SB1383 Engrossed LRB096 09535 ASK 19694 b

1     AN ACT concerning professional 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, 9, and 25.15 and by adding Section 8.5 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7     (Section scheduled to be repealed on January 1, 2018)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,

 

 

SB1383 Engrossed - 2 - LRB096 09535 ASK 19694 b

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.

 

 

SB1383 Engrossed - 3 - LRB096 09535 ASK 19694 b

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

 

 

SB1383 Engrossed - 4 - LRB096 09535 ASK 19694 b

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

 

 

SB1383 Engrossed - 5 - LRB096 09535 ASK 19694 b

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

 

 

SB1383 Engrossed - 6 - LRB096 09535 ASK 19694 b

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, that delivers, dispenses, or distributes,
12 through the United States Postal Service, commercially
13 acceptable parcel delivery service, or other common carrier, to
14 Illinois residents, any substance which requires a
15 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

 

 

SB1383 Engrossed - 7 - LRB096 09535 ASK 19694 b

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 student pharmacist pharmacy intern under the
10 supervision of a pharmacist and a patient or the patient's
11 representative about the patient's medication or device for the
12 purpose of optimizing proper use of prescription medications or
13 devices. "Patient counseling" may include without limitation
14 (1) 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 student pharmacist
24 intern; and (3) acquiring a patient's allergies and health
25 conditions.
26     (s) "Patient profiles" or "patient drug therapy record"

 

 

SB1383 Engrossed - 8 - LRB096 09535 ASK 19694 b

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

 

 

SB1383 Engrossed - 9 - LRB096 09535 ASK 19694 b

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

 

 

SB1383 Engrossed - 10 - LRB096 09535 ASK 19694 b

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

 

 

SB1383 Engrossed - 11 - LRB096 09535 ASK 19694 b

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

 

 

SB1383 Engrossed - 12 - LRB096 09535 ASK 19694 b

1     definition of "electronic media" in the federal Health
2     Insurance Portability and Accountability Act; or
3             (3) transmitted or maintained in any other form or
4         medium.
5 "Protected health information" does not include individually
6 identifiable health information found in:
7             (1) education records covered by the federal
8         Family Educational Right and Privacy Act; or
9             (2) employment records held by a licensee in its
10         role as an employer.
11     (dd) "Standing order" means a specific order for a patient
12 or group of patients issued by a physician licensed to practice
13 medicine in all its branches in Illinois.
14     (ee) "Address of record" means the address recorded by the
15 Department in the applicant's or licensee's application file or
16 license file, as maintained by the Department's licensure
17 maintenance unit.
18     (ff) "Home pharmacy" means the location of a pharmacy's
19 primary operations.
20 (Source: P.A. 94-459, eff. 1-1-06; 95-689, eff. 10-29-07.)
 
21     (225 ILCS 85/8.5 new)
22     Sec. 8.5. Registration as a student pharmacist.
23     (a) Any person may register with the Department as a
24 student pharmacist if he or she provides proof that he or she
25 (i) is actively enrolled in a course of study for his or her

 

 

SB1383 Engrossed - 13 - LRB096 09535 ASK 19694 b

1 first professional degree in pharmacy at a college of pharmacy
2 accredited by the Accreditation Council for Pharmacy Education
3 (ACPE) or has graduated from such a college of pharmacy within
4 the past 18 months, (ii) has not engaged in conduct or behavior
5 determined to be grounds for discipline under this Act, and
6 (iii) has filed a written application for registration on a
7 form to be prescribed and furnished by the Department for that
8 purpose.
9     (b) The Department shall issue a certificate of
10 registration as a student pharmacist to any applicant who has
11 qualified under subsection (a) of this Section, and such
12 registration shall be the sole authority required to assist
13 licensed pharmacists in the practice of pharmacy. A student
14 pharmacist may, under the supervision of a pharmacist, assist
15 in the practice of pharmacy and perform any and all functions
16 delegated to him or her by the pharmacist.
17     The Department, upon the recommendation of the Board, may
18 take any action set forth in Section 30 of this Act with regard
19 to certificates issued by the Department pursuant to this
20 Section.
21     (c) The Department may require verification of active
22 enrollment of a student pharmacist applicant from his or her
23 college of pharmacy and may request regular enrollment updates
24 from colleges of pharmacy in this State and other states.
25     (d) Any person who is enrolled in a non-traditional
26 Pharm.D. program at an ACPE accredited college of pharmacy and

 

 

SB1383 Engrossed - 14 - LRB096 09535 ASK 19694 b

1 is a licensed pharmacist under the laws of another U.S.
2 jurisdiction shall be permitted to engage in the program of
3 practice experience required in the academic program by virtue
4 of such license. Such person shall be exempt from the
5 requirement of registration as a student pharmacist while
6 engaged in the program of practice experience required in the
7 academic program.
8     (e) An applicant for registration as a student pharmacist
9 may assist a pharmacist in the practice of pharmacy for a
10 period of up to 90 days prior to the issuance of a certificate
11 of registration if the applicant has submitted the required fee
12 and an application for registration to the Department. The
13 applicant shall keep a copy of the submitted application on the
14 premises where the applicant is assisting in the practice of
15 pharmacy. The Department shall forward confirmation of receipt
16 of the application with start and expiration dates of practice
17 pending registration.
 
