Illinois General Assembly - Full Text of HB4260
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Full Text of HB4260  95th General Assembly

HB4260 95TH GENERAL ASSEMBLY


 


 
95TH GENERAL ASSEMBLY
State of Illinois
2007 and 2008
HB4260

 

Introduced , by Rep. Jack D. Franks

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3   from Ch. 111, par. 4123
225 ILCS 85/16a   from Ch. 111, par. 4136a

    Amends the Pharmacy Practice Act. Provides that a pharmacy that is located in a province of Canada may obtain a nonresident special pharmacy registration from the Department of Financial and Professional Regulation upon meeting certain criteria set forth under the Act.


LRB095 14847 RAS 40787 b

FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

HB4260 LRB095 14847 RAS 40787 b

1     AN ACT concerning regulation.
 
2     Be it enacted by the People of the State of Illinois,
3 represented in the General Assembly:
 
4     Section 5. The Pharmacy Practice Act is amended by changing
5 Sections 3 and 16a as follows:
 
6     (225 ILCS 85/3)  (from Ch. 111, par. 4123)
7     (Section scheduled to be repealed on January 1, 2018)
8     Sec. 3. Definitions. For the purpose of this Act, except
9 where otherwise limited therein:
10     (a) "Pharmacy" or "drugstore" means and includes every
11 store, shop, pharmacy department, or other place where
12 pharmacist care is provided by a pharmacist (1) where drugs,
13 medicines, or poisons are dispensed, sold or offered for sale
14 at retail, or displayed for sale at retail; or (2) where
15 prescriptions of physicians, dentists, advanced practice
16 nurses, physician assistants, veterinarians, podiatrists, or
17 optometrists, within the limits of their licenses, are
18 compounded, filled, or dispensed; or (3) which has upon it or
19 displayed within it, or affixed to or used in connection with
20 it, 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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1 either in the English language or any other language; or (4)
2 where the characteristic prescription sign (Rx) or similar
3 design is exhibited; or (5) any store, or shop, or other place
4 with respect to which any of the above words, objects, signs or
5 designs are used in any advertisement.
6     (b) "Drugs" means and includes (l) articles recognized in
7 the official United States Pharmacopoeia/National Formulary
8 (USP/NF), or any supplement thereto and being intended for and
9 having for their main use the diagnosis, cure, mitigation,
10 treatment or prevention of disease in man or other animals, as
11 approved by the United States Food and Drug Administration, but
12 does not include devices or their components, parts, or
13 accessories; and (2) all other articles intended for and having
14 for their main use the diagnosis, cure, mitigation, treatment
15 or prevention of disease in man or other animals, as approved
16 by the United States Food and Drug Administration, but does not
17 include devices or their components, parts, or accessories; and
18 (3) articles (other than food) having for their main use and
19 intended to affect the structure or any function of the body of
20 man or other animals; and (4) articles having for their main
21 use and intended for use as a component or any articles
22 specified in clause (l), (2) or (3); but does not include
23 devices or their components, parts or accessories.
24     (c) "Medicines" means and includes all drugs intended for
25 human or veterinary use approved by the United States Food and
26 Drug Administration.

 

 

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1     (d) "Practice of pharmacy" means (1) the interpretation and
2 the provision of assistance in the monitoring, evaluation, and
3 implementation of prescription drug orders; (2) the dispensing
4 of prescription drug orders; (3) participation in drug and
5 device selection; (4) drug administration limited to the
6 administration of oral, topical, injectable, and inhalation as
7 follows: in the context of patient education on the proper use
8 or delivery of medications; vaccination of patients 14 years of
9 age and older pursuant to a valid prescription or standing
10 order, by a physician licensed to practice medicine in all its
11 branches, upon completion of appropriate training, including
12 how to address contraindications and adverse reactions set
13 forth by rule, with notification to the patient's physician and
14 appropriate record retention, or pursuant to hospital pharmacy
15 and therapeutics committee policies and procedures; (5) drug
16 regimen review; (6) drug or drug-related research; (7) the
17 provision of patient counseling; (8) the practice of
18 telepharmacy; (9) the provision of those acts or services
19 necessary to provide pharmacist care; (10) medication therapy
20 management; and (11) the responsibility for compounding and
21 labeling of drugs and devices (except labeling by a
22 manufacturer, repackager, or distributor of non-prescription
23 drugs and commercially packaged legend drugs and devices),
24 proper and safe storage of drugs and devices, and maintenance
25 of required records. A pharmacist who performs any of the acts
26 defined as the practice of pharmacy in this State must be

 

 

