Bill Text: IL HB5530 | 2023-2024 | 103rd General Assembly | Enrolled

NOTE: There are more recent revisions of this legislation. Read Latest Draft

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Bill Title: Amends the Pharmacy Practice Act. In the definition of "practice of pharmacy": includes in the practice of pharmacy the administration of long-acting injectables for mental health or substance use disorders (rather than injections of long-term antipsychotic medications); and removes language providing that the definition includes administration of injections of long-acting or extended-release form opioid antagonists for the treatment of a substance use disorder following the initial administration of long-acting or extended-release form opioid antagonists by a physician licensed to practice medicine in all its branches.

Spectrum: Partisan Bill (Democrat 4-0)

Status: (Passed) 2024-07-01 - Effective Date January 1, 2025 [HB5530 Detail]

Download: Illinois-2023-HB5530-Enrolled.html

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HB5530 Enrolled LRB103 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(Section scheduled to be repealed on January 1, 2028)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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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