Definitions. In this Act:
14        "Manufacturer" includes:
15             (1)  An   entity   that   is   engaged  in  (a)  the
16        production,   preparation,   propagation,    compounding,
17        conversion,  or  processing of prescription drug products
18        (i) directly or indirectly by extraction from  substances
19        of   natural  origin,  (ii)  independently  by  means  of
20        chemical synthesis, or (iii) by combination of extraction
21        and   chemical   synthesis;   or   (b)   the   packaging,
22        repackaging, labeling or re-labeling, or distribution  of
23        prescription drug products.
24             (2)  The entity holding legal title to or possession
25        of   the  national  drug  code  number  for  the  covered
26        prescription drug.
27        The term does not  include  a  wholesale  distributor  of
28    drugs,  drugstore  chain  organization,  or  retail  pharmacy
29    licensed  by  the  State.  The  term also does not include an
30    entity that is engaged  in  the  packaging,  repackaging,  or
31    labeling  of  a prescription drug only to the extent required
32    under Section 12-4.25d of the Illinois Public Aid Code.
 
                            -11-     LRB093 04118 DRJ 04158 b
 1        "Prescription drug" means a drug that  may  be  dispensed
 2    only  upon  prescription by an authorized prescriber and that
 3    is approved for safety and effectiveness  as  a  prescription
 4    drug  under  Section 505 or 507 of the Federal Food, Drug and
 5    Cosmetic Act.
 6        "Senior citizen" or "senior" means a person 65  years  of
 7    age or older.
 8    (Source: P.A. 92-594, eff. 6-27-02.)

 9        Section 25.   The Illinois Food, Drug and Cosmetic Act is
10    amended by changing Section 16 as follows:

11        (410 ILCS 620/16) (from Ch. 56 1/2, par. 516)
12        Sec.  16.  (a)  The  Director  is  hereby  authorized  to
13    promulgate   regulations   exempting  from  any  labeling  or
14    packaging requirement of this Act drugs and devices which are
15    (i), in accordance with the practice  of  the  trade,  to  be
16    processed,  labeled  or repacked in substantial quantities at
17    establishments other than those where originally processed or
18    packaged on condition that such drugs  and  devices  are  not
19    adulterated  or  misbranded  under the provisions of this Act
20    upon removal from  such  processing,  labeling  or  repacking
21    establishment or (ii) packaged, repackaged, or labeled to the
22    extent required under Section 12-4.25d of the Illinois Public
23    Aid Code.
24        (b)  Drugs  and  device  labeling or packaging exemptions
25    adopted under the Federal  Act  and  supplements  thereto  or
26    revisions  thereof  shall  apply  to  drugs  and  devices  in
27    Illinois   except   insofar   as   modified  or  rejected  by
28    regulations promulgated by the Director.
29        (c)  A drug intended for  use  by  man  which  (A)  is  a
30    habit-forming  drug  to  which Section 15 (d) applies; or (B)
31    because of its toxicity or  other  potentiality  for  harmful
32    effect  or  the  method of its use or the collateral measures
 
