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


Sen. Iris Y. Martinez

Filed: 3/15/2012





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2    AMENDMENT NO. ______. Amend Senate Bill 3513, AS AMENDED,
3by replacing everything after the enacting clause with the
5    "Section 5. The Pharmacy Practice Act is amended by
6changing Section 3 as follows:
7    (225 ILCS 85/3)
8    (Section scheduled to be repealed on January 1, 2018)
9    Sec. 3. Definitions. For the purpose of this Act, except
10where otherwise limited therein:
11    (a) "Pharmacy" or "drugstore" means and includes every
12store, shop, pharmacy department, or other place where
13pharmacist care is provided by a pharmacist (1) where drugs,
14medicines, or poisons are dispensed, sold or offered for sale
15at retail, or displayed for sale at retail; or (2) where
16prescriptions of physicians, dentists, advanced practice



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



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



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1diphtheria, acellular pertussis) vaccines, pursuant to a valid
2prescription or standing order, by a physician licensed to
3practice medicine in all its branches, upon completion of
4appropriate training, including how to address
5contraindications and adverse reactions set forth by rule, with
6notification to the patient's physician and appropriate record
7retention, or pursuant to hospital pharmacy and therapeutics
8committee policies and procedures; (6) drug regimen review; (7)
9(6) drug or drug-related research; (8) (7) the provision of
10patient counseling; (9) (8) the practice of telepharmacy; (10)
11(9) the provision of those acts or services necessary to
12provide pharmacist care; (11) (10) medication therapy
13management; and (12) (11) the responsibility for compounding
14and labeling of drugs and devices (except labeling by a
15manufacturer, repackager, or distributor of non-prescription
16drugs and commercially packaged legend drugs and devices),
17proper and safe storage of drugs and devices, and maintenance
18of required records. A pharmacist who performs any of the acts
19defined as the practice of pharmacy in this State must be
20actively licensed as a pharmacist under this Act.
21    (e) "Prescription" means and includes any written, oral,
22facsimile, or electronically transmitted order for drugs or
23medical devices, issued by a physician licensed to practice
24medicine in all its branches, dentist, veterinarian, or
25podiatrist, or optometrist, within the limits of their
26licenses, by a physician assistant in accordance with



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1subsection (f) of Section 4, or by an advanced practice nurse
2in accordance with subsection (g) of Section 4, containing the
3following: (l) name of the patient; (2) date when prescription
4was issued; (3) name and strength of drug or description of the
5medical device prescribed; and (4) quantity; (5) directions for
6use; (6) prescriber's name, address, and signature; and (7) DEA
7number where required, for controlled substances. The
8prescription may, but is not required to, list the illness,
9disease, or condition for which the drug or device is being
10prescribed. DEA numbers shall not be required on inpatient drug
12    (f) "Person" means and includes a natural person,
13copartnership, association, corporation, government entity, or
14any other legal entity.
15    (g) "Department" means the Department of Financial and
16Professional Regulation.
17    (h) "Board of Pharmacy" or "Board" means the State Board of
18Pharmacy of the Department of Financial and Professional
20    (i) "Secretary" means the Secretary of Financial and
21Professional Regulation.
22    (j) "Drug product selection" means the interchange for a
23prescribed pharmaceutical product in accordance with Section
2425 of this Act and Section 3.14 of the Illinois Food, Drug and
25Cosmetic Act.
26    (k) "Inpatient drug order" means an order issued by an



