093_SB1983sam001 LRB093 08954 AMC 14338 a 1 AMENDMENT TO SENATE BILL 1983 2 AMENDMENT NO. . Amend Senate Bill 1983 by replacing 3 everything after the enacting clause with the following: 4 "Section 5. The Pharmacy Practice Act of 1987 is amended 5 by changing Section 3 as follows: 6 (225 ILCS 85/3) (from Ch. 111, par. 4123) 7 (Section scheduled to be repealed on January 1, 2008) 8 (Text of Section before amendment by P.A. 92-880) 9 Sec. 3.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", -2- LRB093 08954 AMC 14338 a 1 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or 2 any word or words of similar or like import, either in the 3 English language or any other language; or (4) where the 4 characteristic prescription sign (Rx) or similar design is 5 exhibited; or (5) any store, or shop, or other place with 6 respect to which any of the above words, objects, signs or 7 designs are used in any advertisement. 8 (b) "Drugs" means and includes (l) articles recognized 9 in the official United States Pharmacopoeia/National 10 Formulary (USP/NF), or any supplement thereto and being 11 intended for and having for their main use the diagnosis, 12 cure, mitigation, treatment or prevention of disease in man 13 or other animals, as approved by the United States Food and 14 Drug Administration, but does not include devices or their 15 components, parts, or accessories; and (2) all other articles 16 intended for and having for their main use the diagnosis, 17 cure, mitigation, treatment or prevention of disease in man 18 or other animals, as approved by the United States Food and 19 Drug Administration, but does not include devices or their 20 components, parts, or accessories; and (3) articles (other 21 than food) having for their main use and intended to affect 22 the structure or any function of the body of man or other 23 animals; and (4) articles having for their main use and 24 intended for use as a component or any articles specified in 25 clause (l), (2) or (3); but does not include devices or their 26 components, parts or accessories. 27 (c) "Medicines" means and includes all drugs intended 28 for human or veterinary use approved by the United States 29 Food and Drug Administration. 30 (d) "Practice of pharmacy" means the provision of 31 pharmaceutical care to patients as determined by the 32 pharmacist's professional judgment in the following areas, 33 which may include but are not limited to (1) patient 34 counseling, (2) interpretation and assisting in the -3- LRB093 08954 AMC 14338 a 1 monitoring of appropriate drug use and prospective drug 2 utilization review, (3) providing information on the 3 therapeutic values, reactions, drug interactions, side 4 effects, uses, selection of medications and medical devices, 5 and outcome of drug therapy, (4) participation in drug 6 selection, drug monitoring, drug utilization review, 7 evaluation, administration, interpretation, application of 8 pharmacokinetic and laboratory data to design safe and 9 effective drug regimens, (5) drug research (clinical and 10 scientific), and (6) compounding and dispensing of drugs and 11 medical devices. 12 (e) "Prescription" means and includes any written, oral, 13 facsimile, or electronically transmitted order for drugs or 14 medical devices, issued by a physician licensed to practice 15 medicine in all its branches, dentist, veterinarian, or 16 podiatrist, or therapeutically certified optometrist, within 17 the limits of their licenses, by a physician assistant in 18 accordance with subsection (f) of Section 4, or by an 19 advanced practice nurse in accordance with subsection (g) of 20 Section 4, containing the following: (l) name of the patient; 21 (2) date when prescription was issued; (3) name and strength 22 of drug or description of the medical device prescribed; and 23 (4) quantity, (5) directions for use, (6) prescriber's name, 24 address and signature, and (7) DEA number where required, for 25 controlled substances. DEA numbers shall not be required on 26 inpatient drug orders. 27 (f) "Person" means and includes a natural person, 28 copartnership, association, corporation, government entity, 29 or any other legal entity. 30 (g) "Department" means the Department of Professional 31 Regulation. 32 (h) "Board of Pharmacy" or "Board" means the State Board 33 of Pharmacy of the Department of Professional Regulation. 34 (i) "Director" means the Director of Professional -4- LRB093 08954 AMC 14338 a 1 Regulation. 2 (j) "Drug product selection" means the interchange for a 3 prescribed pharmaceutical product in accordance with Section 4 25 of this Act and Section 3.14 of the Illinois Food, Drug 5 and Cosmetic Act. 6 (k) "Inpatient drug order" means an order issued by an 7 authorized prescriber for a resident or patient of a facility 8 licensed under the Nursing Home Care Act or the Hospital 9 Licensing Act, or "An Act in relation to the founding and 10 operation of the University of Illinois Hospital and the 11 conduct of University of Illinois health care programs", 12 approved July 3, 1931, as amended, or a facility which is 13 operated by the Department of Human Services (as successor to 14 the Department of Mental Health and Developmental 15 Disabilities) or the Department of Corrections. 