093_SB1983sam001

 










                                     LRB093 08954 AMC 14338 a

 1                    AMENDMENT TO SENATE BILL 1983

 2        AMENDMENT NO.     .  Amend Senate Bill 1983 by  replacing
 3    everything after the enacting clause with the following:

 4        "Section 5.  The Pharmacy Practice Act of 1987 is amended
 5    by changing Section 3 as follows:

 6        (225 ILCS 85/3) (from Ch. 111, par. 4123)
 7        (Section scheduled to be repealed on January 1, 2008)
 8        (Text of Section before amendment by P.A. 92-880)
 9        Sec. 3. Definitions.  For the purpose of this Act, except
10    where otherwise limited therein:
11        (a)  "Pharmacy"  or  "drugstore" means and includes every
12    store,  shop,  pharmacy  department,  or  other  place  where
13    pharmaceutical care is provided by  a  pharmacist  (1)  where
14    drugs,  medicines,  or poisons are dispensed, sold or offered
15    for sale at retail, or displayed for sale at retail;  or  (2)
16    where  prescriptions  of physicians, dentists, veterinarians,
17    podiatrists,  or  therapeutically   certified   optometrists,
18    within  the limits of their licenses, are compounded, filled,
19    or dispensed; or (3) which has upon it  or  displayed  within
20    it,  or  affixed  to  or  used  in connection with it, a sign
21    bearing  the  word   or   words   "Pharmacist",   "Druggist",
22    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
 
                            -2-      LRB093 08954 AMC 14338 a
 1    "Medicine  Store",  "Prescriptions", "Drugs", "Medicines", or
 2    any word or words of similar or like import,  either  in  the
 3    English  language  or  any  other  language; or (4) where the
 4    characteristic prescription sign (Rx) or  similar  design  is
 5    exhibited;  or  (5)  any  store, or shop, or other place with
 6    respect to which any of the above words,  objects,  signs  or
 7    designs are used in any advertisement.
 8        (b)  "Drugs"  means  and includes (l) articles recognized
 9    in  the   official   United   States   Pharmacopoeia/National
10    Formulary  (USP/NF),  or  any  supplement  thereto  and being
11    intended for and having for their  main  use  the  diagnosis,
12    cure,  mitigation,  treatment or prevention of disease in man
13    or other animals, as approved by the United States  Food  and
14    Drug  Administration,  but  does not include devices or their
15    components, parts, or accessories; and (2) all other articles
16    intended for and having for their  main  use  the  diagnosis,
17    cure,  mitigation,  treatment or prevention of disease in man
18    or other animals, as approved by the United States  Food  and
19    Drug  Administration,  but  does not include devices or their
20    components, parts, or accessories; and  (3)  articles  (other
21    than  food)  having for their main use and intended to affect
22    the structure or any function of the body  of  man  or  other
23    animals;  and  (4)  articles  having  for  their main use and
24    intended for use as a component or any articles specified  in
25    clause (l), (2) or (3); but does not include devices or their
26    components, parts or accessories.
27        (c)  "Medicines"  means  and  includes all drugs intended
28    for human or veterinary use approved  by  the  United  States
29    Food and Drug Administration.
30        (d)  "Practice   of  pharmacy"  means  the  provision  of
31    pharmaceutical  care  to  patients  as  determined   by   the
32    pharmacist's  professional  judgment  in the following areas,
33    which  may  include  but  are  not  limited  to  (1)  patient
34    counseling,  (2)  interpretation   and   assisting   in   the
 
                            -3-      LRB093 08954 AMC 14338 a
 1    monitoring  of  appropriate  drug  use  and  prospective drug
 2    utilization  review,  (3)  providing   information   on   the
 3    therapeutic   values,   reactions,  drug  interactions,  side
 4    effects, uses, selection of medications and medical  devices,
 5    and  outcome  of  drug  therapy,  (4)  participation  in drug
 6    selection,  drug   monitoring,   drug   utilization   review,
 7    evaluation,  administration,  interpretation,  application of
 8    pharmacokinetic  and  laboratory  data  to  design  safe  and
 9    effective drug regimens,  (5)  drug  research  (clinical  and
10    scientific),  and (6) compounding and dispensing of drugs and
11    medical devices.
12        (e)  "Prescription" means and includes any written, oral,
13    facsimile, or electronically transmitted order for  drugs  or
14    medical  devices,  issued by a physician licensed to practice
15    medicine in  all  its  branches,  dentist,  veterinarian,  or
16    podiatrist,  or therapeutically certified optometrist, within
17    the  limits  of  their  licenses, by a physician assistant in
18    accordance with  subsection  (f)  of  Section  4,  or  by  an
19    advanced  practice nurse in accordance with subsection (g) of
20    Section 4, containing the following: (l) name of the patient;
21    (2) date when prescription was issued; (3) name and  strength
22    of  drug or description of the medical device prescribed; and
23    (4) quantity, (5) directions for use, (6) prescriber's  name,
24    address and signature, and (7) DEA number where required, for
25    controlled  substances.  DEA numbers shall not be required on
26    inpatient drug orders.
27        (f)  "Person"  means  and  includes  a  natural   person,
28    copartnership,  association,  corporation, government entity,
29    or any other legal entity.
30        (g)  "Department" means the  Department  of  Professional
31    Regulation.
32        (h)  "Board of Pharmacy" or "Board" means the State Board
33    of Pharmacy of the Department of Professional Regulation.
34        (i)  "Director"   means   the  Director  of  Professional
 
