093_HB2778eng HB2778 Engrossed LRB093 03709 AMC 03739 b 1 AN ACT concerning pharmacies. 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 Section 3 and adding Section 15.5 as follows: 6 (225 ILCS 85/3) (from Ch. 111, par. 4123) 7 (Section scheduled to be repealed on January 1, 2008) 8 (Text of Section before amendment by P.A. 92-880) 9 Sec. 3.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 HB2778 Engrossed -2- LRB093 03709 AMC 03739 b 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 HB2778 Engrossed -3- LRB093 03709 AMC 03739 b 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 HB2778 Engrossed -4- LRB093 03709 AMC 03739 b 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 that delivers, dispenses or distributes, through the United 30 States Postal Service or other common carrier, to Illinois 31 residents, any substance which requires a prescription. 32 (o) "Compounding" means the preparation, mixing, 33 assembling, packaging, or labeling of a drug or medical 34 device: (1) as the result of a practitioner's prescription HB2778 Engrossed -5- LRB093 03709 AMC 03739 b 1 drug order or initiative that is dispensed pursuant to a 2 prescription in the course of professional practice; or (2) 3 for the purpose of, or incident to, research, teaching, or 4 chemical analysis; or (3) in anticipation of prescription 5 drug orders based on routine, regularly observed prescribing 6 patterns. 7 (p) "Confidential information" means information, 8 maintained by the pharmacist in the patient's records, 9 released only (i) to the patient or, as the patient directs, 10 to other practitioners and other pharmacists or (ii) to any 11 other person authorized by law to receive the information. 12 (q) "Prospective drug review" or "drug utilization 13 evaluation" means a screening for potential drug therapy 14 problems due to therapeutic duplication, drug-disease 15 contraindications, drug-drug interactions (including serious 16 interactions with nonprescription or over-the-counter drugs), 17 drug-food interactions, incorrect drug dosage or duration of 18 drug treatment, drug-allergy interactions, and clinical abuse 19 or misuse. 20 (r) "Patient counseling" means the communication between 21 a pharmacist or a student pharmacist under the direct 22 supervision of a pharmacist and a patient or the patient's 23 representative about the patient's medication or device for 24 the purpose of optimizing proper use of prescription 25 medications or devices. The offer to counsel by the 26 pharmacist or the pharmacist's designee, and subsequent 27 patient counseling by the pharmacist or student pharmacist, 28 shall be made in a face-to-face communication with the 29 patient or patient's representative unless, in the 30 professional judgment of the pharmacist, a face-to-face 31 communication is deemed inappropriate or unnecessary. In 32 that instance, the offer to counsel or patient counseling may 33 be made in a written communication, by telephone, or in a 34 manner determined by the pharmacist to be appropriate. HB2778 Engrossed -6- LRB093 03709 AMC 03739 b 1 (s) "Patient profiles" or "patient drug therapy record" 2 means the obtaining, recording, and maintenance of patient 3 prescription and personal information. 4 (t) "Pharmaceutical care" includes, but is not limited 5 to, the act of monitoring drug use and other patient care 6 services intended to achieve outcomes that improve the 7 patient's quality of life but shall not include the sale of 8 over-the-counter drugs by a seller of goods and services who 9 does not dispense prescription drugs. 10 (u) "Medical device" means an instrument, apparatus, 11 implement, machine, contrivance, implant, in vitro reagent, 12 or other similar or related article, including any component 13 part or accessory, required under federal law to bear the 14 label "Caution: Federal law requires dispensing by or on the 15 order of a physician". A seller of goods and services who, 16 only for the purpose of retail sales, compounds, sells, 17 rents, or leases medical devices shall not, by reasons 18 thereof, be required to be a licensed pharmacy. 19 (Source: P.A. 89-202, eff. 7-21-95; 89-507, eff. 7-1-97; 20 90-116, eff. 7-14-97; 90-253, eff. 7-29-97; 90-655, eff. 21 7-30-98; 90-742, eff. 8-13-98.) 