                            -12-     LRB093 04118 DRJ 04158 b
 1    necessary to its use is not safe for  use  except  under  the
 2    supervision  of  a practitioner licensed by law to administer
 3    such drug; or (C) is limited by an approved application under
 4    Section 505 of the Federal Act or Section 17 of this  Act  to
 5    use  under  the  professional  supervision  of a practitioner
 6    licensed by law to administer such drug, shall  be  dispensed
 7    only  in  accordance  with  the  provisions  of the "Illinois
 8    Controlled Substances Act". The  act  of  dispensing  a  drug
 9    contrary  to the provisions of this paragraph shall be deemed
10    to be an act which results in a drug being  misbranded  while
11    held for sale.
12        (d)  Any drug dispensed by filling or refilling a written
13    or  oral  prescription  of  a practitioner licensed by law to
14    administer such drug shall be exempt from the requirements of
15    Section 15, except subsections (a), (k) and (l)  and  clauses
16    (2) and (3) of subsection (i), and the packaging requirements
17    of  subsections  (g),  (h) and (q), if the drug bears a label
18    containing the proprietary name or  names,  or  if  there  is
19    none,  the established name or names of the drugs, the dosage
20    and quantity, unless the  prescribing  practitioner,  in  the
21    interest  of  the health of the patient, directs otherwise in
22    writing, the name and address of the  dispenser,  the  serial
23    number  and  date  of the prescription or of its filling, the
24    name of the prescriber and, if stated  in  the  prescription,
25    the  name  of the patient, and the directions for use and the
26    cautionary   statements,   if   any,   contained   in    such
27    prescription.  This  exemption  shall  not  apply to any drug
28    dispensed in  the  course  of  the  conduct  of  business  of
29    dispensing  drugs pursuant to diagnosis by mail, or to a drug
30    dispensed in violation of subsection (a) of this Section.
31        (e)  The Director may by regulation remove drugs  subject
32    to  Section  15  (d)  and Section 17 from the requirements of
33    subsection (c) of this Section when such requirements are not
34    necessary for the protection of the public health.
 
                            -13-     LRB093 04118 DRJ 04158 b
 1        (f)  A drug which is subject to subsection  (c)  of  this
 2    Section  shall  be  deemed  to  be  misbranded if at any time
 3    before dispensing its  label  fails  to  bear  the  statement
 4    "Caution:    Federal   Law   Prohibits   Dispensing   Without
 5    Prescription" or "Caution:  State  Law  Prohibits  Dispensing
 6    Without Prescription". A drug to which subsection (c) of this
 7    Section does not apply shall be deemed to be misbranded if at
 8    any  time  prior  to  dispensing  its label bears the caution
 9    statement quoted in the preceding sentence.
10        (g)  Nothing  in  this  Section  shall  be  construed  to
11    relieve any person from  any  requirement  prescribed  by  or
12    under  authority of law with respect to controlled substances
13    now included or which may hereafter be  included  within  the
14    classifications  of controlled substances cannabis as defined
15    in applicable Federal laws relating to controlled  substances
16    or cannabis or the Cannabis Control Act.
17    (Source: P.A. 84-1308.)

18        Section  30.  The  Illinois  Controlled Substances Act is
19    amended by changing Section 102 as follows:

20        (720 ILCS 570/102) (from Ch. 56 1/2, par. 1102)
21        Sec. 102.  Definitions.  As used in this Act, unless  the
22    context otherwise requires:
23        (a)  "Addict"  means  any  person who habitually uses any
24    drug,  chemical,  substance  or  dangerous  drug  other  than
25    alcohol so as to endanger the public morals,  health,  safety
26    or  welfare  or  who  is  so  far  addicted  to  the use of a
27    dangerous drug or controlled substance other than alcohol  as
28    to  have lost the power of self control with reference to his
29    addiction.
30        (b)  "Administer"  means  the  direct  application  of  a
31    controlled  substance,  whether  by  injection,   inhalation,
32    ingestion,  or  any  other means, to the body of a patient or
 
                            -14-     LRB093 04118 DRJ 04158 b
 1    research subject by:
 2             (1)  a practitioner (or, in  his  presence,  by  his
 3        authorized agent), or
 4             (2)  the  patient  or research subject at the lawful
 5        direction of the practitioner.
 6        (c)  "Agent" means  an  authorized  person  who  acts  on
 7    behalf of or at the direction of a manufacturer, distributor,
 8    or  dispenser.   It  does  not  include  a common or contract
 9    carrier, public warehouseman or employee of  the  carrier  or
10    warehouseman.
11        (c-1)  "Anabolic  Steroids"  means  any  drug or hormonal
12    substance,  chemically  and  pharmacologically   related   to
13    testosterone   (other   than   estrogens,   progestins,   and
14    corticosteroids) that promotes muscle growth, and includes:
15                  (i)  boldenone,
16                  (ii)  chlorotestosterone,
17                  (iii)  chostebol,
18                  (iv)  dehydrochlormethyltestosterone,
19                  (v)  dihydrotestosterone,
20                  (vi)  drostanolone,
21                  (vii)  ethylestrenol,
22                  (viii)  fluoxymesterone,
23                  (ix)  formebulone,
24                  (x)  mesterolone,
25                  (xi)  methandienone,
26                  (xii)  methandranone,
27                  (xiii)  methandriol,
28                  (xiv)  methandrostenolone,
29                  (xv)  methenolone,
30                  (xvi)  methyltestosterone,
31                  (xvii)  mibolerone,
32                  (xviii)  nandrolone,
33                  (xix)  norethandrolone,
34                  (xx)  oxandrolone,
 
