94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
HB0647


 
Introduced 1/28/2005, by Rep. Jack D. Franks
 
SYNOPSIS AS INTRODUCED:
 		













225 ILCS 85/3
  from Ch. 111, par. 4123




225 ILCS 85/16a
  from Ch. 111, par. 4136a




225 ILCS 85/16b new





225 ILCS 85/35.1
  from Ch. 111, par. 4155.1









    Amends the Pharmacy Practice Act of 1987. Provides for the registration of
foreign mail-order pharmacies as nonresident pharmacies if specified
disclosures and
certifications are provided and the pharmacies are located in a foreign
country, state or
province whose pharmacy laws and regulations have been determined by the
Department
of Financial and Professional Regulation to be substantially similar to those of the State of
Illinois and
whose regulatory scheme for approval and quality contro of prescription drugs
has been
found by the Department to be substantially equivalent tol that of the State of
Illinois and
the federal government. Effective immediately.
















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FISCAL NOTE ACT MAY APPLY
















 


 


A BILL FOR









 











HB0647

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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 by 
5
changing
Sections 3, 16a, and 35.1 and adding Section 16b as 
6
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    (Section scheduled to be repealed on January 1, 2008)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 for 
15
sale at retail, or displayed for sale at retail; or
(2)
where

16
prescriptions of physicians, dentists, veterinarians, 
17
podiatrists, or
therapeutically certified optometrists, within 
18
the limits of their
licenses, are
compounded, filled, or 
19
dispensed; or (3) which has upon it or
displayed within
it, or 
20
affixed to or used in connection with it, a sign bearing the 
21
word or
words "Pharmacist", "Druggist", "Pharmacy", 
22
"Pharmaceutical
Care", "Apothecary", "Drugstore",
"Medicine 
23
Store", "Prescriptions", "Drugs", "Medicines", or any word
or 
24
words of similar or like import, either in the English language

25
or any other language; or (4) where the characteristic 
26
prescription
sign (Rx) or similar design is exhibited; or (5) 
27
any store, or
shop,
or other place with respect to which any of 
28
the above words, objects,
signs or designs are used in any 
29
advertisement.


30
    (b) "Drugs" means and includes (l) articles recognized
in 
31
the official United States Pharmacopoeia/National Formulary 
32
(USP/NF),
or any supplement thereto and being intended for and 
 


 






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1
having for their
main use the diagnosis, cure, mitigation, 
2
treatment or prevention of
disease in man or other animals, as 
3
approved by the United States Food and
Drug Administration, but 
4
does not include devices or their components, parts,
or 
5
accessories; and (2) all other articles intended
for and having 
6
for their main use the diagnosis, cure, mitigation,
treatment 
7
or prevention of disease in man or other animals, as approved

8
by the United States Food and Drug Administration, but does not 
9
include
devices or their components, parts, or accessories; and 
10
(3) articles
(other than food) having for their main use and 
11
intended
to affect the structure or any function of the body of 
12
man or other
animals; and (4) articles having for their main 
13
use and intended
for use as a component or any articles 
14
specified in clause (l), (2)
or (3); but does not include 
15
devices or their components, parts or
accessories.


16
    (c) "Medicines" means and includes all drugs intended for

17
human or veterinary use approved by the United States Food and 
18
Drug
Administration.


19
    (d) "Practice of pharmacy" means the provision of 
20
pharmaceutical care to
patients as determined by the 
21
pharmacist's professional judgment in the
following areas,

22
which may include but are not limited to (1) patient

23
counseling, (2)
interpretation and assisting in the monitoring 
24
of appropriate drug use and
prospective drug utilization 
25
review, (3) providing information on the
therapeutic values, 
26
reactions, drug interactions, side effects, uses, selection
of 
27
medications and medical devices, and outcome of drug therapy, 
28
(4)
participation in drug selection, drug monitoring, drug 
29
utilization review,
evaluation, administration, 
30
interpretation, application of
pharmacokinetic and
laboratory 
31
data to design safe and effective drug
regimens, (5) drug 
32
research
(clinical and scientific), and (6) compounding and 
33
dispensing of drugs and medical
devices.


34
    (e) "Prescription" means and includes any written, oral, 
35
facsimile, or
electronically transmitted order for drugs
or 
36
medical devices, issued by a physician licensed to practice 
 


 






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1
medicine in
all its branches, dentist, veterinarian, or 
2
podiatrist,  or therapeutically
certified
optometrist, within 
3
the
limits of their licenses, by a physician assistant in 
4
accordance with
subsection (f) of Section 4, or by an advanced 
5
practice nurse in
accordance with subsection (g) of Section 4, 
6
containing the
following: (l) name
of the patient; (2) date 
7
when prescription was issued; (3) name
and strength of drug or 
8
description of the medical device prescribed;
and (4) quantity, 
9
(5) directions for use, (6) prescriber's name,
address
and 
10
signature, and (7) DEA number where required, for controlled

11
substances.
DEA numbers shall not be required on inpatient drug 
12
orders.


