093_HB3906

                                     LRB093 13996 AMC 19408 b

 1        AN ACT concerning pharmacies.

 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, 16a, and 35.1 and adding Section 16b
 6    as follows:

 7        (225 ILCS 85/3) (from Ch. 111, par. 4123)
 8        (Section scheduled to be repealed on January 1, 2008)
 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
 
                            -2-      LRB093 13996 AMC 19408 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
 
                            -3-      LRB093 13996 AMC 19408 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
 
                            -4-      LRB093 13996 AMC 19408 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  and  who   is
12    responsible  for  all aspects of the operation related to the
13    practice of 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)  "Domestic mail-order pharmacy" means a pharmacy that
29    is  located  in  a  state  of  the  United States, other than
30    Illinois, that delivers, dispenses  or  distributes,  through
31    the  United States Postal Service or other common carrier, to
32    Illinois  residents,   any   substance   which   requires   a
33    prescription.
34        (n-5)  "Foreign  mail-order  pharmacy"  means  a pharmacy
 
                            -5-      LRB093 13996 AMC 19408 b
 1    that is located in a country other  than  the  United  States
 2    that  delivers, dispenses, or distributes, through the United
 3    States Postal Service or other common  carrier,  to  Illinois
 4    residents any substance that requires a prescription.
 5        (o)  "Compounding"   means   the   preparation,   mixing,
 6    assembling,  packaging,  or  labeling  of  a  drug or medical
 7    device: (1) as the result of  a  practitioner's  prescription
 8    drug  order  or  initiative  that  is dispensed pursuant to a
 9    prescription in the course of professional practice;  or  (2)
10    for  the  purpose  of, or incident to, research, teaching, or
11    chemical analysis; or (3)  in  anticipation  of  prescription
12    drug  orders based on routine, regularly observed prescribing
13    patterns.
14        (p)  "Confidential   information"   means    information,
15    maintained  by  the  pharmacist  in  the  patient's  records,
16    released  only (i) to the patient or, as the patient directs,
17    to other practitioners and other pharmacists or (ii)  to  any
18    other person authorized by law to receive the information.
19        (q)  "Prospective   drug  review"  or  "drug  utilization
20    evaluation" means a  screening  for  potential  drug  therapy
21    problems   due   to   therapeutic  duplication,  drug-disease
22    contraindications, drug-drug interactions (including  serious
23    interactions with nonprescription or over-the-counter drugs),
24    drug-food  interactions, incorrect drug dosage or duration of
25    drug treatment, drug-allergy interactions, and clinical abuse
26    or misuse.
27        (r)  "Patient counseling" means the communication between
28    a  pharmacist  or  a  student  pharmacist  under  the  direct
29    supervision of a pharmacist and a patient  or  the  patient's
30    representative  about  the patient's medication or device for
31    the  purpose  of  optimizing  proper  use   of   prescription
32    medications   or  devices.   The  offer  to  counsel  by  the
33    pharmacist  or  the  pharmacist's  designee,  and  subsequent
34    patient counseling by the pharmacist or  student  pharmacist,
 
                            -6-      LRB093 13996 AMC 19408 b
 1    shall  be  made  in  a  face-to-face  communication  with the
 2    patient  or   patient's   representative   unless,   in   the
 3    professional  judgment  of  the  pharmacist,  a  face-to-face
 4    communication  is  deemed  inappropriate  or unnecessary.  In
 5    that instance, the offer to counsel or patient counseling may
 6    be made in a written communication, by  telephone,  or  in  a
 7    manner determined by the pharmacist to be appropriate.
 8        (s)  "Patient  profiles" or "patient drug therapy record"
 9    means the obtaining, recording, and  maintenance  of  patient
10    prescription   information,   including   prescriptions   for
11    controlled substances, and personal information.
12        (t)  "Pharmaceutical  care"  includes, but is not limited
13    to, the act of monitoring drug use  and  other  patient  care
14    services  intended  to  achieve  outcomes  that  improve  the
15    patient's  quality  of life but shall not include the sale of
16    over-the-counter drugs by a seller of goods and services  who
17    does not dispense prescription drugs.
18        (u)  "Medical  device"  means  an  instrument, apparatus,
19    implement, machine, contrivance, implant, in  vitro  reagent,
20    or  other similar or related article, including any component
21    part or accessory, required under federal  law  to  bear  the
22    label  "Caution: Federal law requires dispensing by or on the
23    order of a physician". A seller of goods  and  services  who,
24    only  for  the  purpose  of  retail  sales, compounds, sells,
25    rents, or  leases  medical  devices  shall  not,  by  reasons
26    thereof, be required to be a licensed pharmacy.
27        (v)  "Unique  identifier"  means an electronic signature,
28    handwritten signature or  initials,  thumb  print,  or  other
29    acceptable  individual biometric or electronic identification
30    process as approved by the Department.
31    (Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03.)

