103RD GENERAL ASSEMBLY
State of Illinois
2023 and 2024
HB5530

 

Introduced 2/9/2024, by Rep. Maurice A. West, II

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3

    Amends the Pharmacy Practice Act. In the definition of "practice of pharmacy": provides for 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.


LRB103 37122 RTM 67241 b

 

 

A BILL FOR

 

HB5530LRB103 37122 RTM 67241 b

1    AN ACT concerning regulation.
 
2    Be it enacted by the People of the State of Illinois,
3represented in the General Assembly:
 
4    Section 5. The Pharmacy Practice Act is amended by
5changing Section 3 as follows:
 
6    (225 ILCS 85/3)
7    (Section scheduled to be repealed on January 1, 2028)
8    Sec. 3. Definitions. For the purpose of this Act, except
9where otherwise limited therein:
10    (a) "Pharmacy" or "drugstore" means and includes every
11store, shop, pharmacy department, or other place where
12pharmacist care is provided by a pharmacist (1) where drugs,
13medicines, or poisons are dispensed, sold or offered for sale
14at retail, or displayed for sale at retail; or (2) where
15prescriptions of physicians, dentists, advanced practice
16registered nurses, physician assistants, veterinarians,
17podiatric physicians, or optometrists, within the limits of
18their licenses, are compounded, filled, or dispensed; or (3)
19which has upon it or displayed within it, or affixed to or used
20in connection with it, a sign bearing the word or words
21"Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical Care",
22"Apothecary", "Drugstore", "Medicine Store", "Prescriptions",
23"Drugs", "Dispensary", "Medicines", or any word or words of

 

 

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1similar or like import, either in the English language or any
2other language; or (4) where the characteristic prescription
3sign (Rx) or similar design is exhibited; or (5) any store, or
4shop, or other place with respect to which any of the above
5words, objects, signs or designs are used in any
6advertisement.
7    (b) "Drugs" means and includes (1) articles recognized in
8the official United States Pharmacopoeia/National Formulary
9(USP/NF), or any supplement thereto and being intended for and
10having for their main use the diagnosis, cure, mitigation,
11treatment or prevention of disease in man or other animals, as
12approved by the United States Food and Drug Administration,
13but does not include devices or their components, parts, or
14accessories; and (2) all other articles intended for and
15having for their main use the diagnosis, cure, mitigation,
16treatment or prevention of disease in man or other animals, as
17approved by the United States Food and Drug Administration,
18but does not include devices or their components, parts, or
19accessories; and (3) articles (other than food) having for
20their main use and intended to affect the structure or any
21function of the body of man or other animals; and (4) articles
22having for their main use and intended for use as a component
23or any articles specified in clause (1), (2) or (3); but does
24not include devices or their components, parts or accessories.
25    (c) "Medicines" means and includes all drugs intended for
26human or veterinary use approved by the United States Food and

 

 

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1Drug Administration.
2    (d) "Practice of pharmacy" means:
3        (1) the interpretation and the provision of assistance
4    in the monitoring, evaluation, and implementation of
5    prescription drug orders;
6        (2) the dispensing of prescription drug orders;
7        (3) participation in drug and device selection;
8        (4) drug administration limited to the administration
9    of oral, topical, injectable, and inhalation as follows:
10            (A) in the context of patient education on the
11        proper use or delivery of medications;
12            (B) vaccination of patients 7 years of age and
13        older pursuant to a valid prescription or standing
14        order, by a physician licensed to practice medicine in
15        all its branches, except for vaccinations covered by
16        paragraph (15), upon completion of appropriate
17        training, including how to address contraindications
18        and adverse reactions set forth by rule, with
19        notification to the patient's physician and
20        appropriate record retention, or pursuant to hospital
21        pharmacy and therapeutics committee policies and
22        procedures. Eligible vaccines are those listed on the
23        U.S. Centers for Disease Control and Prevention (CDC)
24        Recommended Immunization Schedule, the CDC's Health
25        Information for International Travel, or the U.S. Food
26        and Drug Administration's Vaccines Licensed and

 

 