                            -15-     LRB093 04118 DRJ 04158 b
 1                  (xxi)  oxymesterone,
 2                  (xxii)  oxymetholone,
 3                  (xxiii)  stanolone,
 4                  (xxiv)  stanozolol,
 5                  (xxv)  testolactone,
 6                  (xxvi)  testosterone,
 7                  (xxvii)  trenbolone, and
 8                  (xxviii)  any  salt, ester, or isomer of a drug
 9             or substance described or listed in this  paragraph,
10             if  that  salt,  ester,  or  isomer  promotes muscle
11             growth.
12        Any person who is otherwise lawfully in possession of  an
13    anabolic  steroid,  or  who  otherwise lawfully manufactures,
14    distributes, dispenses, delivers, or possesses with intent to
15    deliver  an  anabolic  steroid,  which  anabolic  steroid  is
16    expressly  intended  for   and   lawfully   allowed   to   be
17    administered  through implants to livestock or other nonhuman
18    species, and which is approved by the Secretary of Health and
19    Human Services for such administration, and which the  person
20    intends  to  administer  or  have  administered  through such
21    implants, shall not  be  considered  to  be  in  unauthorized
22    possession   or   to   unlawfully   manufacture,  distribute,
23    dispense, deliver, or possess with  intent  to  deliver  such
24    anabolic steroid for purposes of this Act.
25        (d)  "Administration"    means   the   Drug   Enforcement
26    Administration, United States Department of Justice,  or  its
27    successor agency.
28        (e)  "Control" means to add a drug or other substance, or
29    immediate  precursor,  to a Schedule under Article II of this
30    Act whether by transfer from another Schedule or otherwise.
31        (f)  "Controlled Substance" means a drug,  substance,  or
32    immediate  precursor  in  the Schedules of Article II of this
33    Act.
34        (g)  "Counterfeit   substance"   means    a    controlled
 
                            -16-     LRB093 04118 DRJ 04158 b
 1    substance,  which,  or  the  container  or labeling of which,
 2    without authorization bears the  trademark,  trade  name,  or
 3    other  identifying  mark,  imprint,  number or device, or any
 4    likeness  thereof,  of  a   manufacturer,   distributor,   or
 5    dispenser  other  than  the  person who in fact manufactured,
 6    distributed, or dispensed the substance.
 7        (h)  "Deliver"   or   "delivery"   means   the    actual,
 8    constructive   or  attempted  transfer  of  possession  of  a
 9    controlled substance, with or without consideration,  whether
10    or not there is an agency relationship.
11        (i)  "Department"  means the Illinois Department of Human
12    Services (as successor to the Department  of  Alcoholism  and
13    Substance Abuse) or its successor agency.
14        (j)  "Department of State Police" means the Department of
15    State  Police  of  the  State  of  Illinois  or its successor
16    agency.
17        (k)  "Department of Corrections" means the Department  of
18    Corrections of the State of Illinois or its successor agency.
19        (l)  "Department  of  Professional  Regulation" means the
20    Department  of  Professional  Regulation  of  the  State   of
21    Illinois or its successor agency.
22        (m)  "Depressant" or "stimulant substance" means:
23             (1)  a  drug  which  contains  any  quantity  of (i)
24        barbituric acid or any of the salts  of  barbituric  acid
25        which  has been designated as habit forming under section
26        502 (d) of the Federal Food, Drug, and Cosmetic  Act  (21
27        U.S.C. 352 (d)); or
28             (2)  a  drug  which  contains  any  quantity  of (i)
29        amphetamine or methamphetamine and any of  their  optical
30        isomers;  (ii) any salt of amphetamine or methamphetamine
31        or any salt of an optical isomer of amphetamine; or (iii)
32        any substance which the Department, after  investigation,
33        has found to be, and by rule designated as, habit forming
34        because  of  its  depressant  or  stimulant effect on the
 
