093_SB1769
LRB093 07965 AMC 11678 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7 (Section scheduled to be repealed on January 1, 2008)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 (Text of Section before amendment by P.A. 92-880)
9 Sec. 3. Definitions. For the purpose of this Act, except
10 where otherwise limited therein:
11 (a) "Pharmacy" or "drugstore" means and includes every
12 store, shop, pharmacy department, or other place where
13 pharmaceutical care is provided by a pharmacist (1) where
14 drugs, medicines, or poisons are dispensed, sold or offered
15 for sale at retail, or displayed for sale at retail; or (2)
16 where prescriptions of physicians, dentists, veterinarians,
17 podiatrists, or therapeutically certified optometrists,
18 within the limits of their licenses, are compounded, filled,
19 or dispensed; or (3) which has upon it or displayed within
20 it, or affixed to or used in connection with it, a sign
21 bearing the word or words "Pharmacist", "Druggist",
22 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
23 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or
24 any word or words of similar or like import, either in the
25 English language or any other language; or (4) where the
26 characteristic prescription sign (Rx) or similar design is
27 exhibited; or (5) any store, or shop, or other place with
28 respect to which any of the above words, objects, signs or
29 designs are used in any advertisement.
30 (b) "Drugs" means and includes (l) articles recognized
31 in the official United States Pharmacopoeia/National
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1 Formulary (USP/NF), or any supplement thereto and being
2 intended for and having for their main use the diagnosis,
3 cure, mitigation, treatment or prevention of disease in man
4 or other animals, as approved by the United States Food and
5 Drug Administration, but does not include devices or their
6 components, parts, or accessories; and (2) all other articles
7 intended for and having for their main use the diagnosis,
8 cure, mitigation, treatment or prevention of disease in man
9 or other animals, as approved by the United States Food and
10 Drug Administration, but does not include devices or their
11 components, parts, or accessories; and (3) articles (other
12 than food) having for their main use and intended to affect
13 the structure or any function of the body of man or other
14 animals; and (4) articles having for their main use and
15 intended for use as a component or any articles specified in
16 clause (l), (2) or (3); but does not include devices or their
17 components, parts or accessories.
18 (c) "Medicines" means and includes all drugs intended
19 for human or veterinary use approved by the United States
20 Food and Drug Administration.
21 (d) "Practice of pharmacy" means the provision of
22 pharmaceutical care to patients as determined by the
23 pharmacist's professional judgment in the following areas,
24 which may include but are not limited to (1) patient
25 counseling, (2) interpretation and assisting in the
26 monitoring of appropriate drug use and prospective drug
27 utilization review, (3) providing information on the
28 therapeutic values, reactions, drug interactions, side
29 effects, uses, selection of medications and medical devices,
30 and outcome of drug therapy, (4) participation in drug
31 selection, drug monitoring, drug utilization review,
32 evaluation, administration, interpretation, application of
33 pharmacokinetic and laboratory data to design safe and
34 effective drug regimens, (5) drug research (clinical and
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1 scientific), and (6) compounding and dispensing of drugs and
2 medical devices.
3 (e) "Prescription" means and includes any written, oral,
4 facsimile, or electronically transmitted order for drugs or
5 medical devices, issued by a physician licensed to practice
6 medicine in all its branches, dentist, veterinarian, or
7 podiatrist, or therapeutically certified optometrist, within
8 the limits of their licenses, by a physician assistant in
9 accordance with subsection (f) of Section 4, or by an
10 advanced practice nurse in accordance with subsection (g) of
11 Section 4, containing the following: (l) name of the patient;
12 (2) date when prescription was issued; (3) name and strength
13 of drug or description of the medical device prescribed; and
14 (4) quantity, (5) directions for use, (6) prescriber's name,
15 address and signature, and (7) DEA number where required, for
16 controlled substances. DEA numbers shall not be required on
17 inpatient drug orders.
18 (f) "Person" means and includes a natural person,
19 copartnership, association, corporation, government entity,
20 or any other legal entity.
21 (g) "Department" means the Department of Professional
22 Regulation.
23 (h) "Board of Pharmacy" or "Board" means the State Board
24 of Pharmacy of the Department of Professional Regulation.
25 (i) "Director" means the Director of Professional
26 Regulation.
27 (j) "Drug product selection" means the interchange for a
28 prescribed pharmaceutical product in accordance with Section
29 25 of this Act and Section 3.14 of the Illinois Food, Drug
30 and Cosmetic Act.