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1        Authorized for Use in the United States. As applicable
2        to the State's Medicaid program and other payers,
3        vaccines ordered and administered in accordance with
4        this subsection shall be covered and reimbursed at no
5        less than the rate that the vaccine is reimbursed when
6        ordered and administered by a physician;
7            (B-5) (blank); following the initial
8        administration of long-acting or extended-release form
9        opioid antagonists by a physician licensed to practice
10        medicine in all its branches, administration of
11        injections of long-acting or extended-release form
12        opioid antagonists for the treatment of substance use
13        disorder, pursuant to a valid prescription by a
14        physician licensed to practice medicine in all its
15        branches, upon completion of appropriate training,
16        including how to address contraindications and adverse
17        reactions, including, but not limited to, respiratory
18        depression and the performance of cardiopulmonary
19        resuscitation, set forth by rule, with notification to
20        the patient's physician and appropriate record
21        retention, or pursuant to hospital pharmacy and
22        therapeutics committee policies and procedures;
23            (C) administration of injections of
24        alpha-hydroxyprogesterone caproate, pursuant to a
25        valid prescription, by a physician licensed to
26        practice medicine in all its branches, upon completion

 

 

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1        of appropriate training, including how to address
2        contraindications and adverse reactions set forth by
3        rule, with notification to the patient's physician and
4        appropriate record retention, or pursuant to hospital
5        pharmacy and therapeutics committee policies and
6        procedures; and
7            (D) administration of long-acting injectables for
8        mental health or substance use disorders injections of
9        long-term antipsychotic medications pursuant to a
10        valid prescription by a physician licensed to practice
11        medicine in all its branches, upon completion of
12        appropriate training conducted by an Accreditation
13        Council of Pharmaceutical Education accredited
14        provider, including how to address contraindications
15        and adverse reactions set forth by rule, with
16        notification to the patient's physician and
17        appropriate record retention, or pursuant to hospital
18        pharmacy and therapeutics committee policies and
19        procedures.
20        (5) (blank);
21        (6) drug regimen review;
22        (7) drug or drug-related research;
23        (8) the provision of patient counseling;
24        (9) the practice of telepharmacy;
25        (10) the provision of those acts or services necessary
26    to provide pharmacist care;

 

 

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1        (11) medication therapy management;
2        (12) the responsibility for compounding and labeling
3    of drugs and devices (except labeling by a manufacturer,
4    repackager, or distributor of non-prescription drugs and
5    commercially packaged legend drugs and devices), proper
6    and safe storage of drugs and devices, and maintenance of
7    required records;
8        (13) the assessment and consultation of patients and
9    dispensing of hormonal contraceptives;
10        (14) the initiation, dispensing, or administration of
11    drugs, laboratory tests, assessments, referrals, and
12    consultations for human immunodeficiency virus
13    pre-exposure prophylaxis and human immunodeficiency virus
14    post-exposure prophylaxis under Section 43.5;
15        (15) vaccination of patients 7 years of age and older
16    for COVID-19 or influenza subcutaneously, intramuscularly,
17    or orally as authorized, approved, or licensed by the
18    United States Food and Drug Administration, pursuant to
19    the following conditions:
20            (A) the vaccine must be authorized or licensed by
21        the United States Food and Drug Administration;
22            (B) the vaccine must be ordered and administered
23        according to the Advisory Committee on Immunization
24        Practices standard immunization schedule;
25            (C) the pharmacist must complete a course of
26        training accredited by the Accreditation Council on

 

 

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1        Pharmacy Education or a similar health authority or
2        professional body approved by the Division of
3        Professional Regulation;
4            (D) the pharmacist must have a current certificate
5        in basic cardiopulmonary resuscitation;
6            (E) the pharmacist must complete, during each
7        State licensing period, a minimum of 2 hours of
8        immunization-related continuing pharmacy education
9        approved by the Accreditation Council on Pharmacy
10        Education;
11            (F) the pharmacist must comply with recordkeeping
12        and reporting requirements of the jurisdiction in
13        which the pharmacist administers vaccines, including
14        informing the patient's primary-care provider, when
15        available, and complying with requirements whereby the
16        person administering a vaccine must review the vaccine
17        registry or other vaccination records prior to
18        administering the vaccine; and
19            (G) the pharmacist must inform the pharmacist's
20        patients who are less than 18 years old, as well as the
21        adult caregiver accompanying the child, of the
22        importance of a well-child visit with a pediatrician
23        or other licensed primary-care provider and must refer
24        patients as appropriate;
25        (16) the ordering and administration of COVID-19
26    therapeutics subcutaneously, intramuscularly, or orally

