093_SB1983eng

 
SB1983 Engrossed                     LRB093 08954 RCE 09186 b

 1        AN ACT in relation to the regulation of professions.

 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 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 7        (Section scheduled to be repealed on January 1, 2008)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",
23    "Medicine  Store",  "Prescriptions", "Drugs", "Medicines", or
24    any word or words of similar or like import,  either  in  the
25    English  language  or  any  other  language; or (4) where the
26    characteristic prescription sign (Rx) or  similar  design  is
27    exhibited;  or  (5)  any  store, or shop, or other place with
28    respect to which any of the above words,  objects,  signs  or
29    designs are used in any advertisement.
30        (b)  "Drugs"  means  and includes (l) articles recognized
31    in  the   official   United   States   Pharmacopoeia/National
 
SB1983 Engrossed            -2-      LRB093 08954 RCE 09186 b
 1    Formulary  (USP/NF),  or  any  supplement  thereto  and being
 2    intended for and having for their  main  use  the  diagnosis,
 3    cure,  mitigation,  treatment or prevention of disease in man
 4    or other animals, as approved by the United States  Food  and
 5    Drug  Administration,  but  does not include devices or their
 6    components, parts, or accessories; and (2) all other articles
 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  (3)  articles  (other
12    than  food)  having for their main use and intended to affect
13    the structure or any function of the body  of  man  or  other
14    animals;  and  (4)  articles  having  for  their main use and
15    intended for use as a component or any articles specified  in
16    clause (l), (2) or (3); but does not include devices or their
17    components, parts or accessories.
18        (c)  "Medicines"  means  and  includes all drugs intended
19    for human or veterinary use approved  by  the  United  States
20    Food and Drug Administration.
21        (d)  "Practice   of  pharmacy"  means  the  provision  of
22    pharmaceutical  care  to  patients  as  determined   by   the
23    pharmacist's  professional  judgment  in the following areas,
24    which  may  include  but  are  not  limited  to  (1)  patient
25    counseling,  (2)  interpretation   and   assisting   in   the
26    monitoring  of  appropriate  drug  use  and  prospective drug
27    utilization  review,  (3)  providing   information   on   the
28    therapeutic   values,   reactions,  drug  interactions,  side
29    effects, uses, selection of medications and medical  devices,
30    and  outcome  of  drug  therapy,  (4)  participation  in drug
31    selection,  drug   monitoring,   drug   utilization   review,
32    evaluation,  administration,  interpretation,  application of
33    pharmacokinetic  and  laboratory  data  to  design  safe  and
34    effective drug regimens,  (5)  drug  research  (clinical  and
 
SB1983 Engrossed            -3-      LRB093 08954 RCE 09186 b
 1    scientific),  and (6) compounding and dispensing of drugs and
 2    medical devices.
 3        (e)  "Prescription" means and includes any written, oral,
 4    facsimile, or electronically transmitted order for  drugs  or
 5    medical  devices,  issued by a physician licensed to practice
 6    medicine in  all  its  branches,  dentist,  veterinarian,  or
 7    podiatrist,  or therapeutically certified optometrist, within
 8    the  limits  of  their  licenses, by a physician assistant in
 9    accordance with  subsection  (f)  of  Section  4,  or  by  an
10    advanced  practice nurse in accordance with subsection (g) of
11    Section 4, containing the following: (l) name of the patient;
12    (2) date when prescription was issued; (3) name and  strength
13    of  drug or description of the medical device prescribed; and
14    (4) quantity, (5) directions for use, (6) prescriber's  name,
15    address and signature, and (7) DEA number where required, for
16    controlled  substances.  DEA numbers shall not be required on
17    inpatient drug orders.
18        (f)  "Person"  means  and  includes  a  natural   person,
19    copartnership,  association,  corporation, government entity,
20    or any other legal entity.
21        (g)  "Department" means the  Department  of  Professional
22    Regulation.
23        (h)  "Board of Pharmacy" or "Board" means the State Board
24    of Pharmacy of the Department of Professional Regulation.
25        (i)  "Director"   means   the  Director  of  Professional
26    Regulation.
27        (j)  "Drug product selection" means the interchange for a
28    prescribed pharmaceutical product in accordance with  Section
29    25  of  this  Act and Section 3.14 of the Illinois Food, Drug
30    and Cosmetic Act.
31        (k)  "Inpatient drug order" means an order issued  by  an
32    authorized prescriber for a resident or patient of a facility
33    licensed  under  the  Nursing  Home  Care Act or the Hospital
34    Licensing Act, or "An Act in relation  to  the  founding  and
 
