Registration and Regulation Committee

Adopted in House Comm. on May 19, 2004

 

 


 

 


 
09300SB2253ham001 LRB093 15878 AMC 50122 a

1
AMENDMENT TO SENATE BILL 2253

2     AMENDMENT NO. ______. Amend Senate Bill 2253 by replacing
3 everything after the enacting clause with the following:
 
4     "Section 5. The Pharmacy Practice Act of 1987 is amended by
5 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7     (Section scheduled to be repealed on January 1, 2008)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     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 for
14 sale at retail, or displayed for sale at retail; or (2) where
15 prescriptions of physicians, dentists, veterinarians,
16 podiatrists, or therapeutically certified optometrists, within
17 the limits of their licenses, are compounded, filled, or
18 dispensed; or (3) which has upon it or displayed within it, or
19 affixed to or used in connection with it, a sign bearing the
20 word or words "Pharmacist", "Druggist", "Pharmacy",
21 "Pharmaceutical Care", "Apothecary", "Drugstore", "Medicine
22 Store", "Prescriptions", "Drugs", "Medicines", or any word or
23 words of similar or like import, either in the English language
24 or any other language; or (4) where the characteristic

 

 

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1 prescription sign (Rx) or similar design is exhibited; or (5)
2 any store, or shop, or other place with respect to which any of
3 the above words, objects, signs or designs are used in any
4 advertisement.
5     (b) "Drugs" means and includes (l) articles recognized in
6 the official United States Pharmacopoeia/National Formulary
7 (USP/NF), or any supplement thereto and being intended for and
8 having for their main use the diagnosis, cure, mitigation,
9 treatment or prevention of disease in man or other animals, as
10 approved by the United States Food and Drug Administration, but
11 does not include devices or their components, parts, or
12 accessories; and (2) all other articles intended for and having
13 for their main use the diagnosis, cure, mitigation, treatment
14 or prevention of disease in man or other animals, as approved
15 by the United States Food and Drug Administration, but does not
16 include devices or their components, parts, or accessories; and
17 (3) articles (other than food) having for their main use and
18 intended to affect the structure or any function of the body of
19 man or other animals; and (4) articles having for their main
20 use and intended for use as a component or any articles
21 specified in clause (l), (2) or (3); but does not include
22 devices or their components, parts or accessories.
23     (c) "Medicines" means and includes all drugs intended for
24 human or veterinary use approved by the United States Food and
25 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 monitoring
31 of appropriate drug use and prospective drug utilization
32 review, (3) providing information on the therapeutic values,
33 reactions, drug interactions, side effects, uses, selection of
34 medications and medical devices, and outcome of drug therapy,

 

 

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1 (4) participation in drug selection, drug monitoring, drug
2 utilization review, evaluation, administration,
3 interpretation, application of pharmacokinetic and laboratory
4 data to design safe and effective drug regimens, (5) drug
5 research (clinical and scientific), and (6) compounding and
6 dispensing of drugs and medical devices.
7     (e) "Prescription" means and includes any written, oral,
8 facsimile, or electronically transmitted order for drugs or
9 medical devices, issued by a physician licensed to practice
10 medicine in all its branches, dentist, veterinarian, or
11 podiatrist, or therapeutically certified optometrist, within
12 the limits of their licenses, by a physician assistant in
13 accordance with subsection (f) of Section 4, or by an advanced
14 practice nurse in accordance with subsection (g) of Section 4,
15 containing the following: (l) name of the patient; (2) date
16 when prescription was issued; (3) name and strength of drug or
17 description of the medical device prescribed; and (4) quantity,
18 (5) directions for use, (6) prescriber's name, address and
19 signature, and (7) DEA number where required, for controlled
20 substances. DEA numbers shall not be required on inpatient drug
21 orders.
22     (f) "Person" means and includes a natural person,
23 copartnership, association, corporation, government entity, or
24 any other legal entity.
25     (g) "Department" means the Department of Professional
26 Regulation.
27     (h) "Board of Pharmacy" or "Board" means the State Board of
28 Pharmacy of the Department of Professional Regulation.
29     (i) "Director" means the Director of Professional
30 Regulation.
31     (j) "Drug product selection" means the interchange for a
32 prescribed pharmaceutical product in accordance with Section
33 25 of this Act and Section 3.14 of the Illinois Food, Drug and
34 Cosmetic Act.