 

 

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1    with notification to the patient's physician and
2    appropriate record retention or pursuant to hospital
3    pharmacy and therapeutics committee policies and
4    procedures. Eligible therapeutics are those approved,
5    authorized, or licensed by the United States Food and Drug
6    Administration and must be administered subcutaneously,
7    intramuscularly, or orally in accordance with that
8    approval, authorization, or licensing; and
9        (17) the ordering and administration of tests and
10    screenings for (i) influenza, (ii) SARS-COV 2, and (iii)
11    health conditions identified by a statewide public health
12    emergency, as defined in the Illinois Emergency Management
13    Agency Act, with notification to the patient's physician
14    and appropriate record retention or pursuant to hospital
15    pharmacy and therapeutics committee policies and
16    procedures. Eligible tests and screenings are those
17    approved, authorized, or licensed by the United States
18    Food and Drug Administration and must be administered in
19    accordance with that approval, authorization, or
20    licensing.
21        A pharmacist who orders or administers tests or
22    screenings for health conditions described in this
23    paragraph may use a test that may guide clinical
24    decision-making for the health condition that is waived
25    under the federal Clinical Laboratory Improvement
26    Amendments of 1988 and regulations promulgated thereunder

 

 

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1    or any established screening procedure that is established
2    under a statewide protocol.
3        A pharmacist may delegate the administrative and
4    technical tasks of performing a test for the health
5    conditions described in this paragraph to a registered
6    pharmacy technician or student pharmacist acting under the
7    supervision of the pharmacist.
8    A pharmacist who performs any of the acts defined as the
9practice of pharmacy in this State must be actively licensed
10as a pharmacist under this Act.
11    (e) "Prescription" means and includes any written, oral,
12facsimile, or electronically transmitted order for drugs or
13medical devices, issued by a physician licensed to practice
14medicine in all its branches, dentist, veterinarian, podiatric
15physician, or optometrist, within the limits of his or her
16license, by a physician assistant in accordance with
17subsection (f) of Section 4, or by an advanced practice
18registered nurse in accordance with subsection (g) of Section
194, containing the following: (1) name of the patient; (2) date
20when prescription was issued; (3) name and strength of drug or
21description of the medical device prescribed; and (4)
22quantity; (5) directions for use; (6) prescriber's name,
23address, and signature; and (7) DEA registration number where
24required, for controlled substances. The prescription may, but
25is not required to, list the illness, disease, or condition
26for which the drug or device is being prescribed. DEA

 

 

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1registration numbers shall not be required on inpatient drug
2orders. A prescription for medication other than controlled
3substances shall be valid for up to 15 months from the date
4issued for the purpose of refills, unless the prescription
5states otherwise.
6    (f) "Person" means and includes a natural person,
7partnership, association, corporation, government entity, or
8any other legal entity.
9    (g) "Department" means the Department of Financial and
10Professional Regulation.
11    (h) "Board of Pharmacy" or "Board" means the State Board
12of Pharmacy of the Department of Financial and Professional
13Regulation.
14    (i) "Secretary" means the Secretary of Financial and
15Professional Regulation.
16    (j) "Drug product selection" means the interchange for a
17prescribed pharmaceutical product in accordance with Section
1825 of this Act and Section 3.14 of the Illinois Food, Drug and
19Cosmetic Act.
20    (k) "Inpatient drug order" means an order issued by an
21authorized prescriber for a resident or patient of a facility
22licensed under the Nursing Home Care Act, the ID/DD Community
23Care Act, the MC/DD Act, the Specialized Mental Health
24Rehabilitation Act of 2013, the Hospital Licensing Act, or the
25University of Illinois Hospital Act, or a facility which is
26operated by the Department of Human Services (as successor to

 

 

