Public Act 103-0612
 
HB5530 EnrolledLRB103 37122 RTM 67241 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    (Section scheduled to be repealed on January 1, 2028)
    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 7 years of age and
        older pursuant to a valid prescription or standing
        order, by a physician licensed to practice medicine in
        all its branches, except for vaccinations covered by
        paragraph (15), 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. Eligible vaccines are those listed on the
        U.S. Centers for Disease Control and Prevention (CDC)
        Recommended Immunization Schedule, the CDC's Health
        Information for International Travel, or the U.S. Food
        and Drug Administration's Vaccines Licensed and
        Authorized for Use in the United States. As applicable
        to the State's Medicaid program and other payers,
        vaccines ordered and administered in accordance with
        this subsection shall be covered and reimbursed at no
        less than the rate that the vaccine is reimbursed when
        ordered and administered by a physician;
            (B-5) (blank); 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 long-acting injectables for
        mental health or substance use disorders injections of
        long-term antipsychotic medications pursuant to a
        valid prescription by the patient's a physician
        licensed to practice medicine in all its branches,
        advanced practice registered nurse, or physician
        assistant 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) (blank);
        (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;
        (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;
        (13) the assessment and consultation of patients and
    dispensing of hormonal contraceptives;
        (14) the initiation, dispensing, or administration of
    drugs, laboratory tests, assessments, referrals, and
    consultations for human immunodeficiency virus
    pre-exposure prophylaxis and human immunodeficiency virus
    post-exposure prophylaxis under Section 43.5;
        (15) vaccination of patients 7 years of age and older
    for COVID-19 or influenza subcutaneously, intramuscularly,
    or orally as authorized, approved, or licensed by the
    United States Food and Drug Administration, pursuant to
    the following conditions:
            (A) the vaccine must be authorized or licensed by
        the United States Food and Drug Administration;
            (B) the vaccine must be ordered and administered
        according to the Advisory Committee on Immunization
        Practices standard immunization schedule;
            (C) the pharmacist must complete a course of
        training accredited by the Accreditation Council on
        Pharmacy Education or a similar health authority or
        professional body approved by the Division of
        Professional Regulation;
            (D) the pharmacist must have a current certificate
        in basic cardiopulmonary resuscitation;
            (E) the pharmacist must complete, during each
        State licensing period, a minimum of 2 hours of
        immunization-related continuing pharmacy education
        approved by the Accreditation Council on Pharmacy
        Education;
            (F) the pharmacist must comply with recordkeeping
        and reporting requirements of the jurisdiction in
        which the pharmacist administers vaccines, including
        informing the patient's primary-care provider, when
        available, and complying with requirements whereby the
        person administering a vaccine must review the vaccine
        registry or other vaccination records prior to
        administering the vaccine; and
            (G) the pharmacist must inform the pharmacist's
        patients who are less than 18 years old, as well as the
        adult caregiver accompanying the child, of the
        importance of a well-child visit with a pediatrician
        or other licensed primary-care provider and must refer
        patients as appropriate;
        (16) the ordering and administration of COVID-19
    therapeutics subcutaneously, intramuscularly, or orally
    with notification to the patient's physician and
    appropriate record retention or pursuant to hospital
    pharmacy and therapeutics committee policies and
    procedures. Eligible therapeutics are those approved,
    authorized, or licensed by the United States Food and Drug
    Administration and must be administered subcutaneously,
    intramuscularly, or orally in accordance with that
    approval, authorization, or licensing; and
        (17) the ordering and administration of tests and
    screenings for (i) influenza, (ii) SARS-COV 2, and (iii)
    health conditions identified by a statewide public health
    emergency, as defined in the Illinois Emergency Management
    Agency Act, with notification to the patient's physician
    and appropriate record retention or pursuant to hospital
    pharmacy and therapeutics committee policies and
    procedures. Eligible tests and screenings are those
    approved, authorized, or licensed by the United States
    Food and Drug Administration and must be administered in
    accordance with that approval, authorization, or
    licensing.
        A pharmacist who orders or administers tests or
    screenings for health conditions described in this
    paragraph may use a test that may guide clinical
    decision-making for the health condition that is waived
    under the federal Clinical Laboratory Improvement
    Amendments of 1988 and regulations promulgated thereunder
    or any established screening procedure that is established
    under a statewide protocol.
        A pharmacist may delegate the administrative and
    technical tasks of performing a test for the health
    conditions described in this paragraph to a registered
    pharmacy technician or student pharmacist acting under the
    supervision of the pharmacist.
    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. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
1-1-23; 103-1, eff. 4-27-23.)

Effective Date: 1/1/2025