State of Illinois
90th General Assembly
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90_HB0945

      225 ILCS 85/3             from Ch. 111, par. 4123
      225 ILCS 85/10            from Ch. 111, par. 4130
      225 ILCS 85/14            from Ch. 111, par. 4134
      225 ILCS 85/18            from Ch. 111, par. 4138
      225 ILCS 85/22            from Ch. 111, par. 4142
      225 ILCS 85/22a new
          Amends the Pharmacy Practice Act of 1987 to  provide  for
      staggered  terms  for  members of the State Board of Pharmacy
      beginning April 1, 1999. Revises definitions  of  "pharmacy",
      "prescription",   "dispense",   and   "patient   counseling".
      Provides that the Department of Professional Regulation shall
      adopt  rules  concerning labeling in Division II and Division
      III pharmacies  and  the  use  of  automated  dispensing  and
      storage  systems.  Allows pharmacies and drugstores to retain
      records in an alternative data retention system under  stated
      conditions. Effective immediately.
                                                     LRB9004158DPcc
                                               LRB9004158DPcc
 1        AN  ACT  to  amend  the  Pharmacy Practice Act of 1987 by
 2    changing Sections 3, 10, 14, 18, and 22  and  adding  Section
 3    22a.
 4        Be  it  enacted  by  the People of the State of Illinois,
 5    represented in the General Assembly:
 6        Section 5.  The Pharmacy Practice Act of 1987 is  amended
 7    by changing Sections 3, 10, 14, 18, and 22 and adding Section
 8    22a as follows:
 9        (225 ILCS 85/3) (from Ch. 111, par. 4123)
10        (Text of Section before amendment by P.A. 89-507)
11        Sec.  3.   For  the  purpose  of  this  Act, except where
12    otherwise limited therein:
13        (a)  "Pharmacy" or "drugstore" means and  includes  every
14    store,  or  shop,  pharmacy department, or other place where:
15    (l) pharmaceutical care is provided by a pharmacist;  or  (2)
16    drugs,  medicines,  or  poisons  are  dispensed,  or  sold or
17    offered for sale at retail,; or displayed for sale at retail;
18    or (2)  (3)  where  prescriptions  of  physicians,  dentists,
19    veterinarians, or other persons authorized to prescribe drugs
20    within  the  limits of their licenses are compounded, filled,
21    or dispensed; or (3) (4)  which  has  upon  it  or  displayed
22    within  it,  or  affixed  to or used in connection with it, a
23    sign bearing the  word  or  words  "Pharmacist",  "Druggist",
24    "Pharmacy",   "Apothecary",  "Drugstore",  "Medicine  Store",
25    "Prescriptions", "Drugs", "Medicines", or any word  or  words
26    of  similar or like import, either in the English language or
27    any other language;  or  (4)  (5)  where  the  characteristic
28    prescription sign (Rx) or similar design is exhibited; or (5)
29    (6)  any store, or shop, or other place with respect to which
30    any of the above words, objects, signs or designs are used in
31    any advertisement.
                            -2-                LRB9004158DPcc
 1        (b)  "Drugs" means and includes (l)  articles  recognized
 2    in   the   official   United   States  Pharmacopoeia/National
 3    Formulary (USP/NF),  or  any  supplement  thereto  and  being
 4    intended  for  and  having  for their main use the diagnosis,
 5    cure, mitigation, treatment or prevention of disease  in  man
 6    or  other  animals, as approved by the United States Food and
 7    Drug Administration, but does not include  devices  or  their
 8    components, parts, or accessories; and (2) all other articles
 9    intended  for  and  having  for their main use the diagnosis,
10    cure, mitigation, treatment or prevention of disease  in  man
11    or  other  animals, as approved by the United States Food and
12    Drug Administration, but does not include  devices  or  their
13    components,  parts,  or  accessories; and (3) articles (other
14    than food) having for their main use and intended  to  affect
15    the  structure  or  any  function of the body of man or other
16    animals; and (4) articles  having  for  their  main  use  and
17    intended  for use as a component or any articles specified in
18    clause (l), (2) or (3); but does not include devices or their
19    components, parts or accessories.