31 (k) "Inpatient drug order" means an order issued by an
32 authorized prescriber for a resident or patient of a facility
33 licensed under the Nursing Home Care Act or the Hospital
34 Licensing Act, or "An Act in relation to the founding and
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1 operation of the University of Illinois Hospital and the
2 conduct of University of Illinois health care programs",
3 approved July 3, 1931, as amended, or a facility which is
4 operated by the Department of Human Services (as successor to
5 the Department of Mental Health and Developmental
6 Disabilities) or the Department of Corrections.
7 (k-5) "Pharmacist" means an individual currently
8 licensed by this State to engage in the practice of pharmacy.
9 (l) "Pharmacist in charge" means the licensed pharmacist
10 whose name appears on a pharmacy license who is responsible
11 for all aspects of the operation related to the practice of
12 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 in a state of the United States, other than Illinois,
29 or a province of Canada that delivers, dispenses or
30 distributes, through the United States Postal Service or
31 other common carrier, to Illinois residents, any substance
32 which requires 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 and personal information.
5 (t) "Pharmaceutical care" includes, but is not limited
6 to, the act of monitoring drug use and other patient care
7 services intended to achieve outcomes that improve the
8 patient's quality of life but shall not include the sale of
9 over-the-counter drugs by a seller of goods and services who
10 does not dispense prescription drugs.
11 (u) "Medical device" means an instrument, apparatus,
12 implement, machine, contrivance, implant, in vitro reagent,
13 or other similar or related article, including any component
14 part or accessory, required under federal law to bear the
15 label "Caution: Federal law requires dispensing by or on the
16 order of a physician". A seller of goods and services who,
17 only for the purpose of retail sales, compounds, sells,
18 rents, or leases medical devices shall not, by reasons
19 thereof, be required to be a licensed pharmacy.
20 (Source: P.A. 89-202, eff. 7-21-95; 89-507, eff. 7-1-97;
21 90-116, eff. 7-14-97; 90-253, eff. 7-29-97; 90-655, eff.
22 7-30-98; 90-742, eff. 8-13-98.)
23 (Text of Section after amendment by P.A. 92-880)
24 Sec. 3. Definitions. For the purpose of this Act, except
25 where otherwise limited therein:
26 (a) "Pharmacy" or "drugstore" means and includes every
27 store, shop, pharmacy department, or other place where
28 pharmaceutical care is provided by a pharmacist (1) where
29 drugs, medicines, or poisons are dispensed, sold or offered
30 for sale at retail, or displayed for sale at retail; or (2)
31 where prescriptions of physicians, dentists, veterinarians,
32 podiatrists, or therapeutically certified optometrists,
33 within the limits of their licenses, are compounded, filled,
34 or dispensed; or (3) which has upon it or displayed within
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1 it, or affixed to or used in connection with it, a sign
2 bearing the word or words "Pharmacist", "Druggist",
3 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore",
4 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or
5 any word or words of similar or like import, either in the
6 English language or any other language; or (4) where the
7 characteristic prescription sign (Rx) or similar design is
8 exhibited; or (5) any store, or shop, or other place with
9 respect to which any of the above words, objects, signs or
10 designs are used in any advertisement.
11 (b) "Drugs" means and includes (l) articles recognized
12 in the official United States Pharmacopoeia/National
13 Formulary (USP/NF), or any supplement thereto and being
14 intended for and having for their main use the diagnosis,
15 cure, mitigation, treatment or prevention of disease in man
16 or other animals, as approved by the United States Food and
17 Drug Administration, but does not include devices or their
18 components, parts, or accessories; and (2) all other articles
19 intended for and having for their main use the diagnosis,
20 cure, mitigation, treatment or prevention of disease in man
21 or other animals, as approved by the United States Food and
22 Drug Administration, but does not include devices or their
23 components, parts, or accessories; and (3) articles (other
24 than food) having for their main use and intended to affect
25 the structure or any function of the body of man or other
26 animals; and (4) articles having for their main use and
27 intended for use as a component or any articles specified in
28 clause (l), (2) or (3); but does not include devices or their
29 components, parts or accessories.
30 (c) "Medicines" means and includes all drugs intended
31 for human or veterinary use approved by the United States
32 Food and Drug Administration.
33 (d) "Practice of pharmacy" means the provision of
34 pharmaceutical care to patients as determined by the
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1 pharmacist's professional judgment in the following areas,
2 which may include but are not limited to (1) patient
3 counseling, (2) interpretation and assisting in the
4 monitoring of appropriate drug use and prospective drug
5 utilization review, (3) providing information on the
6 therapeutic values, reactions, drug interactions, side
7 effects, uses, selection of medications and medical devices,
8 and outcome of drug therapy, (4) participation in drug
9 selection, drug monitoring, drug utilization review,
10 evaluation, administration, interpretation, application of
11 pharmacokinetic and laboratory data to design safe and
12 effective drug regimens, (5) drug research (clinical and
13 scientific), and (6) compounding and dispensing of drugs and
14 medical devices.