16 (k-5) "Pharmacist" means an individual health care 17 professional and provider currently licensed by this State to 18 engage in the practice of pharmacy. 19 (l) "Pharmacist in charge" means the licensed pharmacist 20 whose name appears on a pharmacy license who is responsible 21 for all aspects of the operation related to the practice of 22 pharmacy. 23 (m) "Dispense" means the delivery of drugs and medical 24 devices, in accordance with applicable State and federal laws 25 and regulations, to the patient or the patient's 26 representative authorized to receive these products, 27 including the compounding, packaging, and labeling necessary 28 for delivery, and any recommending or advising concerning the 29 contents and therapeutic values and uses thereof. "Dispense" 30 does not mean the physical delivery to a patient or a 31 patient's representative in a home or institution by a 32 designee of a pharmacist or by common carrier. "Dispense" 33 also does not mean the physical delivery of a drug or medical 34 device to a patient or patient's representative by a -5- LRB093 08954 AMC 14338 a 1 pharmacist's designee within a pharmacy or drugstore while 2 the pharmacist is on duty and the pharmacy is open. 3 (n) "Mail-order pharmacy" means a pharmacy that is 4 located in a state of the United States, other than Illinois, 5 that delivers, dispenses or distributes, through the United 6 States Postal Service or other common carrier, to Illinois 7 residents, any substance which requires a prescription. 8 (o) "Compounding" means the preparation, mixing, 9 assembling, packaging, or labeling of a drug or medical 10 device: (1) as the result of a practitioner's prescription 11 drug order or initiative that is dispensed pursuant to a 12 prescription in the course of professional practice; or (2) 13 for the purpose of, or incident to, research, teaching, or 14 chemical analysis; or (3) in anticipation of prescription 15 drug orders based on routine, regularly observed prescribing 16 patterns. 17 (p) "Confidential information" means information, 18 maintained by the pharmacist in the patient's records, 19 released only (i) to the patient or, as the patient directs, 20 to other practitioners and other pharmacists or (ii) to any 21 other person authorized by law to receive the information. 22 (q) "Prospective drug review" or "drug utilization 23 evaluation" means a screening for potential drug therapy 24 problems due to therapeutic duplication, drug-disease 25 contraindications, drug-drug interactions (including serious 26 interactions with nonprescription or over-the-counter drugs), 27 drug-food interactions, incorrect drug dosage or duration of 28 drug treatment, drug-allergy interactions, and clinical abuse 29 or misuse. 30 (r) "Patient counseling" means the communication between 31 a pharmacist or a student pharmacist under the direct 32 supervision of a pharmacist and a patient or the patient's 33 representative about the patient's medication or device for 34 the purpose of optimizing proper use of prescription -6- LRB093 08954 AMC 14338 a 1 medications or devices. The offer to counsel by the 2 pharmacist or the pharmacist's designee, and subsequent 3 patient counseling by the pharmacist or student pharmacist, 4 shall be made in a face-to-face communication with the 5 patient or patient's representative unless, in the 6 professional judgment of the pharmacist, a face-to-face 7 communication is deemed inappropriate or unnecessary. In 8 that instance, the offer to counsel or patient counseling may 9 be made in a written communication, by telephone, or in a 10 manner determined by the pharmacist to be appropriate. 11 (s) "Patient profiles" or "patient drug therapy record" 12 means the obtaining, recording, and maintenance of patient 13 prescription and personal information. 14 (t) "Pharmaceutical care" includes, but is not limited 15 to, the act of monitoring drug use and other patient care 16 services intended to achieve outcomes that improve the 17 patient's quality of life but shall not include the sale of 18 over-the-counter drugs by a seller of goods and services who 19 does not dispense prescription drugs. 20 (u) "Medical device" means an instrument, apparatus, 21 implement, machine, contrivance, implant, in vitro reagent, 22 or other similar or related article, including any component 23 part or accessory, required under federal law to bear the 24 label "Caution: Federal law requires dispensing by or on the 25 order of a physician". A seller of goods and services who, 26 only for the purpose of retail sales, compounds, sells, 27 rents, or leases medical devices shall not, by reasons 28 thereof, be required to be a licensed pharmacy. 29 (Source: P.A. 89-202, eff. 7-21-95; 89-507, eff. 7-1-97; 30 90-116, eff. 7-14-97; 90-253, eff. 7-29-97; 90-655, eff. 31 7-30-98; 90-742, eff. 8-13-98.) 