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1the Department of Mental Health and Developmental
2Disabilities) or the Department of Corrections.
3    (k-5) "Pharmacist" means an individual health care
4professional and provider currently licensed by this State to
5engage in the practice of pharmacy.
6    (l) "Pharmacist in charge" means the licensed pharmacist
7whose name appears on a pharmacy license and who is
8responsible for all aspects of the operation related to the
9practice of pharmacy.
10    (m) "Dispense" or "dispensing" means the interpretation,
11evaluation, and implementation of a prescription drug order,
12including the preparation and delivery of a drug or device to a
13patient or patient's agent in a suitable container
14appropriately labeled for subsequent administration to or use
15by a patient in accordance with applicable State and federal
16laws and regulations. "Dispense" or "dispensing" does not mean
17the physical delivery to a patient or a patient's
18representative in a home or institution by a designee of a
19pharmacist or by common carrier. "Dispense" or "dispensing"
20also does not mean the physical delivery of a drug or medical
21device to a patient or patient's representative by a
22pharmacist's designee within a pharmacy or drugstore while the
23pharmacist is on duty and the pharmacy is open.
24    (n) "Nonresident pharmacy" means a pharmacy that is
25located in a state, commonwealth, or territory of the United
26States, other than Illinois, that delivers, dispenses, or

 

 

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1distributes, through the United States Postal Service,
2commercially acceptable parcel delivery service, or other
3common carrier, to Illinois residents, any substance which
4requires a prescription.
5    (o) "Compounding" means the preparation and mixing of
6components, excluding flavorings, (1) as the result of a
7prescriber's prescription drug order or initiative based on
8the prescriber-patient-pharmacist relationship in the course
9of professional practice or (2) for the purpose of, or
10incident to, research, teaching, or chemical analysis and not
11for sale or dispensing. "Compounding" includes the preparation
12of drugs or devices in anticipation of receiving prescription
13drug orders based on routine, regularly observed dispensing
14patterns. Commercially available products may be compounded
15for dispensing to individual patients only if all of the
16following conditions are met: (i) the commercial product is
17not reasonably available from normal distribution channels in
18a timely manner to meet the patient's needs and (ii) the
19prescribing practitioner has requested that the drug be
20compounded.
21    (p) (Blank).
22    (q) (Blank).
23    (r) "Patient counseling" means the communication between a
24pharmacist or a student pharmacist under the supervision of a
25pharmacist and a patient or the patient's representative about
26the patient's medication or device for the purpose of

 

 

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1optimizing proper use of prescription medications or devices.
2"Patient counseling" may include without limitation (1)
3obtaining a medication history; (2) acquiring a patient's
4allergies and health conditions; (3) facilitation of the
5patient's understanding of the intended use of the medication;
6(4) proper directions for use; (5) significant potential
7adverse events; (6) potential food-drug interactions; and (7)
8the need to be compliant with the medication therapy. A
9pharmacy technician may only participate in the following
10aspects of patient counseling under the supervision of a
11pharmacist: (1) obtaining medication history; (2) providing
12the offer for counseling by a pharmacist or student
13pharmacist; and (3) acquiring a patient's allergies and health
14conditions.
15    (s) "Patient profiles" or "patient drug therapy record"
16means the obtaining, recording, and maintenance of patient
17prescription information, including prescriptions for
18controlled substances, and personal information.
19    (t) (Blank).
20    (u) "Medical device" or "device" means an instrument,
21apparatus, implement, machine, contrivance, implant, in vitro
22reagent, or other similar or related article, including any
23component part or accessory, required under federal law to
24bear the label "Caution: Federal law requires dispensing by or
25on the order of a physician". A seller of goods and services
26who, only for the purpose of retail sales, compounds, sells,

 

 

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1rents, or leases medical devices shall not, by reasons
2thereof, be required to be a licensed pharmacy.
3    (v) "Unique identifier" means an electronic signature,
4handwritten signature or initials, thumb print, or other
5acceptable biometric or electronic identification process as
6approved by the Department.
7    (w) "Current usual and customary retail price" means the
8price that a pharmacy charges to a non-third-party payor.
9    (x) "Automated pharmacy system" means a mechanical system
10located within the confines of the pharmacy or remote location
11that performs operations or activities, other than compounding
12or administration, relative to storage, packaging, dispensing,
13or distribution of medication, and which collects, controls,
14and maintains all transaction information.
15    (y) "Drug regimen review" means and includes the
16evaluation of prescription drug orders and patient records for
17(1) known allergies; (2) drug or potential therapy
18contraindications; (3) reasonable dose, duration of use, and
19route of administration, taking into consideration factors
20such as age, gender, and contraindications; (4) reasonable
21directions for use; (5) potential or actual adverse drug
22reactions; (6) drug-drug interactions; (7) drug-food
23interactions; (8) drug-disease contraindications; (9)
24therapeutic duplication; (10) patient laboratory values when
25authorized and available; (11) proper utilization (including
26over or under utilization) and optimum therapeutic outcomes;