13
    (f) "Person" means and includes a natural person, 
14
copartnership,
association, corporation, government entity, or 
15
any other legal
entity.


16
    (g) "Department" means the Department of Professional 
17
Regulation.


18
    (h) "Board of Pharmacy" or "Board" means the State Board
of 
19
Pharmacy of the Department of Professional Regulation.


20
    (i) "Director" means the Director of Professional 
21
Regulation.


22
    (j) "Drug product selection" means the interchange for a

23
prescribed pharmaceutical product in accordance with Section 
24
25 of
this Act and Section 3.14 of the Illinois Food, Drug and 
25
Cosmetic Act.


26
    (k) "Inpatient drug order" means an order issued by an 
27
authorized
prescriber for a resident or patient of a facility 
28
licensed under the
Nursing Home Care Act or the Hospital 
29
Licensing Act, or "An Act in relation to
the founding and 
30
operation of the University of Illinois Hospital and the

31
conduct of University of Illinois health care programs", 
32
approved July 3, 1931,
as amended, or a facility which is 
33
operated by the Department of Human
Services (as successor to 
34
the Department of Mental Health
and Developmental 
35
Disabilities) or the Department of Corrections.


36
    (k-5) "Pharmacist" means an individual health care 
 


 






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1
professional and
provider currently licensed by this State to 
2
engage in the practice of
pharmacy.


3
    (l) "Pharmacist in charge" means the licensed pharmacist 
4
whose name appears
on a pharmacy license and who is responsible 
5
for all aspects of the
operation related to the practice of 
6
pharmacy.


7
    (m) "Dispense" means the delivery of drugs and medical 
8
devices, in
accordance with applicable State and federal laws 
9
and regulations, to the
patient or the patient's representative 
10
authorized to receive these products,
including the 
11
compounding, packaging, and labeling necessary for delivery, 
12
and
any recommending or advising concerning the contents and 
13
therapeutic values and
uses thereof.  "Dispense" does not mean 
14
the physical delivery to a patient or a
patient's 
15
representative in a home or institution by a designee of a 
16
pharmacist
or by common carrier.  "Dispense" also does not mean 
17
the physical delivery
of a drug or medical device to a patient 
18
or patient's representative by a
pharmacist's designee within a 
19
pharmacy or drugstore while the pharmacist is
on duty and the 
20
pharmacy is open.


21
    (n) "Domestic mail-order pharmacy" means a pharmacy that is 
22
located in a
state
of the United States, other than Illinois, 
23
that delivers, dispenses or
distributes, through the United 
24
States Postal Service or other common
carrier, to Illinois 
25
residents, any substance which requires a prescription.


26
    (n-5) "Foreign mail-order pharmacy" means a pharmacy that 
27
is located in a
country other than the United States that 
28
delivers, dispenses, or distributes,
through the
United States 
29
Postal Service or other common carrier, to Illinois residents 
30
any
substance
that requires a prescription.


31
    (o) "Compounding" means the preparation, mixing, 
32
assembling,
packaging, or labeling of a drug or medical device: 
33
(1) as the result of a
practitioner's prescription drug order 
34
or initiative that is dispensed pursuant
to a prescription in 
35
the course of professional practice; or (2) for the
purpose of, 
36
or incident to, research, teaching, or chemical analysis; or 
 


 






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1
(3) in
anticipation of prescription drug orders
based on 
2
routine, regularly observed prescribing patterns.


3
    (p) "Confidential information" means information,

4
maintained by the
pharmacist in the patient's records, released 
5
only (i) to the patient or,
as the patient directs, to other 
6
practitioners and other pharmacists or (ii)
to any other person 
7
authorized by law to receive the
information.


8
    (q) "Prospective drug review" or "drug utilization 
9
evaluation" means a
screening for potential drug therapy 
10
problems due to
therapeutic duplication, drug-disease 
11
contraindications, drug-drug
interactions (including serious 
12
interactions with nonprescription or
over-the-counter drugs), 
13
drug-food interactions, incorrect drug dosage
or duration of 
14
drug
treatment, drug-allergy interactions, and clinical abuse 
15
or misuse.


