093_HB3848

 
                                     LRB093 13377 AMC 18672 b

 1        AN ACT concerning professional regulation.

 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 Sections 3 and 16a as follows:

 6        (225 ILCS 85/3) (from Ch. 111, par. 4123)
 7        (Section scheduled to be repealed on January 1, 2008)
 8        Sec. 3. Definitions.  For the purpose of this Act, except
 9    where otherwise limited therein:
10        (a)  "Pharmacy" or "drugstore" means and  includes  every
11    store,  shop,  pharmacy  department,  or  other  place  where
12    pharmaceutical  care  is  provided  by a pharmacist (1) where
13    drugs, medicines, or poisons are dispensed, sold  or  offered
14    for  sale  at retail, or displayed for sale at retail; or (2)
15    where prescriptions of physicians,  dentists,  veterinarians,
16    podiatrists,   or   therapeutically  certified  optometrists,
17    within the limits of their licenses, are compounded,  filled,
18    or  dispensed;  or  (3) which has upon it or displayed within
19    it, or affixed to or used  in  connection  with  it,  a  sign
20    bearing   the   word   or   words  "Pharmacist",  "Druggist",
21    "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
22    "Medicine Store", "Prescriptions", "Drugs",  "Medicines",  or
23    any  word  or  words of similar or like import, either in the
24    English language or any other  language;  or  (4)  where  the
25    characteristic  prescription  sign  (Rx) or similar design is
26    exhibited; or (5) any store, or shop,  or  other  place  with
27    respect  to  which  any of the above words, objects, signs or
28    designs are used in any advertisement.
29        (b)  "Drugs" means and includes (l)  articles  recognized
30    in   the   official   United   States  Pharmacopoeia/National
31    Formulary (USP/NF),  or  any  supplement  thereto  and  being
 
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 1    intended  for  and  having  for their main use the diagnosis,
 2    cure, mitigation, treatment or prevention of disease  in  man
 3    or  other  animals, as approved by the United States Food and
 4    Drug Administration, but does not include  devices  or  their
 5    components, parts, or accessories; and (2) all other articles
 6    intended  for  and  having  for their main use the diagnosis,
 7    cure, mitigation, treatment or prevention of disease  in  man
 8    or  other  animals, as approved by the United States Food and
 9    Drug Administration, but does not include  devices  or  their
10    components,  parts,  or  accessories; and (3) articles (other
11    than food) having for their main use and intended  to  affect
12    the  structure  or  any  function of the body of man or other
13    animals; and (4) articles  having  for  their  main  use  and
14    intended  for use as a component or any articles specified in
15    clause (l), (2) or (3); but does not include devices or their
16    components, parts or accessories.
17        (c)  "Medicines" means and includes  all  drugs  intended
18    for  human  or  veterinary  use approved by the United States
19    Food and Drug Administration.
20        (d)  "Practice  of  pharmacy"  means  the  provision   of
21    pharmaceutical   care   to  patients  as  determined  by  the
22    pharmacist's professional judgment in  the  following  areas,
23    which  may  include  but  are  not  limited  to  (1)  patient
24    counseling,   (2)   interpretation   and   assisting  in  the
25    monitoring of  appropriate  drug  use  and  prospective  drug
26    utilization   review,   (3)   providing  information  on  the
27    therapeutic  values,  reactions,  drug   interactions,   side
28    effects,  uses, selection of medications and medical devices,
29    and outcome  of  drug  therapy,  (4)  participation  in  drug
30    selection,   drug   monitoring,   drug   utilization  review,
31    evaluation, administration,  interpretation,  application  of
32    pharmacokinetic  and  laboratory  data  to  design  safe  and
33    effective  drug  regimens,  (5)  drug  research (clinical and
34    scientific), and (6) compounding and dispensing of drugs  and
 
