96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010
HB5890


 
Introduced 2/10/2010, by Rep. Sandra M. Pihos
 
SYNOPSIS AS INTRODUCED:
 		





 








225 ILCS 85/3










     Amends the Pharmacy Practice Act. In the  definition of "prescription", provides that an order may contain, at the discretion of the individual issuing the order, information on the indicated use of the drug or device as approved by the United States Food and Drug Administration (FDA). Effective immediately.
  















LRB096 18739 ASK 34124 b

















 


 


A BILL FOR









 




  






HB5890

LRB096 18739 ASK 34124 b





  
1
    AN ACT concerning 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 is amended  by changing 
5
Section 3 as follows:
 
 

6
    (225 ILCS 85/3)

 
7
    (Text of Section before amendment by P.A. 96-339)
8
    (Section scheduled to be repealed on January 1, 2018)

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
pharmacist
 care is
provided
by a pharmacist (1) where drugs, 
14
medicines, or poisons are
dispensed, sold or
offered for sale 
15
at retail, or displayed for sale at retail; or
(2)
where

16
prescriptions of physicians, dentists, advanced practice 
17
nurses, physician assistants, veterinarians, podiatrists, or
 
18
optometrists, within the limits of their
licenses, are

19
compounded, filled, or dispensed; or (3) which has upon it or

20
displayed within
it, or affixed to or used in connection with 
21
it, a sign bearing the word or
words "Pharmacist", "Druggist", 
22
"Pharmacy", "Pharmaceutical
Care", "Apothecary", "Drugstore",

23
"Medicine Store", "Prescriptions", "Drugs", "Dispensary", 
 


 






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1
"Medicines", or any word
or words of similar or like import, 
2
either in the English language
or any other language; or (4) 
3
where the characteristic prescription
sign (Rx) or similar 
4
design is exhibited; or (5) any store, or
shop,
or other place 
5
with respect to which any of the above words, objects,
signs or 
6
designs are used in any advertisement.

7
    (b) "Drugs" means and includes (l) articles recognized
in 
8
the official United States Pharmacopoeia/National Formulary 
9
(USP/NF),
or any supplement thereto and being intended for and 
10
having for their
main use the diagnosis, cure, mitigation, 
11
treatment or prevention of
disease in man or other animals, as 
12
approved by the United States Food and
Drug Administration, but 
13
does not include devices or their components, parts,
or 
14
accessories; and (2) all other articles intended
for and having 
15
for their main use the diagnosis, cure, mitigation,
treatment 
16
or prevention of disease in man or other animals, as approved

17
by the United States Food and Drug Administration, but does not 
18
include
devices or their components, parts, or accessories; and 
19
(3) articles
(other than food) having for their main use and 
20
intended
to affect the structure or any function of the body of 
21
man or other
animals; and (4) articles having for their main 
22
use and intended
for use as a component or any articles 
23
specified in clause (l), (2)
or (3); but does not include 
24
devices or their components, parts or
accessories.

25
    (c) "Medicines" means and includes all drugs intended for

26
human or veterinary use approved by the United States Food and 
 


 






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1
Drug
Administration.

2
    (d) "Practice of pharmacy" means (1) the interpretation and 
3
the provision of assistance in the monitoring, evaluation, and 
4
implementation of prescription drug orders; (2) the dispensing 
5
of prescription drug orders; (3) participation in drug and 
6
device selection; (4) drug administration limited to the 
7
administration of oral, topical, injectable, and inhalation as 
8
follows:  in the context of patient education on the proper use 
9
or delivery of medications; vaccination of patients 14 years of 
10
age and older pursuant to a valid prescription or standing 
11
order, by a physician licensed to practice medicine in all its 
12
branches, upon completion of appropriate training, including 
13
how to address contraindications and adverse reactions set 
14
forth by rule, with notification to the patient's physician and 
15
appropriate record retention, or pursuant to hospital pharmacy 
16
and therapeutics committee policies and procedures; (5) drug 
17
regimen review; (6) drug or drug-related research; (7) the 
18
provision of patient counseling; (8) the practice of 
19
telepharmacy; (9) the provision of those acts or services 
20
necessary to provide pharmacist care; (10) medication therapy 
21
management; and (11) the responsibility for compounding and 
22
labeling of drugs and devices (except labeling by a 
23
manufacturer, repackager, or distributor of non-prescription 
24
drugs and commercially packaged legend drugs and devices), 
25
proper and safe storage of drugs and devices, and maintenance 
26
of required records. A pharmacist  who performs any of the acts 
 


