093_HB2778ham001











                                     LRB093 03709 AMC 13080 a

 1                    AMENDMENT TO HOUSE BILL 2778

 2        AMENDMENT NO.     .  Amend House Bill 2778 in Section  5,
 3    by replacing Sec. 3 with the following:
 4        "(225 ILCS 85/3) (from Ch. 111, par. 4123)
 5        (Section scheduled to be repealed on January 1, 2008)
 6        (Text of Section before amendment by P.A. 92-880)
 7        Sec. 3. Definitions.  For the purpose of this Act, except
 8    where otherwise limited therein:
 9        (a)  "Pharmacy"  or  "drugstore" means and includes every
10    store,  shop,  pharmacy  department,  or  other  place  where
11    pharmaceutical care is provided by  a  pharmacist  (1)  where
12    drugs,  medicines,  or poisons are dispensed, sold or offered
13    for sale at retail, or displayed for sale at retail;  or  (2)
14    where  prescriptions  of physicians, dentists, veterinarians,
15    podiatrists,  or  therapeutically   certified   optometrists,
16    within  the limits of their licenses, are compounded, filled,
17    or dispensed; or (3) which has upon it  or  displayed  within
18    it,  or  affixed  to  or  used  in connection with it, a sign
19    bearing  the  word   or   words   "Pharmacist",   "Druggist",
20    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
21    "Medicine  Store",  "Prescriptions", "Drugs", "Medicines", or
22    any word or words of similar or like import,  either  in  the
23    English  language  or  any  other  language; or (4) where the
24    characteristic prescription sign (Rx) or  similar  design  is
 
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 1    exhibited;  or  (5)  any  store, or shop, or other place with
 2    respect to which any of the above words,  objects,  signs  or
 3    designs are used in any advertisement.
 4        (b)  "Drugs"  means  and includes (l) articles recognized
 5    in  the   official   United   States   Pharmacopoeia/National
 6    Formulary  (USP/NF),  or  any  supplement  thereto  and being
 7    intended for and having for their  main  use  the  diagnosis,
 8    cure,  mitigation,  treatment or prevention of disease in man
 9    or other animals, as approved by the United States  Food  and
10    Drug  Administration,  but  does not include devices or their
11    components, parts, or accessories; and (2) all other articles
12    intended for and having for their  main  use  the  diagnosis,
13    cure,  mitigation,  treatment or prevention of disease in man
14    or other animals, as approved by the United States  Food  and
15    Drug  Administration,  but  does not include devices or their
16    components, parts, or accessories; and  (3)  articles  (other
17    than  food)  having for their main use and intended to affect
18    the structure or any function of the body  of  man  or  other
19    animals;  and  (4)  articles  having  for  their main use and
20    intended for use as a component or any articles specified  in
21    clause (l), (2) or (3); but does not include devices or their
22    components, parts or accessories.
23        (c)  "Medicines"  means  and  includes all drugs intended
24    for human or veterinary use approved  by  the  United  States
25    Food and Drug Administration.
26        (d)  "Practice   of  pharmacy"  means  the  provision  of
27    pharmaceutical  care  to  patients  as  determined   by   the
28    pharmacist's  professional  judgment  in the following areas,
29    which  may  include  but  are  not  limited  to  (1)  patient
30    counseling,  (2)  interpretation   and   assisting   in   the
31    monitoring  of  appropriate  drug  use  and  prospective drug
32    utilization  review,  (3)  providing   information   on   the
33    therapeutic   values,   reactions,  drug  interactions,  side
34    effects, uses, selection of medications and medical  devices,
 