22 (Text of Section after amendment by P.A. 92-880) 23 Sec. 3. Definitions. For the purpose of this Act, except 24 where otherwise limited therein: 25 (a) "Pharmacy" or "drugstore" means and includes every 26 store, shop, pharmacy department, or other place where 27 pharmaceutical care is provided by a pharmacist (1) where 28 drugs, medicines, or poisons are dispensed, sold or offered 29 for sale at retail, or displayed for sale at retail; or (2) 30 where prescriptions of physicians, dentists, veterinarians, 31 podiatrists, or therapeutically certified optometrists, 32 within the limits of their licenses, are compounded, filled, 33 or dispensed; or (3) which has upon it or displayed within 34 it, or affixed to or used in connection with it, a sign HB2778 Engrossed -7- LRB093 03709 AMC 03739 b 1 bearing the word or words "Pharmacist", "Druggist", 2 "Pharmacy", "Pharmaceutical Care", "Apothecary", "Drugstore", 3 "Medicine Store", "Prescriptions", "Drugs", "Medicines", or 4 any word or words of similar or like import, either in the 5 English language or any other language; or (4) where the 6 characteristic prescription sign (Rx) or similar design is 7 exhibited; or (5) any store, or shop, or other place with 8 respect to which any of the above words, objects, signs or 9 designs are used in any advertisement. 10 (b) "Drugs" means and includes (l) articles recognized 11 in the official United States Pharmacopoeia/National 12 Formulary (USP/NF), or any supplement thereto and being 13 intended for and having for their main use the diagnosis, 14 cure, mitigation, treatment or prevention of disease in man 15 or other animals, as approved by the United States Food and 16 Drug Administration, but does not include devices or their 17 components, parts, or accessories; and (2) all other articles 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 (3) articles (other 23 than food) having for their main use and intended to affect 24 the structure or any function of the body of man or other 25 animals; and (4) articles having for their main use and 26 intended for use as a component or any articles specified in 27 clause (l), (2) or (3); but does not include devices or their 28 components, parts or accessories. 29 (c) "Medicines" means and includes all drugs intended 30 for human or veterinary use approved by the United States 31 Food and Drug Administration. 32 (d) "Practice of pharmacy" means the provision of 33 pharmaceutical care to patients as determined by the 34 pharmacist's professional judgment in the following areas, HB2778 Engrossed -8- LRB093 03709 AMC 03739 b 1 which may include but are not limited to (1) patient 2 counseling, (2) interpretation and assisting in the 3 monitoring of appropriate drug use and prospective drug 4 utilization review, (3) providing information on the 5 therapeutic values, reactions, drug interactions, side 6 effects, uses, selection of medications and medical devices, 7 and outcome of drug therapy, (4) participation in drug 8 selection, drug monitoring, drug utilization review, 9 evaluation, administration, interpretation, application of 10 pharmacokinetic and laboratory data to design safe and 11 effective drug regimens, (5) drug research (clinical and 12 scientific), and (6) compounding and dispensing of drugs and 13 medical devices. 14 (e) "Prescription" means and includes any written, oral, 15 facsimile, or electronically transmitted order for drugs or 16 medical devices, issued by a physician licensed to practice 17 medicine in all its branches, dentist, veterinarian, or 18 podiatrist, or therapeutically certified optometrist, within 19 the limits of their licenses, by a physician assistant in 20 accordance with subsection (f) of Section 4, or by an 21 advanced practice nurse in accordance with subsection (g) of 22 Section 4, containing the following: (l) name of the patient; 23 (2) date when prescription was issued; (3) name and strength 24 of drug or description of the medical device prescribed; and 25 (4) quantity, (5) directions for use, (6) prescriber's name, 26 address and signature, and (7) DEA number where required, for 27 controlled substances. DEA numbers shall not be required on 28 inpatient drug orders. 29 (f) "Person" means and includes a natural person, 30 copartnership, association, corporation, government entity, 31 or any other legal entity. 32 (g) "Department" means the Department of Professional 33 Regulation. 34 (h) "Board of Pharmacy" or "Board" means the State Board HB2778 Engrossed -9- LRB093 03709 AMC 03739 b 1 of Pharmacy of the Department of Professional Regulation. 2 (i) "Director" means the Director of Professional 3 Regulation. 