32        (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
33        (Section scheduled to be repealed on January 1, 2008)
 
                            -7-      LRB093 13996 AMC 19408 b
 1        Sec. 16a. (a) The Department shall  establish  rules  and
 2    regulations,  consistent  with  the  provisions  of this Act,
 3    governing   domestic   mail-order    pharmacies,    including
 4    pharmacies  providing  services via the Internet, which sell,
 5    or offer for sale, drugs, medicines, or other  pharmaceutical
 6    services in this State.
 7        (b)  The  Board  shall  require and provide for an annual
 8    nonresident special pharmacy registration for all  pharmacies
 9    located  outside  of this State that dispense medications for
10    Illinois residents and mail, ship,  or  deliver  prescription
11    medications  into  this  State.  Nonresident special pharmacy
12    registration  shall  be  granted  by  the  Board   upon   the
13    disclosure and certification by a pharmacy:
14             (1)  that  it  is licensed in the state in which the
15        dispensing facility is located and from which  the  drugs
16        are dispensed;
17             (2)  of  the  location,  names,  and  titles  of all
18        principal corporate officers and all pharmacists who  are
19        dispensing drugs to residents of this State;
20             (3)  that it complies with all lawful directions and
21        requests  for  information  from the board of pharmacy of
22        each state in which it is licensed or registered,  except
23        that it shall respond directly to all communications from
24        the Board concerning emergency circumstances arising from
25        the dispensing of drugs to residents of this State;
26             (4)  that   it   maintains   its  records  of  drugs
27        dispensed to residents of this State so that the  records
28        are  readily  retrievable from the records of other drugs
29        dispensed;
30             (5)  that it cooperates with the Board in  providing
31        information  to  the  board  of  pharmacy of the state in
32        which it is licensed concerning matters  related  to  the
33        dispensing of drugs to residents of this State; and
34             (6)  that during its regular hours of operation, but
 
                            -8-      LRB093 13996 AMC 19408 b
 1        not  less than 6 days per week, for a minimum of 40 hours
 2        per week, a toll-free telephone service  is  provided  to
 3        facilitate  communication  between patients in this State
 4        and a pharmacist at the pharmacy who has  access  to  the
 5        patients' records. The toll-free number must be disclosed
 6        on the label affixed to each container of drugs dispensed
 7        to residents of this State.
 8        (c)  The  provisions  of  this  Section  do  not apply to
 9    pharmacies for which registration is provided  under  Section
10    16b.
11    (Source: P.A. 91-438, eff. 1-1-00.)

12        (225 ILCS 85/16b new)
13        Sec. 16b.  Foreign mail-order pharmacy.
14        (a)  Notwithstanding  any  other Section of this Act, the
15    Department shall provide  for  the  registration  of  foreign
16    mail-order  pharmacies  as  nonresident  pharmacies, upon the
17    disclosure and certification by a foreign mail-order pharmacy
18    of the following:
19             (1)  That it is licensed in the country,  state,  or
20        province  in which the dispensing facility is located and
21        from which the drugs are dispensed.
22             (2)  The  location,  names,  and   titles   of   all
23        principal  corporate officers and all pharmacists who are
24        dispensing drugs to residents of this State.
25             (3)  That it complies with all lawful directions and
26        requests for information from the board  of  pharmacy  of
27        each  country, state, or province in which it is licensed
28        or registered, except that it shall respond  directly  to
29        all  communications  from  the Board concerning emergency
30        circumstances arising from the  dispensing  of  drugs  to
31        residents of this State.
32             (4)  That   it   maintains   its  records  of  drugs
33        dispensed to residents of this State so that the  records
 