                            -4-      LRB093 08954 AMC 14338 a
 1    Regulation.
 2        (j)  "Drug product selection" means the interchange for a
 3    prescribed pharmaceutical product in accordance with  Section
 4    25  of  this  Act and Section 3.14 of the Illinois Food, Drug
 5    and Cosmetic Act.
 6        (k)  "Inpatient drug order" means an order issued  by  an
 7    authorized prescriber for a resident or patient of a facility
 8    licensed  under  the  Nursing  Home  Care Act or the Hospital
 9    Licensing Act, or "An Act in relation  to  the  founding  and
10    operation  of  the  University  of  Illinois Hospital and the
11    conduct of University  of  Illinois  health  care  programs",
12    approved  July  3,  1931,  as amended, or a facility which is
13    operated by the Department of Human Services (as successor to
14    the   Department   of   Mental   Health   and   Developmental
15    Disabilities) or the Department of Corrections.
16        (k-5)  "Pharmacist"  means  an  individual  health   care
17    professional and provider currently licensed by this State to
18    engage in the practice of pharmacy.
19        (l)  "Pharmacist in charge" means the licensed pharmacist
20    whose  name  appears on a pharmacy license who is responsible
21    for all aspects of the operation related to the  practice  of
22    pharmacy.
23        (m)  "Dispense"  means  the delivery of drugs and medical
24    devices, in accordance with applicable State and federal laws
25    and  regulations,   to   the   patient   or   the   patient's
26    representative   authorized   to   receive   these  products,
27    including the compounding, packaging, and labeling  necessary
28    for delivery, and any recommending or advising concerning the
29    contents  and therapeutic values and uses thereof. "Dispense"
30    does not mean  the  physical  delivery  to  a  patient  or  a
31    patient's  representative  in  a  home  or  institution  by a
32    designee of a pharmacist or by  common  carrier.   "Dispense"
33    also does not mean the physical delivery of a drug or medical
34    device   to  a  patient  or  patient's  representative  by  a
 
                            -5-      LRB093 08954 AMC 14338 a
 1    pharmacist's designee within a pharmacy  or  drugstore  while
 2    the pharmacist is on duty and the pharmacy is open.
 3        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
 4    located in a state of the United States, other than Illinois,
 5    that  delivers,  dispenses or distributes, through the United
 6    States Postal Service or other common  carrier,  to  Illinois
 7    residents, any substance which requires a prescription.
 8        (o)  "Compounding"   means   the   preparation,   mixing,
 9    assembling,  packaging,  or  labeling  of  a  drug or medical
10    device: (1) as the result of  a  practitioner's  prescription
11    drug  order  or  initiative  that  is dispensed pursuant to a
12    prescription in the course of professional practice;  or  (2)
13    for  the  purpose  of, or incident to, research, teaching, or
14    chemical analysis; or (3)  in  anticipation  of  prescription
15    drug  orders based on routine, regularly observed prescribing
16    patterns.
17        (p)  "Confidential   information"   means    information,
18    maintained  by  the  pharmacist  in  the  patient's  records,
19    released  only (i) to the patient or, as the patient directs,
20    to other practitioners and other pharmacists or (ii)  to  any
21    other person authorized by law to receive the information.
22        (q)  "Prospective   drug  review"  or  "drug  utilization
23    evaluation" means a  screening  for  potential  drug  therapy
24    problems   due   to   therapeutic  duplication,  drug-disease
25    contraindications, drug-drug interactions (including  serious
26    interactions with nonprescription or over-the-counter drugs),
27    drug-food  interactions, incorrect drug dosage or duration of
28    drug treatment, drug-allergy interactions, and clinical abuse
29    or misuse.
30        (r)  "Patient counseling" means the communication between
31    a  pharmacist  or  a  student  pharmacist  under  the  direct
32    supervision of a pharmacist and a patient  or  the  patient's
33    representative  about  the patient's medication or device for
34    the  purpose  of  optimizing  proper  use   of   prescription
 