                            -3-      LRB093 13377 AMC 18672 b
 1    medical devices.
 2        (e)  "Prescription" means and includes any written, oral,
 3    facsimile,  or  electronically transmitted order for drugs or
 4    medical devices, issued by a physician licensed  to  practice
 5    medicine  in  all  its  branches,  dentist,  veterinarian, or
 6    podiatrist,  or therapeutically certified optometrist, within
 7    the limits of their licenses, by  a  physician  assistant  in
 8    accordance  with  subsection  (f)  of  Section  4,  or  by an
 9    advanced practice nurse in accordance with subsection (g)  of
10    Section 4, containing the following: (l) name of the patient;
11    (2)  date when prescription was issued; (3) name and strength
12    of drug or description of the medical device prescribed;  and
13    (4)  quantity, (5) directions for use, (6) prescriber's name,
14    address and signature, and (7) DEA number where required, for
15    controlled substances. DEA numbers shall not be  required  on
16    inpatient drug orders.
17        (f)  "Person"   means  and  includes  a  natural  person,
18    copartnership, association, corporation,  government  entity,
19    or any other legal entity.
20        (g)  "Department"  means  the  Department of Professional
21    Regulation.
22        (h)  "Board of Pharmacy" or "Board" means the State Board
23    of Pharmacy of the Department of Professional Regulation.
24        (i)  "Director"  means  the  Director   of   Professional
25    Regulation.
26        (j)  "Drug product selection" means the interchange for a
27    prescribed  pharmaceutical product in accordance with Section
28    25 of this Act and Section 3.14 of the  Illinois  Food,  Drug
29    and Cosmetic Act.
30        (k)  "Inpatient  drug  order" means an order issued by an
31    authorized prescriber for a resident or patient of a facility
32    licensed under the Nursing Home  Care  Act  or  the  Hospital
33    Licensing  Act,  or  "An  Act in relation to the founding and
34    operation of the University  of  Illinois  Hospital  and  the
 
                            -4-      LRB093 13377 AMC 18672 b
 1    conduct  of  University  of  Illinois  health care programs",
 2    approved July 3, 1931, as amended, or  a  facility  which  is
 3    operated by the Department of Human Services (as successor to
 4    the   Department   of   Mental   Health   and   Developmental
 5    Disabilities) or the Department of Corrections.
 6        (k-5)  "Pharmacist"   means  an  individual  health  care
 7    professional and provider currently licensed by this State to
 8    engage in the practice of pharmacy.
 9        (l)  "Pharmacist in charge" means the licensed pharmacist
10    whose  name  appears  on  a  pharmacy  license  and  who   is
11    responsible  for  all aspects of the operation related to the
12    practice of pharmacy.
13        (m)  "Dispense" means the delivery of drugs  and  medical
14    devices, in accordance with applicable State and federal laws
15    and   regulations,   to   the   patient   or   the  patient's
16    representative  authorized   to   receive   these   products,
17    including  the compounding, packaging, and labeling necessary
18    for delivery, and any recommending or advising concerning the
19    contents and therapeutic values and uses thereof.  "Dispense"
20    does not mean  the  physical  delivery  to  a  patient  or  a
21    patient's  representative  in  a  home  or  institution  by a
22    designee of a pharmacist or by  common  carrier.   "Dispense"
23    also does not mean the physical delivery of a drug or medical
24    device   to  a  patient  or  patient's  representative  by  a
25    pharmacist's designee within a pharmacy  or  drugstore  while
26    the pharmacist is on duty and the pharmacy is open.
27        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
28    located  outside of Illinois in a state of the United States,
29    other than Illinois, that delivers, dispenses or distributes,
30    through the United States  Postal  Service  or  other  common
31    carrier,  to Illinois residents, any substance which requires
32    a prescription.
33        (o)  "Compounding"   means   the   preparation,   mixing,
34    assembling, packaging, or  labeling  of  a  drug  or  medical
 
                            -5-      LRB093 13377 AMC 18672 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
 
