Illinois General Assembly - Full Text of SB1715
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Full Text of SB1715  101st General Assembly




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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 changing
5Section 3 as follows:
6    (225 ILCS 85/3)
7    (Section scheduled to be repealed on January 1, 2020)
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 advertisement.
6    (b) "Drugs" means and includes (1) articles recognized in
7the official United States Pharmacopoeia/National Formulary
8(USP/NF), or any supplement thereto and being intended for and
9having for their main use the diagnosis, cure, mitigation,
10treatment or prevention of disease in man or other animals, as
11approved by the United States Food and Drug Administration, but
12does not include devices or their components, parts, or
13accessories; and (2) all other articles intended for and having
14for their main use the diagnosis, cure, mitigation, treatment
15or prevention of disease in man or other animals, as approved
16by the United States Food and Drug Administration, but does not
17include devices or their components, parts, or accessories; and
18(3) articles (other than food) having for their main use and
19intended to affect the structure or any function of the body of
20man or other animals; and (4) articles having for their main
21use and intended for use as a component or any articles
22specified in clause (1), (2) or (3); but does not include
23devices or their components, parts or accessories.
24    (c) "Medicines" means and includes all drugs intended for
25human or veterinary use approved by the United States Food and
26Drug Administration.



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1    (d) "Practice of pharmacy" means:
2        (1) the interpretation and the provision of assistance
3    in the monitoring, evaluation, and implementation of
4    prescription drug orders;
5        (2) the dispensing of prescription drug orders;
6        (3) participation in drug and device selection;
7        (4) drug administration limited to the administration
8    of oral, topical, injectable, and inhalation as follows:
9            (A) in the context of patient education on the
10        proper use or delivery of medications;
11            (B) vaccination of patients 14 years of age and
12        older pursuant to a valid prescription or standing
13        order, by a physician licensed to practice medicine in
14        all its branches, upon completion of appropriate
15        training, including how to address contraindications
16        and adverse reactions set forth by rule, with
17        notification to the patient's physician and
18        appropriate record retention, or pursuant to hospital
19        pharmacy and therapeutics committee policies and
20        procedures; and
21            (B-5) following the initial administration of
22        long-acting or extended release form opioid
23        antagonists by a physician licensed to practice
24        medicine in all its branches, administration of
25        injections of long-acting or extended-release form
26        opioid antagonists for the treatment of substance use



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1        disorder, pursuant to a valid prescription by a
2        physician licensed to practice medicine in all its
3        branches, upon completion of appropriate training,
4        including how to address contraindications and adverse
5        reactions, including, but not limited to, respiratory
6        depression and the performance of cardiopulmonary
7        resuscitation, set forth by rule, with notification to
8        the patient's physician and appropriate record
9        retention, or pursuant to hospital pharmacy and
10        therapeutics committee policies and procedures;
11            (C) administration of injections of
12        alpha-hydroxyprogesterone caproate, pursuant to a
13        valid prescription, by a physician licensed to
14        practice medicine in all its branches, upon completion
15        of appropriate training, including how to address
16        contraindications and adverse reactions set forth by
17        rule, with notification to the patient's physician and
18        appropriate record retention, or pursuant to hospital
19        pharmacy and therapeutics committee policies and
20        procedures; and
21            (D) administration of injections of long-term
22        antipsychotic medications pursuant to a valid
23        prescription by a physician licensed to practice
24        medicine in all its branches, upon completion of
25        appropriate training conducted by an Accreditation
26        Council of Pharmaceutical Education accredited



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1        provider, including how to address contraindications
2        and adverse reactions set forth by rule, with
3        notification to the patient's physician and
4        appropriate record retention, or pursuant to hospital
5        pharmacy and therapeutics committee policies and
6        procedures.
7        (5) vaccination of patients ages 10 through 13 limited
8    to the Influenza (inactivated influenza vaccine and live
9    attenuated influenza intranasal vaccine) and Tdap (defined
10    as tetanus, diphtheria, acellular pertussis) vaccines,
11    pursuant to a valid prescription or standing order, by a
12    physician licensed to practice medicine in all its
13    branches, upon completion of appropriate training,
14    including how to address contraindications and adverse
15    reactions set forth by rule, with notification to the
16    patient's physician and appropriate record retention, or
17    pursuant to hospital pharmacy and therapeutics committee
18    policies and procedures;
19        (6) drug regimen review;
20        (7) drug or drug-related research;
21        (8) the provision of patient counseling;
22        (9) the practice of telepharmacy;
23        (10) the provision of those acts or services necessary
24    to provide pharmacist care;
25        (11) medication therapy management; and
26        (12) the responsibility for compounding and labeling