32 (Text of Section after amendment by P.A. 92-880) 33 Sec. 3. Definitions. For the purpose of this Act, except 34 where otherwise limited therein: -7- LRB093 08954 AMC 14338 a 1 (a) "Pharmacy" or "drugstore" means and includes every 2 store, shop, pharmacy department, or other place where 3 pharmaceutical care is provided by a pharmacist (1) where 4 drugs, medicines, or poisons are dispensed, sold or offered 5 for sale at retail, or displayed for sale at retail; or (2) 6 where prescriptions of physicians, dentists, veterinarians, 7 podiatrists, or therapeutically certified optometrists, 8 within the limits of their licenses, are compounded, filled, 9 or dispensed; or (3) which has upon it or displayed within 10 it, or affixed to or used in connection with it, a sign 11 bearing the word or words "Pharmacist", "Druggist", 12 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore", 13 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or 14 any word or words of similar or like import, either in the 15 English language or any other language; or (4) where the 16 characteristic prescription sign (Rx) or similar design is 17 exhibited; or (5) any store, or shop, or other place with 18 respect to which any of the above words, objects, signs or 19 designs are used in any advertisement. 20 (b) "Drugs" means and includes (l) articles recognized 21 in the official United States Pharmacopoeia/National 22 Formulary (USP/NF), or any supplement thereto and being 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 (2) all other articles 28 intended for and having for their main use the diagnosis, 29 cure, mitigation, treatment or prevention of disease in man 30 or other animals, as approved by the United States Food and 31 Drug Administration, but does not include devices or their 32 components, parts, or accessories; and (3) articles (other 33 than food) having for their main use and intended to affect 34 the structure or any function of the body of man or other -8- LRB093 08954 AMC 14338 a 1 animals; and (4) articles having for their main use and 2 intended for use as a component or any articles specified in 3 clause (l), (2) or (3); but does not include devices or their 4 components, parts or accessories. 5 (c) "Medicines" means and includes all drugs intended 6 for human or veterinary use approved by the United States 7 Food and Drug Administration. 8 (d) "Practice of pharmacy" means the provision of 9 pharmaceutical care to patients as determined by the 10 pharmacist's professional judgment in the following areas, 11 which may include but are not limited to (1) patient 12 counseling, (2) interpretation and assisting in the 13 monitoring of appropriate drug use and prospective drug 14 utilization review, (3) providing information on the 15 therapeutic values, reactions, drug interactions, side 16 effects, uses, selection of medications and medical devices, 17 and outcome of drug therapy, (4) participation in drug 18 selection, drug monitoring, drug utilization review, 19 evaluation, administration, interpretation, application of 20 pharmacokinetic and laboratory data to design safe and 21 effective drug regimens, (5) drug research (clinical and 22 scientific), and (6) compounding and dispensing of drugs and 23 medical devices. 24 (e) "Prescription" means and includes any written, oral, 25 facsimile, or electronically transmitted order for drugs or 26 medical devices, issued by a physician licensed to practice 27 medicine in all its branches, dentist, veterinarian, or 28 podiatrist, or therapeutically certified optometrist, within 29 the limits of their licenses, by a physician assistant in 30 accordance with subsection (f) of Section 4, or by an 31 advanced practice nurse in accordance with subsection (g) of 32 Section 4, containing the following: (l) name of the patient; 33 (2) date when prescription was issued; (3) name and strength 34 of drug or description of the medical device prescribed; and -9- LRB093 08954 AMC 14338 a 1 (4) quantity, (5) directions for use, (6) prescriber's name, 2 address and signature, and (7) DEA number where required, for 3 controlled substances. DEA numbers shall not be required on 4 inpatient drug orders. 5 (f) "Person" means and includes a natural person, 6 copartnership, association, corporation, government entity, 7 or any other legal entity. 8 (g) "Department" means the Department of Professional 9 Regulation. 10 (h) "Board of Pharmacy" or "Board" means the State Board 11 of Pharmacy of the Department of Professional Regulation. 12 (i) "Director" means the Director of Professional 13 Regulation. 14 (j) "Drug product selection" means the interchange for a 15 prescribed pharmaceutical product in accordance with Section 16 25 of this Act and Section 3.14 of the Illinois Food, Drug 17 and Cosmetic Act. 18 (k) "Inpatient drug order" means an order issued by an 19 authorized prescriber for a resident or patient of a facility 20 licensed under the Nursing Home Care Act or the Hospital 21 Licensing Act, or "An Act in relation to the founding and 22 operation of the University of Illinois Hospital and the 23 conduct of University of Illinois health care programs", 24 approved July 3, 1931, as amended, or a facility which is 25 operated by the Department of Human Services (as successor to 26 the Department of Mental Health and Developmental 27 Disabilities) or the Department of Corrections. 28 (k-5) "Pharmacist" means an individual health care 29 professional and provider currently licensed by this State to 30 engage in the practice of pharmacy. 