 






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1
defined as the practice of pharmacy in this State must be 
2
actively licensed as a pharmacist under this Act.


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
optometrist, within the
limits of their 
8
licenses, by a physician assistant in accordance with

9
subsection (f) of Section 4, or by an advanced practice nurse 
10
in
accordance with subsection (g) of Section 4, containing the

11
following: (l) name
of the patient; (2) date when prescription 
12
was issued; (3) name
and strength of drug or description of the 
13
medical device prescribed;
and (4) quantity; , (5) directions 
14
for use; , (6) prescriber's name,
address
and signature; , and 
15
(7) DEA number where required, for controlled
substances; and 
16
(8), at the discretion of the individual issuing the order, the 
17
indicated use of the drug or device as approved by the United 
18
States Food and Drug Administration (FDA).
DEA numbers shall 
19
not be required on inpatient drug orders.

20
    (f) "Person" means and includes a natural person, 
21
copartnership,
association, corporation, government entity, or 
22
any other legal
entity.

23
    (g) "Department" means the  Department of Financial and

24
Professional Regulation.

25
    (h) "Board of Pharmacy" or "Board" means the State Board
of 
26
Pharmacy of the Department of Financial and Professional 
 


 






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1
Regulation.

2
    (i) "Secretary"
means the Secretary
 of Financial and 
3
Professional Regulation.

4
    (j) "Drug product selection" means the interchange for a

5
prescribed pharmaceutical product in accordance with Section 
6
25 of
this Act and Section 3.14 of the Illinois Food, Drug and 
7
Cosmetic Act.

8
    (k) "Inpatient drug order" means an order issued by an 
9
authorized
prescriber for a resident or patient of a facility 
10
licensed under the
Nursing Home Care Act or the Hospital 
11
Licensing Act, or "An Act in relation to
the founding and 
12
operation of the University of Illinois Hospital and the

13
conduct of University of Illinois health care programs", 
14
approved July 3, 1931,
as amended, or a facility which is 
15
operated by the Department of Human
Services (as successor to 
16
the Department of Mental Health
and Developmental 
17
Disabilities) or the Department of Corrections.

18
    (k-5) "Pharmacist" means an individual health care 
19
professional and
provider currently licensed by this State to 
20
engage in the practice of
pharmacy.

21
    (l) "Pharmacist in charge" means the licensed pharmacist 
22
whose name appears
on a pharmacy license and who is responsible 
23
for all aspects of the
operation related to the practice of 
24
pharmacy.

25
    (m) "Dispense" or "dispensing" means the interpretation, 
26
evaluation, and implementation of a prescription drug order, 
 


 






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1
including the preparation and delivery of a drug or device to a 
2
patient or patient's agent in a suitable container 
3
appropriately labeled for subsequent administration to or use 
4
by a patient in accordance with applicable State and federal 
5
laws and regulations.
  "Dispense" or "dispensing" does not mean 
6
the physical delivery to a patient or a
patient's 
7
representative in a home or institution by a designee of a 
8
pharmacist
or by common carrier.  "Dispense" or "dispensing" 
9
also does not mean the physical delivery
of a drug or medical 
10
device to a patient or patient's representative by a

11
pharmacist's designee within a pharmacy or drugstore while the 
12
pharmacist is
on duty and the pharmacy is open.