15 (e) "Prescription" means and includes any written, oral,
16 facsimile, or electronically transmitted order for drugs or
17 medical devices, issued by a physician licensed to practice
18 medicine in all its branches, dentist, veterinarian, or
19 podiatrist, or therapeutically certified optometrist, within
20 the limits of their licenses, by a physician assistant in
21 accordance with subsection (f) of Section 4, or by an
22 advanced practice nurse in accordance with subsection (g) of
23 Section 4, containing the following: (l) name of the patient;
24 (2) date when prescription was issued; (3) name and strength
25 of drug or description of the medical device prescribed; and
26 (4) quantity, (5) directions for use, (6) prescriber's name,
27 address and signature, and (7) DEA number where required, for
28 controlled substances. DEA numbers shall not be required on
29 inpatient drug orders.
30 (f) "Person" means and includes a natural person,
31 copartnership, association, corporation, government entity,
32 or any other legal entity.
33 (g) "Department" means the Department of Professional
34 Regulation.
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1 (h) "Board of Pharmacy" or "Board" means the State Board
2 of Pharmacy of the Department of Professional Regulation.
3 (i) "Director" means the Director of Professional
4 Regulation.
5 (j) "Drug product selection" means the interchange for a
6 prescribed pharmaceutical product in accordance with Section
7 25 of this Act and Section 3.14 of the Illinois Food, Drug
8 and Cosmetic Act.
9 (k) "Inpatient drug order" means an order issued by an
10 authorized prescriber for a resident or patient of a facility
11 licensed under the Nursing Home Care Act or the Hospital
12 Licensing Act, or "An Act in relation to the founding and
13 operation of the University of Illinois Hospital and the
14 conduct of University of Illinois health care programs",
15 approved July 3, 1931, as amended, or a facility which is
16 operated by the Department of Human Services (as successor to
17 the Department of Mental Health and Developmental
18 Disabilities) or the Department of Corrections.
19 (k-5) "Pharmacist" means an individual currently
20 licensed by this State to engage in the practice of pharmacy.
21 (l) "Pharmacist in charge" means the licensed pharmacist
22 whose name appears on a pharmacy license and who is
23 responsible for all aspects of the operation related to the
24 practice of pharmacy.
25 (m) "Dispense" means the delivery of drugs and medical
26 devices, in accordance with applicable State and federal laws
27 and regulations, to the patient or the patient's
28 representative authorized to receive these products,
29 including the compounding, packaging, and labeling necessary
30 for delivery, and any recommending or advising concerning the
31 contents and therapeutic values and uses thereof. "Dispense"
32 does not mean the physical delivery to a patient or a
33 patient's representative in a home or institution by a
34 designee of a pharmacist or by common carrier. "Dispense"
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1 also does not mean the physical delivery of a drug or medical
2 device to a patient or patient's representative by a
3 pharmacist's designee within a pharmacy or drugstore while
4 the pharmacist is on duty and the pharmacy is open.
5 (n) "Mail-order pharmacy" means a pharmacy that is
6 located in a state of the United States, other than Illinois,
7 or a province of Canada that delivers, dispenses or
8 distributes, through the United States Postal Service or
9 other common carrier, to Illinois residents, any substance
10 which requires a prescription.
11 (o) "Compounding" means the preparation, mixing,
12 assembling, packaging, or labeling of a drug or medical
13 device: (1) as the result of a practitioner's prescription
14 drug order or initiative that is dispensed pursuant to a
15 prescription in the course of professional practice; or (2)
16 for the purpose of, or incident to, research, teaching, or
17 chemical analysis; or (3) in anticipation of prescription
18 drug orders based on routine, regularly observed prescribing
19 patterns.
20 (p) "Confidential information" means information,
21 maintained by the pharmacist in the patient's records,
22 released only (i) to the patient or, as the patient directs,
23 to other practitioners and other pharmacists or (ii) to any
24 other person authorized by law to receive the information.
25 (q) "Prospective drug review" or "drug utilization
26 evaluation" means a screening for potential drug therapy
27 problems due to therapeutic duplication, drug-disease
28 contraindications, drug-drug interactions (including serious
29 interactions with nonprescription or over-the-counter drugs),
30 drug-food interactions, incorrect drug dosage or duration of
31 drug treatment, drug-allergy interactions, and clinical abuse
32 or misuse.