                            -17-     LRB093 04118 DRJ 04158 b
 1        central nervous system; or
 2             (3)  lysergic acid diethylamide; or
 3             (4)  any drug  which  contains  any  quantity  of  a
 4        substance  which the Department, after investigation, has
 5        found to have,  and  by  rule  designated  as  having,  a
 6        potential   for   abuse  because  of  its  depressant  or
 7        stimulant effect on the central  nervous  system  or  its
 8        hallucinogenic effect.
 9        (n)  (Blank).
10        (o)  "Director"  means  the Director of the Department of
11    State Police or the Department of Professional Regulation  or
12    his designated agents.
13        (p)  "Dispense"  means  to deliver a controlled substance
14    to an ultimate user or research subject by or pursuant to the
15    lawful order of  a  prescriber,  including  the  prescribing,
16    administering,  packaging, labeling, or compounding necessary
17    to prepare the substance for that delivery.
18        (q)  "Dispenser" means a practitioner who dispenses.
19        (r)  "Distribute"  means  to  deliver,  other   than   by
20    administering or dispensing, a controlled substance.
21        (s)  "Distributor" means a person who distributes.
22        (t)  "Drug"  means  (1) substances recognized as drugs in
23    the   official   United   States   Pharmacopoeia,    Official
24    Homeopathic  Pharmacopoeia  of the United States, or official
25    National Formulary, or any supplement to  any  of  them;  (2)
26    substances  intended  for use in diagnosis, cure, mitigation,
27    treatment, or prevention of disease in man  or  animals;  (3)
28    substances (other than food) intended to affect the structure
29    of  any  function  of  the  body  of  man  or animals and (4)
30    substances intended for use as a  component  of  any  article
31    specified  in clause (1), (2), or (3) of this subsection.  It
32    does not include  devices  or  their  components,  parts,  or
33    accessories.
34        (t-5)  "Euthanasia  agency"  means an entity certified by
 
                            -18-     LRB093 04118 DRJ 04158 b
 1    the Department of Professional Regulation for the purpose  of
 2    animal  euthanasia  that  holds  an  animal  control facility
 3    license or animal shelter license under  the  Animal  Welfare
 4    Act.   A  euthanasia agency is authorized to purchase, store,
 5    possess, and utilize Schedule II nonnarcotic and Schedule III
 6    nonnarcotic drugs for the sole purpose of animal euthanasia.
 7        (u)  "Good faith" means the prescribing or dispensing  of
 8    a  controlled  substance  by  a  practitioner  in the regular
 9    course of professional treatment to or for any person who  is
10    under  his  treatment for a pathology or condition other than
11    that individual's physical or psychological  dependence  upon
12    or  addiction  to  a controlled substance, except as provided
13    herein:  and application of the term to  a  pharmacist  shall
14    mean the dispensing of a controlled substance pursuant to the
15    prescriber's  order which in the professional judgment of the
16    pharmacist is lawful.  The  pharmacist  shall  be  guided  by
17    accepted professional standards including, but not limited to
18    the following, in making the judgment:
19             (1)  lack    of    consistency   of   doctor-patient
20        relationship,
21             (2)  frequency of prescriptions for same drug by one
22        prescriber for large numbers of patients,
23             (3)  quantities beyond those normally prescribed,
24             (4)  unusual dosages,
25             (5)  unusual geographic distances  between  patient,
26        pharmacist and prescriber,
27             (6)  consistent prescribing of habit-forming drugs.
28        (u-1)  "Home  infusion  services" means services provided
29    by  a  pharmacy   in   compounding   solutions   for   direct
30    administration to a patient in a private residence, long-term
31    care  facility,  or  hospice  setting by means of parenteral,
32    intravenous,  intramuscular,  subcutaneous,  or   intraspinal
33    infusion.
34        (v)  "Immediate precursor" means a substance:
 