13
    (n) "Nonresident pharmacy"
means a pharmacy that is located 
14
in a state, commonwealth, or territory
of the United States, 
15
other than Illinois, that delivers, dispenses, or
distributes, 
16
through the United States Postal Service, commercially 
17
acceptable parcel delivery service, or other common
carrier, to 
18
Illinois residents, any substance which requires a 
19
prescription.

20
    (o) "Compounding" means the preparation and mixing of 
21
components, excluding flavorings, (1) as the result of a 
22
prescriber's prescription drug order or initiative based on the 
23
prescriber-patient-pharmacist relationship in the course of 
24
professional practice or (2) for the purpose of, or incident 
25
to, research, teaching, or chemical analysis and not for sale 
26
or dispensing. "Compounding" includes the preparation of drugs 
 


 






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1
or devices in anticipation of receiving prescription drug 
2
orders based on routine, regularly observed dispensing 
3
patterns. Commercially available products may be compounded 
4
for dispensing to individual patients only if all of the 
5
following conditions are met:  (i) the commercial product is not 
6
reasonably available from normal distribution channels in a 
7
timely manner to meet the patient's needs and (ii) the 
8
prescribing practitioner has requested that the drug be 
9
compounded.

10
    (p) (Blank).


11
    (q) (Blank).


12
    (r) "Patient counseling" means the communication between a 
13
pharmacist or a student pharmacist under the supervision of a 
14
pharmacist and a patient or the patient's representative about 
15
the patient's medication or device for the purpose of 
16
optimizing proper use of prescription medications or devices.  
17
"Patient counseling" may include without limitation (1) 
18
obtaining a medication history; (2) acquiring a patient's 
19
allergies and health conditions; (3) facilitation of the 
20
patient's understanding of  the intended  use of the medication; 
21
(4) proper directions for use; (5) significant potential 
22
adverse events; (6) potential food-drug interactions;  and (7) 
23
the need to be compliant with the medication therapy.  A 
24
pharmacy technician may only participate in the following 
25
aspects of patient counseling under the  supervision of a 
26
pharmacist: (1) obtaining medication history; (2) providing 
 


 






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1
the offer for counseling by a pharmacist or student pharmacist;  
2
and (3) acquiring a patient's allergies and health conditions.


3
    (s) "Patient profiles" or "patient drug therapy record" 
4
means the
obtaining, recording, and maintenance of patient 
5
prescription
information, including prescriptions for 
6
controlled substances, and
personal information.

7
    (t) (Blank).


8
    (u) "Medical device" means an instrument, apparatus, 
9
implement, machine,
contrivance, implant, in vitro reagent, or 
10
other similar or related article,
including any component part 
11
or accessory, required under federal law to
bear the label 
12
"Caution: Federal law requires dispensing by or on the order
of 
13
a physician". A seller of goods and services who, only for the 
14
purpose of
retail sales, compounds, sells, rents, or leases 
15
medical devices shall not,
by reasons thereof, be required to 
16
be a licensed pharmacy.

17
    (v) "Unique identifier" means an electronic signature, 
18
handwritten
signature or initials, thumb print, or other 
19
acceptable biometric
or electronic identification process as 
20
approved by the Department.

21
    (w) "Current usual and customary retail price" means the 
22
price that a pharmacy charges to a non-third-party payor.


23
    (x) "Automated pharmacy system" means a mechanical system 
24
located within the confines of the pharmacy or remote location 
25
that performs operations or activities, other than compounding 
26
or administration, relative to storage, packaging, dispensing, 
 


 






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1
or distribution of medication, and which collects, controls, 
2
and maintains all transaction information.
3
    (y) "Drug regimen review" means and includes the evaluation 
4
of prescription drug orders and patient records for (1)
known 
5
allergies; (2) drug or potential therapy contraindications;

6
(3) reasonable dose, duration of use, and route of 
7
administration, taking into consideration factors such as age, 
8
gender, and contraindications; (4) reasonable directions for 
9
use; (5) potential or actual adverse drug reactions; (6) 
10
drug-drug interactions; (7) drug-food interactions; (8) 
11
drug-disease contraindications; (9) therapeutic duplication; 
12
(10) patient laboratory values when authorized and available; 
13
(11) proper utilization (including over or under utilization) 
14
and optimum therapeutic outcomes; and (12) abuse and misuse.