                            -3-      LRB093 03709 AMC 13080 a
 1    and  outcome  of  drug  therapy,  (4)  participation  in drug
 2    selection,  drug   monitoring,   drug   utilization   review,
 3    evaluation,  administration,  interpretation,  application of
 4    pharmacokinetic  and  laboratory  data  to  design  safe  and
 5    effective drug regimens,  (5)  drug  research  (clinical  and
 6    scientific),  and (6) compounding and dispensing of drugs and
 7    medical devices.
 8        (e)  "Prescription" means and includes any written, oral,
 9    facsimile, or electronically transmitted order for  drugs  or
10    medical  devices,  issued by a physician licensed to practice
11    medicine in  all  its  branches,  dentist,  veterinarian,  or
12    podiatrist,  or therapeutically certified optometrist, within
13    the  limits  of  their  licenses, by a physician assistant in
14    accordance with  subsection  (f)  of  Section  4,  or  by  an
15    advanced  practice nurse in accordance with subsection (g) of
16    Section 4, containing the following: (l) name of the patient;
17    (2) date when prescription was issued; (3) name and  strength
18    of  drug or description of the medical device prescribed; and
19    (4) quantity, (5) directions for use, (6) prescriber's  name,
20    address and signature, and (7) DEA number where required, for
21    controlled  substances.  DEA numbers shall not be required on
22    inpatient drug orders.
23        (f)  "Person"  means  and  includes  a  natural   person,
24    copartnership,  association,  corporation, government entity,
25    or any other legal entity.
26        (g)  "Department" means the  Department  of  Professional
27    Regulation.
28        (h)  "Board of Pharmacy" or "Board" means the State Board
29    of Pharmacy of the Department of Professional Regulation.
30        (i)  "Director"   means   the  Director  of  Professional
31    Regulation.
32        (j)  "Drug product selection" means the interchange for a
33    prescribed pharmaceutical product in accordance with  Section
34    25  of  this  Act and Section 3.14 of the Illinois Food, Drug
 
                            -4-      LRB093 03709 AMC 13080 a
 1    and Cosmetic Act.
 2        (k)  "Inpatient drug order" means an order issued  by  an
 3    authorized prescriber for a resident or patient of a facility
 4    licensed  under  the  Nursing  Home  Care Act or the Hospital
 5    Licensing Act, or "An Act in relation  to  the  founding  and
 6    operation  of  the  University  of  Illinois Hospital and the
 7    conduct of University  of  Illinois  health  care  programs",
 8    approved  July  3,  1931,  as amended, or a facility which is
 9    operated by the Department of Human Services (as successor to
10    the   Department   of   Mental   Health   and   Developmental
11    Disabilities) or the Department of Corrections.
12        (k-5)  "Pharmacist"   means   an   individual   currently
13    licensed by this State to engage in the practice of pharmacy.
14        (l)  "Pharmacist in charge" means the licensed pharmacist
15    whose name appears on a pharmacy license who  is  responsible
16    for  all  aspects of the operation related to the practice of
17    pharmacy.
18        (m)  "Dispense" means the delivery of drugs  and  medical
19    devices, in accordance with applicable State and federal laws
20    and   regulations,   to   the   patient   or   the  patient's
21    representative  authorized   to   receive   these   products,
22    including  the compounding, packaging, and labeling necessary
23    for delivery, and any recommending or advising concerning the
24    contents and therapeutic values and uses thereof.  "Dispense"
25    does  not  mean  the  physical  delivery  to  a  patient or a
26    patient's representative  in  a  home  or  institution  by  a
27    designee  of  a  pharmacist or by common carrier.  "Dispense"
28    also does not mean the physical delivery of a drug or medical
29    device  to  a  patient  or  patient's  representative  by   a
30    pharmacist's  designee  within  a pharmacy or drugstore while
31    the pharmacist is on duty and the pharmacy is open.
32        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
33    located in a state of the United States, other than Illinois,
34    that delivers, dispenses or distributes, through  the  United
 
                            -5-      LRB093 03709 AMC 13080 a
 1    States  Postal  Service  or other common carrier, to Illinois
 2    residents, any substance which requires a prescription.
 3        (o)  "Compounding"   means   the   preparation,   mixing,
 4    assembling, packaging, or  labeling  of  a  drug  or  medical
 5    device:  (1)  as  the result of a practitioner's prescription
 6    drug order or initiative that  is  dispensed  pursuant  to  a
 7    prescription  in  the course of professional practice; or (2)
 8    for the purpose of, or incident to,  research,  teaching,  or
 9    chemical  analysis;  or  (3)  in anticipation of prescription
10    drug orders based on routine, regularly observed  prescribing
11    patterns.
12        (p)  "Confidential    information"   means   information,
13    maintained  by  the  pharmacist  in  the  patient's  records,
14    released only (i) to the patient or, as the patient  directs,
15    to  other  practitioners and other pharmacists or (ii) to any
16    other person authorized by law to receive the information.
17        (q)  "Prospective  drug  review"  or  "drug   utilization
18    evaluation"  means  a  screening  for  potential drug therapy
19    problems  due  to   therapeutic   duplication,   drug-disease
20    contraindications,  drug-drug interactions (including serious
21    interactions with nonprescription or over-the-counter drugs),
22    drug-food interactions, incorrect drug dosage or duration  of
23    drug treatment, drug-allergy interactions, and clinical abuse
24    or misuse.
25        (r)  "Patient counseling" means the communication between
26    a  pharmacist  or  a  student  pharmacist  under  the  direct
27    supervision  of  a  pharmacist and a patient or the patient's
28    representative about the patient's medication or  device  for
29    the   purpose   of  optimizing  proper  use  of  prescription
30    medications  or  devices.   The  offer  to  counsel  by   the
31    pharmacist  or  the  pharmacist's  designee,  and  subsequent
32    patient  counseling  by the pharmacist or student pharmacist,
33    shall be  made  in  a  face-to-face  communication  with  the
34    patient   or   patient's   representative   unless,   in  the
 
