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Public Act 101-0349


 

Public Act 0349 101ST GENERAL ASSEMBLY

  
  
  

 


 
Public Act 101-0349
 
SB1715 EnrolledLRB101 08622 JRG 53702 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    (Section scheduled to be repealed on January 1, 2020)
    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
registered nurses, physician assistants, veterinarians,
podiatric physicians, 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 (1) 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 (1), (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:
            (A) in the context of patient education on the
        proper use or delivery of medications;
            (B) 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; and
            (B-5) following the initial administration of
        long-acting or extended release form opioid
        antagonists by a physician licensed to practice
        medicine in all its branches, administration of
        injections of long-acting or extended-release form
        opioid antagonists for the treatment of substance use
        disorder, pursuant to a valid prescription by a
        physician licensed to practice medicine in all its
        branches, upon completion of appropriate training,
        including how to address contraindications and adverse
        reactions, including, but not limited to, respiratory
        depression and the performance of cardiopulmonary
        resuscitation, 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;
            (C) administration of injections of
        alpha-hydroxyprogesterone caproate, pursuant to a
        valid prescription, 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; and
            (D) administration of injections of long-term
        antipsychotic medications pursuant to a valid
        prescription by a physician licensed to practice
        medicine in all its branches, upon completion of
        appropriate training conducted by an Accreditation
        Council of Pharmaceutical Education accredited
        provider, 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) drug or drug-related research;
        (8) the provision of patient counseling;
        (9) the practice of telepharmacy;
        (10) the provision of those acts or services necessary
    to provide pharmacist care;
        (11) medication therapy management; and
        (12) 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, podiatric
physician, or optometrist, within the limits of his or her
license, by a physician assistant in accordance with subsection
(f) of Section 4, or by an advanced practice registered nurse
in accordance with subsection (g) of Section 4, containing the
following: (1) 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
registration 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 registration numbers shall not be required on
inpatient drug orders. A prescription for medication other than
controlled substances shall be valid for up to 15 months from
the date issued for the purpose of refills, unless the
prescription states otherwise.
    (f) "Person" means and includes a natural person,
partnership, 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 MC/DD Act, the Specialized Mental Health
Rehabilitation Act of 2013, the Hospital Licensing Act, or the
University of Illinois Hospital Act, 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" or "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) "Electronically transmitted prescription" means a
prescription that is created, recorded, or stored by electronic
means; issued and validated with an electronic signature; and
transmitted by electronic means directly from the prescriber to
a pharmacy. An electronic prescription is not an image of a
physical prescription that is transferred by electronic means
from computer to computer, facsimile to facsimile, or facsimile
to computer.
    (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 registered 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 designated address
recorded by the Department in the applicant's application file
or licensee's license file maintained by the Department's
licensure maintenance unit.
    (ff) "Home pharmacy" means the location of a pharmacy's
primary operations.
    (gg) "Email address of record" means the designated email
address recorded by the Department in the applicant's
application file or the licensee's license file, as maintained
by the Department's licensure maintenance unit.
(Source: P.A. 99-180, eff. 7-29-15; 100-208, eff. 1-1-18;
100-497, eff. 9-8-17; 100-513, eff. 1-1-18; 100-804, eff.
1-1-19; 100-863, eff. 8-14-18.)

Effective Date: 1/1/2020