15
    (z) "Electronic transmission prescription" means any 
16
prescription order for which a facsimile  or electronic image of 
17
the order is electronically transmitted from a licensed 
18
prescriber to a pharmacy. "Electronic transmission 
19
prescription" includes both data and image prescriptions.

20
    (aa) "Medication therapy management services" means a 
21
distinct service or group of services offered by licensed 
22
pharmacists, physicians licensed to practice medicine in all 
23
its branches, advanced practice nurses authorized in a written 
24
agreement with a physician licensed to practice medicine in all 
25
its branches, or physician assistants authorized in guidelines 
26
by a supervising physician that optimize therapeutic outcomes 
 


 






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1
for individual patients through improved medication use. In a 
2
retail or other non-hospital pharmacy, medication therapy 
3
management services shall consist of the evaluation of 
4
prescription drug orders and patient medication records to 
5
resolve conflicts with the following:
6
        (1) known allergies;
7
        (2) drug or potential  therapy contraindications;
8
        (3) reasonable dose, duration of use, and route of 
9
    administration, taking into consideration factors such as 
10
    age, gender, and contraindications;
11
        (4) reasonable directions for use;
12
        (5) potential or actual adverse drug reactions;
13
        (6) drug-drug interactions;
14
        (7) drug-food interactions;
15
        (8) drug-disease contraindications;
16
        (9) identification of therapeutic duplication;
17
        (10) patient laboratory values when authorized and 
18
    available;
19
        (11) proper utilization (including over or under 
20
    utilization) and optimum therapeutic outcomes; and
21
        (12) drug abuse and misuse.
22
"Medication therapy management services" includes the 
23
following:
24
        (1) documenting the services delivered and 
25
    communicating the information provided to patients' 
26
    prescribers  within an appropriate time frame, not to exceed 
 


 






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1
    48 hours;
2
        (2) providing patient counseling designed to enhance a 
3
    patient's understanding and the appropriate use of his or 
4
    her medications; and
5
        (3) providing information, support services, and 
6
    resources designed to enhance a patient's adherence with 
7
    his or her prescribed therapeutic regimens.

8
"Medication therapy management services" may also include 
9
patient care functions authorized by a physician licensed to 
10
practice medicine in all its branches for his or her identified 
11
patient or groups of patients under specified conditions or 
12
limitations in a standing order from the physician.
13
"Medication therapy management services" in a licensed 
14
hospital  may also include the following:
15
        (1) reviewing assessments of the patient's health 
16
    status; and
17
        (2) following protocols of a hospital pharmacy and 
18
    therapeutics committee with respect to the fulfillment of 
19
    medication orders.

20
    (bb) "Pharmacist care" means the provision by a pharmacist 
21
of medication therapy management services, with or without the 
22
dispensing of drugs or devices, intended to achieve outcomes 
23
that improve patient health, quality of life, and comfort and 
24
enhance patient safety.

25
    (cc) "Protected health information" means individually 
26
identifiable health information that, except as otherwise 
 


 






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1
provided, is:

2
        (1) transmitted by electronic media;
3
        (2) maintained in any medium set forth in the 
4
    definition of "electronic media" in the federal Health 
5
    Insurance Portability and Accountability Act; or
6
        (3) transmitted or maintained in any other form or 
7
    medium.
8
"Protected health information" does not include individually 
9
identifiable health information found in:
10
        (1) education records covered by the federal Family 
11
    Educational Right and Privacy Act; or
12
        (2) employment records held by a licensee in its role 
13
    as an employer.
14
    (dd) "Standing order" means a specific order for a patient 
15
or group of patients issued by a physician licensed to practice 
16
medicine in all its branches in Illinois.
17
    (ee) "Address of record" means the address recorded by the 
18
Department in the applicant's or licensee's application file or 
19
license file, as maintained by the Department's licensure 
20
maintenance unit.
21
    (ff) "Home pharmacy" means the location of a pharmacy's 
22
primary operations.