 

 

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1     (k) "Inpatient drug order" means an order issued by an
2 authorized prescriber for a resident or patient of a facility
3 licensed under the Nursing Home Care Act or the Hospital
4 Licensing Act, or "An Act in relation to the founding and
5 operation of the University of Illinois Hospital and the
6 conduct of University of Illinois health care programs",
7 approved July 3, 1931, as amended, or a facility which is
8 operated by the Department of Human Services (as successor to
9 the Department of Mental Health and Developmental
10 Disabilities) or the Department of Corrections.
11     (k-5) "Pharmacist" means an individual health care
12 professional and provider currently licensed by this State to
13 engage in the practice of pharmacy.
14     (l) "Pharmacist in charge" means the licensed pharmacist
15 whose name appears on a pharmacy license and 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 representative
21 authorized to receive these products, including the
22 preparation, compounding, packaging, and labeling necessary
23 for delivery, interpretation, computer entry, and verification
24 of medication orders and prescriptions, drug product
25 selection, and any recommending or advising concerning the
26 contents and therapeutic values and uses thereof. "Dispense"
27 does not mean the physical delivery to a patient or a patient's
28 representative in a home or institution by a designee of a
29 pharmacist or by common carrier. "Dispense" also does not mean
30 the physical delivery of a drug or medical device to a patient
31 or patient's representative by a pharmacist's designee within a
32 pharmacy or drugstore while the pharmacist is on duty and the
33 pharmacy is open.
34     (n) "Mail-order pharmacy" means a pharmacy that is located

 

 

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1 in a state of the United States, other than Illinois, that
2 delivers, dispenses or distributes, through the United States
3 Postal Service or other common carrier, to Illinois residents,
4 any substance which requires a prescription.
5     (o) "Compounding" means the preparation, mixing,
6 assembling, packaging, or labeling of a drug or medical device:
7 (1) as the result of a practitioner's prescription drug order
8 or initiative that is dispensed pursuant to a prescription in
9 the course of professional practice; or (2) for the purpose of,
10 or incident to, research, teaching, or chemical analysis; or
11 (3) in anticipation of prescription drug orders based on
12 routine, regularly observed prescribing patterns.
13     (p) "Confidential information" means information,
14 maintained by the pharmacist in the patient's records, released
15 only (i) to the patient or, as the patient directs, to other
16 practitioners and other pharmacists or (ii) to any other person
17 authorized by law to receive the information.
18     (q) "Prospective drug review" or "drug utilization
19 evaluation" means a screening for potential drug therapy
20 problems due to therapeutic duplication, drug-disease
21 contraindications, drug-drug interactions (including serious
22 interactions with nonprescription or over-the-counter drugs),
23 drug-food interactions, incorrect drug dosage or duration of
24 drug treatment, drug-allergy interactions, and clinical abuse
25 or misuse.
26     (r) "Patient counseling" means the communication between a
27 pharmacist or a student pharmacist under the direct supervision
28 of a pharmacist and a patient or the patient's representative
29 about the patient's medication or device for the purpose of
30 optimizing proper use of prescription medications or devices.
31 The offer to counsel by the pharmacist or the pharmacist's
32 designee, and subsequent patient counseling by the pharmacist
33 or student pharmacist, shall be made in a face-to-face
34 communication with the patient or patient's representative

 

 

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1 unless, in the professional judgment of the pharmacist, a
2 face-to-face communication is deemed inappropriate or
3 unnecessary. In that instance, the offer to counsel or patient
4 counseling may be made in a written communication, by
5 telephone, or in a manner determined by the pharmacist to be
6 appropriate.
7     (s) "Patient profiles" or "patient drug therapy record"
8 means the obtaining, recording, and maintenance of patient
9 prescription information, including prescriptions for
10 controlled substances, and personal information.
11     (t) "Pharmaceutical care" includes, but is not limited to,
12 the act of monitoring drug use and other patient care services
13 intended to achieve outcomes that improve the patient's quality
14 of life but shall not include the sale of over-the-counter
15 drugs by a seller of goods and services who does not dispense
16 prescription drugs.
17     (u) "Medical device" means an instrument, apparatus,
18 implement, machine, contrivance, implant, in vitro reagent, or
19 other similar or related article, including any component part
20 or accessory, required under federal law to bear the label
21 "Caution: Federal law requires dispensing by or on the order of
22 a physician". A seller of goods and services who, only for the
23 purpose of retail sales, compounds, sells, rents, or leases
24 medical devices shall not, by reasons thereof, be required to
25 be a licensed pharmacy.
26     (v) "Unique identifier" means an electronic signature,
27 handwritten signature or initials, thumb print, or other
28 acceptable individual biometric or electronic identification
29 process as approved by the Department.
30 (Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03.)
 
31     Section 99. Effective date. This Act takes effect upon
32 becoming law.".