20        (c)  "Medicines" means and includes  all  drugs  intended
21    for  human  or  veterinary  use approved by the United States
22    Food and Drug Administration.
23        (d)  "Practice  of  pharmacy"  means  the  provision   of
24    pharmaceutical care to patients which may include, but is not
25    limited  to,  (1)  patient counseling, (2) interpretation and
26    assisting in the  monitoring  of  appropriate  drug  use  and
27    prospective    drug   utilization   review,   (3)   providing
28    information  on  the  therapeutic  values,  reactions,   drug
29    interactions,  side  effects,  uses, selection of medications
30    and  medical  devices,  and  outcome  of  drug  therapy,  (4)
31    participation  in  drug  selection,  drug  monitoring,   drug
32    utilization      review,      evaluation,     administration,
33    interpretation, and applying pharmacokinetic  and  laboratory
34    data  to  design  safe  and  effective drug regimens and drug
                            -3-                LRB9004158DPcc
 1    research (clinical and scientific)  when  applicable  in  the
 2    pharmacist's  professional  judgment, and (6) compounding and
 3    dispensing of drugs and medical devices.
 4        (e)  "Prescription" means and includes any written, oral,
 5    facsimile, or electronically transmitted order for  drugs  or
 6    medical  devices,  issued by a physician licensed to practice
 7    medicine in  all  its  branches,  dentist,  veterinarian,  or
 8    podiatrist,   containing  the  following:  (l)  name  of  the
 9    patient; (2) date when prescription was given; (3)  name  and
10    strength  of  drug  or  description  of  the  medical  device
11    prescribed;  and  (4)  quantity,  (5) directions for use, (6)
12    prescriber's name, address and signature, and (7) DEA  number
13    where  required, for controlled substances. DEA numbers shall
14    not be required on inpatient drug orders.
15        (f)  "Person"  means  and  includes  a  natural   person,
16    copartnership, association, or corporation.
17        (g)  "Department"  means  the  Department of Professional
18    Regulation.
19        (h)  "Board of Pharmacy" or "Board" means the State Board
20    of Pharmacy of the Department of Professional Regulation.
21        (i)  "Director"  means  the  Director   of   Professional
22    Regulation.
23        (j)  "Drug product selection" means the interchange for a
24    prescribed  pharmaceutical product in accordance with Section
25    25 of this Act and Section 3.14 of the  Illinois  Food,  Drug
26    and Cosmetic Act.
27        (k)  "Inpatient  drug  order" means an order issued by an
28    authorized prescriber for a resident or patient of a facility
29    licensed under the Nursing Home  Care  Act  or  the  Hospital
30    Licensing  Act,  or  "An  Act in relation to the founding and
31    operation of the University  of  Illinois  Hospital  and  the
32    conduct  of  University  of  Illinois  health care programs",
33    approved July 3, 1931, as amended, or  a  facility  which  is
34    operated by the Department of Mental Health and Developmental
                            -4-                LRB9004158DPcc
 1    Disabilities or the Department of Corrections.
 2        (l)  "Pharmacist in charge" means the licensed pharmacist
 3    whose  name  appears on a pharmacy license who is responsible
 4    for all aspects of the operation related to the  practice  of
 5    pharmacy.
 6        (m)  "Dispense"  means  the  preparation  for delivery of
 7    drugs and medical  devices,  in  accordance  with  applicable
 8    State and federal laws and regulations, to the patient or the
 9    patient's   representative   authorized   to   receive  these
10    products, including the compounding, packaging, and  labeling
11    necessary for delivery. "Dispense" does not mean the physical
12    act  of delivery of drugs and medical devices itself, whether
13    by cashier, delivery person, or another individual,  and  any
14    recommending   or   advising   concerning  the  contents  and
15    therapeutic values and uses thereof.
16        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
17    located in a state of the United States, other than Illinois,
18    that delivers, dispenses or distributes, through  the  United
19    States  Postal  Service  or other common carrier, to Illinois
20    residents, any substance which requires a prescription.
