Public Act 097-1043
 
SB3513 EnrolledLRB097 17615 CEL 62822 b


  
    AN ACT concerning regulation.
  
 
    Be it enacted by the People of the State of Illinois,
 
represented in the General Assembly:
  



 
    Section 5. The Pharmacy Practice Act is amended  by changing 
Section 3 as follows:
 
 

    (225 ILCS 85/3)

 
    (Section scheduled to be repealed on January 1, 2018)

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

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

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

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

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

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

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

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

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

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

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


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

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

following: (l) name
of the patient; (2) date when prescription 
was issued; (3) name
and strength of drug or description of the 
medical device prescribed;
and (4) quantity; (5) directions for 
use; (6) prescriber's name,
address,
and signature; and (7) DEA 
number where required, for controlled
substances.
The 
prescription may, but is not required to, list the illness, 
disease, or condition for which the drug or device is being 
prescribed. DEA numbers shall not be required on inpatient drug 
orders.

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

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

Professional Regulation.

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

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

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

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

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

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

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

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

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

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

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

    (p) (Blank).


    (q) (Blank).


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


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

    (t) (Blank).


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

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

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


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

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

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

    (aa) "Medication therapy management services" means a 
distinct service or group of services offered by licensed 
pharmacists, physicians licensed to practice medicine in all 
its branches, advanced practice nurses authorized in a written 
agreement with a physician licensed to practice medicine in all 
its branches, or physician assistants authorized in guidelines 
by a supervising physician that optimize therapeutic outcomes 
for individual patients through improved medication use. In a 
retail or other non-hospital pharmacy, medication therapy 
management services shall consist of the evaluation of 
prescription drug orders and patient medication records to 
resolve conflicts with the following:
        (1) known allergies;
        (2) drug or potential  therapy contraindications;
        (3) reasonable dose, duration of use, and route of 
    administration, taking into consideration factors such as 
    age, gender, and contraindications;
        (4) reasonable directions for use;
        (5) potential or actual adverse drug reactions;
        (6) drug-drug interactions;
        (7) drug-food interactions;
        (8) drug-disease contraindications;
        (9) identification of therapeutic duplication;
        (10) patient laboratory values when authorized and 
    available;
        (11) proper utilization (including over or under 
    utilization) and optimum therapeutic outcomes; and
        (12) drug abuse and misuse.
"Medication therapy management services" includes the 
following:
        (1) documenting the services delivered and 
    communicating the information provided to patients' 
    prescribers  within an appropriate time frame, not to exceed 
    48 hours;
        (2) providing patient counseling designed to enhance a 
    patient's understanding and the appropriate use of his or 
    her medications; and
        (3) providing information, support services, and 
    resources designed to enhance a patient's adherence with 
    his or her prescribed therapeutic regimens.

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

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

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

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

(Source: P.A. 96-339, eff. 7-1-10; 96-673, eff. 1-1-10; 
96-1000, eff. 7-2-10; 96-1353, eff. 7-28-10; 97-38, eff. 
6-28-11; 97-227, eff. 1-1-12; revised 10-4-11.)
 

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