                            -19-     LRB093 04118 DRJ 04158 b
 1             (1)  which  the  Department  has  found to be and by
 2        rule designated as being a principal  compound  used,  or
 3        produced  primarily  for  use,  in  the  manufacture of a
 4        controlled substance;
 5             (2)  which is  an  immediate  chemical  intermediary
 6        used  or  likely  to  be  used in the manufacture of such
 7        controlled substance; and
 8             (3)  the control of which is necessary  to  prevent,
 9        curtail  or  limit  the  manufacture  of  such controlled
10        substance.
11        (w)  "Instructional  activities"  means   the   acts   of
12    teaching,  educating  or  instructing  by practitioners using
13    controlled substances within educational facilities  approved
14    by the State Board of Education or its successor agency.
15        (x)  "Local  authorities"  means  a duly organized State,
16    County or Municipal peace unit or police force.
17        (y)  "Look-alike substance" means a substance, other than
18    a controlled substance  which  (1)  by  overall  dosage  unit
19    appearance,  including  shape,  color, size, markings or lack
20    thereof,  taste,  consistency,  or  any   other   identifying
21    physical  characteristic  of  the  substance,  would  lead  a
22    reasonable   person  to  believe  that  the  substance  is  a
23    controlled  substance,  or  (2)  is  expressly  or  impliedly
24    represented to be a controlled substance  or  is  distributed
25    under  circumstances  which would lead a reasonable person to
26    believe that the substance is a controlled substance. For the
27    purpose of determining whether the  representations  made  or
28    the circumstances of the distribution would lead a reasonable
29    person  to believe the substance to be a controlled substance
30    under this clause (2) of subsection (y), the court  or  other
31    authority  may  consider the following factors in addition to
32    any other factor that may be relevant:
33             (a)  statements made  by  the  owner  or  person  in
34        control  of  the  substance concerning its nature, use or
 
                            -20-     LRB093 04118 DRJ 04158 b
 1        effect;
 2             (b)  statements made to the buyer or recipient  that
 3        the substance may be resold for profit;
 4             (c)  whether  the  substance is packaged in a manner
 5        normally used for the illegal distribution of  controlled
 6        substances;
 7             (d)  whether    the    distribution   or   attempted
 8        distribution included an exchange of or demand for  money
 9        or  other  property  as  consideration,  and  whether the
10        amount of the  consideration  was  substantially  greater
11        than the reasonable retail market value of the substance.
12        Clause  (1)  of  this subsection (y) shall not apply to a
13    noncontrolled substance in its finished dosage form that  was
14    initially  introduced  into  commerce  prior  to  the initial
15    introduction into commerce of a controlled substance  in  its
16    finished dosage form which it may substantially resemble.
17        Nothing  in  this subsection (y) prohibits the dispensing
18    or  distributing  of  noncontrolled  substances  by   persons
19    authorized  to  dispense and distribute controlled substances
20    under this Act, provided that such action would be deemed  to
21    be  carried  out  in  good  faith under subsection (u) if the
22    substances involved were controlled substances.
23        Nothing in this subsection (y) or in this  Act  prohibits
24    the   manufacture,   preparation,  propagation,  compounding,
25    processing, packaging, advertising or distribution of a  drug
26    or  drugs by any person registered pursuant to Section 510 of
27    the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360).
28        (y-1)  "Mail-order pharmacy" means  a  pharmacy  that  is
29    located in a state of the United States, other than Illinois,
30    that  delivers,  dispenses or distributes, through the United
31    States Postal Service or other common  carrier,  to  Illinois
32    residents, any substance which requires a prescription.
33        (z)  "Manufacture"  means  the  production,  preparation,
34    propagation,  compounding,  conversion  or  processing  of  a
 