21        (o)  "Compounding"   means   the   preparation,   mixing,
22    assembling, packaging, or  labeling  of  a  drug  or  medical
23    device:  (1)  as  the result of a practitioner's prescription
24    drug order or initiative that  is  dispensed  pursuant  to  a
25    prescription  in  the course of professional practice; or (2)
26    for the purpose of, or incident to,  research,  teaching,  or
27    chemical   analysis   and   not  for  sale  or  dispensing  a
28    prescriber's order;  or  (3)  the  preparation  of  drugs  or
29    medical  devices  in anticipation of prescription drug orders
30    based on routine, regularly observed prescribing patterns.
31        (p)  "Confidential   information"   means    information,
32    maintained  by  the  pharmacist  in  the  patient's  records,
33    released  only (i) to the patient or, as the patient directs,
34    to other practitioners and other pharmacists or (ii)  to  any
                            -5-                LRB9004158DPcc
 1    other  person  or  governmental  agency  authorized by law to
 2    receive the information.
 3        (q)  "Prospective  drug  review"  or  "drug   utilization
 4    evaluation"  means  a  review  of the screening for potential
 5    drug  therapy  problems  due  to   therapeutic   duplication,
 6    drug-disease    contraindications,   drug-drug   interactions
 7    (including  serious  interactions  with  nonprescription   or
 8    over-the-counter drugs), incorrect drug dosage or duration of
 9    drug treatment, drug-allergy interactions, and clinical abuse
10    or misuse.
11        (r)  "Patient   counseling"   means   the   provision  of
12    drug-related  information  to  a  patient  or   a   patient's
13    caregiver  after acceptance of an offer to counsel. The offer
14    to  counsel  shall  be  made  by  the   pharmacist   or   the
15    pharmacist's  designee  in  a face-to-face communication with
16    the patient  or  the  patient's  caregiver,  unless,  in  the
17    professional   judgment  of  the  pharmacists  it  is  deemed
18    inappropriate or unnecessary. In such instances, it would  be
19    permissible  for the offer to counsel to be made in a written
20    communication, by telephone or in a manner determined by  the
21    pharmacist to be appropriate.
22        (s)  "Patient  profiles" or "patient drug therapy record"
23    means the obtaining, recording, and  maintenance  of  patient
24    information.
25        (t)  "Pharmaceutical  care"  includes, but is not limited
26    to, the act of monitoring drug use  and  other  patient  care
27    services  intended  to  achieve  outcomes  that  improve  the
28    patient's  quality  of life but shall not include the sale of
29    over-the-counter drugs by a seller of goods and services  who
30    does not dispense prescription drugs.
31        (u)  "Medical  device"  means  an  instrument, apparatus,
32    implement, machine, contrivance, implant, in  vitro  reagent,
33    or  other similar or related article, including any component
34    part or accessory, required under federal  law  to  bear  the
                            -6-                LRB9004158DPcc
 1    label  "Caution: Federal law requires dispensing by or on the
 2    order of a physician". A seller of goods  and  services  who,
 3    only  for  the  purpose  of  retail  sales, compounds, sells,
 4    rents, or  leases  medical  devices  shall  not,  by  reasons
 5    thereof, be required to be a licensed pharmacy.
 6    (Source: P.A. 89-202, eff. 7-21-95.)
 7        (Text of Section after amendment by P.A. 89-507)
 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, or shop, pharmacy department, or  other  place  where:
12    (l)  pharmaceutical  care is provided by a pharmacist; or (2)
13    drugs, medicines,  or  poisons  are  dispensed,  or  sold  or
14    offered for sale at retail,; or displayed for sale at retail;
15     or  (2)  (3)  where  prescriptions  of physicians, dentists,
16    veterinarians, or other persons authorized to prescribe drugs
17    within the limits of their licenses are  compounded,  filled,
18    or  dispensed;  or  (3)  (4)  which  has upon it or displayed
19    within it, or affixed to or used in  connection  with  it,  a
20    sign  bearing  the  word  or  words "Pharmacist", "Druggist",
21    "Pharmacy",  "Apothecary",  "Drugstore",  "Medicine   Store",
22    "Prescriptions",  "Drugs",  "Medicines", or any word or words
23    of similar or like import, either in the English language  or
24    any  other  language;  or  (4)  (5)  where the characteristic
25    prescription sign (Rx) or similar design is exhibited; or (5)
26    (6) any store, or shop, or other place with respect to  which
27    any of the above words, objects, signs or designs are used in
28    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
32    intended for and having for their  main  use  the  diagnosis,
33    cure,  mitigation,  treatment or prevention of disease in man
34    or other animals, as approved by the United States  Food  and
                            -7-                LRB9004158DPcc
 1    Drug  Administration,  but  does not include devices or their
 2    components, parts, or accessories; and (2) all other articles
 3    intended for and having for their  main  use  the  diagnosis,
 4    cure,  mitigation,  treatment or prevention of disease in man
 5    or other animals, as approved by the United States  Food  and
 6    Drug  Administration,  but  does not include devices or their
 7    components, parts, or accessories; and  (3)  articles  (other
 8    than  food)  having for their main use and intended to affect
 9    the structure or any function of the body  of  man  or  other
10    animals;  and  (4)  articles  having  for  their main use and
11    intended for use as a component or any articles specified  in
12    clause (l), (2) or (3); but does not include devices or their
13    components, parts or accessories.