                            -6-      LRB093 08954 AMC 14338 a
 1    medications   or  devices.   The  offer  to  counsel  by  the
 2    pharmacist  or  the  pharmacist's  designee,  and  subsequent
 3    patient counseling by the pharmacist or  student  pharmacist,
 4    shall  be  made  in  a  face-to-face  communication  with the
 5    patient  or   patient's   representative   unless,   in   the
 6    professional  judgment  of  the  pharmacist,  a  face-to-face
 7    communication  is  deemed  inappropriate  or unnecessary.  In
 8    that instance, the offer to counsel or patient counseling may
 9    be made in a written communication, by  telephone,  or  in  a
10    manner determined by the pharmacist to be appropriate.
11        (s)  "Patient  profiles" or "patient drug therapy record"
12    means the obtaining, recording, and  maintenance  of  patient
13    prescription and personal information.
14        (t)  "Pharmaceutical  care"  includes, but is not limited
15    to, the act of monitoring drug use  and  other  patient  care
16    services  intended  to  achieve  outcomes  that  improve  the
17    patient's  quality  of life but shall not include the sale of
18    over-the-counter drugs by a seller of goods and services  who
19    does not dispense prescription drugs.
20        (u)  "Medical  device"  means  an  instrument, apparatus,
21    implement, machine, contrivance, implant, in  vitro  reagent,
22    or  other similar or related article, including any component
23    part or accessory, required under federal  law  to  bear  the
24    label  "Caution: Federal law requires dispensing by or on the
25    order of a physician". A seller of goods  and  services  who,
26    only  for  the  purpose  of  retail  sales, compounds, sells,
27    rents, or  leases  medical  devices  shall  not,  by  reasons
28    thereof, be required to be a licensed pharmacy.
29    (Source: P.A.  89-202,  eff.  7-21-95;  89-507,  eff. 7-1-97;
30    90-116, eff. 7-14-97;  90-253,  eff.  7-29-97;  90-655,  eff.
31    7-30-98; 90-742, eff. 8-13-98.)

32        (Text of Section after amendment by P.A. 92-880)
33        Sec. 3. Definitions.  For the purpose of this Act, except
34    where otherwise limited therein:
 
                            -7-      LRB093 08954 AMC 14338 a
 1        (a)  "Pharmacy"  or  "drugstore" means and includes every
 2    store,  shop,  pharmacy  department,  or  other  place  where
 3    pharmaceutical care is provided by  a  pharmacist  (1)  where
 4    drugs,  medicines,  or poisons are dispensed, sold or offered
 5    for sale at retail, or displayed for sale at retail;  or  (2)
 6    where  prescriptions  of physicians, dentists, veterinarians,
 7    podiatrists,  or  therapeutically   certified   optometrists,
 8    within  the limits of their licenses, are compounded, filled,
 9    or dispensed; or (3) which has upon it  or  displayed  within
10    it,  or  affixed  to  or  used  in connection with it, a sign
11    bearing  the  word   or   words   "Pharmacist",   "Druggist",
12    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
13    "Medicine  Store",  "Prescriptions", "Drugs", "Medicines", or
14    any word or words of similar or like import,  either  in  the
15    English  language  or  any  other  language; or (4) where the
16    characteristic prescription sign (Rx) or  similar  design  is
17    exhibited;  or  (5)  any  store, or shop, or other place with
18    respect to which any of the above words,  objects,  signs  or
19    designs are used in any advertisement.
20        (b)  "Drugs"  means  and includes (l) articles recognized
21    in  the   official   United   States   Pharmacopoeia/National
22    Formulary  (USP/NF),  or  any  supplement  thereto  and being
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 (2) all other articles
28    intended for and having for their  main  use  the  diagnosis,
29    cure,  mitigation,  treatment or prevention of disease in man
30    or other animals, as approved by the United States  Food  and
31    Drug  Administration,  but  does not include devices or their
32    components, parts, or accessories; and  (3)  articles  (other
33    than  food)  having for their main use and intended to affect
34    the structure or any function of the body  of  man  or  other
 
