093_HB2778ham001 LRB093 03709 AMC 13080 a 1 AMENDMENT TO HOUSE BILL 2778 2 AMENDMENT NO. . Amend House Bill 2778 in Section 5, 3 by replacing Sec. 3 with the following: 4 "(225 ILCS 85/3) (from Ch. 111, par. 4123) 5 (Section scheduled to be repealed on January 1, 2008) 6 (Text of Section before amendment by P.A. 92-880) 7 Sec. 3. Definitions. For the purpose of this Act, except 8 where otherwise limited therein: 9 (a) "Pharmacy" or "drugstore" means and includes every 10 store, shop, pharmacy department, or other place where 11 pharmaceutical care is provided by a pharmacist (1) where 12 drugs, medicines, or poisons are dispensed, sold or offered 13 for sale at retail, or displayed for sale at retail; or (2) 14 where prescriptions of physicians, dentists, veterinarians, 15 podiatrists, or therapeutically certified optometrists, 16 within the limits of their licenses, are compounded, filled, 17 or dispensed; or (3) which has upon it or displayed within 18 it, or affixed to or used in connection with it, a sign 19 bearing the word or words "Pharmacist", "Druggist", 20 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore", 21 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or 22 any word or words of similar or like import, either in the 23 English language or any other language; or (4) where the 24 characteristic prescription sign (Rx) or similar design is -2- LRB093 03709 AMC 13080 a 1 exhibited; or (5) any store, or shop, or other place with 2 respect to which any of the above words, objects, signs or 3 designs are used in any advertisement. 4 (b) "Drugs" means and includes (l) articles recognized 5 in the official United States Pharmacopoeia/National 6 Formulary (USP/NF), or any supplement thereto and being 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 (2) all other articles 12 intended for and having for their main use the diagnosis, 13 cure, mitigation, treatment or prevention of disease in man 14 or other animals, as approved by the United States Food and 15 Drug Administration, but does not include devices or their 16 components, parts, or accessories; and (3) articles (other 17 than food) having for their main use and intended to affect 18 the structure or any function of the body of man or other 19 animals; and (4) articles having for their main use and 20 intended for use as a component or any articles specified in 21 clause (l), (2) or (3); but does not include devices or their 22 components, parts or accessories. 23 (c) "Medicines" means and includes all drugs intended 24 for human or veterinary use approved by the United States 25 Food and Drug Administration. 26 (d) "Practice of pharmacy" means the provision of 27 pharmaceutical care to patients as determined by the 28 pharmacist's professional judgment in the following areas, 29 which may include but are not limited to (1) patient 30 counseling, (2) interpretation and assisting in the 31 monitoring of appropriate drug use and prospective drug 32 utilization review, (3) providing information on the 33 therapeutic values, reactions, drug interactions, side 34 effects, uses, selection of medications and medical devices, -3- LRB093 03709 AMC 13080 a 1 and outcome of drug therapy, (4) participation in drug 2 selection, drug monitoring, drug utilization review, 3 evaluation, administration, interpretation, application of 4 pharmacokinetic and laboratory data to design safe and 5 effective drug regimens, (5) drug research (clinical and 6 scientific), and (6) compounding and dispensing of drugs and 7 medical devices. 8 (e) "Prescription" means and includes any written, oral, 9 facsimile, or electronically transmitted order for drugs or 10 medical devices, issued by a physician licensed to practice 11 medicine in all its branches, dentist, veterinarian, or 12 podiatrist, or therapeutically certified optometrist, within 13 the limits of their licenses, by a physician assistant in 14 accordance with subsection (f) of Section 4, or by an 15 advanced practice nurse in accordance with subsection (g) of 16 Section 4, containing the following: (l) name of the patient; 17 (2) date when prescription was issued; (3) name and strength 18 of drug or description of the medical device prescribed; and 19 (4) quantity, (5) directions for use, (6) prescriber's name, 20 address and signature, and (7) DEA number where required, for 21 controlled substances. DEA numbers shall not be required on 22 inpatient drug orders. 23 (f) "Person" means and includes a natural person, 24 copartnership, association, corporation, government entity, 25 or any other legal entity. 26 (g) "Department" means the Department of Professional 27 Regulation. 28 (h) "Board of Pharmacy" or "Board" means the State Board 29 of Pharmacy of the Department of Professional Regulation. 30 (i) "Director" means the Director of Professional 31 Regulation. 32 (j) "Drug product selection" means the interchange for a 33 prescribed pharmaceutical product in accordance with Section 34 25 of this Act and Section 3.14 of the Illinois Food, Drug -4- LRB093 03709 AMC 13080 a 1 and Cosmetic Act. 2 (k) "Inpatient drug order" means an order issued by an 3 authorized prescriber for a resident or patient of a facility 4 licensed under the Nursing Home Care Act or the Hospital 5 Licensing Act, or "An Act in relation to the founding and 6 operation of the University of Illinois Hospital and the 7 conduct of University of Illinois health care programs", 8 approved July 3, 1931, as amended, or a facility which is 9 operated by the Department of Human Services (as successor to 10 the Department of Mental Health and Developmental 11 Disabilities) or the Department of Corrections. 