SB1983 Engrossed            -4-      LRB093 08954 RCE 09186 b
 1    operation  of  the  University  of  Illinois Hospital and the
 2    conduct of University  of  Illinois  health  care  programs",
 3    approved  July  3,  1931,  as amended, or a facility which is
 4    operated by the Department of Human Services (as successor to
 5    the   Department   of   Mental   Health   and   Developmental
 6    Disabilities) or the Department of Corrections.
 7        (k-5)  "Pharmacist"  means  an  individual  health   care
 8    professional and provider currently licensed by this State to
 9    engage in the practice of pharmacy.
10        (l)  "Pharmacist in charge" means the licensed pharmacist
11    whose  name  appears on a pharmacy license who is responsible
12    for all aspects of the operation related to the  practice  of
13    pharmacy.
14        (m)  "Dispense"  means  the delivery of drugs and medical
15    devices, in accordance with applicable State and federal laws
16    and  regulations,   to   the   patient   or   the   patient's
17    representative   authorized   to   receive   these  products,
18    including the compounding, packaging, and labeling  necessary
19    for delivery, and any recommending or advising concerning the
20    contents  and therapeutic values and uses thereof. "Dispense"
21    does not mean  the  physical  delivery  to  a  patient  or  a
22    patient's  representative  in  a  home  or  institution  by a
23    designee of a pharmacist or by  common  carrier.   "Dispense"
24    also does not mean the physical delivery of a drug or medical
25    device   to  a  patient  or  patient's  representative  by  a
26    pharmacist's designee within a pharmacy  or  drugstore  while
27    the pharmacist is on duty and the pharmacy is open.
28        (n)  "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        (o)  "Compounding"   means   the   preparation,   mixing,
34    assembling,  packaging,  or  labeling  of  a  drug or medical
 
SB1983 Engrossed            -5-      LRB093 08954 RCE 09186 b
 1    device: (1) as the result of  a  practitioner's  prescription
 2    drug  order  or  initiative  that  is dispensed pursuant to a
 3    prescription in the course of professional practice;  or  (2)
 4    for  the  purpose  of, or incident to, research, teaching, or
 5    chemical analysis; or (3)  in  anticipation  of  prescription
 6    drug  orders based on routine, regularly observed prescribing
 7    patterns.
 8        (p)  "Confidential   information"   means    information,
 9    maintained  by  the  pharmacist  in  the  patient's  records,
10    released  only (i) to the patient or, as the patient directs,
11    to other practitioners and other pharmacists or (ii)  to  any
12    other person authorized by law to receive the information.
13        (q)  "Prospective   drug  review"  or  "drug  utilization
14    evaluation" means a  screening  for  potential  drug  therapy
15    problems   due   to   therapeutic  duplication,  drug-disease
16    contraindications, drug-drug interactions (including  serious
17    interactions with nonprescription or over-the-counter drugs),
18    drug-food  interactions, incorrect drug dosage or duration of
19    drug treatment, drug-allergy interactions, and clinical abuse
20    or misuse.
21        (r)  "Patient counseling" means the communication between
22    a  pharmacist  or  a  student  pharmacist  under  the  direct
23    supervision of a pharmacist and a patient  or  the  patient's
24    representative  about  the patient's medication or device for
25    the  purpose  of  optimizing  proper  use   of   prescription
26    medications   or  devices.   The  offer  to  counsel  by  the
27    pharmacist  or  the  pharmacist's  designee,  and  subsequent
28    patient counseling by the pharmacist or  student  pharmacist,
29    shall  be  made  in  a  face-to-face  communication  with the
30    patient  or   patient's   representative   unless,   in   the
31    professional  judgment  of  the  pharmacist,  a  face-to-face
32    communication  is  deemed  inappropriate  or unnecessary.  In
33    that instance, the offer to counsel or patient counseling may
34    be made in a written communication, by  telephone,  or  in  a
 