                            -8-      LRB093 08954 AMC 14338 a
 1    animals;  and  (4)  articles  having  for  their main use and
 2    intended for use as a component or any articles specified  in
 3    clause (l), (2) or (3); but does not include devices or their
 4    components, parts or accessories.
 5        (c)  "Medicines"  means  and  includes all drugs intended
 6    for human or veterinary use approved  by  the  United  States
 7    Food and Drug Administration.
 8        (d)  "Practice   of  pharmacy"  means  the  provision  of
 9    pharmaceutical  care  to  patients  as  determined   by   the
10    pharmacist's  professional  judgment  in the following areas,
11    which  may  include  but  are  not  limited  to  (1)  patient
12    counseling,  (2)  interpretation   and   assisting   in   the
13    monitoring  of  appropriate  drug  use  and  prospective drug
14    utilization  review,  (3)  providing   information   on   the
15    therapeutic   values,   reactions,  drug  interactions,  side
16    effects, uses, selection of medications and medical  devices,
17    and  outcome  of  drug  therapy,  (4)  participation  in drug
18    selection,  drug   monitoring,   drug   utilization   review,
19    evaluation,  administration,  interpretation,  application of
20    pharmacokinetic  and  laboratory  data  to  design  safe  and
21    effective drug regimens,  (5)  drug  research  (clinical  and
22    scientific),  and (6) compounding and dispensing of drugs and
23    medical devices.
24        (e)  "Prescription" means and includes any written, oral,
25    facsimile, or electronically transmitted order for  drugs  or
26    medical  devices,  issued by a physician licensed to practice
27    medicine in  all  its  branches,  dentist,  veterinarian,  or
28    podiatrist,  or therapeutically certified optometrist, within
29    the  limits  of  their  licenses, by a physician assistant in
30    accordance with  subsection  (f)  of  Section  4,  or  by  an
31    advanced  practice nurse in accordance with subsection (g) of
32    Section 4, containing the following: (l) name of the patient;
33    (2) date when prescription was issued; (3) name and  strength
34    of  drug or description of the medical device prescribed; and
 
                            -9-      LRB093 08954 AMC 14338 a
 1    (4) quantity, (5) directions for use, (6) prescriber's  name,
 2    address and signature, and (7) DEA number where required, for
 3    controlled  substances.  DEA numbers shall not be required on
 4    inpatient drug orders.
 5        (f)  "Person"  means  and  includes  a  natural   person,
 6    copartnership,  association,  corporation, government entity,
 7    or any other legal entity.
 8        (g)  "Department" means the  Department  of  Professional
 9    Regulation.
10        (h)  "Board of Pharmacy" or "Board" means the State Board
11    of Pharmacy of the Department of Professional Regulation.
12        (i)  "Director"   means   the  Director  of  Professional
13    Regulation.
14        (j)  "Drug product selection" means the interchange for a
15    prescribed pharmaceutical product in accordance with  Section
16    25  of  this  Act and Section 3.14 of the Illinois Food, Drug
17    and Cosmetic Act.
18        (k)  "Inpatient drug order" means an order issued  by  an
19    authorized prescriber for a resident or patient of a facility
20    licensed  under  the  Nursing  Home  Care Act or the Hospital
21    Licensing Act, or "An Act in relation  to  the  founding  and
22    operation  of  the  University  of  Illinois Hospital and the
23    conduct of University  of  Illinois  health  care  programs",
24    approved  July  3,  1931,  as amended, or a facility which is
25    operated by the Department of Human Services (as successor to
26    the   Department   of   Mental   Health   and   Developmental
27    Disabilities) or the Department of Corrections.
28        (k-5)  "Pharmacist"  means  an  individual  health   care
29    professional and provider currently licensed by this State to
30    engage in the practice of pharmacy.
31        (l)  "Pharmacist in charge" means the licensed pharmacist
32    whose   name  appears  on  a  pharmacy  license  and  who  is
33    responsible for all aspects of the operation related  to  the
34    practice of pharmacy.
 
