SB3513 EngrossedLRB097 17615 CEL 62822 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 changing
5Section 3 as follows:
 
6    (225 ILCS 85/3)
7    (Section scheduled to be repealed on January 1, 2018)
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
16nurses, physician assistants, veterinarians, podiatrists, or
17optometrists, within the limits of their licenses, are
18compounded, filled, or dispensed; or (3) which has upon it or
19displayed within it, or affixed to or used in connection with
20it, a sign bearing the word or words "Pharmacist", "Druggist",
21"Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
22"Medicine Store", "Prescriptions", "Drugs", "Dispensary",
23"Medicines", or any word or words of similar or like import,

 

 

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1either in the English language or any other language; or (4)
2where the characteristic prescription sign (Rx) or similar
3design is exhibited; or (5) any store, or shop, or other place
4with respect to which any of the above words, objects, signs or
5designs are used in any advertisement.
6    (b) "Drugs" means and includes (l) 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 (l), (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 (1) the interpretation and
2the provision of assistance in the monitoring, evaluation, and
3implementation of prescription drug orders; (2) the dispensing
4of prescription drug orders; (3) participation in drug and
5device selection; (4) drug administration limited to the
6administration of oral, topical, injectable, and inhalation as
7follows: in the context of patient education on the proper use
8or delivery of medications; vaccination of patients 14 years of
9age and older pursuant to a valid prescription or standing
10order, by a physician licensed to practice medicine in all its
11branches, upon completion of appropriate training, including
12how to address contraindications and adverse reactions set
13forth by rule, with notification to the patient's physician and
14appropriate record retention, or pursuant to hospital pharmacy
15and therapeutics committee policies and procedures; (5)
16vaccination of patients ages 10 through 13 limited to the
17Influenza (inactivated influenza vaccine and live attenuated
18influenza intranasal vaccine) and Tdap (defined as tetanus,
19diphtheria, acellular pertussis) vaccines, pursuant to a valid
20prescription or standing order, by a physician licensed to
21practice medicine in all its branches, upon completion of
22appropriate training, including how to address
23contraindications and adverse reactions set forth by rule, with
24notification to the patient's physician and appropriate record
25retention, or pursuant to hospital pharmacy and therapeutics
26committee policies and procedures; (6) drug regimen review; (7)

 

 

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1(6) drug or drug-related research; (8) (7) the provision of
2patient counseling; (9) (8) the practice of telepharmacy; (10)
3(9) the provision of those acts or services necessary to
4provide pharmacist care; (11) (10) medication therapy
5management; and (12) (11) the responsibility for compounding
6and labeling of drugs and devices (except labeling by a
7manufacturer, repackager, or distributor of non-prescription
8drugs and commercially packaged legend drugs and devices),
9proper and safe storage of drugs and devices, and maintenance
10of required records. A pharmacist who performs any of the acts
11defined as the practice of pharmacy in this State must be
12actively licensed as a pharmacist under this Act.
13    (e) "Prescription" means and includes any written, oral,
14facsimile, or electronically transmitted order for drugs or
15medical devices, issued by a physician licensed to practice
16medicine in all its branches, dentist, veterinarian, or
17podiatrist, or optometrist, within the limits of their
18licenses, by a physician assistant in accordance with
19subsection (f) of Section 4, or by an advanced practice nurse
20in accordance with subsection (g) of Section 4, containing the
21following: (l) name of the patient; (2) date when prescription
22was issued; (3) name and strength of drug or description of the
23medical device prescribed; and (4) quantity; (5) directions for
24use; (6) prescriber's name, address, and signature; and (7) DEA
25number where required, for controlled substances. The
26prescription may, but is not required to, list the illness,

 

 

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1disease, or condition for which the drug or device is being
2prescribed. DEA numbers shall not be required on inpatient drug
3orders.
4    (f) "Person" means and includes a natural person,
5copartnership, association, corporation, government entity, or
6any other legal entity.
7    (g) "Department" means the Department of Financial and
8Professional Regulation.
9    (h) "Board of Pharmacy" or "Board" means the State Board of
10Pharmacy of the Department of Financial and Professional
11Regulation.
12    (i) "Secretary" means the Secretary of Financial and
13Professional Regulation.
14    (j) "Drug product selection" means the interchange for a
15prescribed pharmaceutical product in accordance with Section
1625 of this Act and Section 3.14 of the Illinois Food, Drug and
17Cosmetic Act.
18    (k) "Inpatient drug order" means an order issued by an
19authorized prescriber for a resident or patient of a facility
20licensed under the Nursing Home Care Act, the ID/DD Community
21Care Act, the Specialized Mental Health Rehabilitation Act, or
22the Hospital Licensing Act, or "An Act in relation to the
23founding and operation of the University of Illinois Hospital
24and the conduct of University of Illinois health care
25programs", approved July 3, 1931, as amended, or a facility
26which is operated by the Department of Human Services (as

 

 

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1successor to the 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 responsible
8for all aspects of the operation related to the practice of
9pharmacy.
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 located
25in a state, commonwealth, or territory of the United States,
26other than Illinois, that delivers, dispenses, or distributes,

 

 

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1through the United States Postal Service, commercially
2acceptable parcel delivery service, or other common carrier, to
3Illinois residents, any substance which requires a
4prescription.
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 the
8prescriber-patient-pharmacist relationship in the course of
9professional practice or (2) for the purpose of, or incident
10to, research, teaching, or chemical analysis and not for sale
11or dispensing. "Compounding" includes the preparation of drugs
12or devices in anticipation of receiving prescription drug
13orders 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 not
17reasonably available from normal distribution channels in a
18timely 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 pharmacist;
13and (3) acquiring a patient's allergies and health conditions.
14    (s) "Patient profiles" or "patient drug therapy record"
15means the obtaining, recording, and maintenance of patient
16prescription information, including prescriptions for
17controlled substances, and personal information.
18    (t) (Blank).
19    (u) "Medical device" means an instrument, apparatus,
20implement, machine, contrivance, implant, in vitro reagent, or
21other similar or related article, including any component part
22or accessory, required under federal law to bear the label
23"Caution: Federal law requires dispensing by or on the order of
24a physician". A seller of goods and services who, only for the
25purpose of retail sales, compounds, sells, rents, or leases
26medical devices shall not, by reasons thereof, be required to

 

 

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

 

 

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1prescription order for which a facsimile or electronic image of
2the order is electronically transmitted from a licensed
3prescriber to a pharmacy. "Electronic transmission
4prescription" includes both data and image prescriptions.
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 nurses authorized in a written
9agreement with a physician licensed to practice medicine in all
10its branches, or physician assistants authorized in guidelines
11by a supervising physician that optimize therapeutic outcomes
12for individual patients through improved medication use. In a
13retail or other non-hospital pharmacy, medication therapy
14management services shall consist of the evaluation of
15prescription drug orders and patient medication records to
16resolve 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
8following:
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 individually
20identifiable 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 address recorded by the
3Department in the applicant's or licensee's application file or
4license file, as maintained by the Department's licensure
5maintenance unit.
6    (ff) "Home pharmacy" means the location of a pharmacy's
7primary operations.
8(Source: P.A. 96-339, eff. 7-1-10; 96-673, eff. 1-1-10;
996-1000, eff. 7-2-10; 96-1353, eff. 7-28-10; 97-38, eff.
106-28-11; 97-227, eff. 1-1-12; revised 10-4-11.)
 
11    Section 99. Effective date. This Act takes effect upon
12becoming law.