HB5530 EnrolledLRB103 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7    (Section scheduled to be repealed on January 1, 2028)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 the patient's a physician
11        licensed to practice medicine in all its branches,
12        advanced practice registered nurse, or physician
13        assistant upon completion of appropriate training
14        conducted by an Accreditation Council of
15        Pharmaceutical Education accredited provider,
16        including how to address contraindications and adverse
17        reactions set forth by rule, with notification to the
18        patient's physician and appropriate record retention,
19        or pursuant to hospital pharmacy and therapeutics
20        committee policies and procedures; .
21        (5) (blank);
22        (6) drug regimen review;
23        (7) drug or drug-related research;
24        (8) the provision of patient counseling;
25        (9) the practice of telepharmacy;
26        (10) the provision of those acts or services necessary

 

 

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

 

 

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

 

 

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

 

 

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1    Amendments of 1988 and regulations promulgated thereunder
2    or any established screening procedure that is established
3    under a statewide protocol.
4        A pharmacist may delegate the administrative and
5    technical tasks of performing a test for the health
6    conditions described in this paragraph to a registered
7    pharmacy technician or student pharmacist acting under the
8    supervision of the pharmacist.
9    A pharmacist who performs any of the acts defined as the
10practice of pharmacy in this State must be actively licensed
11as a pharmacist under this Act.
12    (e) "Prescription" means and includes any written, oral,
13facsimile, or electronically transmitted order for drugs or
14medical devices, issued by a physician licensed to practice
15medicine in all its branches, dentist, veterinarian, podiatric
16physician, or optometrist, within the limits of his or her
17license, by a physician assistant in accordance with
18subsection (f) of Section 4, or by an advanced practice
19registered nurse in accordance with subsection (g) of Section
204, containing the following: (1) name of the patient; (2) date
21when prescription was issued; (3) name and strength of drug or
22description of the medical device prescribed; and (4)
23quantity; (5) directions for use; (6) prescriber's name,
24address, and signature; and (7) DEA registration number where
25required, for controlled substances. The prescription may, but
26is not required to, list the illness, disease, or condition

 

 

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1for which the drug or device is being prescribed. DEA
2registration numbers shall not be required on inpatient drug
3orders. A prescription for medication other than controlled
4substances shall be valid for up to 15 months from the date
5issued for the purpose of refills, unless the prescription
6states otherwise.
7    (f) "Person" means and includes a natural person,
8partnership, association, corporation, government entity, or
9any other legal entity.
10    (g) "Department" means the Department of Financial and
11Professional Regulation.
12    (h) "Board of Pharmacy" or "Board" means the State Board
13of Pharmacy of the Department of Financial and Professional
14Regulation.
15    (i) "Secretary" means the Secretary of Financial and
16Professional Regulation.
17    (j) "Drug product selection" means the interchange for a
18prescribed pharmaceutical product in accordance with Section
1925 of this Act and Section 3.14 of the Illinois Food, Drug and
20Cosmetic Act.
21    (k) "Inpatient drug order" means an order issued by an
22authorized prescriber for a resident or patient of a facility
23licensed under the Nursing Home Care Act, the ID/DD Community
24Care Act, the MC/DD Act, the Specialized Mental Health
25Rehabilitation Act of 2013, the Hospital Licensing Act, or the
26University of Illinois Hospital Act, or a facility which is

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1individually identifiable health information found in:
2        (1) education records covered by the federal Family
3    Educational Right and Privacy Act; or
4        (2) employment records held by a licensee in its role
5    as an employer.
6    (dd) "Standing order" means a specific order for a patient
7or group of patients issued by a physician licensed to
8practice medicine in all its branches in Illinois.
9    (ee) "Address of record" means the designated address
10recorded by the Department in the applicant's application file
11or licensee's license file maintained by the Department's
12licensure maintenance unit.
13    (ff) "Home pharmacy" means the location of a pharmacy's
14primary operations.
15    (gg) "Email address of record" means the designated email
16address recorded by the Department in the applicant's
17application file or the licensee's license file, as maintained
18by the Department's licensure maintenance unit.
19(Source: P.A. 102-16, eff. 6-17-21; 102-103, eff. 1-1-22;
20102-558, eff. 8-20-21; 102-813, eff. 5-13-22; 102-1051, eff.
211-1-23; 103-1, eff. 4-27-23.)