12 (k-5) "Pharmacist" means an individual currently 13 licensed by this State to engage in the practice of pharmacy. 14 (l) "Pharmacist in charge" means the licensed pharmacist 15 whose name appears on a pharmacy license who is responsible 16 for all aspects of the operation related to the practice of 17 pharmacy. 18 (m) "Dispense" means the delivery of drugs and medical 19 devices, in accordance with applicable State and federal laws 20 and regulations, to the patient or the patient's 21 representative authorized to receive these products, 22 including the compounding, packaging, and labeling necessary 23 for delivery, and any recommending or advising concerning the 24 contents and therapeutic values and uses thereof. "Dispense" 25 does not mean the physical delivery to a patient or a 26 patient's representative in a home or institution by a 27 designee of a pharmacist or by common carrier. "Dispense" 28 also does not mean the physical delivery of a drug or medical 29 device to a patient or patient's representative by a 30 pharmacist's designee within a pharmacy or drugstore while 31 the pharmacist is on duty and the pharmacy is open. 32 (n) "Mail-order pharmacy" means a pharmacy that is 33 located in a state of the United States, other than Illinois, 34 that delivers, dispenses or distributes, through the United -5- LRB093 03709 AMC 13080 a 1 States Postal Service or other common carrier, to Illinois 2 residents, any substance which requires a prescription. 3 (o) "Compounding" means the preparation, mixing, 4 assembling, packaging, or labeling of a drug or medical 5 device: (1) as the result of a practitioner's prescription 6 drug order or initiative that is dispensed pursuant to a 7 prescription in the course of professional practice; or (2) 8 for the purpose of, or incident to, research, teaching, or 9 chemical analysis; or (3) in anticipation of prescription 10 drug orders based on routine, regularly observed prescribing 11 patterns. 12 (p) "Confidential information" means information, 13 maintained by the pharmacist in the patient's records, 14 released only (i) to the patient or, as the patient directs, 15 to other practitioners and other pharmacists or (ii) to any 16 other person authorized by law to receive the information. 17 (q) "Prospective drug review" or "drug utilization 18 evaluation" means a screening for potential drug therapy 19 problems due to therapeutic duplication, drug-disease 20 contraindications, drug-drug interactions (including serious 21 interactions with nonprescription or over-the-counter drugs), 22 drug-food interactions, incorrect drug dosage or duration of 23 drug treatment, drug-allergy interactions, and clinical abuse 24 or misuse. 25 (r) "Patient counseling" means the communication between 26 a pharmacist or a student pharmacist under the direct 27 supervision of a pharmacist and a patient or the patient's 28 representative about the patient's medication or device for 29 the purpose of optimizing proper use of prescription 30 medications or devices. The offer to counsel by the 31 pharmacist or the pharmacist's designee, and subsequent 32 patient counseling by the pharmacist or student pharmacist, 33 shall be made in a face-to-face communication with the 34 patient or patient's representative unless, in the -6- LRB093 03709 AMC 13080 a 1 professional judgment of the pharmacist, a face-to-face 2 communication is deemed inappropriate or unnecessary. In 3 that instance, the offer to counsel or patient counseling may 4 be made in a written communication, by telephone, or in a 5 manner determined by the pharmacist to be appropriate. 6 (s) "Patient profiles" or "patient drug therapy record" 7 means the obtaining, recording, and maintenance of patient 8 prescription and personal information. 9 (t) "Pharmaceutical care" includes, but is not limited 10 to, the act of monitoring drug use and other patient care 11 services intended to achieve outcomes that improve the 12 patient's quality of life but shall not include the sale of 13 over-the-counter drugs by a seller of goods and services who 14 does not dispense prescription drugs. 15 (u) "Medical device" means an instrument, apparatus, 16 implement, machine, contrivance, implant, in vitro reagent, 17 or other similar or related article, including any component 18 part or accessory, required under federal law to bear the 19 label "Caution: Federal law requires dispensing by or on the 20 order of a physician". A seller of goods and services who, 21 only for the purpose of retail sales, compounds, sells, 22 rents, or leases medical devices shall not, by reasons 23 thereof, be required to be a licensed pharmacy. 24 (Source: P.A. 89-202, eff. 7-21-95; 89-507, eff. 7-1-97; 25 90-116, eff. 7-14-97; 90-253, eff. 7-29-97; 90-655, eff. 26 7-30-98; 90-742, eff. 8-13-98.) 