23
(Source: P.A. 95-689, eff. 10-29-07; 96-673, eff. 1-1-10.)
 
24
    (Text of Section after amendment by P.A. 96-339)
  
25
    (Section scheduled to be repealed on January 1, 2018)

 


 






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1
    Sec. 3. Definitions. For the purpose of this Act, except 
2
where otherwise
limited therein:

3
    (a) "Pharmacy" or "drugstore" means and includes every 
4
store, shop,
pharmacy department, or other place where 
5
pharmacist
 care is
provided
by a pharmacist (1) where drugs, 
6
medicines, or poisons are
dispensed, sold or
offered for sale 
7
at retail, or displayed for sale at retail; or
(2)
where

8
prescriptions of physicians, dentists, advanced practice 
9
nurses, physician assistants, veterinarians, podiatrists, or
 
10
optometrists, within the limits of their
licenses, are

11
compounded, filled, or dispensed; or (3) which has upon it or

12
displayed within
it, or affixed to or used in connection with 
13
it, a sign bearing the word or
words "Pharmacist", "Druggist", 
14
"Pharmacy", "Pharmaceutical
Care", "Apothecary", "Drugstore",

15
"Medicine Store", "Prescriptions", "Drugs", "Dispensary", 
16
"Medicines", or any word
or words of similar or like import, 
17
either in the English language
or any other language; or (4) 
18
where the characteristic prescription
sign (Rx) or similar 
19
design is exhibited; or (5) any store, or
shop,
or other place 
20
with respect to which any of the above words, objects,
signs or 
21
designs are used in any advertisement.

22
    (b) "Drugs" means and includes (l) articles recognized
in 
23
the official United States Pharmacopoeia/National Formulary 
24
(USP/NF),
or any supplement thereto and being intended for and 
25
having for their
main use the diagnosis, cure, mitigation, 
26
treatment or prevention of
disease in man or other animals, as 
 


 






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

6
by the United States Food and Drug Administration, but does not 
7
include
devices or their components, parts, or accessories; and 
8
(3) articles
(other than food) having for their main use and 
9
intended
to affect the structure or any function of the body of 
10
man or other
animals; and (4) articles having for their main 
11
use and intended
for use as a component or any articles 
12
specified in clause (l), (2)
or (3); but does not include 
13
devices or their components, parts or
accessories.

14
    (c) "Medicines" means and includes all drugs intended for

15
human or veterinary use approved by the United States Food and 
16
Drug
Administration.

17
    (d) "Practice of pharmacy" means (1) the interpretation and 
18
the provision of assistance in the monitoring, evaluation, and 
19
implementation of prescription drug orders; (2) the dispensing 
20
of prescription drug orders; (3) participation in drug and 
21
device selection; (4) drug administration limited to the 
22
administration of oral, topical, injectable, and inhalation as 
23
follows:  in the context of patient education on the proper use 
24
or delivery of medications; vaccination of patients 14 years of 
25
age and older pursuant to a valid prescription or standing 
26
order, by a physician licensed to practice medicine in all its 
 


 






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1
branches, upon completion of appropriate training, including 
2
how to address contraindications and adverse reactions set 
3
forth by rule, with notification to the patient's physician and 
4
appropriate record retention, or pursuant to hospital pharmacy 
5
and therapeutics committee policies and procedures; (5) drug 
6
regimen review; (6) drug or drug-related research; (7) the 
7
provision of patient counseling; (8) the practice of 
8
telepharmacy; (9) the provision of those acts or services 
9
necessary to provide pharmacist care; (10) medication therapy 
10
management; and (11) the responsibility for compounding and 
11
labeling of drugs and devices (except labeling by a 
12
manufacturer, repackager, or distributor of non-prescription 
13
drugs and commercially packaged legend drugs and devices), 
14
proper and safe storage of drugs and devices, and maintenance 
15
of required records. A pharmacist  who performs any of the acts 
16
defined as the practice of pharmacy in this State must be 
17
actively licensed as a pharmacist under this Act.