4 (j) "Drug product selection" means the interchange for a 5 prescribed pharmaceutical product in accordance with Section 6 25 of this Act and Section 3.14 of the Illinois Food, Drug 7 and Cosmetic Act. 8 (k) "Inpatient drug order" means an order issued by an 9 authorized prescriber for a resident or patient of a facility 10 licensed under the Nursing Home Care Act or the Hospital 11 Licensing Act, or "An Act in relation to the founding and 12 operation of the University of Illinois Hospital and the 13 conduct of University of Illinois health care programs", 14 approved July 3, 1931, as amended, or a facility which is 15 operated by the Department of Human Services (as successor to 16 the Department of Mental Health and Developmental 17 Disabilities) or the Department of Corrections. 18 (k-5) "Pharmacist" means an individual health care 19 professional and provider currently licensed by this State to 20 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" HB2778 Engrossed -10- LRB093 03709 AMC 03739 b 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 that delivers, dispenses or distributes, through the United 8 States Postal Service or other common carrier, to Illinois 9 residents, any substance which requires a prescription. 10 (o) "Compounding" means the preparation, mixing, 11 assembling, packaging, or labeling of a drug or medical 12 device: (1) as the result of a practitioner's prescription 13 drug order or initiative that is dispensed pursuant to a 14 prescription in the course of professional practice; or (2) 15 for the purpose of, or incident to, research, teaching, or 16 chemical analysis; or (3) in anticipation of prescription 17 drug orders based on routine, regularly observed prescribing 18 patterns. 19 (p) "Confidential information" means information, 20 maintained by the pharmacist in the patient's records, 21 released only (i) to the patient or, as the patient directs, 22 to other practitioners and other pharmacists or (ii) to any 23 other person authorized by law to receive the information. 24 (q) "Prospective drug review" or "drug utilization 25 evaluation" means a screening for potential drug therapy 26 problems due to therapeutic duplication, drug-disease 27 contraindications, drug-drug interactions (including serious 28 interactions with nonprescription or over-the-counter drugs), 29 drug-food interactions, incorrect drug dosage or duration of 30 drug treatment, drug-allergy interactions, and clinical abuse 31 or misuse. 32 (r) "Patient counseling" means the communication between 33 a pharmacist or a student pharmacist under the direct 34 supervision of a pharmacist and a patient or the patient's HB2778 Engrossed -11- LRB093 03709 AMC 03739 b 1 representative about the patient's medication or device for 2 the purpose of optimizing proper use of prescription 3 medications or devices. The offer to counsel by the 4 pharmacist or the pharmacist's designee, and subsequent 5 patient counseling by the pharmacist or student pharmacist, 6 shall be made in a face-to-face communication with the 7 patient or patient's representative unless, in the 8 professional judgment of the pharmacist, a face-to-face 9 communication is deemed inappropriate or unnecessary. In 10 that instance, the offer to counsel or patient counseling may 11 be made in a written communication, by telephone, or in a 12 manner determined by the pharmacist to be appropriate. 13 (s) "Patient profiles" or "patient drug therapy record" 14 means the obtaining, recording, and maintenance of patient 15 prescription information, including prescriptions for 16 controlled substances, 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 HB2778 Engrossed -12- LRB093 03709 AMC 03739 b 1 process as approved by the Department. 2 (Source: P.A. 92-880, eff. 1-1-04.) 3 (225 ILCS 85/15.5 new) 4 Sec. 15.5. Prescription information. 5 (a) Uncoordinated multiple controlled substances and 6 drug seeking tendencies pose a significant threat to the 7 health, safety, and welfare of patients. To address this 8 threat, the General Assembly believes a physician who 9 prescribes controlled substances should be provided with 10 prescription information from pharmacies. 11 (b) Upon request, a pharmacist shall provide a physician 12 licensed to practice medicine in all its branches who is 13 prepared to prescribe or has prescribed a controlled 14 substance for a patient with information from the patient's 15 most recent patient profile, including information about any 16 prescriptions for controlled substances.