14        (c)  "Medicines"  means  and  includes all drugs intended
15    for human or veterinary use approved  by  the  United  States
16    Food and Drug Administration.
17        (d)  "Practice   of  pharmacy"  means  the  provision  of
18    pharmaceutical care to patients which may include, but is not
19    limited to, (1) patient counseling,  (2)  interpretation  and
20    assisting  in  the  monitoring  of  appropriate  drug use and
21    prospective   drug   utilization   review,   (3)    providing
22    information   on  the  therapeutic  values,  reactions,  drug
23    interactions, side effects, uses,  selection  of  medications
24    and  medical  devices,  and  outcome  of  drug  therapy,  (4)
25    participation   in  drug  selection,  drug  monitoring,  drug
26    utilization     review,      evaluation,      administration,
27    interpretation,  and  applying pharmacokinetic and laboratory
28    data to design safe and  effective  drug  regimens  and  drug
29    research  (clinical  and  scientific)  when applicable in the
30    pharmacist's professional judgment, and (6)  compounding  and
31    dispensing of drugs and medical devices.
32        (e)  "Prescription" means and includes any written, oral,
33    facsimile,  or  electronically transmitted order for drugs or
34    medical devices, issued by a physician licensed  to  practice
                            -8-                LRB9004158DPcc
 1    medicine  in  all  its  branches,  dentist,  veterinarian, or
 2    podiatrist,  containing  the  following:  (l)  Name  of   the
 3    patient;  (2)  date when prescription was given; (3) name and
 4    strength  of  drug  or  description  of  the  medical  device
 5    prescribed; and (4) quantity, (5)  directions  for  use,  (6)
 6    prescriber's  name, address and signature, and (7) DEA number
 7    where required, for controlled substances. DEA numbers  shall
 8    not be required on inpatient drug orders.
 9        (f)  "Person"   means  and  includes  a  natural  person,
10    copartnership, association, or corporation.
11        (g)  "Department" means the  Department  of  Professional
12    Regulation.
13        (h)  "Board of Pharmacy" or "Board" means the State Board
14    of Pharmacy of the Department of Professional Regulation.
15        (i)  "Director"   means   the  Director  of  Professional
16    Regulation.
17        (j)  "Drug product selection" means the interchange for a
18    prescribed pharmaceutical product in accordance with  Section
19    25  of  this  Act and Section 3.14 of the Illinois Food, Drug
20    and Cosmetic Act.
21        (k)  "Inpatient drug order" means an order issued  by  an
22    authorized prescriber for a resident or patient of a facility
23    licensed  under  the  Nursing  Home  Care Act or the Hospital
24    Licensing Act, or "An Act in relation  to  the  founding  and
25    operation  of  the  University  of  Illinois Hospital and the
26    conduct of University  of  Illinois  health  care  programs",
27    approved  July  3,  1931,  as amended, or a facility which is
28    operated by the Department of Human Services (as successor to
29    the   Department   of   Mental   Health   and   Developmental
30    Disabilities) or the Department of Corrections.
31        (l)  "Pharmacist in charge" means the licensed pharmacist
32    whose name appears on a pharmacy license who  is  responsible
33    for  all  aspects of the operation related to the practice of
34    pharmacy.
