96TH GENERAL ASSEMBLY
State of Illinois
2009 and 2010
SB3270


 
Introduced 2/9/2010, by Sen. Donne E. Trotter
 
SYNOPSIS AS INTRODUCED:
 		





 








225 ILCS 85/3










     Amends the Pharmacy Practice Act. Makes a technical change in a Section concerning definitions.
  















LRB096 16561 ASK 31834 b

















 


 


A BILL FOR









 




  






SB3270

LRB096 16561 ASK 31834 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    (Section scheduled to be repealed on January 1, 2018)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 the purpose of this Act, 
10
except 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 for 
14
use, (6) prescriber's name,
address
and signature, and (7) DEA 
15
number where required, for controlled
substances.
DEA numbers 
16
shall not be required on inpatient drug orders.

17
    (f) "Person" means and includes a natural person, 
18
copartnership,
association, corporation, government entity, or 
19
any other legal
entity.

20
    (g) "Department" means the  Department of Financial and

21
Professional Regulation.

22
    (h) "Board of Pharmacy" or "Board" means the State Board
of 
23
Pharmacy of the Department of Financial and Professional 
24
Regulation.

25
    (i) "Secretary"
means the Secretary
 of Financial and 
26
Professional Regulation.

 


 






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1
    (j) "Drug product selection" means the interchange for a

2
prescribed pharmaceutical product in accordance with Section 
3
25 of
this Act and Section 3.14 of the Illinois Food, Drug and 
4
Cosmetic Act.

5
    (k) "Inpatient drug order" means an order issued by an 
6
authorized
prescriber for a resident or patient of a facility 
7
licensed under the
Nursing Home Care Act or the Hospital 
8
Licensing Act, or "An Act in relation to
the founding and 
9
operation of the University of Illinois Hospital and the

10
conduct of University of Illinois health care programs", 
11
approved July 3, 1931,
as amended, or a facility which is 
12
operated by the Department of Human
Services (as successor to 
13
the Department of Mental Health
and Developmental 
14
Disabilities) or the Department of Corrections.

15
    (k-5) "Pharmacist" means an individual health care 
16
professional and
provider currently licensed by this State to 
17
engage in the practice of
pharmacy.

18
    (l) "Pharmacist in charge" means the licensed pharmacist 
19
whose name appears
on a pharmacy license and who is responsible 
20
for all aspects of the
operation related to the practice of 
21
pharmacy.

22
    (m) "Dispense" or "dispensing" means the interpretation, 
23
evaluation, and implementation of a prescription drug order, 
24
including the preparation and delivery of a drug or device to a 
25
patient or patient's agent in a suitable container 
26
appropriately labeled for subsequent administration to or use 
 


 






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1
by a patient in accordance with applicable State and federal 
2
laws and regulations.
  "Dispense" or "dispensing" does not mean 
3
the physical delivery to a patient or a
patient's 
4
representative in a home or institution by a designee of a 
5
pharmacist
or by common carrier.  "Dispense" or "dispensing" 
6
also does not mean the physical delivery
of a drug or medical 
7
device to a patient or patient's representative by a

8
pharmacist's designee within a pharmacy or drugstore while the 
9
pharmacist is
on duty and the pharmacy is open.

10
    (n) "Nonresident pharmacy"
means a pharmacy that is located 
11
in a state, commonwealth, or territory
of the United States, 
12
other than Illinois, that delivers, dispenses, or
distributes, 
13
through the United States Postal Service, commercially 
14
acceptable parcel delivery service, or other common
carrier, to 
15
Illinois residents, any substance which requires a 
16
prescription.