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1    of drugs and devices (except labeling by a manufacturer,
2    repackager, or distributor of non-prescription drugs and
3    commercially packaged legend drugs and devices), proper
4    and safe storage of drugs and devices, and maintenance of
5    required records.
6    A pharmacist who performs any of the acts defined as the
7practice of pharmacy in this State must be actively licensed as
8a pharmacist under this Act.
9    (e) "Prescription" means and includes any written, oral,
10facsimile, or electronically transmitted order for drugs or
11medical devices, issued by a physician licensed to practice
12medicine in all its branches, dentist, veterinarian, podiatric
13physician, or optometrist, within the limits of his or her
14license, by a physician assistant in accordance with subsection
15(f) of Section 4, or by an advanced practice registered nurse
16in accordance with subsection (g) of Section 4, containing the
17following: (1) name of the patient; (2) date when prescription
18was issued; (3) name and strength of drug or description of the
19medical device prescribed; and (4) quantity; (5) directions for
20use; (6) prescriber's name, address, and signature; and (7) DEA
21registration number where required, for controlled substances.
22The prescription may, but is not required to, list the illness,
23disease, or condition for which the drug or device is being
24prescribed. DEA registration numbers shall not be required on
25inpatient drug orders. A prescription for medication other than
26controlled substances shall be valid for up to 15 months from



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1the date issued for the purpose of refills, unless the
2prescription states otherwise.
3    (f) "Person" means and includes a natural person,
4partnership, association, corporation, government entity, or
5any other legal entity.
6    (g) "Department" means the Department of Financial and
7Professional Regulation.
8    (h) "Board of Pharmacy" or "Board" means the State Board of
9Pharmacy of the Department of Financial and Professional
11    (i) "Secretary" means the Secretary of Financial and
12Professional Regulation.
13    (j) "Drug product selection" means the interchange for a
14prescribed pharmaceutical product in accordance with Section
1525 of this Act and Section 3.14 of the Illinois Food, Drug and
16Cosmetic Act.
17    (k) "Inpatient drug order" means an order issued by an
18authorized prescriber for a resident or patient of a facility
19licensed under the Nursing Home Care Act, the ID/DD Community
20Care Act, the MC/DD Act, the Specialized Mental Health
21Rehabilitation Act of 2013, the Hospital Licensing Act, or the
22University of Illinois Hospital Act, or a facility which is
23operated by the Department of Human Services (as successor to
24the Department of Mental Health and Developmental
25Disabilities) or the Department of Corrections.
26    (k-5) "Pharmacist" means an individual health care



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



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2    (o) "Compounding" means the preparation and mixing of
3components, excluding flavorings, (1) as the result of a
4prescriber's prescription drug order or initiative based on the
5prescriber-patient-pharmacist relationship in the course of
6professional practice or (2) for the purpose of, or incident
7to, research, teaching, or chemical analysis and not for sale
8or dispensing. "Compounding" includes the preparation of drugs
9or devices in anticipation of receiving prescription drug
10orders based on routine, regularly observed dispensing
11patterns. Commercially available products may be compounded
12for dispensing to individual patients only if all of the
13following conditions are met: (i) the commercial product is not
14reasonably available from normal distribution channels in a
15timely manner to meet the patient's needs and (ii) the
16prescribing practitioner has requested that the drug be
18    (p) (Blank).
19    (q) (Blank).
20    (r) "Patient counseling" means the communication between a
21pharmacist or a student pharmacist under the supervision of a
22pharmacist and a patient or the patient's representative about
23the patient's medication or device for the purpose of
24optimizing proper use of prescription medications or devices.
25"Patient counseling" may include without limitation (1)
26obtaining a medication history; (2) acquiring a patient's