                            -9-                LRB9004158DPcc
 1        (m)  "Dispense" means the  preparation  for  delivery  of
 2    drugs  and  medical  devices,  in  accordance with applicable
 3    State and federal laws and regulations, to the patient or the
 4    patient's  representative   authorized   to   receive   these
 5    products,  including the compounding, packaging, and labeling
 6    necessary for delivery. "Dispense" does not mean the physical
 7    act of delivery of drugs and medical devices itself,  whether
 8    by  cashier,  delivery person, or another individual, and any
 9    recommending  or  advising  concerning   the   contents   and
10    therapeutic values and uses thereof.
11        (n)  "Mail-order  pharmacy"  means  a  pharmacy  that  is
12    located in a state of the United States, other than Illinois,
13    that  delivers,  dispenses or distributes, through the United
14    States Postal Service or other common  carrier,  to  Illinois
15    residents, any substance which requires a prescription.
16        (o)  "Compounding"   means   the   preparation,   mixing,
17    assembling,  packaging,  or  labeling  of  a  drug or medical
18    device: (1) as the result of  a  practitioner's  prescription
19    drug  order  or  initiative  that  is dispensed pursuant to a
20    prescription in the course of professional practice;  or  (2)
21    for  the  purpose  of, or incident to, research, teaching, or
22    chemical  analysis  and  not  for  sale   or   dispensing   a
23    prescriber's  order;  or  (3)  the  preparation  of  drugs or
24    medical devices in anticipation of prescription  drug  orders
25    based on routine, regularly observed prescribing patterns.
26        (p)  "Confidential    information"   means   information,
27    maintained  by  the  pharmacist  in  the  patient's  records,
28    released only (i) to the patient or, as the patient  directs,
29    to  other  practitioners and other pharmacists or (ii) to any
30    other person or governmental  agency  authorized  by  law  to
31    receive the information.
32        (q)  "Prospective   drug  review"  or  "drug  utilization
33    evaluation" means a review of  the  screening  for  potential
34    drug   therapy   problems  due  to  therapeutic  duplication,
                            -10-               LRB9004158DPcc
 1    drug-disease   contraindications,   drug-drug    interactions
 2    (including   serious  interactions  with  nonprescription  or
 3    over-the-counter drugs), incorrect drug dosage or duration of
 4    drug treatment, drug-allergy interactions, and clinical abuse
 5    or misuse.
 6        (r)  "Patient  counseling"   means   the   provision   of
 7    drug-related   information   to  a  patient  or  a  patient's
 8    caregiver after acceptance of an offer to counsel. The  offer
 9    to   counsel   shall   be  made  by  the  pharmacist  or  the
10    pharmacist's designee in a  face-to-face  communication  with
11    the  patient  or  the  patient's  caregiver,  unless,  in the
12    professional  judgment  of  the  pharmacists  it  is   deemed
13    inappropriate  or unnecessary. In such instances, it would be
14    permissible for the offer to counsel to be made in a  written
15    communication,  by telephone or in a manner determined by the
16    pharmacist to be appropriate.
17        (s)  "Patient profiles" or "patient drug therapy  record"
18    means  the  obtaining,  recording, and maintenance of patient
19    information.
20        (t)  "Pharmaceutical care" includes, but is  not  limited
21    to,  the  act  of  monitoring drug use and other patient care
22    services  intended  to  achieve  outcomes  that  improve  the
23    patient's quality of life but shall not include the  sale  of
24    over-the-counter  drugs by a seller of goods and services who
25    does not dispense prescription drugs.
26        (u)  "Medical device"  means  an  instrument,  apparatus,
27    implement,  machine,  contrivance, implant, in vitro reagent,
28    or other similar or related article, including any  component
29    part  or  accessory,  required  under federal law to bear the
30    label "Caution: Federal law requires dispensing by or on  the
31    order  of  a  physician". A seller of goods and services who,
32    only for the  purpose  of  retail  sales,  compounds,  sells,
33    rents,  or  leases  medical  devices  shall  not,  by reasons
34    thereof, be required to be a licensed pharmacy.
                            -11-               LRB9004158DPcc
 1    (Source: P.A. 89-202, eff. 7-21-95; 89-507, eff. 7-1-97.)