                            -6-      LRB093 03709 AMC 13080 a
 1    professional  judgment  of  the  pharmacist,  a  face-to-face
 2    communication is deemed  inappropriate  or  unnecessary.   In
 3    that instance, the offer to counsel or patient counseling may
 4    be  made  in  a  written communication, by telephone, or in a
 5    manner determined by the pharmacist to be appropriate.
 6        (s)  "Patient profiles" or "patient drug therapy  record"
 7    means  the  obtaining,  recording, and maintenance of patient
 8    prescription and personal information.
 9        (t)  "Pharmaceutical care" includes, but is  not  limited
10    to,  the  act  of  monitoring drug use and other patient care
11    services  intended  to  achieve  outcomes  that  improve  the
12    patient's quality of life but shall not include the  sale  of
13    over-the-counter  drugs by a seller of goods and services who
14    does not dispense prescription drugs.
15        (u)  "Medical device"  means  an  instrument,  apparatus,
16    implement,  machine,  contrivance, implant, in vitro reagent,
17    or other similar or related article, including any  component
18    part  or  accessory,  required  under federal law to bear the
19    label "Caution: Federal law requires dispensing by or on  the
20    order  of  a  physician". A seller of goods and services who,
21    only for the  purpose  of  retail  sales,  compounds,  sells,
22    rents,  or  leases  medical  devices  shall  not,  by reasons
23    thereof, be required to be a licensed pharmacy.
24    (Source: P.A. 89-202,  eff.  7-21-95;  89-507,  eff.  7-1-97;
25    90-116,  eff.  7-14-97;  90-253,  eff.  7-29-97; 90-655, eff.
26    7-30-98; 90-742, eff. 8-13-98.)

27        (Text of Section after amendment by P.A. 92-880)
28        Sec. 3. Definitions.  For the purpose of this Act, except
29    where otherwise limited therein:
30        (a)  "Pharmacy" or "drugstore" means and  includes  every
31    store,  shop,  pharmacy  department,  or  other  place  where
32    pharmaceutical  care  is  provided  by a pharmacist (1) where
33    drugs, medicines, or poisons are dispensed, sold  or  offered
34    for  sale  at retail, or displayed for sale at retail; or (2)
 
                            -7-      LRB093 03709 AMC 13080 a
 1    where prescriptions of physicians,  dentists,  veterinarians,
 2    podiatrists,   or   therapeutically  certified  optometrists,
 3    within the limits of their licenses, are compounded,  filled,
 4    or  dispensed;  or  (3) which has upon it or displayed within
 5    it, or affixed to or used  in  connection  with  it,  a  sign
 6    bearing   the   word   or   words  "Pharmacist",  "Druggist",
 7    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
 8    "Medicine Store", "Prescriptions", "Drugs",  "Medicines",  or
 9    any  word  or  words of similar or like import, either in the
10    English language or any other  language;  or  (4)  where  the
11    characteristic  prescription  sign  (Rx) or similar design is
12    exhibited; or (5) any store, or shop,  or  other  place  with
13    respect  to  which  any of the above words, objects, signs or
14    designs are used in any advertisement.
15        (b)  "Drugs" means and includes (l)  articles  recognized
16    in   the   official   United   States  Pharmacopoeia/National
17    Formulary (USP/NF),  or  any  supplement  thereto  and  being
18    intended  for  and  having  for their main use the diagnosis,
19    cure, mitigation, treatment or prevention of disease  in  man
20    or  other  animals, as approved by the United States Food and
21    Drug Administration, but does not include  devices  or  their
22    components, parts, or accessories; and (2) all other articles
23    intended  for  and  having  for their main use the diagnosis,
24    cure, mitigation, treatment or prevention of disease  in  man
25    or  other  animals, as approved by the United States Food and
26    Drug Administration, but does not include  devices  or  their
27    components,  parts,  or  accessories; and (3) articles (other
28    than food) having for their main use and intended  to  affect
29    the  structure  or  any  function of the body of man or other
30    animals; and (4) articles  having  for  their  main  use  and
31    intended  for use as a component or any articles specified in
32    clause (l), (2) or (3); but does not include devices or their
33    components, parts or accessories.
34        (c)  "Medicines" means and includes  all  drugs  intended
 