18
    (e) "Prescription" means and includes any written, oral, 
19
facsimile, or
electronically transmitted order for drugs
or 
20
medical devices, issued by a physician licensed to practice 
21
medicine in
all its branches, dentist, veterinarian, or 
22
podiatrist,  or
optometrist, within the
limits of their 
23
licenses, by a physician assistant in accordance with

24
subsection (f) of Section 4, or by an advanced practice nurse 
25
in
accordance with subsection (g) of Section 4, containing the

26
following: (l) name
of the patient; (2) date when prescription 
 


 






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1
was issued; (3) name
and strength of drug or description of the 
2
medical device prescribed;
and (4) quantity, (5) directions for 
3
use, (6) prescriber's name,
address
and signature, and (7) DEA 
4
number where required, for controlled
substances.
DEA numbers 
5
shall not be required on inpatient drug orders, and (8), at the 
6
discretion of the individual issuing the order, the indicated 
7
use of the drug or device as approved by the United States Food 
8
and Drug Administration (FDA).

9
    (f) "Person" means and includes a natural person, 
10
copartnership,
association, corporation, government entity, or 
11
any other legal
entity.

12
    (g) "Department" means the  Department of Financial and

13
Professional Regulation.

14
    (h) "Board of Pharmacy" or "Board" means the State Board
of 
15
Pharmacy of the Department of Financial and Professional 
16
Regulation.

17
    (i) "Secretary"
means the Secretary
 of Financial and 
18
Professional Regulation.

19
    (j) "Drug product selection" means the interchange for a

20
prescribed pharmaceutical product in accordance with Section 
21
25 of
this Act and Section 3.14 of the Illinois Food, Drug and 
22
Cosmetic Act.

23
    (k) "Inpatient drug order" means an order issued by an 
24
authorized
prescriber for a resident or patient of a facility 
25
licensed under the
Nursing Home Care Act, the MR/DD Community 
26
Care Act, or the Hospital Licensing Act, or "An Act in relation 
 


 






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1
to
the founding and operation of the University of Illinois 
2
Hospital and the
conduct of University of Illinois health care 
3
programs", approved July 3, 1931,
as amended, or a facility 
4
which is operated by the Department of Human
Services (as 
5
successor to 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 responsible 
12
for all aspects of the
operation related to the practice of 
13
pharmacy.

14
    (m) "Dispense" or "dispensing" means the interpretation, 
15
evaluation, and implementation of a prescription drug order, 
16
including the preparation and delivery of a drug or device to a 
17
patient or patient's agent in a suitable container 
18
appropriately labeled for subsequent administration to or use 
19
by a patient in accordance with applicable State and federal 
20
laws and regulations.
  "Dispense" or "dispensing" does not mean 
21
the physical delivery to a patient or a
patient's 
22
representative in a home or institution by a designee of a 
23
pharmacist
or by common carrier.  "Dispense" or "dispensing" 
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 the 
 


 






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pharmacist is
on duty and the pharmacy is open.

2
    (n) "Nonresident pharmacy"
means a pharmacy that is located 
3
in a state, commonwealth, or territory
of the United States, 
4
other than Illinois, that delivers, dispenses, or
distributes, 
5
through the United States Postal Service, commercially 
6
acceptable parcel delivery service, or other common
carrier, to 
7
Illinois residents, any substance which requires a 
8
prescription.