 2        (225 ILCS 85/10) (from Ch. 111, par. 4130)
 3        Sec. 10.  There is created in the  Department  the  State
 4    Board  of  Pharmacy. It shall consist of 9 members, 7 of whom
 5    shall be licensed pharmacists. Each of those 7  members  must
 6    be  a  licensed  pharmacist in good standing in this State, a
 7    graduate of an accredited  college  of  pharmacy  or  hold  a
 8    Bachelor  of  Science  degree in Pharmacy and have at least 5
 9    years' practical  experience  in  the  practice  of  pharmacy
10    subsequent  to  the  date  of  his  licensure  as  a licensed
11    pharmacist in the State of Illinois. There shall be 2  public
12    members,  who  shall  be  voting  members,  who  shall not be
13    licensed pharmacists in this State or any other state.
14        Each member shall be appointed by the Governor.
15        The terms of Board members serving as of  April  1,  1999
16    shall  expire  on  that  date.  The  Governor shall appoint 4
17    persons to serve a term of 3 years and 5 persons to  serve  a
18    term   of  5  years,  each  term  beginning  April  1,  1999.
19    Thereafter, members shall  be  appointed  to  5-year  5  year
20    terms.   No  member  shall be eligible to serve for or during
21    more  than  2  successive  terms.  Members  serving  on   the
22    effective  date of this Act shall complete their current term
23    and be eligible to serve one additional term.
24        In making the appointment of members on  the  Board,  the
25    Governor  shall  give due consideration to recommendations by
26    the  members  of  the   profession   of   pharmacy   and   by
27    pharmaceutical  organizations  therein.   The  Governor shall
28    notify  the  pharmaceutical  organizations  promptly  of  any
29    vacancy of members on the Board  and  in  appointing  members
30    shall  give consideration to individuals engaged in all types
31    and settings of pharmacy practice.
32        The Governor may remove  any  member  of  the  Board  for
33    misconduct, incapacity or neglect of duty and he shall be the
                            -12-               LRB9004158DPcc
 1    sole judge of the sufficiency of the cause for removal.
 2        Every  person  appointed a member of the Board shall take
 3    and subscribe the constitutional oath of office and  file  it
 4    with  the Secretary of State.  Each member of the Board shall
 5    be reimbursed for such actual and legitimate expenses  as  he
 6    may  incur  in  going  to  and  from the place of meeting and
 7    remaining thereat during sessions of the Board.  In addition,
 8    each member of the Board shall receive a per diem payment  in
 9    an  amount  determined  from time to time by the Director for
10    attendance at meetings of  the  Board  and  conducting  other
11    official business of the Board.
12        The  Board  shall  hold  quarterly meetings and an annual
13    meeting in January of each year and such  other  meetings  at
14    such  times  and places and upon such notice as the Board may
15    determine and as its business may require.  Five  members  of
16    the  Board  shall  constitute a quorum for the transaction of
17    business. The Director shall appoint a pharmacy  coordinator,
18    who  shall  be someone other than a member of the Board.  The
19    pharmacy coordinator shall be a registered pharmacist in good
20    standing in this State, shall be a graduate of an  accredited
21    college  of  pharmacy,  or  hold  at  a minimum a Bachelor of
22    Science degree in Pharmacy and shall have at least  5  years'
23    experience  in  the practice of pharmacy immediately prior to
24    his  appointment.  The  pharmacy  coordinator  shall  be  the
25    executive administrator and the chief enforcement officer  of
26    the "Pharmacy Practice Act".
27        The  Board  shall  exercise the rights, powers and duties
28    which have been vested in the Board under this Act,  and  any
29    other duties conferred upon the Board by law.
30        The  Director  shall,  in  conformity  with the Personnel
31    Code, employ not less than 7  pharmacy  investigators  and  2
32    pharmacy  supervisors.   Each  pharmacy investigator and each
33    supervisor shall be a registered pharmacist in good  standing
34    in  this  State,  and  shall  be  a graduate of an accredited
                            -13-               LRB9004158DPcc
 1    college of pharmacy and have at least 5 years  of  experience
 2    in the practice of pharmacy. The Department shall also employ
 3    one  pharmacist  who  is  an attorney. The Department may, in
 4    conformity with the Personnel Code, employ such clerical  and
 5    other  employees  as are necessary to carry out the duties of
 6    the Board.