                            -8-      LRB093 03709 AMC 13080 a
 1    for  human  or  veterinary  use approved by the United States
 2    Food and Drug Administration.
 3        (d)  "Practice  of  pharmacy"  means  the  provision   of
 4    pharmaceutical   care   to  patients  as  determined  by  the
 5    pharmacist's professional judgment in  the  following  areas,
 6    which  may  include  but  are  not  limited  to  (1)  patient
 7    counseling,   (2)   interpretation   and   assisting  in  the
 8    monitoring of  appropriate  drug  use  and  prospective  drug
 9    utilization   review,   (3)   providing  information  on  the
10    therapeutic  values,  reactions,  drug   interactions,   side
11    effects,  uses, selection of medications and medical devices,
12    and outcome  of  drug  therapy,  (4)  participation  in  drug
13    selection,   drug   monitoring,   drug   utilization  review,
14    evaluation, administration,  interpretation,  application  of
15    pharmacokinetic  and  laboratory  data  to  design  safe  and
16    effective  drug  regimens,  (5)  drug  research (clinical and
17    scientific), and (6) compounding and dispensing of drugs  and
18    medical devices.
19        (e)  "Prescription" means and includes any written, oral,
20    facsimile,  or  electronically transmitted order for drugs or
21    medical devices, issued by a physician licensed  to  practice
22    medicine  in  all  its  branches,  dentist,  veterinarian, or
23    podiatrist,  or therapeutically certified optometrist, within
24    the limits of their licenses, by  a  physician  assistant  in
25    accordance  with  subsection  (f)  of  Section  4,  or  by an
26    advanced practice nurse in accordance with subsection (g)  of
27    Section 4, containing the following: (l) name of the patient;
28    (2)  date when prescription was issued; (3) name and strength
29    of drug or description of the medical device prescribed;  and
30    (4)  quantity, (5) directions for use, (6) prescriber's name,
31    address and signature, and (7) DEA number where required, for
32    controlled substances. DEA numbers shall not be  required  on
33    inpatient drug orders.
34        (f)  "Person"   means  and  includes  a  natural  person,
 
                            -9-      LRB093 03709 AMC 13080 a
 1    copartnership, association, corporation,  government  entity,
 2    or any other legal entity.
 3        (g)  "Department"  means  the  Department of Professional
 4    Regulation.
 5        (h)  "Board of Pharmacy" or "Board" means the State Board
 6    of Pharmacy of the Department of Professional Regulation.
 7        (i)  "Director"  means  the  Director   of   Professional
 8    Regulation.
 9        (j)  "Drug product selection" means the interchange for a
10    prescribed  pharmaceutical product in accordance with Section
11    25 of this Act and Section 3.14 of the  Illinois  Food,  Drug
12    and Cosmetic Act.
13        (k)  "Inpatient  drug  order" means an order issued by an
14    authorized prescriber for a resident or patient of a facility
15    licensed under the Nursing Home  Care  Act  or  the  Hospital
16    Licensing  Act,  or  "An  Act in relation to the founding and
17    operation of the University  of  Illinois  Hospital  and  the
18    conduct  of  University  of  Illinois  health care programs",
19    approved July 3, 1931, as amended, or  a  facility  which  is
20    operated by the Department of Human Services (as successor to
21    the   Department   of   Mental   Health   and   Developmental
22    Disabilities) or the Department of Corrections.
23        (k-5)  "Pharmacist"   means  an  individual  health  care
24    professional and provider currently licensed by this State to
25    engage in the practice of pharmacy.
26        (l)  "Pharmacist in charge" means the licensed pharmacist
27    whose  name  appears  on  a  pharmacy  license  and  who   is
28    responsible  for  all aspects of the operation related to the
29    practice of pharmacy.
30        (m)  "Dispense" means the delivery of drugs  and  medical
31    devices, in accordance with applicable State and federal laws
32    and   regulations,   to   the   patient   or   the  patient's
33    representative  authorized   to   receive   these   products,
34    including  the compounding, packaging, and labeling necessary
 