                            -6-      LRB093 13377 AMC 18672 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   information,   including   prescriptions   for
 5    controlled substances, and personal information.
 6        (t)  "Pharmaceutical care" includes, but is  not  limited
 7    to,  the  act  of  monitoring drug use and other patient care
 8    services  intended  to  achieve  outcomes  that  improve  the
 9    patient's quality of life but shall not include the  sale  of
10    over-the-counter  drugs by a seller of goods and services who
11    does not dispense prescription drugs.
12        (u)  "Medical device"  means  an  instrument,  apparatus,
13    implement,  machine,  contrivance, implant, in vitro reagent,
14    or other similar or related article, including any  component
15    part  or  accessory,  required  under federal law to bear the
16    label "Caution: Federal law requires dispensing by or on  the
17    order  of  a  physician". A seller of goods and services who,
18    only for the  purpose  of  retail  sales,  compounds,  sells,
19    rents,  or  leases  medical  devices  shall  not,  by reasons
20    thereof, be required to be a licensed pharmacy.
21        (v)  "Unique identifier" means an  electronic  signature,
22    handwritten  signature  or  initials,  thumb  print, or other
23    acceptable individual biometric or electronic  identification
24    process as approved by the Department.
25    (Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03.)

26        (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
27        (Section scheduled to be repealed on January 1, 2008)
28        Sec. 16a.  Mail-order pharmacies.
29        (a)The  Department shall establish rules and regulations,
30    consistent  with  the  provisions  of  this  Act,   governing
31    mail-order   pharmacies,   including   pharmacies   providing
32    services  via  the  Internet,  which sell, or offer for sale,
33    drugs, medicines, or other pharmaceutical  services  in  this
 
                            -7-      LRB093 13377 AMC 18672 b
 1    State.
 2        (b)  The  Board  shall  require and provide for an annual
 3    nonresident special pharmacy registration for all  pharmacies
 4    located  outside  of this State that dispense medications for
 5    Illinois residents and mail, ship,  or  deliver  prescription
 6    medications  into  this  State.  Nonresident special pharmacy
 7    registration  shall  be  granted  by  the  Board   upon   the
 8    disclosure and certification by a pharmacy:
 9             (1)  that  it  is licensed in the jurisdiction state
10        in which the dispensing  facility  is  located  and  from
11        which the drugs are dispensed;
12             (2)  of  the  location,  names,  and  titles  of all
13        principal corporate officers and all pharmacists who  are
14        dispensing drugs to residents of this State;
15             (3)  that it complies with all lawful directions and
16        requests  for  information  from the board of pharmacy of
17        each state in which it is licensed or registered,  except
18        that it shall respond directly to all communications from
19        the Board concerning emergency circumstances arising from
20        the dispensing of drugs to residents of this State;
21             (4)  that   it   maintains   its  records  of  drugs
22        dispensed to residents of this State so that the  records
23        are  readily  retrievable from the records of other drugs
24        dispensed;
25             (5)  that it cooperates with the Board in  providing
26        information  to the board of pharmacy of the jurisdiction
27        state in which it is licensed concerning matters  related
28        to  the  dispensing  of drugs to residents of this State;
29        and
30             (6)  that during its regular hours of operation, but
31        not less than 6 days per week, for a minimum of 40  hours
32        per  week,  a  toll-free telephone service is provided to
33        facilitate communication between patients in  this  State
34        and  a  pharmacist  at the pharmacy who has access to the
 
                            -8-      LRB093 13377 AMC 18672 b
 1        patients' records. The toll-free number must be disclosed
 2        on the label affixed to each container of drugs dispensed
 3        to residents of this State.
 4        (c)  The Department  may  (i)  in  cooperation  with  the
 5    jurisdiction  under which the pharmacy is licensed, make site
 6    visits to  a  pharmacy  registered  under  this  Section  for
 7    quality  assurance purposes and (ii) notify the United States
 8    Food and Drug Administration that a pharmacy registered under
 9    this Section is in  compliance  with  State  laws  and  rules
10    governing mail-order pharmacies.
11    (Source: P.A. 91-438, eff. 1-1-00.)