 7        The  duly  authorized  pharmacy  investigators   of   the
 8    Department  shall  have the right to enter and inspect during
 9    business hours any pharmacy or any other place in  the  State
10    of  Illinois  holding  itself  out  to  be  a  pharmacy where
11    medicines or drugs or drug products or proprietary  medicines
12    are  sold,  offered  for  sale, exposed for sale, or kept for
13    sale. The pharmacy investigators shall be the only Department
14    investigators authorized to inspect, investigate, and monitor
15    probation compliance of pharmacists and pharmacies.
16        The Board shall render annually to the Director a  report
17    of their proceedings during the preceding year, together with
18    such other information and recommendations as the Board deems
19    proper.
20    (Source: P.A. 87-1237; 88-428.)
21        (225 ILCS 85/14) (from Ch. 111, par. 4134)
22        Sec.  14.  New  location;  verified  statement. No person
23    shall establish or move to a new location any pharmacy unless
24    the pharmacy is licensed with the Department and has on  file
25    with the Department a verified statement that:
26             (1)  1.  such  pharmacy is or will be engaged in the
27        practice of pharmacy; and
28             (2) 2.  such pharmacy will have in stock  and  shall
29        maintain sufficient drugs and materials as to protect the
30        public   within   30  days  after  the  issuance  of  the
31        registration of the pharmacy.
32        Every pharmacy shall be in a suitable,  well-lighted  and
33    well-ventilated  area  with at least 300 square feet of clean
                            -14-               LRB9004158DPcc
 1    and sanitary contiguous space and shall be suitably  equipped
 2    for  compounding  prescriptions, storage of drugs and sale of
 3    drugs and to otherwise conduct the practice of pharmacy.  The
 4    space occupied shall be equipped with a  sink  with  hot  and
 5    cold  water  or  facilities  for heating water, proper sewage
 6    outlet, refrigeration storage equipment, and  such  fixtures,
 7    facilities,   drugs,  equipment  and  material,  which  shall
 8    include  the  current   editions   of   the   United   States
 9    Pharmacopoeia/DI, Facts and Comparisons, or any other current
10    compendium   approved  by  the  Department,  and  other  such
11    reference works, as will  enable  a  pharmacist  to  practice
12    pharmacy,  including this Act and the rules promulgated under
13    this Act.  Such pharmacy shall have the following items:  (i)
14    accurate  weights  of  0.5  gr. to 4 oz. and 20 mg to 100 Gm,
15    (ii); and a prescription  balance  equipped  with  a  balance
16    indicator   and   with  mechanical  means  of  arresting  the
17    oscillations of the mechanism  and  which  balance  shall  be
18    sensitive  to  0.5  grain  (32 mg) or less, or an alternative
19    weighing device approved by the Department,  and  (iii)  such
20    other  measuring  devices as may be necessary for the conduct
21    of the practice of pharmacy.
22        The provisions of this Section with regard to 300  square
23    feet  of  space  shall  apply to any pharmacy which is opened
24    after the effective date of this Act.  Nothing shall  require
25    a  pharmacy  in  existence  on the effective date of this Act
26    which is comprised of less than 300 square  feet  to  provide
27    additional space to meet these requirements.
28    (Source: P.A. 87-1237; 88-428.)
29        (225 ILCS 85/18) (from Ch. 111, par. 4138)
30        Sec.  18.  Record retention. There shall be kept in every
31    drugstore or pharmacy a suitable book,  file,  or  electronic
32    record  keeping  system  in  which  shall  be preserved for a
33    period of not less than 5 years the original of every written
                            -15-               LRB9004158DPcc
 1    prescription and the original transcript  or  copy  of  every
 2    verbal prescription filled, compounded, or dispensed, in such
 3    pharmacy; and such book or file of prescriptions shall at all
 4    reasonable  times  be  open  to  inspection  to  the pharmacy
 5    coordinator and the duly authorized agents  or  employees  of
 6    the Department.