16
    (r) "Patient counseling" means the communication between a 
17
pharmacist or
a student pharmacist under the direct supervision 
18
of a pharmacist and a
patient or the patient's representative 
19
about the patient's medication or
device for the purpose of 
20
optimizing proper use of prescription medications
or devices.  
21
The offer to counsel by the pharmacist or the pharmacist's

22
designee, and subsequent patient counseling by the pharmacist 
23
or student
pharmacist, shall be made in a face-to-face 
24
communication with the patient
or patient's representative 
25
unless, in the professional judgment of the
pharmacist, a 
26
face-to-face communication is deemed inappropriate or

27
unnecessary.  In that instance, the offer to counsel or patient 
28
counseling may
be made in a written communication, by 
29
telephone, or in a manner determined by
the pharmacist to be 
30
appropriate.


31
    (s) "Patient profiles" or "patient drug therapy record" 
32
means the
obtaining, recording, and maintenance of patient 
33
prescription
information, including prescriptions for 
34
controlled substances, and
personal information.


35
    (t) "Pharmaceutical care" includes, but is not limited to, 
36
the act of
monitoring drug use and other patient care services 
 


 






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1
intended to achieve
outcomes that improve the patient's quality 
2
of life but shall not include
the sale of over-the-counter 
3
drugs by a seller of goods and services who
does not dispense 
4
prescription drugs.


5
    (u) "Medical device" means an instrument, apparatus, 
6
implement, machine,
contrivance, implant, in vitro reagent, or 
7
other similar or related article,
including any component part 
8
or accessory, required under federal law to
bear the label 
9
"Caution: Federal law requires dispensing by or on the order
of 
10
a physician". A seller of goods and services who, only for the 
11
purpose of
retail sales, compounds, sells, rents, or leases 
12
medical devices shall not,
by reasons thereof, be required to 
13
be a licensed pharmacy.


14
    (v) "Unique identifier" means an electronic signature, 
15
handwritten
signature or initials, thumb print, or other 
16
acceptable individual biometric
or electronic identification 
17
process as approved by the Department.


18
(Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03.)

 
19
    (225 ILCS 85/16a)  (from Ch. 111, par. 4136a)

20
    (Section scheduled to be repealed on January 1, 2008)


21
    Sec. 16a. (a) The Department shall establish rules and 
22
regulations,
consistent with the provisions of this Act, 
23
governing domestic mail-order
pharmacies,
including pharmacies 
24
providing services via the Internet,
which sell, or offer for 
25
sale, drugs, medicines, or other pharmaceutical
services in 
26
this State.


27
    (b) The Board shall require and provide for an annual 
28
nonresident
special pharmacy registration for all pharmacies 
29
located outside of this
State that dispense medications for 
30
Illinois residents and mail, ship, or
deliver prescription 
31
medications into this State. Nonresident special
pharmacy 
32
registration shall be granted by the Board upon the disclosure 
33
and
certification by a pharmacy:


34
        (1) that it is licensed in the state in which the 
35
    dispensing facility
is located and from which the drugs are 
 


 






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1
    dispensed;


2
        (2) of the location, names, and titles of all principal 
3
    corporate
officers and all pharmacists who are dispensing 
4
    drugs to residents of this
State;


5
        (3) that it complies with all lawful directions and 
6
    requests for
information from the board of pharmacy of each 
7
    state in which it is
licensed or registered, except that it 
8
    shall respond directly to all
communications from the Board 
9
    concerning emergency circumstances arising
from the 
10
    dispensing of drugs to residents of this State;


11
        (4) that it maintains its records of drugs dispensed to 
12
    residents of
this State so that the records are readily 
13
    retrievable from the records of
other drugs dispensed;


14
        (5) that it cooperates with the Board in providing 
15
    information to the
board of pharmacy of the state in which 
16
    it is licensed concerning matters
related to the dispensing 
17
    of drugs to residents of this State; and


18
        (6) that during its regular hours of operation, but not 
19
    less than 6
days per week, for a minimum of 40 hours per 
20
    week, a toll-free telephone
service is provided to 
21
    facilitate communication between patients in this
State 
22
    and a pharmacist at the pharmacy who has access to the 
23
    patients'
records. The toll-free number must be disclosed 
24
    on the label affixed to
each container of drugs dispensed 
25
    to residents of this State.


26
    (c) The provisions of this Section do not apply to 
27
pharmacies for which
registration is provided under Section 
28
16b.


29
(Source: P.A. 91-438, eff. 1-1-00.)

 
30
    (225 ILCS 85/16b new)

31
    Sec. 16b. Foreign mail-order pharmacy.

32
    (a) Notwithstanding any other Section of this Act, the 
33
Department shall
provide
for the registration of foreign 
34
mail-order pharmacies as nonresident
pharmacies, upon the

35
disclosure and certification by a foreign mail-order pharmacy 
 


 






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1
of the following:

2
        (1) That it is licensed in the country, state, or 
3
    province in which the
dispensing facility is located and 
4
    from which the drugs are dispensed.