                            -21-     LRB093 04118 DRJ 04158 b
 1    controlled  substance,  either  directly  or  indirectly,  by
 2    extraction    from   substances   of   natural   origin,   or
 3    independently  by  means  of  chemical  synthesis,  or  by  a
 4    combination  of  extraction  and  chemical   synthesis,   and
 5    includes  any  packaging  or  repackaging of the substance or
 6    labeling of its container, except that  this  term  does  not
 7    include:
 8             (1)  by   an   ultimate  user,  the  preparation  or
 9        compounding of a controlled substance for his own use; or
10             (2)  by a  practitioner,  or  his  authorized  agent
11        under  his  supervision,  the  preparation,  compounding,
12        packaging, or labeling of a controlled substance:
13                  (a)  as  an  incident  to  his administering or
14             dispensing of a controlled substance in  the  course
15             of his professional practice; or
16                  (b)  as   an   incident   to  lawful  research,
17             teaching or chemical analysis and not for sale or;.
18             (3)  the packaging, repackaging, or  labeling  of  a
19        prescription  drug  to  the extent required under Section
20        12-4.25d of the Illinois Public Aid Code.
21        (z-1)  "Methamphetamine manufacturing chemical" means any
22    of the following chemicals or substances  containing  any  of
23    the  following  chemicals:  benzyl  methyl ketone, ephedrine,
24    methyl benzyl ketone, phenylacetone,  phenyl-2-propanone,  or
25    pseudoephedrine  or  any  of  the  salts, optical isomers, or
26    salts of optical isomers of the above-listed chemicals.
27        (aa)  "Narcotic drug" means any of the following, whether
28    produced directly or indirectly by extraction from substances
29    of natural origin, or  independently  by  means  of  chemical
30    synthesis,  or  by  a  combination of extraction and chemical
31    synthesis:
32             (1)  opium  and  opiate,  and  any  salt,  compound,
33        derivative, or preparation of opium or opiate;
34             (2)  any  salt,  compound,  isomer,  derivative,  or
 
                            -22-     LRB093 04118 DRJ 04158 b
 1        preparation thereof which  is  chemically  equivalent  or
 2        identical  with  any  of  the  substances  referred to in
 3        clause (1), but not including the isoquinoline  alkaloids
 4        of opium;
 5             (3)  opium poppy and poppy straw;
 6             (4)  coca  leaves  and  any salts, compound, isomer,
 7        salt of an isomer, derivative,  or  preparation  of  coca
 8        leaves  including  cocaine  or  ecgonine,  and  any salt,
 9        compound,  isomer,  derivative,  or  preparation  thereof
10        which is chemically equivalent or identical with  any  of
11        these  substances,  but  not  including decocainized coca
12        leaves or extractions of coca leaves which do not contain
13        cocaine or ecgonine (for the purpose of  this  paragraph,
14        the   term  "isomer"  includes  optical,  positional  and
15        geometric isomers).
16        (bb)  "Nurse" means a registered nurse licensed under the
17    Nursing and Advanced Practice Nursing Act.
18        (cc)  (Blank).
19        (dd)  "Opiate" means any substance  having  an  addiction
20    forming or addiction sustaining liability similar to morphine
21    or  being  capable of conversion into a drug having addiction
22    forming or addiction sustaining liability.
23        (ee)  "Opium  poppy"  means  the  plant  of  the  species
24    Papaver somniferum L., except its seeds.
25        (ff)  "Parole and Pardon  Board"  means  the  Parole  and
26    Pardon  Board  of  the  State  of  Illinois  or its successor
27    agency.
28        (gg)  "Person"   means   any   individual,   corporation,
29    mail-order pharmacy, government or  governmental  subdivision
30    or  agency,  business  trust,  estate,  trust, partnership or
31    association, or any other entity.
32        (hh)  "Pharmacist"  means  any   person   who   holds   a
33    certificate  of  registration  as  a registered pharmacist, a
34    local  registered  pharmacist  or  a   registered   assistant
 