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1authorized prescriber for a resident or patient of a facility
2licensed under the Nursing Home Care Act, the ID/DD Community
3Care Act, the Specialized Mental Health Rehabilitation Act, or
4the Hospital Licensing Act, or "An Act in relation to the
5founding and operation of the University of Illinois Hospital
6and the conduct of University of Illinois health care
7programs", approved July 3, 1931, as amended, or a facility
8which is operated by the Department of Human Services (as
9successor to the Department of Mental Health and Developmental
10Disabilities) or the Department of Corrections.
11    (k-5) "Pharmacist" means an individual health care
12professional and provider currently licensed by this State to
13engage in the practice of pharmacy.
14    (l) "Pharmacist in charge" means the licensed pharmacist
15whose name appears on a pharmacy license and who is responsible
16for all aspects of the operation related to the practice of
18    (m) "Dispense" or "dispensing" means the interpretation,
19evaluation, and implementation of a prescription drug order,
20including the preparation and delivery of a drug or device to a
21patient or patient's agent in a suitable container
22appropriately labeled for subsequent administration to or use
23by a patient in accordance with applicable State and federal
24laws and regulations. "Dispense" or "dispensing" does not mean
25the physical delivery to a patient or a patient's
26representative in a home or institution by a designee of a



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1pharmacist or by common carrier. "Dispense" or "dispensing"
2also does not mean the physical delivery of a drug or medical
3device to a patient or patient's representative by a
4pharmacist's designee within a pharmacy or drugstore while the
5pharmacist is on duty and the pharmacy is open.
6    (n) "Nonresident pharmacy" means a pharmacy that is located
7in a state, commonwealth, or territory of the United States,
8other than Illinois, that delivers, dispenses, or distributes,
9through the United States Postal Service, commercially
10acceptable parcel delivery service, or other common carrier, to
11Illinois residents, any substance which requires a
13    (o) "Compounding" means the preparation and mixing of
14components, excluding flavorings, (1) as the result of a
15prescriber's prescription drug order or initiative based on the
16prescriber-patient-pharmacist relationship in the course of
17professional practice or (2) for the purpose of, or incident
18to, research, teaching, or chemical analysis and not for sale
19or dispensing. "Compounding" includes the preparation of drugs
20or devices in anticipation of receiving prescription drug
21orders based on routine, regularly observed dispensing
22patterns. Commercially available products may be compounded
23for dispensing to individual patients only if all of the
24following conditions are met: (i) the commercial product is not
25reasonably available from normal distribution channels in a
26timely manner to meet the patient's needs and (ii) the



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1prescribing practitioner has requested that the drug be
3    (p) (Blank).
4    (q) (Blank).
5    (r) "Patient counseling" means the communication between a
6pharmacist or a student pharmacist under the supervision of a
7pharmacist and a patient or the patient's representative about
8the patient's medication or device for the purpose of
9optimizing proper use of prescription medications or devices.
10"Patient counseling" may include without limitation (1)
11obtaining a medication history; (2) acquiring a patient's
12allergies and health conditions; (3) facilitation of the
13patient's understanding of the intended use of the medication;
14(4) proper directions for use; (5) significant potential
15adverse events; (6) potential food-drug interactions; and (7)
16the need to be compliant with the medication therapy. A
17pharmacy technician may only participate in the following
18aspects of patient counseling under the supervision of a
19pharmacist: (1) obtaining medication history; (2) providing
20the offer for counseling by a pharmacist or student pharmacist;
21and (3) acquiring a patient's allergies and health conditions.
22    (s) "Patient profiles" or "patient drug therapy record"
23means the obtaining, recording, and maintenance of patient
24prescription information, including prescriptions for
25controlled substances, and personal information.
26    (t) (Blank).



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1    (u) "Medical device" means an instrument, apparatus,
2implement, machine, contrivance, implant, in vitro reagent, or
3other similar or related article, including any component part
4or accessory, required under federal law to bear the label
5"Caution: Federal law requires dispensing by or on the order of
6a physician". A seller of goods and services who, only for the
7purpose of retail sales, compounds, sells, rents, or leases
8medical devices shall not, by reasons thereof, be required to
9be a licensed pharmacy.
10    (v) "Unique identifier" means an electronic signature,
11handwritten signature or initials, thumb print, or other
12acceptable biometric or electronic identification process as
13approved by the Department.
14    (w) "Current usual and customary retail price" means the
15price that a pharmacy charges to a non-third-party payor.
16    (x) "Automated pharmacy system" means a mechanical system
17located within the confines of the pharmacy or remote location
18that performs operations or activities, other than compounding
19or administration, relative to storage, packaging, dispensing,
20or distribution of medication, and which collects, controls,
21and maintains all transaction information.
22    (y) "Drug regimen review" means and includes the evaluation
23of prescription drug orders and patient records for (1) known
24allergies; (2) drug or potential therapy contraindications;
25(3) reasonable dose, duration of use, and route of
26administration, taking into consideration factors such as age,



