093_HB3848
LRB093 13377 AMC 18672 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 of 1987 is amended
5 by changing 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7 (Section scheduled to be repealed on January 1, 2008)
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 pharmaceutical care is provided by a pharmacist (1) where
13 drugs, medicines, or poisons are dispensed, sold or offered
14 for sale at retail, or displayed for sale at retail; or (2)
15 where prescriptions of physicians, dentists, veterinarians,
16 podiatrists, or therapeutically certified optometrists,
17 within the limits of their licenses, are compounded, filled,
18 or dispensed; or (3) which has upon it or displayed within
19 it, or affixed to or used in connection with it, a sign
20 bearing the word or words "Pharmacist", "Druggist",
21 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
22 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or
23 any word or words of similar or like import, either in the
24 English language or any other language; or (4) where the
25 characteristic prescription sign (Rx) or similar design is
26 exhibited; or (5) any store, or shop, or other place with
27 respect to which any of the above words, objects, signs or
28 designs are used in any advertisement.
29 (b) "Drugs" means and includes (l) articles recognized
30 in the official United States Pharmacopoeia/National
31 Formulary (USP/NF), or any supplement thereto and being
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1 intended for and having for their main use the diagnosis,
2 cure, mitigation, treatment or prevention of disease in man
3 or other animals, as approved by the United States Food and
4 Drug Administration, but does not include devices or their
5 components, parts, or accessories; and (2) all other articles
6 intended for and having for their main use the diagnosis,
7 cure, mitigation, treatment or prevention of disease in man
8 or other animals, as approved by the United States Food and
9 Drug Administration, but does not include devices or their
10 components, parts, or accessories; and (3) articles (other
11 than food) having for their main use and intended to affect
12 the structure or any function of the body of man or other
13 animals; and (4) articles having for their main use and
14 intended for use as a component or any articles specified in
15 clause (l), (2) or (3); but does not include devices or their
16 components, parts or accessories.
17 (c) "Medicines" means and includes all drugs intended
18 for human or veterinary use approved by the United States
19 Food and Drug Administration.
20 (d) "Practice of pharmacy" means the provision of
21 pharmaceutical care to patients as determined by the
22 pharmacist's professional judgment in the following areas,
23 which may include but are not limited to (1) patient
24 counseling, (2) interpretation and assisting in the
25 monitoring of appropriate drug use and prospective drug
26 utilization review, (3) providing information on the
27 therapeutic values, reactions, drug interactions, side
28 effects, uses, selection of medications and medical devices,
29 and outcome of drug therapy, (4) participation in drug
30 selection, drug monitoring, drug utilization review,
31 evaluation, administration, interpretation, application of
32 pharmacokinetic and laboratory data to design safe and
33 effective drug regimens, (5) drug research (clinical and
34 scientific), and (6) compounding and dispensing of drugs and
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1 medical devices.
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 therapeutically certified optometrist, within
7 the limits of their licenses, by a physician assistant in
8 accordance with subsection (f) of Section 4, or by an
9 advanced practice nurse in accordance with subsection (g) of
10 Section 4, containing the following: (l) name of the patient;
11 (2) date when prescription was issued; (3) name and strength
12 of drug or description of the medical device prescribed; and
13 (4) quantity, (5) directions for use, (6) prescriber's name,
14 address and signature, and (7) DEA number where required, for
15 controlled substances. DEA numbers shall not be required on
16 inpatient drug orders.
17 (f) "Person" means and includes a natural person,
18 copartnership, association, corporation, government entity,
19 or any other legal entity.
20 (g) "Department" means the Department of Professional
21 Regulation.
22 (h) "Board of Pharmacy" or "Board" means the State Board
23 of Pharmacy of the Department of Professional Regulation.
24 (i) "Director" means the Director of Professional
25 Regulation.
26 (j) "Drug product selection" means the interchange for a
27 prescribed pharmaceutical product in accordance with Section
28 25 of this Act and Section 3.14 of the Illinois Food, Drug
29 and Cosmetic Act.
30 (k) "Inpatient drug order" means an order issued by an
31 authorized prescriber for a resident or patient of a facility
32 licensed under the Nursing Home Care Act or the Hospital
33 Licensing Act, or "An Act in relation to the founding and
34 operation of the University of Illinois Hospital and the
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1 conduct of University of Illinois health care programs",
2 approved July 3, 1931, as amended, or a facility which is
3 operated by the Department of Human Services (as successor to
4 the Department of Mental Health and Developmental
5 Disabilities) or the Department of Corrections.
6 (k-5) "Pharmacist" means an individual health care
7 professional and provider currently licensed by this State to
8 engage in the practice of pharmacy.
9 (l) "Pharmacist in charge" means the licensed pharmacist
10 whose name appears on a pharmacy license and who is
11 responsible for all aspects of the operation related to the
12 practice of pharmacy.
13 (m) "Dispense" means the delivery of drugs and medical
14 devices, in accordance with applicable State and federal laws
15 and regulations, to the patient or the patient's
16 representative authorized to receive these products,
17 including the compounding, packaging, and labeling necessary
18 for delivery, and any recommending or advising concerning the
19 contents and therapeutic values and uses thereof. "Dispense"
20 does not mean the physical delivery to a patient or a
21 patient's representative in a home or institution by a
22 designee of a pharmacist or by common carrier. "Dispense"
23 also does not mean the physical delivery of a drug or medical
24 device to a patient or patient's representative by a
25 pharmacist's designee within a pharmacy or drugstore while
26 the pharmacist is on duty and the pharmacy is open.