27 (Text of Section after amendment by P.A. 92-880) 28 Sec. 3. Definitions. For the purpose of this Act, except 29 where otherwise limited therein: 30 (a) "Pharmacy" or "drugstore" means and includes every 31 store, shop, pharmacy department, or other place where 32 pharmaceutical care is provided by a pharmacist (1) where 33 drugs, medicines, or poisons are dispensed, sold or offered 34 for sale at retail, or displayed for sale at retail; or (2) -7- LRB093 03709 AMC 13080 a 1 where prescriptions of physicians, dentists, veterinarians, 2 podiatrists, or therapeutically certified optometrists, 3 within the limits of their licenses, are compounded, filled, 4 or dispensed; or (3) which has upon it or displayed within 5 it, or affixed to or used in connection with it, a sign 6 bearing the word or words "Pharmacist", "Druggist", 7 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore", 8 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or 9 any word or words of similar or like import, either in the 10 English language or any other language; or (4) where the 11 characteristic prescription sign (Rx) or similar design is 12 exhibited; or (5) any store, or shop, or other place with 13 respect to which any of the above words, objects, signs or 14 designs are used in any advertisement. 15 (b) "Drugs" means and includes (l) articles recognized 16 in the official United States Pharmacopoeia/National 17 Formulary (USP/NF), or any supplement thereto and being 18 intended for and having for their main use the diagnosis, 19 cure, mitigation, treatment or prevention of disease in man 20 or other animals, as approved by the United States Food and 21 Drug Administration, but does not include devices or their 22 components, parts, or accessories; and (2) all other articles 23 intended for and having for their main use the diagnosis, 24 cure, mitigation, treatment or prevention of disease in man 25 or other animals, as approved by the United States Food and 26 Drug Administration, but does not include devices or their 27 components, parts, or accessories; and (3) articles (other 28 than food) having for their main use and intended to affect 29 the structure or any function of the body of man or other 30 animals; and (4) articles having for their main use and 31 intended for use as a component or any articles specified in 32 clause (l), (2) or (3); but does not include devices or their 33 components, parts or accessories. 34 (c) "Medicines" means and includes all drugs intended -8- LRB093 03709 AMC 13080 a 1 for human or veterinary use approved by the United States 2 Food and Drug Administration. 3 (d) "Practice of pharmacy" means the provision of 4 pharmaceutical care to patients as determined by the 5 pharmacist's professional judgment in the following areas, 6 which may include but are not limited to (1) patient 7 counseling, (2) interpretation and assisting in the 8 monitoring of appropriate drug use and prospective drug 9 utilization review, (3) providing information on the 10 therapeutic values, reactions, drug interactions, side 11 effects, uses, selection of medications and medical devices, 12 and outcome of drug therapy, (4) participation in drug 13 selection, drug monitoring, drug utilization review, 14 evaluation, administration, interpretation, application of 15 pharmacokinetic and laboratory data to design safe and 16 effective drug regimens, (5) drug research (clinical and 17 scientific), and (6) compounding and dispensing of drugs and 18 medical devices. 19 (e) "Prescription" means and includes any written, oral, 20 facsimile, or electronically transmitted order for drugs or 21 medical devices, issued by a physician licensed to practice 22 medicine in all its branches, dentist, veterinarian, or 23 podiatrist, or therapeutically certified optometrist, within 24 the limits of their licenses, by a physician assistant in 25 accordance with subsection (f) of Section 4, or by an 26 advanced practice nurse in accordance with subsection (g) of 27 Section 4, containing the following: (l) name of the patient; 28 (2) date when prescription was issued; (3) name and strength 29 of drug or description of the medical device prescribed; and 30 (4) quantity, (5) directions for use, (6) prescriber's name, 31 address and signature, and (7) DEA number where required, for 32 controlled substances. DEA numbers shall not be required on 33 inpatient drug orders. 34 (f) "Person" means and includes a natural person, -9- LRB093 03709 AMC 13080 a 1 copartnership, association, corporation, government entity, 2 or any other legal entity. 3 (g) "Department" means the Department of Professional 4 Regulation. 5 (h) "Board of Pharmacy" or "Board" means the State Board 6 of Pharmacy of the Department of Professional Regulation. 7 (i) "Director" means the Director of Professional 8 Regulation. 9 (j) "Drug product selection" means the interchange for a 10 prescribed pharmaceutical product in accordance with Section 11 25 of this Act and Section 3.14 of the Illinois Food, Drug 12 and Cosmetic Act. 13 (k) "Inpatient drug order" means an order issued by an 14 authorized prescriber for a resident or patient of a facility 15 licensed under the Nursing Home Care Act or the Hospital 16 Licensing Act, or "An Act in relation to the founding and 17 operation of the University of Illinois Hospital and the 18 conduct of University of Illinois health care programs", 19 approved July 3, 1931, as amended, or a facility which is 20 operated by the Department of Human Services (as successor to 21 the Department of Mental Health and Developmental 22 Disabilities) or the Department of Corrections. 