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1allergies and health conditions; (3) facilitation of the
2patient's understanding of the intended use of the medication;
3(4) proper directions for use; (5) significant potential
4adverse events; (6) potential food-drug interactions; and (7)
5the need to be compliant with the medication therapy. A
6pharmacy technician may only participate in the following
7aspects of patient counseling under the supervision of a
8pharmacist: (1) obtaining medication history; (2) providing
9the offer for counseling by a pharmacist or student pharmacist;
10and (3) acquiring a patient's allergies and health conditions.
11    (s) "Patient profiles" or "patient drug therapy record"
12means the obtaining, recording, and maintenance of patient
13prescription information, including prescriptions for
14controlled substances, and personal information.
15    (t) (Blank).
16    (u) "Medical device" or "device" means an instrument,
17apparatus, implement, machine, contrivance, implant, in vitro
18reagent, or other similar or related article, including any
19component part or accessory, required under federal law to bear
20the label "Caution: Federal law requires dispensing by or on
21the order of a physician". A seller of goods and services who,
22only for the purpose of retail sales, compounds, sells, rents,
23or leases medical devices shall not, by reasons thereof, be
24required to be a licensed pharmacy.
25    (v) "Unique identifier" means an electronic signature,
26handwritten signature or initials, thumb print, or other



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1acceptable biometric or electronic identification process as
2approved by the Department.
3    (w) "Current usual and customary retail price" means the
4price that a pharmacy charges to a non-third-party payor.
5    (x) "Automated pharmacy system" means a mechanical system
6located within the confines of the pharmacy or remote location
7that performs operations or activities, other than compounding
8or administration, relative to storage, packaging, dispensing,
9or distribution of medication, and which collects, controls,
10and maintains all transaction information.
11    (y) "Drug regimen review" means and includes the evaluation
12of prescription drug orders and patient records for (1) known
13allergies; (2) drug or potential therapy contraindications;
14(3) reasonable dose, duration of use, and route of
15administration, taking into consideration factors such as age,
16gender, and contraindications; (4) reasonable directions for
17use; (5) potential or actual adverse drug reactions; (6)
18drug-drug interactions; (7) drug-food interactions; (8)
19drug-disease contraindications; (9) therapeutic duplication;
20(10) patient laboratory values when authorized and available;
21(11) proper utilization (including over or under utilization)
22and optimum therapeutic outcomes; and (12) abuse and misuse.
23    (z) "Electronically transmitted prescription" means a
24prescription that is created, recorded, or stored by electronic
25means; issued and validated with an electronic signature; and
26transmitted by electronic means directly from the prescriber to



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



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



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1    status; and
2        (2) following protocols of a hospital pharmacy and
3    therapeutics committee with respect to the fulfillment of
4    medication orders.
5    (bb) "Pharmacist care" means the provision by a pharmacist
6of medication therapy management services, with or without the
7dispensing of drugs or devices, intended to achieve outcomes
8that improve patient health, quality of life, and comfort and
9enhance patient safety.
10    (cc) "Protected health information" means individually
11identifiable health information that, except as otherwise
12provided, is:
13        (1) transmitted by electronic media;
14        (2) maintained in any medium set forth in the
15    definition of "electronic media" in the federal Health
16    Insurance Portability and Accountability Act; or
17        (3) transmitted or maintained in any other form or
18    medium.
19    "Protected health information" does not include
20individually identifiable health information found in:
21        (1) education records covered by the federal Family
22    Educational Right and Privacy Act; or
23        (2) employment records held by a licensee in its role
24    as an employer.
25    (dd) "Standing order" means a specific order for a patient
26or group of patients issued by a physician licensed to practice



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1medicine in all its branches in Illinois.
2    (ee) "Address of record" means the designated address
3recorded by the Department in the applicant's application file
4or licensee's license file maintained by the Department's
5licensure maintenance unit.
6    (ff) "Home pharmacy" means the location of a pharmacy's
7primary operations.
8    (gg) "Email address of record" means the designated email
9address recorded by the Department in the applicant's
10application file or the licensee's license file, as maintained
11by the Department's licensure maintenance unit.
12(Source: P.A. 99-180, eff. 7-29-15; 100-208, eff. 1-1-18;
13100-497, eff. 9-8-17; 100-513, eff. 1-1-18; 100-804, eff.
141-1-19; 100-863, eff. 8-14-18.)