SB1983 Engrossed            -6-      LRB093 08954 RCE 09186 b
 1    manner determined by the pharmacist to be appropriate.
 2        (s)  "Patient  profiles" or "patient drug therapy record"
 3    means the obtaining, recording, and  maintenance  of  patient
 4    prescription and personal information.
 5        (t)  "Pharmaceutical  care"  includes, but is not limited
 6    to, the act of monitoring drug use  and  other  patient  care
 7    services  intended  to  achieve  outcomes  that  improve  the
 8    patient's  quality  of life but shall not include the sale of
 9    over-the-counter drugs by a seller of goods and services  who
10    does not dispense prescription drugs.
11        (u)  "Medical  device"  means  an  instrument, apparatus,
12    implement, machine, contrivance, implant, in  vitro  reagent,
13    or  other similar or related article, including any component
14    part or accessory, required under federal  law  to  bear  the
15    label  "Caution: Federal law requires dispensing by or on the
16    order of a physician". A seller of goods  and  services  who,
17    only  for  the  purpose  of  retail  sales, compounds, sells,
18    rents, or  leases  medical  devices  shall  not,  by  reasons
19    thereof, be required to be a licensed pharmacy.
20    (Source: P.A.  89-202,  eff.  7-21-95;  89-507,  eff. 7-1-97;
21    90-116, eff. 7-14-97;  90-253,  eff.  7-29-97;  90-655,  eff.
22    7-30-98; 90-742, eff. 8-13-98.)

23        (Text of Section after amendment by P.A. 92-880)
24        Sec. 3. Definitions.  For the purpose of this Act, except
25    where otherwise limited therein:
26        (a)  "Pharmacy"  or  "drugstore" means and includes every
27    store,  shop,  pharmacy  department,  or  other  place  where
28    pharmaceutical care is provided by  a  pharmacist  (1)  where
29    drugs,  medicines,  or poisons are dispensed, sold or offered
30    for sale at retail, or displayed for sale at retail;  or  (2)
31    where  prescriptions  of physicians, dentists, veterinarians,
32    podiatrists,  or  therapeutically   certified   optometrists,
33    within  the limits of their licenses, are compounded, filled,
34    or dispensed; or (3) which has upon it  or  displayed  within
 
SB1983 Engrossed            -7-      LRB093 08954 RCE 09186 b
 1    it,  or  affixed  to  or  used  in connection with it, a sign
 2    bearing  the  word   or   words   "Pharmacist",   "Druggist",
 3    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
 4    "Medicine  Store",  "Prescriptions", "Drugs", "Medicines", or
 5    any word or words of similar or like import,  either  in  the
 6    English  language  or  any  other  language; or (4) where the
 7    characteristic prescription sign (Rx) or  similar  design  is
 8    exhibited;  or  (5)  any  store, or shop, or other place with
 9    respect to which any of the above words,  objects,  signs  or
10    designs are used in any advertisement.
11        (b)  "Drugs"  means  and includes (l) articles recognized
12    in  the   official   United   States   Pharmacopoeia/National
13    Formulary  (USP/NF),  or  any  supplement  thereto  and being
14    intended for and having for their  main  use  the  diagnosis,
15    cure,  mitigation,  treatment or prevention of disease in man
16    or other animals, as approved by the United States  Food  and
17    Drug  Administration,  but  does not include devices or their
18    components, parts, or accessories; and (2) all other articles
19    intended for and having for their  main  use  the  diagnosis,
20    cure,  mitigation,  treatment or prevention of disease in man
21    or other animals, as approved by the United States  Food  and
22    Drug  Administration,  but  does not include devices or their
23    components, parts, or accessories; and  (3)  articles  (other
24    than  food)  having for their main use and intended to affect
25    the structure or any function of the body  of  man  or  other
26    animals;  and  (4)  articles  having  for  their main use and
27    intended for use as a component or any articles specified  in
28    clause (l), (2) or (3); but does not include devices or their
29    components, parts or accessories.
30        (c)  "Medicines"  means  and  includes all drugs intended
31    for human or veterinary use approved  by  the  United  States
32    Food and Drug Administration.
33        (d)  "Practice   of  pharmacy"  means  the  provision  of
34    pharmaceutical  care  to  patients  as  determined   by   the
 