                            -23-     LRB093 04118 DRJ 04158 b
 1    pharmacist under the Pharmacy Practice Act of 1987.
 2        (ii)  "Pharmacy"  means any store, ship or other place in
 3    which pharmacy  is  authorized  to  be  practiced  under  the
 4    Pharmacy Practice Act of 1987.
 5        (jj)  "Poppy straw" means all parts, except the seeds, of
 6    the opium poppy, after mowing.
 7        (kk)  "Practitioner"   means   a  physician  licensed  to
 8    practice medicine in all its branches,  dentist,  podiatrist,
 9    veterinarian,  scientific investigator, pharmacist, physician
10    assistant, advanced practice nurse, licensed practical nurse,
11    registered nurse, hospital, laboratory, or pharmacy, or other
12    person licensed, registered, or otherwise lawfully  permitted
13    by  the  United States or this State to distribute, dispense,
14    conduct research  with  respect  to,  administer  or  use  in
15    teaching  or chemical analysis, a controlled substance in the
16    course of professional practice or research.
17        (ll)  "Pre-printed   prescription"   means   a    written
18    prescription   upon   which  the  designated  drug  has  been
19    indicated prior to the time of issuance.
20        (mm)  "Prescriber" means a physician licensed to practice
21    medicine  in  all  its  branches,  dentist,   podiatrist   or
22    veterinarian who issues a prescription, a physician assistant
23    who  issues  a  prescription  for  a  Schedule  III, IV, or V
24    controlled substance in accordance with  Section  303.05  and
25    the  written  guidelines  required  under  Section 7.5 of the
26    Physician Assistant Practice Act  of  1987,  or  an  advanced
27    practice nurse with prescriptive authority in accordance with
28    Section  303.05  and  a written collaborative agreement under
29    Sections 15-15 and 15-20 of the Nursing and Advanced Practice
30    Nursing Act.
31        (nn)  "Prescription" means a lawful  written,  facsimile,
32    or  verbal order of a physician licensed to practice medicine
33    in all its branches, dentist, podiatrist or veterinarian  for
34    any  controlled  substance,  of  a  physician assistant for a
 
                            -24-     LRB093 04118 DRJ 04158 b
 1    Schedule III, IV, or V  controlled  substance  in  accordance
 2    with Section 303.05 and the written guidelines required under
 3    Section  7.5 of the Physician Assistant Practice Act of 1987,
 4    or of an advanced practice nurse who  issues  a  prescription
 5    for  a  Schedule  III,  IV,  or  V  controlled  substance  in
 6    accordance  with  Section  303.05 and a written collaborative
 7    agreement under Sections 15-15 and 15-20 of the  Nursing  and
 8    Advanced Practice Nursing Act.
 9        (oo)  "Production"   or   "produce"   means  manufacture,
10    planting, cultivating, growing, or harvesting of a controlled
11    substance.
12        (pp)  "Registrant" means every person who is required  to
13    register under Section 302 of this Act.
14        (qq)  "Registry number" means the number assigned to each
15    person  authorized  to handle controlled substances under the
16    laws of the United States and of this State.
17        (rr)  "State" includes the  State  of  Illinois  and  any
18    state,  district, commonwealth, territory, insular possession
19    thereof, and any area subject to the legal authority  of  the
20    United States of America.
21        (ss)  "Ultimate   user"   means  a  person  who  lawfully
22    possesses a controlled substance for his own use or  for  the
23    use  of  a member of his household or for administering to an
24    animal owned by him or by a member of his household.
25    (Source: P.A.  91-403,  eff.  1-1-00;  91-714,  eff.  6-2-00;
26    92-449, eff. 1-1-02.)