5
        (2) The location, names, and titles of all principal 
6
    corporate officers
and
all pharmacists who are dispensing 
7
    drugs to residents of this State.

8
        (3) That it complies with all lawful directions and 
9
    requests for information
from the board of pharmacy of each 
10
    country, state, or province in which it is
licensed or 
11
    registered, except that it shall respond directly to all 
12
    communications
from the Board concerning emergency 
13
    circumstances arising from the dispensing
of drugs to 
14
    residents of this State.

15
        (4) That it maintains its records of drugs dispensed to 
16
    residents of this
State so that the records are readily 
17
    retrievable from the records of other drugs
dispensed.

18
        (5) That it cooperates with the Board of Pharmacy in 
19
    providing
information to the board of pharmacy of the 
20
    country, state, or province in which it
is licensed 
21
    concerning matters related to the dispensing of drugs to 
22
    residents of
this State.

23
        (6) That during its regular hours of operation, but not 
24
    less than 6 days per
week, for a minimum of 40 hours per 
25
    week, a toll-free telephone service is
provided to 
26
    facilitate communication between patients in this State 
27
    and a
pharmacist at the pharmacy who has access to the 
28
    patients' records. The toll-free
number must be disclosed 
29
    on the label affixed to each container of drugs
dispensed 
30
    to residents of this State.

31
        (7) That it consents to the jurisdiction of the 
32
    Department over pharmacy
practices affecting the State of 
33
    Illinois.

34
    (b) Only a pharmacy located within a foreign country, 
35
state, or province
whose pharmacy laws and regulations have 
36
been determined by the Department to
be
substantially similar 
 


 






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1
to those of the State of Illinois and whose regulatory
scheme 
2
for
approval and quality control of prescription drugs has been 
3
found by the
Department to
be substantially equivalent to that 
4
of the State of Illinois and the federal
government may
be 
5
registered as a nonresident pharmacy.

6
    (c) The Department's criteria for determining substantial 
7
equivalence shall
be
set
by rule.

8
    (d) The Department shall maintain a list of all foreign 
9
countries, states, and
provinces that have been evaluated on 
10
its website with a designation of
"approved" or
"denied". Any 
11
pharmacy located within a foreign country, state, or province

12
that has not
been evaluated by the Department may request that 
13
the Department conduct an
evaluation.


 
14
    (225 ILCS 85/35.1)  (from Ch. 111, par. 4155.1)

15
    (Section scheduled to be repealed on January 1, 2008)


16
    Sec. 35.1. (a) If any person violates the provision of this 
17
Act,
the
Director may, in the name of the People of the State 
18
of Illinois, through the
Attorney General of the State of 
19
Illinois, or the State's Attorney
of any county in which the 
20
action is brought, petition, for an order
enjoining such 
21
violation or for an order enforcing compliance with
this Act.  
22
Upon the filing of a verified petition in such court, the
court 
23
may issue a temporary restraining order, without notice or 
24
bond,
and may preliminarily and permanently enjoin such 
25
violation, and if
it is established that such person has 
26
violated or is violating the
injunction, the Court may punish 
27
the offender for contempt of court.
 Proceedings under this 
28
Section shall be in addition to, and not in
lieu of, all other 
29
remedies and penalties provided by this Act.


30
    (b) If any person shall practice as a pharmacist or hold 
31
himself
out
as a pharmacist or operate a pharmacy or drugstore, 
32
including a domestic
mail-order
pharmacy under Section 16a or a 
33
foreign mail-order pharmacy under Section
16b, without being 
34
licensed under the provisions of
this
Act, then any licensed 
35
pharmacist, any interested party or any person
injured thereby 
 


 






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1
may, in addition to the Director, petition for relief
as 
2
provided in subsection (a) of this Section.


3
    Whoever knowingly practices or offers to practice in this 
4
State without
being appropriately licensed or registered under 
5
this Act shall be guilty
of a Class A misdemeanor and for each 
6
subsequent conviction, shall
be guilty of a Class 4 felony.


7
    (c) Whenever in the opinion of the Department any person 
8
not
licensed
in good standing under this Act violates any 
9
provision of this Act,
the Department may issue a rule to show 
10
cause why an order to cease
and desist should not be entered 
11
against him.  The rule shall clearly
set forth the grounds 
12
relied upon by the Department and shall provide
a period of 7 
13
days from the date of the rule to file an answer to the

14
satisfaction of the Department.  Failure to answer to the 
15
satisfaction
of the Department shall cause an order to cease 
16
and desist to be issued
forthwith.


17
(Source: P.A. 92-678, eff. 7-16-02.)


 
18
    Section 99. Effective date.   This Act takes effect upon 
19
becoming law.