Illinois General Assembly - Full Text of SB3513
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Full Text of SB3513  97th General Assembly


Sen. Iris Y. Martinez

Filed: 3/2/2012





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2    AMENDMENT NO. ______. Amend Senate Bill 3513 by replacing
3everything after the enacting clause with the following:
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7    (Section scheduled to be repealed on January 1, 2018)
8    Sec. 3. Definitions. For the the purpose of this Act,
9except where 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



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1optometrists, within the limits of their licenses, are
2compounded, filled, or dispensed; or (3) which has upon it or
3displayed within it, or affixed to or used in connection with
4it, a sign bearing the word or words "Pharmacist", "Druggist",
5"Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
6"Medicine Store", "Prescriptions", "Drugs", "Dispensary",
7"Medicines", or any word or words of similar or like import,
8either in the English language or any other language; or (4)
9where the characteristic prescription sign (Rx) or similar
10design is exhibited; or (5) any store, or shop, or other place
11with respect to which any of the above words, objects, signs or
12designs are used in any advertisement.
13    (b) "Drugs" means and includes (l) articles recognized in
14the official United States Pharmacopoeia/National Formulary
15(USP/NF), or any supplement thereto and being intended for and
16having for their main use the diagnosis, cure, mitigation,
17treatment or prevention of disease in man or other animals, as
18approved by the United States Food and Drug Administration, but
19does not include devices or their components, parts, or
20accessories; and (2) all other articles intended for and having
21for their main use the diagnosis, cure, mitigation, treatment
22or prevention of disease in man or other animals, as approved
23by the United States Food and Drug Administration, but does not
24include devices or their components, parts, or accessories; and
25(3) articles (other than food) having for their main use and
26intended to affect the structure or any function of the body of



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1man or other animals; and (4) articles having for their main
2use and intended for use as a component or any articles
3specified in clause (l), (2) or (3); but does not include
4devices or their components, parts or accessories.
5    (c) "Medicines" means and includes all drugs intended for
6human or veterinary use approved by the United States Food and
7Drug Administration.
8    (d) "Practice of pharmacy" means (1) the interpretation and
9the provision of assistance in the monitoring, evaluation, and
10implementation of prescription drug orders; (2) the dispensing
11of prescription drug orders; (3) participation in drug and
12device selection; (4) drug administration limited to the
13administration of oral, topical, injectable, and inhalation as
14follows: in the context of patient education on the proper use
15or delivery of medications; vaccination of patients 14 years of
16age and older pursuant to a valid prescription or standing
17order, by a physician licensed to practice medicine in all its
18branches, upon completion of appropriate training, including
19how to address contraindications and adverse reactions set
20forth by rule, with notification to the patient's physician and
21appropriate record retention, or pursuant to hospital pharmacy
22and therapeutics committee policies and procedures; (5) drug
23regimen review; (6) drug or drug-related research; (7) the
24provision of patient counseling; (8) the practice of
25telepharmacy; (9) the provision of those acts or services
26necessary to provide pharmacist care; (10) medication therapy



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1management; and (11) the responsibility for compounding and
2labeling of drugs and devices (except labeling by a
3manufacturer, repackager, or distributor of non-prescription
4drugs and commercially packaged legend drugs and devices),
5proper and safe storage of drugs and devices, and maintenance
6of required records. A pharmacist who performs any of the acts
7defined as the practice of pharmacy in this State must be
8actively licensed as a 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, or
13podiatrist, or optometrist, within the limits of their
14licenses, by a physician assistant in accordance with
15subsection (f) of Section 4, or by an advanced practice nurse
16in accordance with subsection (g) of Section 4, containing the
17following: (l) 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
21number where required, for controlled substances. The
22prescription may, but is not required to, list the illness,
23disease, or condition for which the drug or device is being
24prescribed. DEA numbers shall not be required on inpatient drug
26    (f) "Person" means and includes a natural person,



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1copartnership, association, corporation, government entity, or
2any other legal entity.
3    (g) "Department" means the Department of Financial and
4Professional Regulation.
5    (h) "Board of Pharmacy" or "Board" means the State Board of
6Pharmacy of the Department of Financial and Professional
8    (i) "Secretary" means the Secretary of Financial and
9Professional Regulation.
10    (j) "Drug product selection" means the interchange for a
11prescribed pharmaceutical product in accordance with Section
1225 of this Act and Section 3.14 of the Illinois Food, Drug and
13Cosmetic Act.
14    (k) "Inpatient drug order" means an order issued by an
15authorized prescriber for a resident or patient of a facility
16licensed under the Nursing Home Care Act, the ID/DD Community
17Care Act, the Specialized Mental Health Rehabilitation Act, or
18the Hospital Licensing Act, or "An Act in relation to the
19founding and operation of the University of Illinois Hospital
20and the conduct of University of Illinois health care
21programs", approved July 3, 1931, as amended, or a facility
22which is operated by the Department of Human Services (as
23successor to the Department of Mental Health and Developmental
24Disabilities) or the Department of Corrections.
25    (k-5) "Pharmacist" means an individual health care
26professional and provider currently licensed by this State to



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



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



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



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



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1    (aa) "Medication therapy management services" means a
2distinct service or group of services offered by licensed
3pharmacists, physicians licensed to practice medicine in all
4its branches, advanced practice nurses authorized in a written
5agreement with a physician licensed to practice medicine in all
6its branches, or physician assistants authorized in guidelines
7by a supervising physician that optimize therapeutic outcomes
8for individual patients through improved medication use. In a
9retail or other non-hospital pharmacy, medication therapy
10management services shall consist of the evaluation of
11prescription drug orders and patient medication records to
12resolve conflicts with the following:
13        (1) known allergies;
14        (2) drug or potential therapy contraindications;
15        (3) reasonable dose, duration of use, and route of
16    administration, taking into consideration factors such as
17    age, gender, and contraindications;
18        (4) reasonable directions for use;
19        (5) potential or actual adverse drug reactions;
20        (6) drug-drug interactions;
21        (7) drug-food interactions;
22        (8) drug-disease contraindications;
23        (9) identification of therapeutic duplication;
24        (10) patient laboratory values when authorized and
25    available;
26        (11) proper utilization (including over or under



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



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



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1maintenance unit.
2    (ff) "Home pharmacy" means the location of a pharmacy's
3primary operations.
4(Source: P.A. 96-339, eff. 7-1-10; 96-673, eff. 1-1-10;
596-1000, eff. 7-2-10; 96-1353, eff. 7-28-10; 97-38, eff.
66-28-11; 97-227, eff. 1-1-12; revised 10-4-11.)".