23 (k-5) "Pharmacist" means an individual health care 24 professional and provider currently licensed by this State to 25 engage in the practice of pharmacy. 26 (l) "Pharmacist in charge" means the licensed pharmacist 27 whose name appears on a pharmacy license and who is 28 responsible for all aspects of the operation related to the 29 practice of pharmacy. 30 (m) "Dispense" means the delivery of drugs and medical 31 devices, in accordance with applicable State and federal laws 32 and regulations, to the patient or the patient's 33 representative authorized to receive these products, 34 including the compounding, packaging, and labeling necessary -10- LRB093 03709 AMC 13080 a 1 for delivery, and any recommending or advising concerning the 2 contents and therapeutic values and uses thereof. "Dispense" 3 does not mean the physical delivery to a patient or a 4 patient's representative in a home or institution by a 5 designee of a pharmacist or by common carrier. "Dispense" 6 also does not mean the physical delivery of a drug or medical 7 device to a patient or patient's representative by a 8 pharmacist's designee within a pharmacy or drugstore while 9 the pharmacist is on duty and the pharmacy is open. 10 (n) "Mail-order pharmacy" means a pharmacy that is 11 located in a state of the United States, other than Illinois, 12 that delivers, dispenses or distributes, through the United 13 States Postal Service or other common carrier, to Illinois 14 residents, any substance which requires a prescription. 15 (o) "Compounding" means the preparation, mixing, 16 assembling, packaging, or labeling of a drug or medical 17 device: (1) as the result of a practitioner's prescription 18 drug order or initiative that is dispensed pursuant to a 19 prescription in the course of professional practice; or (2) 20 for the purpose of, or incident to, research, teaching, or 21 chemical analysis; or (3) in anticipation of prescription 22 drug orders based on routine, regularly observed prescribing 23 patterns. 24 (p) "Confidential information" means information, 25 maintained by the pharmacist in the patient's records, 26 released only (i) to the patient or, as the patient directs, 27 to other practitioners and other pharmacists or (ii) to any 28 other person authorized by law to receive the information. 29 (q) "Prospective drug review" or "drug utilization 30 evaluation" means a screening for potential drug therapy 31 problems due to therapeutic duplication, drug-disease 32 contraindications, drug-drug interactions (including serious 33 interactions with nonprescription or over-the-counter drugs), 34 drug-food interactions, incorrect drug dosage or duration of -11- LRB093 03709 AMC 13080 a 1 drug treatment, drug-allergy interactions, and clinical abuse 2 or misuse. 3 (r) "Patient counseling" means the communication between 4 a pharmacist or a student pharmacist under the direct 5 supervision of a pharmacist and a patient or the patient's 6 representative about the patient's medication or device for 7 the purpose of optimizing proper use of prescription 8 medications or devices. The offer to counsel by the 9 pharmacist or the pharmacist's designee, and subsequent 10 patient counseling by the pharmacist or student pharmacist, 11 shall be made in a face-to-face communication with the 12 patient or patient's representative unless, in the 13 professional judgment of the pharmacist, a face-to-face 14 communication is deemed inappropriate or unnecessary. In 15 that instance, the offer to counsel or patient counseling may 16 be made in a written communication, by telephone, or in a 17 manner determined by the pharmacist to be appropriate. 18 (s) "Patient profiles" or "patient drug therapy record" 19 means the obtaining, recording, and maintenance of patient 20 prescription information, including prescriptions for 21 controlled substances, and personal information. 22 (t) "Pharmaceutical care" includes, but is not limited 23 to, the act of monitoring drug use and other patient care 24 services intended to achieve outcomes that improve the 25 patient's quality of life but shall not include the sale of 26 over-the-counter drugs by a seller of goods and services who 27 does not dispense prescription drugs. 28 (u) "Medical device" means an instrument, apparatus, 29 implement, machine, contrivance, implant, in vitro reagent, 30 or other similar or related article, including any component 31 part or accessory, required under federal law to bear the 32 label "Caution: Federal law requires dispensing by or on the 33 order of a physician". A seller of goods and services who, 34 only for the purpose of retail sales, compounds, sells, -12- LRB093 03709 AMC 13080 a 1 rents, or leases medical devices shall not, by reasons 2 thereof, be required to be a licensed pharmacy. 3 (v) "Unique identifier" means an electronic signature, 4 handwritten signature or initials, thumb print, or other 5 acceptable individual biometric or electronic identification 6 process as approved by the Department. 7 (Source: P.A. 92-880, eff. 1-1-04.)".