SB1983 Engrossed            -8-      LRB093 08954 RCE 09186 b
 1    pharmacist's  professional  judgment  in the following areas,
 2    which  may  include  but  are  not  limited  to  (1)  patient
 3    counseling,  (2)  interpretation   and   assisting   in   the
 4    monitoring  of  appropriate  drug  use  and  prospective drug
 5    utilization  review,  (3)  providing   information   on   the
 6    therapeutic   values,   reactions,  drug  interactions,  side
 7    effects, uses, selection of medications and medical  devices,
 8    and  outcome  of  drug  therapy,  (4)  participation  in drug
 9    selection,  drug   monitoring,   drug   utilization   review,
10    evaluation,  administration,  interpretation,  application of
11    pharmacokinetic  and  laboratory  data  to  design  safe  and
12    effective drug regimens,  (5)  drug  research  (clinical  and
13    scientific),  and (6) compounding and dispensing of drugs and
14    medical devices.
15        (e)  "Prescription" means and includes any written, oral,
16    facsimile, or electronically transmitted order for  drugs  or
17    medical  devices,  issued by a physician licensed to practice
18    medicine in  all  its  branches,  dentist,  veterinarian,  or
19    podiatrist,  or therapeutically certified optometrist, within
20    the  limits  of  their  licenses, by a physician assistant in
21    accordance with  subsection  (f)  of  Section  4,  or  by  an
22    advanced  practice nurse in accordance with subsection (g) of
23    Section 4, containing the following: (l) name of the patient;
24    (2) date when prescription was issued; (3) name and  strength
25    of  drug or description of the medical device prescribed; and
26    (4) quantity, (5) directions for use, (6) prescriber's  name,
27    address and signature, and (7) DEA number where required, for
28    controlled  substances.  DEA numbers shall not be required on
29    inpatient drug orders.
30        (f)  "Person"  means  and  includes  a  natural   person,
31    copartnership,  association,  corporation, government entity,
32    or any other legal entity.
33        (g)  "Department" means the  Department  of  Professional
34    Regulation.
 
SB1983 Engrossed            -9-      LRB093 08954 RCE 09186 b
 1        (h)  "Board of Pharmacy" or "Board" means the State Board
 2    of Pharmacy of the Department of Professional Regulation.
 3        (i)  "Director"   means   the  Director  of  Professional
 4    Regulation.
 5        (j)  "Drug product selection" means the interchange for a
 6    prescribed pharmaceutical product in accordance with  Section
 7    25  of  this  Act and Section 3.14 of the Illinois Food, Drug
 8    and Cosmetic Act.
 9        (k)  "Inpatient drug order" means an order issued  by  an
10    authorized prescriber for a resident or patient of a facility
11    licensed  under  the  Nursing  Home  Care Act or the Hospital
12    Licensing Act, or "An Act in relation  to  the  founding  and
13    operation  of  the  University  of  Illinois Hospital and the
14    conduct of University  of  Illinois  health  care  programs",
15    approved  July  3,  1931,  as amended, or a facility which is
16    operated by the Department of Human Services (as successor to
17    the   Department   of   Mental   Health   and   Developmental
18    Disabilities) or the Department of Corrections.
19        (k-5)  "Pharmacist"  means  an  individual  health   care
20    professional and provider currently licensed by this State to
21    engage in the practice of pharmacy.
22        (l)  "Pharmacist in charge" means the licensed pharmacist
23    whose   name  appears  on  a  pharmacy  license  and  who  is
24    responsible for all aspects of the operation related  to  the
25    practice of pharmacy.
26        (m)  "Dispense"  means  the delivery of drugs and medical
27    devices, in accordance with applicable State and federal laws
28    and  regulations,   to   the   patient   or   the   patient's
29    representative   authorized   to   receive   these  products,
30    including the compounding, packaging, and labeling  necessary
31    for delivery, and any recommending or advising concerning the
32    contents and therapeutic values and uses thereof.  "Dispense"
33    does  not  mean  the  physical  delivery  to  a  patient or a
34    patient's representative  in  a  home  or  institution  by  a
 