17
    (o) "Compounding" means the preparation and mixing of 
18
components, excluding flavorings, (1) as the result of a 
19
prescriber's prescription drug order or initiative based on the 
20
prescriber-patient-pharmacist relationship in the course of 
21
professional practice or (2) for the purpose of, or incident 
22
to, research, teaching, or chemical analysis and not for sale 
23
or dispensing. "Compounding" includes the preparation of drugs 
24
or devices in anticipation of receiving prescription drug 
25
orders based on routine, regularly observed dispensing 
26
patterns. Commercially available products may be compounded 
 


 






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1
for dispensing to individual patients only if all of the 
2
following conditions are met:  (i) the commercial product is not 
3
reasonably available from normal distribution channels in a 
4
timely manner to meet the patient's needs and (ii) the 
5
prescribing practitioner has requested that the drug be 
6
compounded.

7
    (p) (Blank).


8
    (q) (Blank).


9
    (r) "Patient counseling" means the communication between a 
10
pharmacist or a student pharmacist under the supervision of a 
11
pharmacist and a patient or the patient's representative about 
12
the patient's medication or device for the purpose of 
13
optimizing proper use of prescription medications or devices.  
14
"Patient counseling" may include without limitation (1) 
15
obtaining a medication history; (2) acquiring a patient's 
16
allergies and health conditions; (3) facilitation of the 
17
patient's understanding of  the intended  use of the medication; 
18
(4) proper directions for use; (5) significant potential 
19
adverse events; (6) potential food-drug interactions;  and (7) 
20
the need to be compliant with the medication therapy.  A 
21
pharmacy technician may only participate in the following 
22
aspects of patient counseling under the  supervision of a 
23
pharmacist: (1) obtaining medication history; (2) providing 
24
the offer for counseling by a pharmacist or student pharmacist;  
25
and (3) acquiring a patient's allergies and health conditions.


26
    (s) "Patient profiles" or "patient drug therapy record" 
 


 






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1
means the
obtaining, recording, and maintenance of patient 
2
prescription
information, including prescriptions for 
3
controlled substances, and
personal information.

4
    (t) (Blank).


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 biometric
or electronic identification process as 
17
approved by the Department.

18
    (w) "Current usual and customary retail price" means the 
19
price that a pharmacy charges to a non-third-party payor.


20
    (x) "Automated pharmacy system" means a mechanical system 
21
located within the confines of the pharmacy or remote location 
22
that performs operations or activities, other than compounding 
23
or administration, relative to storage, packaging, dispensing, 
24
or distribution of medication, and which collects, controls, 
25
and maintains all transaction information.
26
    (y) "Drug regimen review" means and includes the evaluation 
 


 






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1
of prescription drug orders and patient records for (1)
known 
2
allergies; (2) drug or potential therapy contraindications;

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

12
    (z) "Electronic transmission prescription" means any 
13
prescription order for which a facsimile  or electronic image of 
14
the order is electronically transmitted from a licensed 
15
prescriber to a pharmacy. "Electronic transmission 
16
prescription" includes both data and image prescriptions.

17
    (aa) "Medication therapy management services" means a 
18
distinct service or group of services offered by licensed 
19
pharmacists, physicians licensed to practice medicine in all 
20
its branches, advanced practice nurses authorized in a written 
21
agreement with a physician licensed to practice medicine in all 
22
its branches, or physician assistants authorized in guidelines 
23
by a supervising physician that optimize therapeutic outcomes 
24
for individual patients through improved medication use. In a 
25
retail or other non-hospital pharmacy, medication therapy 
26
management services shall consist of the evaluation of 
 


 






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


 






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1
    her medications; and
2
        (3) providing information, support services, and 
3
    resources designed to enhance a patient's adherence with 
4
    his or her prescribed therapeutic regimens.

5
"Medication therapy management services" may also include 
6
patient care functions authorized by a physician licensed to 
7
practice medicine in all its branches for his or her identified 
8
patient or groups of patients under specified conditions or 
9
limitations in a standing order from the physician.
10
"Medication therapy management services" in a licensed 
11
hospital  may also include the following:
12
        (1) reviewing assessments of the patient's health 
13
    status; and
14
        (2) following protocols of a hospital pharmacy and 
15
    therapeutics committee with respect to the fulfillment of 
16
    medication orders.