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1gender, and contraindications; (4) reasonable directions for
2use; (5) potential or actual adverse drug reactions; (6)
3drug-drug interactions; (7) drug-food interactions; (8)
4drug-disease contraindications; (9) therapeutic duplication;
5(10) patient laboratory values when authorized and available;
6(11) proper utilization (including over or under utilization)
7and optimum therapeutic outcomes; and (12) abuse and misuse.
8    (z) "Electronic transmission prescription" means any
9prescription order for which a facsimile or electronic image of
10the order is electronically transmitted from a licensed
11prescriber to a pharmacy. "Electronic transmission
12prescription" includes both data and image prescriptions.
13    (aa) "Medication therapy management services" means a
14distinct service or group of services offered by licensed
15pharmacists, physicians licensed to practice medicine in all
16its branches, advanced practice nurses authorized in a written
17agreement with a physician licensed to practice medicine in all
18its branches, or physician assistants authorized in guidelines
19by a supervising physician that optimize therapeutic outcomes
20for individual patients through improved medication use. In a
21retail or other non-hospital pharmacy, medication therapy
22management services shall consist of the evaluation of
23prescription drug orders and patient medication records to
24resolve conflicts with the following:
25        (1) known allergies;
26        (2) drug or potential therapy contraindications;



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



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1"Medication therapy management services" may also include
2patient care functions authorized by a physician licensed to
3practice medicine in all its branches for his or her identified
4patient or groups of patients under specified conditions or
5limitations in a standing order from the physician.
6"Medication therapy management services" in a licensed
7hospital may also include the following:
8        (1) reviewing assessments of the patient's health
9    status; and
10        (2) following protocols of a hospital pharmacy and
11    therapeutics committee with respect to the fulfillment of
12    medication orders.
13    (bb) "Pharmacist care" means the provision by a pharmacist
14of medication therapy management services, with or without the
15dispensing of drugs or devices, intended to achieve outcomes
16that improve patient health, quality of life, and comfort and
17enhance patient safety.
18    (cc) "Protected health information" means individually
19identifiable health information that, except as otherwise
20provided, is:
21        (1) transmitted by electronic media;
22        (2) maintained in any medium set forth in the
23    definition of "electronic media" in the federal Health
24    Insurance Portability and Accountability Act; or
25        (3) transmitted or maintained in any other form or
26    medium.



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1"Protected health information" does not include individually
2identifiable health information found in:
3        (1) education records covered by the federal Family
4    Educational Right and Privacy Act; or
5        (2) employment records held by a licensee in its role
6    as an employer.
7    (dd) "Standing order" means a specific order for a patient
8or group of patients issued by a physician licensed to practice
9medicine in all its branches in Illinois.
10    (ee) "Address of record" means the address recorded by the
11Department in the applicant's or licensee's application file or
12license file, as maintained by the Department's licensure
13maintenance unit.
14    (ff) "Home pharmacy" means the location of a pharmacy's
15primary operations.
16(Source: P.A. 96-339, eff. 7-1-10; 96-673, eff. 1-1-10;
1796-1000, eff. 7-2-10; 96-1353, eff. 7-28-10; 97-38, eff.
186-28-11; 97-227, eff. 1-1-12; revised 10-4-11.)
19    Section 99. Effective date. This Act takes effect upon
20becoming law.".