 

 

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1and (12) abuse and misuse.
2    (z) "Electronically transmitted prescription" means a
3prescription that is created, recorded, or stored by
4electronic means; issued and validated with an electronic
5signature; and transmitted by electronic means directly from
6the prescriber to a pharmacy. An electronic prescription is
7not an image of a physical prescription that is transferred by
8electronic means from computer to computer, facsimile to
9facsimile, or facsimile to computer.
10    (aa) "Medication therapy management services" means a
11distinct service or group of services offered by licensed
12pharmacists, physicians licensed to practice medicine in all
13its branches, advanced practice registered nurses authorized
14in a written agreement with a physician licensed to practice
15medicine in all its branches, or physician assistants
16authorized in guidelines by a supervising physician that
17optimize therapeutic outcomes for individual patients through
18improved medication use. In a retail or other non-hospital
19pharmacy, medication therapy management services shall consist
20of the evaluation of prescription drug orders and patient
21medication records to resolve conflicts with the following:
22        (1) known allergies;
23        (2) drug or potential therapy contraindications;
24        (3) reasonable dose, duration of use, and route of
25    administration, taking into consideration factors such as
26    age, gender, and contraindications;

 

 

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1        (4) reasonable directions for use;
2        (5) potential or actual adverse drug reactions;
3        (6) drug-drug interactions;
4        (7) drug-food interactions;
5        (8) drug-disease contraindications;
6        (9) identification of therapeutic duplication;
7        (10) patient laboratory values when authorized and
8    available;
9        (11) proper utilization (including over or under
10    utilization) and optimum therapeutic outcomes; and
11        (12) drug abuse and misuse.
12    "Medication therapy management services" includes the
13following:
14        (1) documenting the services delivered and
15    communicating the information provided to patients'
16    prescribers within an appropriate time frame, not to
17    exceed 48 hours;
18        (2) providing patient counseling designed to enhance a
19    patient's understanding and the appropriate use of his or
20    her medications; and
21        (3) providing information, support services, and
22    resources designed to enhance a patient's adherence with
23    his or her prescribed therapeutic regimens.
24    "Medication therapy management services" may also include
25patient care functions authorized by a physician licensed to
26practice medicine in all its branches for his or her

 

 

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1identified patient or groups of patients under specified
2conditions or limitations in a standing order from the
3physician.
4    "Medication therapy management services" in a licensed
5hospital may also include the following:
6        (1) reviewing assessments of the patient's health
7    status; and
8        (2) following protocols of a hospital pharmacy and
9    therapeutics committee with respect to the fulfillment of
10    medication orders.
11    (bb) "Pharmacist care" means the provision by a pharmacist
12of medication therapy management services, with or without the
13dispensing of drugs or devices, intended to achieve outcomes
14that improve patient health, quality of life, and comfort and
15enhance patient safety.
16    (cc) "Protected health information" means individually
17identifiable health information that, except as otherwise
18provided, is:
19        (1) transmitted by electronic media;
20        (2) maintained in any medium set forth in the
21    definition of "electronic media" in the federal Health
22    Insurance Portability and Accountability Act; or
23        (3) transmitted or maintained in any other form or
24    medium.
25    "Protected health information" does not include
26individually identifiable health information found in:

 

 

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1        (1) education records covered by the federal Family
2    Educational Right and Privacy Act; or
3        (2) employment records held by a licensee in its role
4    as an employer.
5    (dd) "Standing order" means a specific order for a patient
6or group of patients issued by a physician licensed to
7practice medicine in all its branches in Illinois.
8    (ee) "Address of record" means the designated address
9recorded by the Department in the applicant's application file
10or licensee's license file maintained by the Department's
11licensure maintenance unit.
12    (ff) "Home pharmacy" means the location of a pharmacy's
13primary operations.
14    (gg) "Email address of record" means the designated email
15address recorded by the Department in the applicant's
16application file or the licensee's license file, as maintained
17by the Department's licensure maintenance unit.
18(Source: P.A. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
19102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
201-1-23; 103-1, eff. 4-27-23.)