31 (l) "Pharmacist in charge" means the licensed pharmacist 32 whose name appears on a pharmacy license and who is 33 responsible for all aspects of the operation related to the 34 practice of pharmacy. -10- LRB093 08954 AMC 14338 a 1 (m) "Dispense" means the delivery of drugs and medical 2 devices, in accordance with applicable State and federal laws 3 and regulations, to the patient or the patient's 4 representative authorized to receive these products, 5 including the compounding, packaging, and labeling necessary 6 for delivery, and any recommending or advising concerning the 7 contents and therapeutic values and uses thereof. "Dispense" 8 does not mean the physical delivery to a patient or a 9 patient's representative in a home or institution by a 10 designee of a pharmacist or by common carrier. "Dispense" 11 also does not mean the physical delivery of a drug or medical 12 device to a patient or patient's representative by a 13 pharmacist's designee within a pharmacy or drugstore while 14 the pharmacist is on duty and the pharmacy is open. 15 (n) "Mail-order pharmacy" means a pharmacy that is 16 located in a state of the United States, other than Illinois, 17 that delivers, dispenses or distributes, through the United 18 States Postal Service or other common carrier, to Illinois 19 residents, any substance which requires a prescription. 20 (o) "Compounding" means the preparation, mixing, 21 assembling, packaging, or labeling of a drug or medical 22 device: (1) as the result of a practitioner's prescription 23 drug order or initiative that is dispensed pursuant to a 24 prescription in the course of professional practice; or (2) 25 for the purpose of, or incident to, research, teaching, or 26 chemical analysis; or (3) in anticipation of prescription 27 drug orders based on routine, regularly observed prescribing 28 patterns. 29 (p) "Confidential information" means information, 30 maintained by the pharmacist in the patient's records, 31 released only (i) to the patient or, as the patient directs, 32 to other practitioners and other pharmacists or (ii) to any 33 other person authorized by law to receive the information. 34 (q) "Prospective drug review" or "drug utilization -11- LRB093 08954 AMC 14338 a 1 evaluation" means a screening for potential drug therapy 2 problems due to therapeutic duplication, drug-disease 3 contraindications, drug-drug interactions (including serious 4 interactions with nonprescription or over-the-counter drugs), 5 drug-food interactions, incorrect drug dosage or duration of 6 drug treatment, drug-allergy interactions, and clinical abuse 7 or misuse. 8 (r) "Patient counseling" means the communication between 9 a pharmacist or a student pharmacist under the direct 10 supervision of a pharmacist and a patient or the patient's 11 representative about the patient's medication or device for 12 the purpose of optimizing proper use of prescription 13 medications or devices. The offer to counsel by the 14 pharmacist or the pharmacist's designee, and subsequent 15 patient counseling by the pharmacist or student pharmacist, 16 shall be made in a face-to-face communication with the 17 patient or patient's representative unless, in the 18 professional judgment of the pharmacist, a face-to-face 19 communication is deemed inappropriate or unnecessary. In 20 that instance, the offer to counsel or patient counseling may 21 be made in a written communication, by telephone, or in a 22 manner determined by the pharmacist to be appropriate. 23 (s) "Patient profiles" or "patient drug therapy record" 24 means the obtaining, recording, and maintenance of patient 25 prescription and personal information. 26 (t) "Pharmaceutical care" includes, but is not limited 27 to, the act of monitoring drug use and other patient care 28 services intended to achieve outcomes that improve the 29 patient's quality of life but shall not include the sale of 30 over-the-counter drugs by a seller of goods and services who 31 does not dispense prescription drugs. 32 (u) "Medical device" means an instrument, apparatus, 33 implement, machine, contrivance, implant, in vitro reagent, 34 or other similar or related article, including any component -12- LRB093 08954 AMC 14338 a 1 part or accessory, required under federal law to bear the 2 label "Caution: Federal law requires dispensing by or on the 3 order of a physician". A seller of goods and services who, 4 only for the purpose of retail sales, compounds, sells, 5 rents, or leases medical devices shall not, by reasons 6 thereof, be required to be a licensed pharmacy. 7 (v) "Unique identifier" means an electronic signature, 8 handwritten signature or initials, thumb print, or other 9 acceptable individual biometric or electronic identification 10 process as approved by the Department. 11 (Source: P.A. 92-880, eff. 1-1-04.) 12 Section 95. No acceleration or delay. Where this Act 13 makes changes in a statute that is represented in this Act by 14 text that is not yet or no longer in effect (for example, a 15 Section represented by multiple versions), the use of that 16 text does not accelerate or delay the taking effect of (i) 17 the changes made by this Act or (ii) provisions derived from 18 any other Public Act. 19 Section 99. Effective date. This Act takes effect upon 20 becoming law.".