17
    (bb) "Pharmacist care" means the provision by a pharmacist 
18
of medication therapy management services, with or without the 
19
dispensing of drugs or devices, intended to achieve outcomes 
20
that improve patient health, quality of life, and comfort and 
21
enhance patient safety.

22
    (cc) "Protected health information" means individually 
23
identifiable health information that, except as otherwise 
24
provided, is:

25
        (1) transmitted by electronic media;
26
        (2) maintained in any medium set forth in the 
 


 






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

20
(Source: P.A. 95-689, eff. 10-29-07; 96-673, eff. 1-1-10.)
 
21
    (Text of Section after amendment by P.A. 96-339)
  
22
    (Section scheduled to be repealed on January 1, 2018)

23
    Sec. 3. Definitions. For the the purpose of this Act, 
24
except where otherwise
limited therein:

25
    (a) "Pharmacy" or "drugstore" means and includes every 
 


 






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1
store, shop,
pharmacy department, or other place where 
2
pharmacist
 care is
provided
by a pharmacist (1) where drugs, 
3
medicines, or poisons are
dispensed, sold or
offered for sale 
4
at retail, or displayed for sale at retail; or
(2)
where

5
prescriptions of physicians, dentists, advanced practice 
6
nurses, physician assistants, veterinarians, podiatrists, or
 
7
optometrists, within the limits of their
licenses, are

8
compounded, filled, or dispensed; or (3) which has upon it or

9
displayed within
it, or affixed to or used in connection with 
10
it, a sign bearing the word or
words "Pharmacist", "Druggist", 
11
"Pharmacy", "Pharmaceutical
Care", "Apothecary", "Drugstore",

12
"Medicine Store", "Prescriptions", "Drugs", "Dispensary", 
13
"Medicines", or any word
or words of similar or like import, 
14
either in the English language
or any other language; or (4) 
15
where the characteristic prescription
sign (Rx) or similar 
16
design is exhibited; or (5) any store, or
shop,
or other place 
17
with respect to which any of the above words, objects,
signs or 
18
designs are used in any advertisement.

19
    (b) "Drugs" means and includes (l) articles recognized
in 
20
the official United States Pharmacopoeia/National Formulary 
21
(USP/NF),
or any supplement thereto and being intended for and 
22
having for their
main use the diagnosis, cure, mitigation, 
23
treatment or prevention of
disease in man or other animals, as 
24
approved by the United States Food and
Drug Administration, but 
25
does not include devices or their components, parts,
or 
26
accessories; and (2) all other articles intended
for and having 
 


 






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1
for their main use the diagnosis, cure, mitigation,
treatment 
2
or prevention of disease in man or other animals, as approved

3
by the United States Food and Drug Administration, but does not 
4
include
devices or their components, parts, or accessories; and 
5
(3) articles
(other than food) having for their main use and 
6
intended
to affect the structure or any function of the body of 
7
man or other
animals; and (4) articles having for their main 
8
use and intended
for use as a component or any articles 
9
specified in clause (l), (2)
or (3); but does not include 
10
devices or their components, parts or
accessories.

11
    (c) "Medicines" means and includes all drugs intended for

12
human or veterinary use approved by the United States Food and 
13
Drug
Administration.

14
    (d) "Practice of pharmacy" means (1) the interpretation and 
15
the provision of assistance in the monitoring, evaluation, and 
16
implementation of prescription drug orders; (2) the dispensing 
17
of prescription drug orders; (3) participation in drug and 
18
device selection; (4) drug administration limited to the 
19
administration of oral, topical, injectable, and inhalation as 
20
follows:  in the context of patient education on the proper use 
21
or delivery of medications; vaccination of patients 14 years of 
22
age and older pursuant to a valid prescription or standing 
23
order, by a physician licensed to practice medicine in all its 
24
branches, upon completion of appropriate training, including 
25
how to address contraindications and adverse reactions set 
26
forth by rule, with notification to the patient's physician and 
 