 7        Records  kept  pursuant to this Section may be maintained
 8    in an alternative data  retention system, such  as  a  direct
 9    digital imaging system, provided that:
10             (1)  the  records maintained in the alternative data
11        retention system contain all of the information  required
12        in a manual record;
13             (2)  the   data  processing  system  is  capable  of
14        producing a hard copy of the  electronic  record  on  the
15        request  of  the  Board,  its  representative,  or  other
16        authorized  local,  State,  or federal law enforcement or
17        regulatory agency; and
18             (3)  the digital images are recorded and  stored  by
19        means  of  a  technology  that  does not allow subsequent
20        revision or replacement of the images.
21        As used in this Section, "digital imaging system" means a
22    system, including people, machines, methods of  organization,
23    and  procedures,  that  provides  input, storage, processing,
24    communications, output, and control functions  for  digitized
25    representations of original prescription records.
26        Inpatient   drug  orders  may  be  maintained  within  an
27    institution in a manner approved by the Department.
28    (Source: P.A. 85-796.)
29        (225 ILCS 85/22) (from Ch. 111, par. 4142)
30        Sec. 22. Labeling requirements. Except only in  the  case
31    of  a  drug,  medicine  or  poison  which is lawfully sold or
32    dispensed, at retail, in the original and unbroken package of
33    the manufacturer, packer, or distributor thereof,  and  which
                            -16-               LRB9004158DPcc
 1    package bears the original label thereon showing the name and
 2    address  of the manufacturer, packer, or distributor thereof,
 3    and the  name  of  the  drug,  medicine,  or  poison  therein
 4    contained,  and  the  directions for its use, no person shall
 5    sell or dispense, at retail, any drug, medicine,  or  poison,
 6    without  affixing  to  the  box,  bottle,  vessel, or package
 7    containing the same, a label bearing the name of the  article
 8    distinctly  shown,  and  the directions for its use, with the
 9    name and address of the pharmacy wherein the same is sold  or
10    dispensed. However, in the case of a drug, medicine or poison
11    which  is  sold  or dispensed pursuant to a prescription of a
12    licensed physician, licensed dentist, licensed  veterinarian,
13    licensed  podiatrist  authorized  by  law to prescribe drugs,
14    medicines or poisons, or other licensed medical practitioner,
15    unless the sale or dispensing occurs  in  a  Division  II  or
16    Division  III pharmacy, the label affixed to the box, bottle,
17    vessel, or package containing the same shall  show:  (a)  The
18    name  and address of the pharmacy wherein the same is sold or
19    dispensed; (b) The name or initials of the person, authorized
20    to practice  pharmacy  under  the  provisions  of  this  Act,
21    selling  or  dispensing  the same, (c) the date on which such
22    prescription was filled; (d) the name of the patient; (e) the
23    serial  number  of  such  prescription  as   filed   in   the
24    prescription  files;   (f)  the last name of the practitioner
25    who prescribed such prescriptions; (g) the directions for use
26    thereof as  contained  in  such  prescription;  and  (h)  the
27    proprietary name or names or the established name or names of
28    the  drugs,  the  dosage  and  quantity,  except as otherwise
29    authorized by regulation of the Department.  Any  person  who
30    sells or dispenses any drug, medicine or poison shall sell or
31    dispense  such drug, medicine or poison in good faith.  "Good
32    faith",  for  purposes  of  this  Section,  has  the  meaning
33    ascribed to it in  subsection  (u)  of  Section  102  of  the
34    "Illinois  Controlled  Substances  Act",  approved August 16,
                            -17-               LRB9004158DPcc
 1    1971,  as  amended.  The  Department  shall  establish  rules
 2    governing  labelling  in  a  Division  II  and  Division  III
 3    pharmacy.
 4    (Source: P.A. 85-796.)
 5        (225 ILCS 85/22a new)
 6        Sec. 22a. Automated dispensing and storage  systems.  The
 7    Department   shall  establish  rules  governing  the  use  of
 8    automated dispensing and storage systems.
 9        Section 95.  No acceleration or delay.   Where  this  Act
10    makes changes in a statute that is represented in this Act by
11    text  that  is not yet or no longer in effect (for example, a
12    Section represented by multiple versions), the  use  of  that
13    text  does  not  accelerate or delay the taking effect of (i)
14    the changes made by this Act or (ii) provisions derived  from
15    any other Public Act.
16        Section  99.  Effective  date. This Act takes effect upon
17    becoming law.

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