                            -9-      LRB093 13996 AMC 19408 b
 1        are  readily  retrievable from the records of other drugs
 2        dispensed.
 3             (5)  That it cooperates with the Board  of  Pharmacy
 4        in  providing information to the board of pharmacy of the
 5        country, state, or  province  in  which  it  is  licensed
 6        concerning  matters related to the dispensing of drugs to
 7        residents of this State.
 8             (6)  That during its regular hours of operation, but
 9        not less than 6 days per week, for a minimum of 40  hours
10        per  week,  a  toll-free telephone service is provided to
11        facilitate communication between patients in  this  State
12        and  a  pharmacist  at the pharmacy who has access to the
13        patients' records. The toll-free number must be disclosed
14        on the label affixed to each container or drugs dispenses
15        to residents of this State.
16             (7)  That it consents to  the  jurisdiction  of  the
17        Department over pharmacy practices affecting the State of
18        Illinois.
19        (b)  Only  a  pharmacy  located within a foreign country,
20    state, or province whose pharmacy laws and  regulations  have
21    been determined by the Department to be substantially similar
22    to those of the State of Illinois and whose regulatory scheme
23    for  approval  and  quality control of prescription drugs has
24    been found by the Department to be  substantially  equivalent
25    to  that  of the State of Illinois and the federal government
26    may be registered as a nonresident pharmacy.
27        (c)  The   Department's    criteria    for    determining
28    substantial equivalence shall be set by rule.
29        (d)  The  Department shall maintain a list of all foreign
30    countries, states, and provinces that have been evaluated  on
31    its website with a designation of "approved" or "denied". Any
32    pharmacy located within a foreign country, state, or province
33    that  has  not  been  evaluated by the Department may request
34    that the Department conduct an evaluation.
 
                            -10-     LRB093 13996 AMC 19408 b
 1        (225 ILCS 85/35.1) (from Ch. 111, par. 4155.1)
 2        (Section scheduled to be repealed on January 1, 2008)
 3        Sec. 35.1.  (a)  If any person violates the provision  of
 4    this  Act, the Director may, in the name of the People of the
 5    State of Illinois, through the Attorney General of the  State
 6    of  Illinois,  or the State's Attorney of any county in which
 7    the action is brought, petition, for an order enjoining  such
 8    violation or for an order enforcing compliance with this Act.
 9    Upon  the  filing  of  a verified petition in such court, the
10    court may issue a temporary restraining order, without notice
11    or bond, and may preliminarily and  permanently  enjoin  such
12    violation,  and  if  it  is  established that such person has
13    violated or is violating the injunction, the Court may punish
14    the offender for contempt of court.  Proceedings  under  this
15    Section  shall  be  in  addition  to, and not in lieu of, all
16    other remedies and penalties provided by this Act.
17        (b)  If any person shall practice as a pharmacist or hold
18    himself  out  as  a  pharmacist  or  operate  a  pharmacy  or
19    drugstore, including a  domestic  mail-order  pharmacy  under
20    Section  16a  or  a foreign mail-order pharmacy under Section
21    16b, without being licensed under the provisions of this Act,
22    then any licensed pharmacist, any  interested  party  or  any
23    person  injured  thereby  may,  in  addition to the Director,
24    petition for relief as provided in  subsection  (a)  of  this
25    Section.
26        Whoever knowingly practices or offers to practice in this
27    State  without  being  appropriately  licensed  or registered
28    under this Act shall be guilty of a Class A  misdemeanor  and
29    for  each subsequent conviction, shall be guilty of a Class 4
30    felony.
31        (c)  Whenever in the opinion of the Department any person
32    not licensed in good standing under  this  Act  violates  any
33    provision  of  this  Act,  the Department may issue a rule to
34    show cause why an order to cease and  desist  should  not  be
 
                            -11-     LRB093 13996 AMC 19408 b
 1    entered  against  him.   The rule shall clearly set forth the
 2    grounds relied upon by the Department  and  shall  provide  a
 3    period  of 7 days from the date of the rule to file an answer
 4    to the satisfaction of the Department.  Failure to answer  to
 5    the  satisfaction  of  the Department shall cause an order to
 6    cease and desist to be issued forthwith.
 7    (Source: P.A. 92-678, eff. 7-16-02.)

 8        Section 99.  Effective date.  This Act takes effect  upon
 9    becoming law.