 






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


15
    (e) "Prescription" means and includes any written, oral, 
16
facsimile, or
electronically transmitted order for drugs
or 
17
medical devices, issued by a physician licensed to practice 
18
medicine in
all its branches, dentist, veterinarian, or 
19
podiatrist,  or
optometrist, within the
limits of their 
20
licenses, by a physician assistant in accordance with

21
subsection (f) of Section 4, or by an advanced practice nurse 
22
in
accordance with subsection (g) of Section 4, containing the

23
following: (l) name
of the patient; (2) date when prescription 
24
was issued; (3) name
and strength of drug or description of the 
25
medical device prescribed;
and (4) quantity, (5) directions for 
26
use, (6) prescriber's name,
address
and signature, and (7) DEA 
 


 






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1
number where required, for controlled
substances.
DEA numbers 
2
shall not be required on inpatient drug orders.

3
    (f) "Person" means and includes a natural person, 
4
copartnership,
association, corporation, government entity, or 
5
any other legal
entity.

6
    (g) "Department" means the  Department of Financial and

7
Professional Regulation.

8
    (h) "Board of Pharmacy" or "Board" means the State Board
of 
9
Pharmacy of the Department of Financial and Professional 
10
Regulation.

11
    (i) "Secretary"
means the Secretary
 of Financial and 
12
Professional Regulation.

13
    (j) "Drug product selection" means the interchange for a

14
prescribed pharmaceutical product in accordance with Section 
15
25 of
this Act and Section 3.14 of the Illinois Food, Drug and 
16
Cosmetic Act.

17
    (k) "Inpatient drug order" means an order issued by an 
18
authorized
prescriber for a resident or patient of a facility 
19
licensed under the
Nursing Home Care Act, the MR/DD Community 
20
Care Act, or the Hospital Licensing Act, or "An Act in relation 
21
to
the founding and operation of the University of Illinois 
22
Hospital and the
conduct of University of Illinois health care 
23
programs", approved July 3, 1931,
as amended, or a facility 
24
which is operated by the Department of Human
Services (as 
25
successor to the Department of Mental Health
and Developmental 
26
Disabilities) or the Department of Corrections.

 


 






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1
    (k-5) "Pharmacist" means an individual health care 
2
professional and
provider currently licensed by this State to 
3
engage in the practice of
pharmacy.

4
    (l) "Pharmacist in charge" means the licensed pharmacist 
5
whose name appears
on a pharmacy license and who is responsible 
6
for all aspects of the
operation related to the practice of 
7
pharmacy.

8
    (m) "Dispense" or "dispensing" means the interpretation, 
9
evaluation, and implementation of a prescription drug order, 
10
including the preparation and delivery of a drug or device to a 
11
patient or patient's agent in a suitable container 
12
appropriately labeled for subsequent administration to or use 
13
by a patient in accordance with applicable State and federal 
14
laws and regulations.
  "Dispense" or "dispensing" does not mean 
15
the physical delivery to a patient or a
patient's 
16
representative in a home or institution by a designee of a 
17
pharmacist
or by common carrier.  "Dispense" or "dispensing" 
18
also does not mean the physical delivery
of a drug or medical 
19
device to a patient or patient's representative by a

20
pharmacist's designee within a pharmacy or drugstore while the 
21
pharmacist is
on duty and the pharmacy is open.

22
    (n) "Nonresident pharmacy"
means a pharmacy that is located 
23
in a state, commonwealth, or territory
of the United States, 
24
other than Illinois, that delivers, dispenses, or
distributes, 
25
through the United States Postal Service, commercially 
26
acceptable parcel delivery service, or other common
carrier, to 
 


 






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Illinois residents, any substance which requires a 
2
prescription.