                            -10-     LRB093 08954 AMC 14338 a
 1        (m)  "Dispense"  means  the delivery of drugs and medical
 2    devices, in accordance with applicable State and federal laws
 3    and  regulations,   to   the   patient   or   the   patient's
 4    representative   authorized   to   receive   these  products,
 5    including the compounding, packaging, and labeling  necessary
 6    for delivery, and any recommending or advising concerning the
 7    contents and therapeutic values and uses thereof.  "Dispense"
 8    does  not  mean  the  physical  delivery  to  a  patient or a
 9    patient's representative  in  a  home  or  institution  by  a
10    designee  of  a  pharmacist or by common carrier.  "Dispense"
11    also does not mean the physical delivery of a drug or medical
12    device  to  a  patient  or  patient's  representative  by   a
13    pharmacist's  designee  within  a pharmacy or drugstore while
14    the pharmacist is on duty and the pharmacy is open.
15        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
16    located in a state of the United States, other than Illinois,
17    that delivers, dispenses or distributes, through  the  United
18    States  Postal  Service  or other common carrier, to Illinois
19    residents, any substance which requires a prescription.
20        (o)  "Compounding"   means   the   preparation,   mixing,
21    assembling, packaging, or  labeling  of  a  drug  or  medical
22    device:  (1)  as  the result of a practitioner's prescription
23    drug order or initiative that  is  dispensed  pursuant  to  a
24    prescription  in  the course of professional practice; or (2)
25    for the purpose of, or incident to,  research,  teaching,  or
26    chemical  analysis;  or  (3)  in anticipation of prescription
27    drug orders based on routine, regularly observed  prescribing
28    patterns.
29        (p)  "Confidential    information"   means   information,
30    maintained  by  the  pharmacist  in  the  patient's  records,
31    released only (i) to the patient or, as the patient  directs,
32    to  other  practitioners and other pharmacists or (ii) to any
33    other person authorized by law to receive the information.
34        (q)  "Prospective  drug  review"  or  "drug   utilization
 
                            -11-     LRB093 08954 AMC 14338 a
 1    evaluation"  means  a  screening  for  potential drug therapy
 2    problems  due  to   therapeutic   duplication,   drug-disease
 3    contraindications,  drug-drug interactions (including serious
 4    interactions with nonprescription or over-the-counter drugs),
 5    drug-food interactions, incorrect drug dosage or duration  of
 6    drug treatment, drug-allergy interactions, and clinical abuse
 7    or misuse.
 8        (r)  "Patient counseling" means the communication between
 9    a  pharmacist  or  a  student  pharmacist  under  the  direct
10    supervision  of  a  pharmacist and a patient or the patient's
11    representative about the patient's medication or  device  for
12    the   purpose   of  optimizing  proper  use  of  prescription
13    medications  or  devices.   The  offer  to  counsel  by   the
14    pharmacist  or  the  pharmacist's  designee,  and  subsequent
15    patient  counseling  by the pharmacist or student pharmacist,
16    shall be  made  in  a  face-to-face  communication  with  the
17    patient   or   patient's   representative   unless,   in  the
18    professional  judgment  of  the  pharmacist,  a  face-to-face
19    communication is deemed  inappropriate  or  unnecessary.   In
20    that instance, the offer to counsel or patient counseling may
21    be  made  in  a  written communication, by telephone, or in a
22    manner determined by the pharmacist to be appropriate.
23        (s)  "Patient profiles" or "patient drug therapy  record"
24    means  the  obtaining,  recording, and maintenance of patient
25    prescription and personal information.
26        (t)  "Pharmaceutical care" includes, but is  not  limited
27    to,  the  act  of  monitoring drug use and other patient care
28    services  intended  to  achieve  outcomes  that  improve  the
29    patient's quality of life but shall not include the  sale  of
30    over-the-counter  drugs by a seller of goods and services who
31    does not dispense prescription drugs.
32        (u)  "Medical device"  means  an  instrument,  apparatus,
33    implement,  machine,  contrivance, implant, in vitro reagent,
34    or other similar or related article, including any  component
 
                            -12-     LRB093 08954 AMC 14338 a
 1    part  or  accessory,  required  under federal law to bear the
 2    label "Caution: Federal law requires dispensing by or on  the
 3    order  of  a  physician". A seller of goods and services who,
 4    only for the  purpose  of  retail  sales,  compounds,  sells,
 5    rents,  or  leases  medical  devices  shall  not,  by reasons
 6    thereof, be required to be a licensed pharmacy.
 7        (v)  "Unique identifier" means an  electronic  signature,
 8    handwritten  signature  or  initials,  thumb  print, or other
 9    acceptable individual biometric or electronic  identification
10    process as approved by the Department.
11    (Source: P.A. 92-880, eff. 1-1-04.)

12        Section  95.   No  acceleration or delay.  Where this Act
13    makes changes in a statute that is represented in this Act by
14    text that is not yet or no longer in effect (for  example,  a
15    Section  represented  by  multiple versions), the use of that
16    text does not accelerate or delay the taking  effect  of  (i)
17    the  changes made by this Act or (ii) provisions derived from
18    any other Public Act.

19        Section 99. Effective date.  This Act takes  effect  upon
20    becoming law.".