SB1983 Engrossed            -10-     LRB093 08954 RCE 09186 b
 1    designee  of  a  pharmacist or by common carrier.  "Dispense"
 2    also does not mean the physical delivery of a drug or medical
 3    device  to  a  patient  or  patient's  representative  by   a
 4    pharmacist's  designee  within  a pharmacy or drugstore while
 5    the pharmacist is on duty and the pharmacy is open.
 6        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
 7    located in a state of the United States, other than Illinois,
 8    that delivers, dispenses or distributes, through  the  United
 9    States  Postal  Service  or other common carrier, to Illinois
10    residents, any substance which requires a prescription.
11        (o)  "Compounding"   means   the   preparation,   mixing,
12    assembling, packaging, or  labeling  of  a  drug  or  medical
13    device:  (1)  as  the result of a practitioner's prescription
14    drug order or initiative that  is  dispensed  pursuant  to  a
15    prescription  in  the course of professional practice; or (2)
16    for the purpose of, or incident to,  research,  teaching,  or
17    chemical  analysis;  or  (3)  in anticipation of prescription
18    drug orders based on routine, regularly observed  prescribing
19    patterns.
20        (p)  "Confidential    information"   means   information,
21    maintained  by  the  pharmacist  in  the  patient's  records,
22    released only (i) to the patient or, as the patient  directs,
23    to  other  practitioners and other pharmacists or (ii) to any
24    other person authorized by law to receive the information.
25        (q)  "Prospective  drug  review"  or  "drug   utilization
26    evaluation"  means  a  screening  for  potential drug therapy
27    problems  due  to   therapeutic   duplication,   drug-disease
28    contraindications,  drug-drug interactions (including serious
29    interactions with nonprescription or over-the-counter drugs),
30    drug-food interactions, incorrect drug dosage or duration  of
31    drug treatment, drug-allergy interactions, and clinical abuse
32    or misuse.
33        (r)  "Patient counseling" means the communication between
34    a  pharmacist  or  a  student  pharmacist  under  the  direct
 
SB1983 Engrossed            -11-     LRB093 08954 RCE 09186 b
 1    supervision  of  a  pharmacist and a patient or the patient's
 2    representative about the patient's medication or  device  for
 3    the   purpose   of  optimizing  proper  use  of  prescription
 4    medications  or  devices.   The  offer  to  counsel  by   the
 5    pharmacist  or  the  pharmacist's  designee,  and  subsequent
 6    patient  counseling  by the pharmacist or student pharmacist,
 7    shall be  made  in  a  face-to-face  communication  with  the
 8    patient   or   patient's   representative   unless,   in  the
 9    professional  judgment  of  the  pharmacist,  a  face-to-face
10    communication is deemed  inappropriate  or  unnecessary.   In
11    that instance, the offer to counsel or patient counseling may
12    be  made  in  a  written communication, by telephone, or in a
13    manner determined by the pharmacist to be appropriate.
14        (s)  "Patient profiles" or "patient drug therapy  record"
15    means  the  obtaining,  recording, and maintenance of patient
16    prescription and personal information.
17        (t)  "Pharmaceutical care" includes, but is  not  limited
18    to,  the  act  of  monitoring drug use and other patient care
19    services  intended  to  achieve  outcomes  that  improve  the
20    patient's quality of life but shall not include the  sale  of
21    over-the-counter  drugs by a seller of goods and services who
22    does not dispense prescription drugs.
23        (u)  "Medical device"  means  an  instrument,  apparatus,
24    implement,  machine,  contrivance, implant, in vitro reagent,
25    or other similar or related article, including any  component
26    part  or  accessory,  required  under federal law to bear the
27    label "Caution: Federal law requires dispensing by or on  the
28    order  of  a  physician". A seller of goods and services who,
29    only for the  purpose  of  retail  sales,  compounds,  sells,
30    rents,  or  leases  medical  devices  shall  not,  by reasons
31    thereof, be required to be a licensed pharmacy.
32        (v)  "Unique identifier" means an  electronic  signature,
33    handwritten  signature  or  initials,  thumb  print, or other
34    acceptable individual biometric or electronic  identification
 
SB1983 Engrossed            -12-     LRB093 08954 RCE 09186 b
 1    process as approved by the Department.
 2    (Source: P.A. 92-880, eff. 1-1-04.)

 3        Section  95.   No  acceleration or delay.  Where this Act
 4    makes changes in a statute that is represented in this Act by
 5    text that is not yet or no longer in effect (for  example,  a
 6    Section  represented  by  multiple versions), the use of that
 7    text does not accelerate or delay the taking  effect  of  (i)
 8    the  changes made by this Act or (ii) provisions derived from
 9    any other Public Act.

10        Section 99. Effective date.  This Act takes  effect  upon
11    becoming law.