3
    (o) "Compounding" means the preparation and mixing of 
4
components, excluding flavorings, (1) as the result of a 
5
prescriber's prescription drug order or initiative based on the 
6
prescriber-patient-pharmacist relationship in the course of 
7
professional practice or (2) for the purpose of, or incident 
8
to, research, teaching, or chemical analysis and not for sale 
9
or dispensing. "Compounding" includes the preparation of drugs 
10
or devices in anticipation of receiving prescription drug 
11
orders based on routine, regularly observed dispensing 
12
patterns. Commercially available products may be compounded 
13
for dispensing to individual patients only if all of the 
14
following conditions are met:  (i) the commercial product is not 
15
reasonably available from normal distribution channels in a 
16
timely manner to meet the patient's needs and (ii) the 
17
prescribing practitioner has requested that the drug be 
18
compounded.

19
    (p) (Blank).


20
    (q) (Blank).


21
    (r) "Patient counseling" means the communication between a 
22
pharmacist or a student pharmacist under the supervision of a 
23
pharmacist and a patient or the patient's representative about 
24
the patient's medication or device for the purpose of 
25
optimizing proper use of prescription medications or devices.  
26
"Patient counseling" may include without limitation (1) 
 


 






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obtaining a medication history; (2) acquiring a patient's 
2
allergies and health conditions; (3) facilitation of the 
3
patient's understanding of  the intended  use of the medication; 
4
(4) proper directions for use; (5) significant potential 
5
adverse events; (6) potential food-drug interactions;  and (7) 
6
the need to be compliant with the medication therapy.  A 
7
pharmacy technician may only participate in the following 
8
aspects of patient counseling under the  supervision of a 
9
pharmacist: (1) obtaining medication history; (2) providing 
10
the offer for counseling by a pharmacist or student pharmacist;  
11
and (3) acquiring a patient's allergies and health conditions.


12
    (s) "Patient profiles" or "patient drug therapy record" 
13
means the
obtaining, recording, and maintenance of patient 
14
prescription
information, including prescriptions for 
15
controlled substances, and
personal information.

16
    (t) (Blank).


17
    (u) "Medical device" means an instrument, apparatus, 
18
implement, machine,
contrivance, implant, in vitro reagent, or 
19
other similar or related article,
including any component part 
20
or accessory, required under federal law to
bear the label 
21
"Caution: Federal law requires dispensing by or on the order
of 
22
a physician". A seller of goods and services who, only for the 
23
purpose of
retail sales, compounds, sells, rents, or leases 
24
medical devices shall not,
by reasons thereof, be required to 
25
be a licensed pharmacy.

26
    (v) "Unique identifier" means an electronic signature, 
 


 






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handwritten
signature or initials, thumb print, or other 
2
acceptable biometric
or electronic identification process as 
3
approved by the Department.

4
    (w) "Current usual and customary retail price" means the 
5
price that a pharmacy charges to a non-third-party payor.


6
    (x) "Automated pharmacy system" means a mechanical system 
7
located within the confines of the pharmacy or remote location 
8
that performs operations or activities, other than compounding 
9
or administration, relative to storage, packaging, dispensing, 
10
or distribution of medication, and which collects, controls, 
11
and maintains all transaction information.
12
    (y) "Drug regimen review" means and includes the evaluation 
13
of prescription drug orders and patient records for (1)
known 
14
allergies; (2) drug or potential therapy contraindications;

15
(3) reasonable dose, duration of use, and route of 
16
administration, taking into consideration factors such as age, 
17
gender, and contraindications; (4) reasonable directions for 
18
use; (5) potential or actual adverse drug reactions; (6) 
19
drug-drug interactions; (7) drug-food interactions; (8) 
20
drug-disease contraindications; (9) therapeutic duplication; 
21
(10) patient laboratory values when authorized and available; 
22
(11) proper utilization (including over or under utilization) 
23
and optimum therapeutic outcomes; and (12) abuse and misuse.

24
    (z) "Electronic transmission prescription" means any 
25
prescription order for which a facsimile  or electronic image of 
26
the order is electronically transmitted from a licensed 
 


 






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prescriber to a pharmacy. "Electronic transmission 
2
prescription" includes both data and image prescriptions.