                            -10-     LRB093 03709 AMC 13080 a
 1    for delivery, and any recommending or advising concerning the
 2    contents and therapeutic values and uses thereof.  "Dispense"
 3    does not mean  the  physical  delivery  to  a  patient  or  a
 4    patient's  representative  in  a  home  or  institution  by a
 5    designee of a pharmacist or by  common  carrier.   "Dispense"
 6    also does not mean the physical delivery of a drug or medical
 7    device   to  a  patient  or  patient's  representative  by  a
 8    pharmacist's designee within a pharmacy  or  drugstore  while
 9    the pharmacist is on duty and the pharmacy is open.
10        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
11    located in a state of the United States, other than Illinois,
12    that  delivers,  dispenses or distributes, through the United
13    States Postal Service or other common  carrier,  to  Illinois
14    residents, any substance which requires a prescription.
15        (o)  "Compounding"   means   the   preparation,   mixing,
16    assembling,  packaging,  or  labeling  of  a  drug or medical
17    device: (1) as the result of  a  practitioner's  prescription
18    drug  order  or  initiative  that  is dispensed pursuant to a
19    prescription in the course of professional practice;  or  (2)
20    for  the  purpose  of, or incident to, research, teaching, or
21    chemical analysis; or (3)  in  anticipation  of  prescription
22    drug  orders based on routine, regularly observed prescribing
23    patterns.
24        (p)  "Confidential   information"   means    information,
25    maintained  by  the  pharmacist  in  the  patient's  records,
26    released  only (i) to the patient or, as the patient directs,
27    to other practitioners and other pharmacists or (ii)  to  any
28    other person authorized by law to receive the information.
29        (q)  "Prospective   drug  review"  or  "drug  utilization
30    evaluation" means a  screening  for  potential  drug  therapy
31    problems   due   to   therapeutic  duplication,  drug-disease
32    contraindications, drug-drug interactions (including  serious
33    interactions with nonprescription or over-the-counter drugs),
34    drug-food  interactions, incorrect drug dosage or duration of
 
                            -11-     LRB093 03709 AMC 13080 a
 1    drug treatment, drug-allergy interactions, and clinical abuse
 2    or misuse.
 3        (r)  "Patient counseling" means the communication between
 4    a  pharmacist  or  a  student  pharmacist  under  the  direct
 5    supervision of a pharmacist and a patient  or  the  patient's
 6    representative  about  the patient's medication or device for
 7    the  purpose  of  optimizing  proper  use   of   prescription
 8    medications   or  devices.   The  offer  to  counsel  by  the
 9    pharmacist  or  the  pharmacist's  designee,  and  subsequent
10    patient counseling by the pharmacist or  student  pharmacist,
11    shall  be  made  in  a  face-to-face  communication  with the
12    patient  or   patient's   representative   unless,   in   the
13    professional  judgment  of  the  pharmacist,  a  face-to-face
14    communication  is  deemed  inappropriate  or unnecessary.  In
15    that instance, the offer to counsel or patient counseling may
16    be made in a written communication, by  telephone,  or  in  a
17    manner determined by the pharmacist to be appropriate.
18        (s)  "Patient  profiles" or "patient drug therapy record"
19    means the obtaining, recording, and  maintenance  of  patient
20    prescription   information,   including   prescriptions   for
21    controlled substances, and personal information.
22        (t)  "Pharmaceutical  care"  includes, but is not limited
23    to, the act of monitoring drug use  and  other  patient  care
24    services  intended  to  achieve  outcomes  that  improve  the
25    patient's  quality  of life but shall not include the sale of
26    over-the-counter drugs by a seller of goods and services  who
27    does not dispense prescription drugs.
28        (u)  "Medical  device"  means  an  instrument, apparatus,
29    implement, machine, contrivance, implant, in  vitro  reagent,
30    or  other similar or related article, including any component
31    part or accessory, required under federal  law  to  bear  the
32    label  "Caution: Federal law requires dispensing by or on the
33    order of a physician". A seller of goods  and  services  who,
34    only  for  the  purpose  of  retail  sales, compounds, sells,
 
                            -12-     LRB093 03709 AMC 13080 a
 1    rents, or  leases  medical  devices  shall  not,  by  reasons
 2    thereof, be required to be a licensed pharmacy.
 3        (v)  "Unique  identifier"  means an electronic signature,
 4    handwritten signature or  initials,  thumb  print,  or  other
 5    acceptable  individual biometric or electronic identification
 6    process as approved by the Department.
 7    (Source: P.A. 92-880, eff. 1-1-04.)".