27        Section   35.    The  Cannabis  and Controlled Substances
28    Tort Claims Act is amended by changing Section 3 as follows:

29        (740 ILCS 20/3) (from Ch. 70, par. 903)
30        Sec. 3.  Definitions.  As used in this  Act,  unless  the
31    context otherwise requires:
32        "Cannabis"   includes   marihuana,   hashish,  and  other
 
                            -25-     LRB093 04118 DRJ 04158 b
 1    substances that are identified as including any parts of  the
 2    plant  Cannabis  Sativa, whether growing or not, the seeds of
 3    that plant, the resin extracted from any part of that  plant,
 4    and  any compound, manufacture, salt, derivative, mixture, or
 5    preparation of that plant, its  seeds,  or  resin,  including
 6    tetrahydrocannabinol   (THC)   and   all   other   cannabinol
 7    derivatives,    including    its   naturally   occurring   or
 8    synthetically produced ingredients, whether produced directly
 9    or  indirectly  by  extraction,  independently  by  means  of
10    chemical synthesis, or by a  combination  of  extraction  and
11    chemical  synthesis.  "Cannabis"  does not include the mature
12    stalks of that plant, fiber produced from those  stalks,  oil
13    or  cake  made  from  the  seeds  of  that  plant,  any other
14    compound,  manufacture,   salt,   derivative,   mixture,   or
15    preparation  of  mature  stalks (except the extracted resin),
16    fiber, oil or cake, or the sterilized  seeds  of  that  plant
17    that are incapable of germination.
18        "Controlled   substance"  means  a  drug,  substance,  or
19    immediate precursor in the Schedules of  Article  II  of  the
20    Illinois Controlled Substances Act.
21        "Counterfeit  substance"  means a controlled substance or
22    the container or labeling of  a  controlled  substance  that,
23    without  authorization,  bears  the trademark, trade name, or
24    other identifying  mark,  imprint,  number,  device,  or  any
25    likeness thereof of a manufacturer, distributor, or dispenser
26    other  than the person who in fact manufactured, distributed,
27    or dispensed the substance.
28        "Deliver" or "delivery" means the  actual,  constructive,
29    or attempted transfer of possession of a controlled substance
30    or  cannabis,  with  or without consideration, whether or not
31    there is an agency relationship.
32        "Manufacture"   means   the   production,    preparation,
33    propagation,  compounding,  conversion,  or  processing  of a
34    controlled  substance,  either  directly  or  indirectly,  by
 
                            -26-     LRB093 04118 DRJ 04158 b
 1    extraction from substances of natural  origin,  independently
 2    by  means  of  chemical  synthesis,  or  by  a combination of
 3    extraction and chemical synthesis, and includes any packaging
 4    or repackaging of the substance or labeling of its container,
 5    except that the term does not include:
 6             (1)  by  an  ultimate  user,  the   preparation   or
 7        compounding of a controlled substance for his own use;
 8             (2)  by a practitioner or his authorized agent under
 9        his supervision, the preparation, compounding, packaging,
10        or labeling of a controlled substance;
11                  (A)  as  an  incident  to  his administering or
12             dispensing of a controlled substance in  the  course
13             of his professional practice; or
14                  (B)  as   an   incident   to  lawful  research,
15             teaching or chemical analysis and not for sale; or
16             (3)  the  preparation,  compounding,  packaging,  or
17        labeling of cannabis as an incident to  lawful  research,
18        teaching, or chemical analysis and not for sale; or.
19             (4)  the  packaging,  repackaging,  or labeling of a
20        prescription drug to the extent  required  under  Section
21        12-4.25d of the Illinois Public Aid Code.
22        "Owner"  means  a  person  who  has  possession of or any
23    interest whatsoever in the property involved.
24        "Person"  means   an   individual,   a   corporation,   a
25    government,  a governmental subdivision or agency, a business
26    trust, an estate, a trust, a partnership or  association,  or
27    any other entity.
28        "Production"  means  planting,  cultivating,  tending, or
29    harvesting.
30        "Property" means real property, including things  growing
31    on, affixed to, and found in land, and tangible or intangible
32    personal  property,  including  rights, services, privileges,
33    interests, claims, and securities.
34    (Source: P.A. 87-544.)