9
    (o) "Compounding" means the preparation and mixing of 
10
components, excluding flavorings, (1) as the result of a 
11
prescriber's prescription drug order or initiative based on the 
12
prescriber-patient-pharmacist relationship in the course of 
13
professional practice or (2) for the purpose of, or incident 
14
to, research, teaching, or chemical analysis and not for sale 
15
or dispensing. "Compounding" includes the preparation of drugs 
16
or devices in anticipation of receiving prescription drug 
17
orders based on routine, regularly observed dispensing 
18
patterns. Commercially available products may be compounded 
19
for dispensing to individual patients only if all of the 
20
following conditions are met:  (i) the commercial product is not 
21
reasonably available from normal distribution channels in a 
22
timely manner to meet the patient's needs and (ii) the 
23
prescribing practitioner has requested that the drug be 
24
compounded.

25
    (p) (Blank).


26
    (q) (Blank).


 


 






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    (r) "Patient counseling" means the communication between a 
2
pharmacist or a student pharmacist under the supervision of a 
3
pharmacist and a patient or the patient's representative about 
4
the patient's medication or device for the purpose of 
5
optimizing proper use of prescription medications or devices.  
6
"Patient counseling" may include without limitation (1) 
7
obtaining a medication history; (2) acquiring a patient's 
8
allergies and health conditions; (3) facilitation of the 
9
patient's understanding of  the intended  use of the medication; 
10
(4) proper directions for use; (5) significant potential 
11
adverse events; (6) potential food-drug interactions;  and (7) 
12
the need to be compliant with the medication therapy.  A 
13
pharmacy technician may only participate in the following 
14
aspects of patient counseling under the  supervision of a 
15
pharmacist: (1) obtaining medication history; (2) providing 
16
the offer for counseling by a pharmacist or student pharmacist;  
17
and (3) acquiring a patient's allergies and health conditions.


18
    (s) "Patient profiles" or "patient drug therapy record" 
19
means the
obtaining, recording, and maintenance of patient 
20
prescription
information, including prescriptions for 
21
controlled substances, and
personal information.

22
    (t) (Blank).


23
    (u) "Medical device" means an instrument, apparatus, 
24
implement, machine,
contrivance, implant, in vitro reagent, or 
25
other similar or related article,
including any component part 
26
or accessory, required under federal law to
bear the label 
 


 






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"Caution: Federal law requires dispensing by or on the order
of 
2
a physician". A seller of goods and services who, only for the 
3
purpose of
retail sales, compounds, sells, rents, or leases 
4
medical devices shall not,
by reasons thereof, be required to 
5
be a licensed pharmacy.

6
    (v) "Unique identifier" means an electronic signature, 
7
handwritten
signature or initials, thumb print, or other 
8
acceptable biometric
or electronic identification process as 
9
approved by the Department.

10
    (w) "Current usual and customary retail price" means the 
11
price that a pharmacy charges to a non-third-party payor.


12
    (x) "Automated pharmacy system" means a mechanical system 
13
located within the confines of the pharmacy or remote location 
14
that performs operations or activities, other than compounding 
15
or administration, relative to storage, packaging, dispensing, 
16
or distribution of medication, and which collects, controls, 
17
and maintains all transaction information.
18
    (y) "Drug regimen review" means and includes the evaluation 
19
of prescription drug orders and patient records for (1)
known 
20
allergies; (2) drug or potential therapy contraindications;

21
(3) reasonable dose, duration of use, and route of 
22
administration, taking into consideration factors such as age, 
23
gender, and contraindications; (4) reasonable directions for 
24
use; (5) potential or actual adverse drug reactions; (6) 
25
drug-drug interactions; (7) drug-food interactions; (8) 
26
drug-disease contraindications; (9) therapeutic duplication; 
 


 






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(10) patient laboratory values when authorized and available; 
2
(11) proper utilization (including over or under utilization) 
3
and optimum therapeutic outcomes; and (12) abuse and misuse.

4
    (z) "Electronic transmission prescription" means any 
5
prescription order for which a facsimile  or electronic image of 
6
the order is electronically transmitted from a licensed 
7
prescriber to a pharmacy. "Electronic transmission 
8
prescription" includes both data and image prescriptions.