18     (225 ILCS 85/9)  (from Ch. 111, par. 4129)
19     (Section scheduled to be repealed on January 1, 2018)
20     Sec. 9. Registration as pharmacy technician. Any person
21 shall be entitled to registration as a registered pharmacy
22 technician who is of the age of 16 or over, has not engaged in
23 conduct or behavior determined to be grounds for discipline
24 under this Act, is attending or has graduated from an
25 accredited high school or comparable school or educational

 

 

SB1383 Engrossed - 15 - LRB096 09535 ASK 19694 b

1 institution or received a GED, and has filed a written
2 application for registration on a form to be prescribed and
3 furnished by the Department for that purpose. The Department
4 shall issue a certificate of registration as a registered
5 pharmacy technician to any applicant who has qualified as
6 aforesaid, and such registration shall be the sole authority
7 required to assist licensed pharmacists in the practice of
8 pharmacy, under the supervision of a licensed pharmacist. A
9 registered pharmacy technician may, under the supervision of a
10 pharmacist, assist in the practice of pharmacy and perform such
11 functions as assisting in the dispensing process, offering
12 counseling, receiving new verbal prescription orders, and
13 having prescriber contact concerning prescription drug order
14 clarification. A registered pharmacy technician may not engage
15 in patient counseling, drug regimen review, or clinical
16 conflict resolution.
17     Beginning on January 1, 2010, within 2 years after being
18 employed as a registered technician, a pharmacy technician must
19 become certified by successfully passing the Pharmacy
20 Technician Certification Board (PTCB) examination or another
21 Board-approved pharmacy technician examination in order to
22 continue to perform pharmacy technician's duties. This
23 requirement does not apply to pharmacy technicians hired prior
24 to January 1, 2008.
25     Any person registered as a pharmacy technician who is also
26 enrolled in a first professional degree program in pharmacy in

 

 

SB1383 Engrossed - 16 - LRB096 09535 ASK 19694 b

1 a school or college of pharmacy or a department of pharmacy of
2 a university approved by the Department shall be considered a
3 "pharmacy intern" and entitled to use the title "pharmacy
4 intern". A pharmacy intern must meet all of the requirements
5 for registration as a pharmacy technician set forth in this
6 Section and pay the required pharmacy technician registration
7 fees .
8     The Department, upon the recommendation of the Board, may
9 take any action set forth in Section 30 of this Act with regard
10 to certificates pursuant to this Section.
11     Any person who is enrolled in a non-traditional Pharm.D.
12 program at an ACPE accredited college of pharmacy and is a
13 licensed pharmacist under the laws of another United States
14 jurisdiction shall be permitted to engage in the program of
15 practice experience required in the academic program by virtue
16 of such license. Such person shall be exempt from the
17 requirement of registration as a registered pharmacy
18 technician while engaged in the program of practice experience
19 required in the academic program.
20     An applicant for registration as a pharmacy technician may
21 assist a pharmacist in the practice of pharmacy for a period of
22 up to 60 days prior to the issuance of a certificate of
23 registration if the applicant has submitted the required fee
24 and an application for registration to the Department. The
25 applicant shall keep a copy of the submitted application on the
26 premises where the applicant is assisting in the practice of

 

 

SB1383 Engrossed - 17 - LRB096 09535 ASK 19694 b

1 pharmacy. The Department shall forward confirmation of receipt
2 of the application with start and expiration dates of practice
3 pending registration.
4 (Source: P.A. 95-689, eff. 10-29-07.)
 
5     (225 ILCS 85/25.15)
6     (Section scheduled to be repealed on January 1, 2018)
7     Sec. 25.15. Telepharmacy.
8     (a) In this Section, "telepharmacy" means the provision of
9 pharmacist care by a pharmacist that is accomplished through
10 the use of telecommunications or other technologies to patients
11 or their agents who are at a distance and are located within
12 the United States, and which follows all federal and State
13 laws, rules, and regulations with regard to privacy and
14 security.
15     (b) Any pharmacy engaged in the practice of telepharmacy
16 must meet all of the following conditions:
17         (1) All events involving the contents of an automated
18     pharmacy system must be stored in a secure location and may
19     be recorded electronically.
20         (2) An automated pharmacy or prescription dispensing
21     machine system may be used in conjunction with the
22     pharmacy's practice of telepharmacy after inspection and
23     approval by the Department.
24         (3) The pharmacist in charge shall:
25             (A) be responsible for the practice of

 

 

SB1383 Engrossed - 18 - LRB096 09535 ASK 19694 b

1         telepharmacy performed at a remote pharmacy, including
2         the supervision of any prescription dispensing machine
3         or automated medication system;
4             (B) ensure that the home pharmacy has sufficient
5         pharmacists on duty for the safe operation and
6         supervision of all remote pharmacies;
7             (C) ensure, through the use of a video and auditory
8         communication system, that a certified pharmacy
9         technician at the remote pharmacy has accurately and
10         correctly prepared any prescription for dispensing
11         according to the prescription;
12             (D) be responsible for the supervision and
13         training of certified pharmacy technicians at remote
14         pharmacies who shall be subject to all rules and
15         regulations; and
16             (E) ensure that patient counseling at the remote
17         pharmacy is performed by a pharmacist or student
18         pharmacist pharmacist intern.
19 (Source: P.A. 95-689, eff. 10-29-07.)
 
20     Section 99. Effective date. This Act takes effect on
21 December 31, 2009.