33 (r) "Patient counseling" means the communication between
34 a pharmacist or a student pharmacist under the direct
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1 supervision of a pharmacist and a patient or the patient's
2 representative about the patient's medication or device for
3 the purpose of optimizing proper use of prescription
4 medications or devices. The offer to counsel by the
5 pharmacist or the pharmacist's designee, and subsequent
6 patient counseling by the pharmacist or student pharmacist,
7 shall be made in a face-to-face communication with the
8 patient or patient's representative unless, in the
9 professional judgment of the pharmacist, a face-to-face
10 communication is deemed inappropriate or unnecessary. In
11 that instance, the offer to counsel or patient counseling may
12 be made in a written communication, by telephone, or in a
13 manner determined by the pharmacist to be appropriate.
14 (s) "Patient profiles" or "patient drug therapy record"
15 means the obtaining, recording, and maintenance of patient
16 prescription and personal information.
17 (t) "Pharmaceutical care" includes, but is not limited
18 to, the act of monitoring drug use and other patient care
19 services intended to achieve outcomes that improve the
20 patient's quality of life but shall not include the sale of
21 over-the-counter drugs by a seller of goods and services who
22 does not dispense prescription drugs.
23 (u) "Medical device" means an instrument, apparatus,
24 implement, machine, contrivance, implant, in vitro reagent,
25 or other similar or related article, including any component
26 part or accessory, required under federal law to bear the
27 label "Caution: Federal law requires dispensing by or on the
28 order of a physician". A seller of goods and services who,
29 only for the purpose of retail sales, compounds, sells,
30 rents, or leases medical devices shall not, by reasons
31 thereof, be required to be a licensed pharmacy.
32 (v) "Unique identifier" means an electronic signature,
33 handwritten signature or initials, thumb print, or other
34 acceptable individual biometric or electronic identification
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1 process as approved by the Department.
2 (Source: P.A. 92-880, eff. 1-1-04.)
3 (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
4 (Section scheduled to be repealed on January 1, 2008)
5 Sec. 16a. (a) The Department shall establish rules and
6 regulations, consistent with the provisions of this Act,
7 governing mail-order pharmacies, including pharmacies
8 providing services via the Internet, which sell, or offer for
9 sale, drugs, medicines, or other pharmaceutical services in
10 this State.
11 (b) The Board shall require and provide for an annual
12 nonresident special pharmacy registration for all pharmacies
13 in another state of the United States or in a province of
14 Canada located outside of this State that dispense
15 medications for Illinois residents and mail, ship, or deliver
16 prescription medications into this State. Nonresident special
17 pharmacy registration shall be granted by the Board upon the
18 disclosure and certification by a pharmacy:
19 (1) that it is licensed in the U.S. state or
20 province of Canada in which the dispensing facility is
21 located and from which the drugs are dispensed;
22 (2) of the location, names, and titles of all
23 principal corporate officers and all pharmacists who are
24 dispensing drugs to residents of this State;
25 (3) that it complies with all lawful directions and
26 requests for information from the board of pharmacy of
27 each state in which it is licensed or registered, except
28 that it shall respond directly to all communications from
29 the Board concerning emergency circumstances arising from
30 the dispensing of drugs to residents of this State;
31 (4) that it maintains its records of drugs
32 dispensed to residents of this State so that the records
33 are readily retrievable from the records of other drugs
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1 dispensed;
2 (5) that it cooperates with the Board in providing
3 information to the board of pharmacy of the U.S. state or
4 province of Canada in which it is licensed concerning
5 matters related to the dispensing of drugs to residents
6 of this State; and
7 (6) that during its regular hours of operation, but
8 not less than 6 days per week, for a minimum of 40 hours
9 per week, a toll-free telephone service is provided to
10 facilitate communication between patients in this State
11 and a pharmacist at the pharmacy who has access to the
12 patients' records. The toll-free number must be disclosed
13 on the label affixed to each container of drugs dispensed
14 to residents of this State.
15 (Source: P.A. 91-438, eff. 1-1-00.)
16 Section 95. No acceleration or delay. Where this Act
17 makes changes in a statute that is represented in this Act by
18 text that is not yet or no longer in effect (for example, a
19 Section represented by multiple versions), the use of that
20 text does not accelerate or delay the taking effect of (i)
21 the changes made by this Act or (ii) provisions derived from
22 any other Public Act.
23 Section 99. Effective date. This Act takes effect upon
24 becoming law.