27 (n) "Mail-order pharmacy" means a pharmacy that is
28 located outside of Illinois in a state of the United States,
29 other than Illinois, that delivers, dispenses or distributes,
30 through the United States Postal Service or other common
31 carrier, to Illinois residents, any substance which requires
32 a prescription.
33 (o) "Compounding" means the preparation, mixing,
34 assembling, packaging, or labeling of a drug or medical
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1 device: (1) as the result of a practitioner's prescription
2 drug order or initiative that is dispensed pursuant to a
3 prescription in the course of professional practice; or (2)
4 for the purpose of, or incident to, research, teaching, or
5 chemical analysis; or (3) in anticipation of prescription
6 drug orders based on routine, regularly observed prescribing
7 patterns.
8 (p) "Confidential information" means information,
9 maintained by the pharmacist in the patient's records,
10 released only (i) to the patient or, as the patient directs,
11 to other practitioners and other pharmacists or (ii) to any
12 other person authorized by law to receive the information.
13 (q) "Prospective drug review" or "drug utilization
14 evaluation" means a screening for potential drug therapy
15 problems due to therapeutic duplication, drug-disease
16 contraindications, drug-drug interactions (including serious
17 interactions with nonprescription or over-the-counter drugs),
18 drug-food interactions, incorrect drug dosage or duration of
19 drug treatment, drug-allergy interactions, and clinical abuse
20 or misuse.
21 (r) "Patient counseling" means the communication between
22 a pharmacist or a student pharmacist under the direct
23 supervision of a pharmacist and a patient or the patient's
24 representative about the patient's medication or device for
25 the purpose of optimizing proper use of prescription
26 medications or devices. The offer to counsel by the
27 pharmacist or the pharmacist's designee, and subsequent
28 patient counseling by the pharmacist or student pharmacist,
29 shall be made in a face-to-face communication with the
30 patient or patient's representative unless, in the
31 professional judgment of the pharmacist, a face-to-face
32 communication is deemed inappropriate or unnecessary. In
33 that instance, the offer to counsel or patient counseling may
34 be made in a written communication, by telephone, or in a
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1 manner determined by the pharmacist to be appropriate.
2 (s) "Patient profiles" or "patient drug therapy record"
3 means the obtaining, recording, and maintenance of patient
4 prescription information, including prescriptions for
5 controlled substances, and personal information.
6 (t) "Pharmaceutical care" includes, but is not limited
7 to, the act of monitoring drug use and other patient care
8 services intended to achieve outcomes that improve the
9 patient's quality of life but shall not include the sale of
10 over-the-counter drugs by a seller of goods and services who
11 does not dispense prescription drugs.
12 (u) "Medical device" means an instrument, apparatus,
13 implement, machine, contrivance, implant, in vitro reagent,
14 or other similar or related article, including any component
15 part or accessory, required under federal law to bear the
16 label "Caution: Federal law requires dispensing by or on the
17 order of a physician". A seller of goods and services who,
18 only for the purpose of retail sales, compounds, sells,
19 rents, or leases medical devices shall not, by reasons
20 thereof, be required to be a licensed pharmacy.
21 (v) "Unique identifier" means an electronic signature,
22 handwritten signature or initials, thumb print, or other
23 acceptable individual biometric or electronic identification
24 process as approved by the Department.
25 (Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03.)
26 (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
27 (Section scheduled to be repealed on January 1, 2008)
28 Sec. 16a. Mail-order pharmacies.
29 (a)The Department shall establish rules and regulations,
30 consistent with the provisions of this Act, governing
31 mail-order pharmacies, including pharmacies providing
32 services via the Internet, which sell, or offer for sale,
33 drugs, medicines, or other pharmaceutical services in this
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1 State.
2 (b) The Board shall require and provide for an annual
3 nonresident special pharmacy registration for all pharmacies
4 located outside of this State that dispense medications for
5 Illinois residents and mail, ship, or deliver prescription
6 medications into this State. Nonresident special pharmacy
7 registration shall be granted by the Board upon the
8 disclosure and certification by a pharmacy:
9 (1) that it is licensed in the jurisdiction state
10 in which the dispensing facility is located and from
11 which the drugs are dispensed;
12 (2) of the location, names, and titles of all
13 principal corporate officers and all pharmacists who are
14 dispensing drugs to residents of this State;
15 (3) that it complies with all lawful directions and
16 requests for information from the board of pharmacy of
17 each state in which it is licensed or registered, except
18 that it shall respond directly to all communications from
19 the Board concerning emergency circumstances arising from
20 the dispensing of drugs to residents of this State;
21 (4) that it maintains its records of drugs
22 dispensed to residents of this State so that the records
23 are readily retrievable from the records of other drugs
24 dispensed;
25 (5) that it cooperates with the Board in providing
26 information to the board of pharmacy of the jurisdiction
27 state in which it is licensed concerning matters related
28 to the dispensing of drugs to residents of this State;
29 and
30 (6) that during its regular hours of operation, but
31 not less than 6 days per week, for a minimum of 40 hours
32 per week, a toll-free telephone service is provided to
33 facilitate communication between patients in this State
34 and a pharmacist at the pharmacy who has access to the
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1 patients' records. The toll-free number must be disclosed
2 on the label affixed to each container of drugs dispensed
3 to residents of this State.
4 (c) The Department may (i) in cooperation with the
5 jurisdiction under which the pharmacy is licensed, make site
6 visits to a pharmacy registered under this Section for
7 quality assurance purposes and (ii) notify the United States
8 Food and Drug Administration that a pharmacy registered under
9 this Section is in compliance with State laws and rules
10 governing mail-order pharmacies.
11 (Source: P.A. 91-438, eff. 1-1-00.)