3
    (aa) "Medication therapy management services" means a 
4
distinct service or group of services offered by licensed 
5
pharmacists, physicians licensed to practice medicine in all 
6
its branches, advanced practice nurses authorized in a written 
7
agreement with a physician licensed to practice medicine in all 
8
its branches, or physician assistants authorized in guidelines 
9
by a supervising physician that optimize therapeutic outcomes 
10
for individual patients through improved medication use. In a 
11
retail or other non-hospital pharmacy, medication therapy 
12
management services shall consist of the evaluation of 
13
prescription drug orders and patient medication records to 
14
resolve conflicts with the following:
15
        (1) known allergies;
16
        (2) drug or potential  therapy contraindications;
17
        (3) reasonable dose, duration of use, and route of 
18
    administration, taking into consideration factors such as 
19
    age, gender, and contraindications;
20
        (4) reasonable directions for use;
21
        (5) potential or actual adverse drug reactions;
22
        (6) drug-drug interactions;
23
        (7) drug-food interactions;
24
        (8) drug-disease contraindications;
25
        (9) identification of therapeutic duplication;
26
        (10) patient laboratory values when authorized and 
 


 






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1
    available;
2
        (11) proper utilization (including over or under 
3
    utilization) and optimum therapeutic outcomes; and
4
        (12) drug abuse and misuse.
5
"Medication therapy management services" includes the 
6
following:
7
        (1) documenting the services delivered and 
8
    communicating the information provided to patients' 
9
    prescribers  within an appropriate time frame, not to exceed 
10
    48 hours;
11
        (2) providing patient counseling designed to enhance a 
12
    patient's understanding and the appropriate use of his or 
13
    her medications; and
14
        (3) providing information, support services, and 
15
    resources designed to enhance a patient's adherence with 
16
    his or her prescribed therapeutic regimens.

17
"Medication therapy management services" may also include 
18
patient care functions authorized by a physician licensed to 
19
practice medicine in all its branches for his or her identified 
20
patient or groups of patients under specified conditions or 
21
limitations in a standing order from the physician.
22
"Medication therapy management services" in a licensed 
23
hospital  may also include the following:
24
        (1) reviewing assessments of the patient's health 
25
    status; and
26
        (2) following protocols of a hospital pharmacy and 
 


 






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1
    therapeutics committee with respect to the fulfillment of 
2
    medication orders.

3
    (bb) "Pharmacist care" means the provision by a pharmacist 
4
of medication therapy management services, with or without the 
5
dispensing of drugs or devices, intended to achieve outcomes 
6
that improve patient health, quality of life, and comfort and 
7
enhance patient safety.

8
    (cc) "Protected health information" means individually 
9
identifiable health information that, except as otherwise 
10
provided, is:

11
        (1) transmitted by electronic media;
12
        (2) maintained in any medium set forth in the 
13
    definition of "electronic media" in the federal Health 
14
    Insurance Portability and Accountability Act; or
15
        (3) transmitted or maintained in any other form or 
16
    medium.
17
"Protected health information" does not include individually 
18
identifiable health information found in:
19
        (1) education records covered by the federal Family 
20
    Educational Right and Privacy Act; or
21
        (2) employment records held by a licensee in its role 
22
    as an employer.
23
    (dd) "Standing order" means a specific order for a patient 
24
or group of patients issued by a physician licensed to practice 
25
medicine in all its branches in Illinois.
26
    (ee) "Address of record" means the address recorded by the 
 


 






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Department in the applicant's or licensee's application file or 
2
license file, as maintained by the Department's licensure 
3
maintenance unit.
4
    (ff) "Home pharmacy" means the location of a pharmacy's 
5
primary operations.

6
(Source: P.A. 95-689, eff. 10-29-07; 96-339, eff. 7-1-10; 
7
96-673, eff. 1-1-10; revised 10-1-09.)