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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7    (Section scheduled to be repealed on January 1, 2020)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            (C) administration of injections of
22        alpha-hydroxyprogesterone caproate, pursuant to a
23        valid prescription, by a physician licensed to
24        practice medicine in all its branches, upon completion
25        of appropriate training, including how to address
26        contraindications and adverse reactions set forth by

 

 

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

 

 

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

 

 

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1    (f) "Person" means and includes a natural person,
2partnership, association, corporation, government entity, or
3any other legal entity.
4    (g) "Department" means the Department of Financial and
5Professional Regulation.
6    (h) "Board of Pharmacy" or "Board" means the State Board of
7Pharmacy of the Department of Financial and Professional
8Regulation.
9    (i) "Secretary" means the Secretary of Financial and
10Professional Regulation.
11    (j) "Drug product selection" means the interchange for a
12prescribed pharmaceutical product in accordance with Section
1325 of this Act and Section 3.14 of the Illinois Food, Drug and
14Cosmetic Act.
15    (k) "Inpatient drug order" means an order issued by an
16authorized prescriber for a resident or patient of a facility
17licensed under the Nursing Home Care Act, the ID/DD Community
18Care Act, the MC/DD Act, the Specialized Mental Health
19Rehabilitation Act of 2013, the Hospital Licensing Act, or the
20University of Illinois Hospital Act "An Act in relation to the
21founding and operation of the University of Illinois Hospital
22and the conduct of University of Illinois health care
23programs", approved July 3, 1931, as amended, or a facility
24which is operated by the Department of Human Services (as
25successor to the Department of Mental Health and Developmental
26Disabilities) or the Department of Corrections.

 

 

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

 

 

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1Illinois residents, any substance which requires a
2prescription.
3    (o) "Compounding" means the preparation and mixing of
4components, excluding flavorings, (1) as the result of a
5prescriber's prescription drug order or initiative based on the
6prescriber-patient-pharmacist relationship in the course of
7professional practice or (2) for the purpose of, or incident
8to, research, teaching, or chemical analysis and not for sale
9or dispensing. "Compounding" includes the preparation of drugs
10or devices in anticipation of receiving prescription drug
11orders based on routine, regularly observed dispensing
12patterns. Commercially available products may be compounded
13for dispensing to individual patients only if all of the
14following conditions are met: (i) the commercial product is not
15reasonably available from normal distribution channels in a
16timely manner to meet the patient's needs and (ii) the
17prescribing practitioner has requested that the drug be
18compounded.
19    (p) (Blank).
20    (q) (Blank).
21    (r) "Patient counseling" means the communication between a
22pharmacist or a student pharmacist under the supervision of a
23pharmacist and a patient or the patient's representative about
24the patient's medication or device for the purpose of
25optimizing proper use of prescription medications or devices.
26"Patient counseling" may include without limitation (1)

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1or group of patients issued by a physician licensed to practice
2medicine in all its branches in Illinois.
3    (ee) "Address of record" means the designated address
4recorded by the Department in the applicant's application file
5or licensee's license file maintained by the Department's
6licensure maintenance unit.
7    (ff) "Home pharmacy" means the location of a pharmacy's
8primary operations.
9    (gg) "Email address of record" means the designated email
10address recorded by the Department in the applicant's
11application file or the licensee's license file, as maintained
12by the Department's licensure maintenance unit.
13(Source: P.A. 99-180, eff. 7-29-15; 100-208, eff. 1-1-18;
14100-497, eff. 9-8-17; 100-513, eff. 1-1-18; revised 9-29-17.)
 
15    Section 10. The Illinois Food, Drug and Cosmetic Act is
16amended by changing Section 2.36 as follows:
 
17    (410 ILCS 620/2.36)  (from Ch. 56 1/2, par. 502.36)
18    Sec. 2.36. "Prescription" means and includes any order for
19drugs or medical devices, written, facsimile, or verbal by a
20physician licensed to practice medicine in all its branches,
21dentist, veterinarian, or podiatric physician containing the
22following: (1) name of the patient; (2) date when prescription
23was given; (3) name and strength of drug or description of the
24medical device prescribed; (4) quantity, (5) directions for

 

 

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1use, (6) prescriber's name, address and signature, and (7) DEA
2number where required, for controlled substances. A
3prescription for medication other than controlled substances
4shall be valid for up to 15 months from the date issued for the
5purpose of refills, unless the prescription states otherwise.
6(Source: P.A. 98-214, eff. 8-9-13.)