9
    (aa) "Medication therapy management services" means a 
10
distinct service or group of services offered by licensed 
11
pharmacists, physicians licensed to practice medicine in all 
12
its branches, advanced practice nurses authorized in a written 
13
agreement with a physician licensed to practice medicine in all 
14
its branches, or physician assistants authorized in guidelines 
15
by a supervising physician that optimize therapeutic outcomes 
16
for individual patients through improved medication use. In a 
17
retail or other non-hospital pharmacy, medication therapy 
18
management services shall consist of the evaluation of 
19
prescription drug orders and patient medication records to 
20
resolve conflicts with the following:
21
        (1) known allergies;
22
        (2) drug or potential  therapy contraindications;
23
        (3) reasonable dose, duration of use, and route of 
24
    administration, taking into consideration factors such as 
25
    age, gender, and contraindications;
26
        (4) reasonable directions for use;
 


 






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        (5) potential or actual adverse drug reactions;
2
        (6) drug-drug interactions;
3
        (7) drug-food interactions;
4
        (8) drug-disease contraindications;
5
        (9) identification of therapeutic duplication;
6
        (10) patient laboratory values when authorized and 
7
    available;
8
        (11) proper utilization (including over or under 
9
    utilization) and optimum therapeutic outcomes; and
10
        (12) drug abuse and misuse.
11
"Medication therapy management services" includes the 
12
following:
13
        (1) documenting the services delivered and 
14
    communicating the information provided to patients' 
15
    prescribers  within an appropriate time frame, not to exceed 
16
    48 hours;
17
        (2) providing patient counseling designed to enhance a 
18
    patient's understanding and the appropriate use of his or 
19
    her medications; and
20
        (3) providing information, support services, and 
21
    resources designed to enhance a patient's adherence with 
22
    his or her prescribed therapeutic regimens.

23
"Medication therapy management services" may also include 
24
patient care functions authorized by a physician licensed to 
25
practice medicine in all its branches for his or her identified 
26
patient or groups of patients under specified conditions or 
 


 






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1
limitations in a standing order from the physician.
2
"Medication therapy management services" in a licensed 
3
hospital  may also include the following:
4
        (1) reviewing assessments of the patient's health 
5
    status; and
6
        (2) following protocols of a hospital pharmacy and 
7
    therapeutics committee with respect to the fulfillment of 
8
    medication orders.

9
    (bb) "Pharmacist care" means the provision by a pharmacist 
10
of medication therapy management services, with or without the 
11
dispensing of drugs or devices, intended to achieve outcomes 
12
that improve patient health, quality of life, and comfort and 
13
enhance patient safety.

14
    (cc) "Protected health information" means individually 
15
identifiable health information that, except as otherwise 
16
provided, is:

17
        (1) transmitted by electronic media;
18
        (2) maintained in any medium set forth in the 
19
    definition of "electronic media" in the federal Health 
20
    Insurance Portability and Accountability Act; or
21
        (3) transmitted or maintained in any other form or 
22
    medium.
23
"Protected health information" does not include individually 
24
identifiable health information found in:
25
        (1) education records covered by the federal Family 
26
    Educational Right and Privacy Act; or
 


 






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1
        (2) employment records held by a licensee in its role 
2
    as an employer.
3
    (dd) "Standing order" means a specific order for a patient 
4
or group of patients issued by a physician licensed to practice 
5
medicine in all its branches in Illinois.
6
    (ee) "Address of record" means the address recorded by the 
7
Department in the applicant's or licensee's application file or 
8
license file, as maintained by the Department's licensure 
9
maintenance unit.
10
    (ff) "Home pharmacy" means the location of a pharmacy's 
11
primary operations.

12
(Source: P.A. 95-689, eff. 10-29-07; 96-339, eff. 7-1-10; 
13
96-673, eff. 1-1-10; revised 10-1-09.)
 
 
14
    Section 99. Effective date. This Act takes effect upon 
15
becoming law.