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1 actively licensed as a pharmacist under this Act.
2     (e) "Prescription" means and includes any written, oral,
3 facsimile, or electronically transmitted order for drugs or
4 medical devices, issued by a physician licensed to practice
5 medicine in all its branches, dentist, veterinarian, or
6 podiatrist, or optometrist, within the limits of their
7 licenses, by a physician assistant in accordance with
8 subsection (f) of Section 4, or by an advanced practice nurse
9 in accordance with subsection (g) of Section 4, containing the
10 following: (l) name of the patient; (2) date when prescription
11 was issued; (3) name and strength of drug or description of the
12 medical device prescribed; and (4) quantity, (5) directions for
13 use, (6) prescriber's name, address and signature, and (7) DEA
14 number where required, for controlled substances. DEA numbers
15 shall not be required on inpatient drug orders.
16     (f) "Person" means and includes a natural person,
17 copartnership, association, corporation, government entity, or
18 any other legal entity.
19     (g) "Department" means the Department of Financial and
20 Professional Regulation.
21     (h) "Board of Pharmacy" or "Board" means the State Board of
22 Pharmacy of the Department of Financial and Professional
23 Regulation.
24     (i) "Secretary" means the Secretary of Financial and
25 Professional Regulation.
26     (j) "Drug product selection" means the interchange for a

 

 

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1 prescribed pharmaceutical product in accordance with Section
2 25 of this Act and Section 3.14 of the Illinois Food, Drug and
3 Cosmetic Act.
4     (k) "Inpatient drug order" means an order issued by an
5 authorized prescriber for a resident or patient of a facility
6 licensed under the Nursing Home Care Act or the Hospital
7 Licensing Act, or "An Act in relation to the founding and
8 operation of the University of Illinois Hospital and the
9 conduct of University of Illinois health care programs",
10 approved July 3, 1931, as amended, or a facility which is
11 operated by the Department of Human Services (as successor to
12 the Department of Mental Health and Developmental
13 Disabilities) or the Department of Corrections.
14     (k-5) "Pharmacist" means an individual health care
15 professional and provider currently licensed by this State to
16 engage in the practice of pharmacy.
17     (l) "Pharmacist in charge" means the licensed pharmacist
18 whose name appears on a pharmacy license and who is responsible
19 for all aspects of the operation related to the practice of
20 pharmacy.
21     (m) "Dispense" or "dispensing" means the interpretation,
22 evaluation, and implementation of a prescription drug order,
23 including the preparation and delivery of a drug or device to a
24 patient or patient's agent in a suitable container
25 appropriately labeled for subsequent administration to or use
26 by a patient in accordance with applicable State and federal

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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

 

 

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1     Insurance Portability and Accountability Act; or
2             (3) transmitted or maintained in any other form or
3         medium.
4 "Protected health information" does not include individually
5 identifiable health information found in:
6             (1) education records covered by the federal
7         Family Educational Right and Privacy Act; or
8             (2) employment records held by a licensee in its
9         role as an employer.
10     (dd) "Standing order" means a specific order for a patient
11 or group of patients issued by a physician licensed to practice
12 medicine in all its branches in Illinois.
13     (ee) "Address of record" means the address recorded by the
14 Department in the applicant's or licensee's application file or
15 license file, as maintained by the Department's licensure
16 maintenance unit.
17     (ff) "Home pharmacy" means the location of a pharmacy's
18 primary operations.
19 (Source: P.A. 94-459, eff. 1-1-06; 95-689, eff. 10-29-07.)
 
20     (225 ILCS 85/16a)  (from Ch. 111, par. 4136a)
21     (Section scheduled to be repealed on January 1, 2018)
22     Sec. 16a. (a) The Department shall establish rules and
23 regulations, consistent with the provisions of this Act,
24 governing nonresident pharmacies, including pharmacies
25 providing services via the Internet, which sell, or offer for

 

 

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1 sale, drugs, medicines, or other pharmaceutical services in
2 this State.
3     (b) The Board shall require and provide for an annual
4 nonresident special pharmacy registration for all pharmacies
5 located outside of this State that dispense medications for
6 Illinois residents and mail, ship, or deliver prescription
7 medications into this State. Nonresident special pharmacy
8 registration shall be granted by the Board upon the disclosure
9 and certification by a pharmacy:
10         (1) that it is licensed in the state or province in
11     which the dispensing facility is located and from which the
12     drugs are dispensed;
13         (2) of the location, names, and titles of all principal
14     corporate officers and all pharmacists who are dispensing
15     drugs to residents of this State;
16         (3) that it complies with all lawful directions and
17     requests for information from the board of pharmacy of each
18     state or province in which it is licensed or registered,
19     except that it shall respond directly to all communications
20     from the Board concerning emergency circumstances arising
21     from the dispensing of drugs to residents of this State;
22         (4) that it maintains its records of drugs dispensed to
23     residents of this State so that the records are readily
24     retrievable from the records of other drugs dispensed;
25         (5) that it cooperates with the Board in providing
26     information to the board of pharmacy of the state or

 

 

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1     province in which it is licensed concerning matters related
2     to the dispensing of drugs to residents of this State; and
3         (6) that during its regular hours of operation, but not
4     less than 6 days per week, for a minimum of 40 hours per
5     week, a toll-free telephone service is provided to
6     facilitate communication between patients in this State
7     and a pharmacist at the pharmacy who has access to the
8     patients' records. The toll-free number must be disclosed
9     on the label affixed to each container of drugs dispensed
10     to residents of this State.
11 (Source: P.A. 95-689, eff. 10-29-07.)