Rep. Angelo Saviano

Filed: 4/5/2005

 

 


 

 


 
09400HB1031ham001 LRB094 07832 RAS 44304 a

1
AMENDMENT TO HOUSE BILL 1031

2     AMENDMENT NO. ______. Amend House Bill 1031 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 Sections 3, 14, 15, and 18 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7     (Section scheduled to be repealed on January 1, 2008)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. A pharmacist may provide
14 pharmaceutical care in conjunction with or independent of a
15 licensed pharmacy.
16     (l) "Pharmacist in charge" means the licensed pharmacist
17 whose name appears on a pharmacy license and who is responsible
18 for all aspects of the operation related to the practice of
19 pharmacy.
20     (m) "Dispense" means the delivery of drugs and medical
21 devices, in accordance with applicable State and federal laws
22 and regulations, to the patient or the patient's representative
23 authorized to receive these products, including the
24 preparation, compounding, packaging, and labeling necessary
25 for delivery, computer entry, and verification of medication
26 orders and prescriptions, and any recommending or advising
27 concerning the contents and therapeutic values and uses
28 thereof. "Dispense" does not mean the physical delivery to a
29 patient or a patient's representative in a home or institution
30 by a designee of a pharmacist or by common carrier. "Dispense"
31 also does not mean the physical delivery of a drug or medical
32 device to a patient or patient's representative by a
33 pharmacist's designee within a pharmacy or drugstore while the
34 pharmacist is on duty and the pharmacy is open.

 

 

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

 

 

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1 communication with the patient or patient's representative
2 unless, in the professional judgment of the pharmacist, a
3 face-to-face communication is deemed inappropriate or
4 unnecessary. In that instance, the offer to counsel or patient
5 counseling may be made in a written communication, by
6 telephone, or in a manner determined by the pharmacist to be
7 appropriate.
8     (s) "Patient profiles" or "patient drug therapy record"
9 means the obtaining, recording, and maintenance of patient
10 prescription information, including prescriptions for
11 controlled substances, and personal information.
12     (t) "Pharmaceutical care" includes, but is not limited to,
13 the act of monitoring drug use and other patient care services
14 intended to achieve outcomes that improve the patient's quality
15 of life but shall not include the sale of over-the-counter
16 drugs by a seller of goods and services who does not dispense
17 prescription drugs.
18     (u) "Medical device" means an instrument, apparatus,
19 implement, machine, contrivance, implant, in vitro reagent, or
20 other similar or related article, including any component part
21 or accessory, required under federal law to bear the label
22 "Caution: Federal law requires dispensing by or on the order of
23 a physician". A seller of goods and services who, only for the
24 purpose of retail sales, compounds, sells, rents, or leases
25 medical devices shall not, by reasons thereof, be required to
26 be a licensed pharmacy.
27     (v) "Unique identifier" means an electronic signature,
28 handwritten signature or initials, thumb print, or other
29 acceptable individual biometric or electronic identification
30 process as approved by the Department.
31 (Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03;
32 93-1075, eff. 1-18-05.)
 
33     (225 ILCS 85/14)  (from Ch. 111, par. 4134)

 

 

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1     (Section scheduled to be repealed on January 1, 2008)
2     Sec. 14. Structural and equipment requirements. No person
3 shall establish or move to a new location any pharmacy unless
4 the pharmacy is licensed with the Department and has on file
5 with the Department a verified statement that:
6         (1) such pharmacy is or will be engaged in the practice
7     of pharmacy; and
8         (2) other than a Division VI pharmacy, such pharmacy
9     will have in stock and shall maintain sufficient drugs and
10     materials as to protect the public it serves within 30 days
11     after the issuance of the registration of the pharmacy.
12     Division I, II, III, IV, or V pharmacies shall be in a
13 suitable, well-lighted and well-ventilated area with at least
14 300 square feet of clean and sanitary contiguous space and
15 shall be suitably equipped for compounding prescriptions,
16 storage of drugs and sale of drugs and to otherwise conduct the
17 practice of pharmacy. The space occupied shall be equipped with
18 a sink with hot and cold water or facilities for heating water,
19 proper sewage outlet, refrigeration storage equipment, and
20 such fixtures, facilities, drugs, equipment and material,
21 which shall include the current editions of the United States
22 Pharmacopoeia/DI, Facts and Comparisons, or any other current
23 compendium approved by the Department, and other such reference
24 works, as will enable a pharmacist to practice pharmacy,
25 including this Act and the rules promulgated under this Act.
26 Such pharmacy shall have the following items: accurate weights
27 of 0.5 gr. to 4 oz. and 20 mg to 100 Gm; and a prescription
28 balance equipped with balance indicator and with mechanical
29 means of arresting the oscillations of the mechanism and which
30 balance shall be sensitive to 0.5 grain (32 mg) or less or an
31 alternative weighing device as approved by the Department, and
32 such other measuring devices as may be necessary for the
33 conduct of the practice of pharmacy.
34     The provisions of this Section with regard to 300 square

 

 

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1 feet of space shall apply to any pharmacy which is opened after
2 the effective date of this Act. Nothing shall require a
3 pharmacy in existence on the effective date of this Act which
4 is comprised of less than 300 square feet to provide additional
5 space to meet these requirements.
6     Any structural and equipment requirements for a Division VI
7 pharmacy shall be set by rule.
8 (Source: P.A. 92-880, eff. 1-1-04.)
 
9     (225 ILCS 85/15)  (from Ch. 111, par. 4135)
10     (Section scheduled to be repealed on January 1, 2008)
11     Sec. 15. Pharmacy requirements. It shall be unlawful for
12 the owner of any pharmacy, as defined in this Act, to operate
13 or conduct the same, or to allow the same to be operated or
14 conducted, unless:
15     (a) It has a licensed pharmacist, authorized to practice
16 pharmacy in this State under the provisions of this Act, on
17 duty whenever the practice of pharmacy is conducted;
18     (b) Security provisions for all drugs and devices, as
19 determined by rule of the Department, are provided during the
20 absence from the licensed pharmacy of all licensed pharmacists.
21 Maintenance of security provisions is the responsibility of the
22 licensed registered pharmacist in charge; and
23     (c) The pharmacy is licensed under this Act to do business.
24     The Department shall, by rule, provide requirements for
25 each division of pharmacy license and shall, as well provide
26 guidelines for the designation of a registered pharmacist in
27 charge for each division.
28     Division I. Retail Licenses for pharmacies which are open
29 to, or offer pharmacy services to, the general public.
30     Division II. Licenses for pharmacies whose primary
31 pharmacy service is provided to patients or residents of
32 facilities licensed under the Nursing Home Care Act or the
33 Hospital Licensing Act, or "An Act in relation to the founding

 

 

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1 and 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, and which are not located in
4 the facilities they serve.
5     Division III. Licenses for pharmacies which are located in
6 a facility licensed under the Nursing Home Care Act or the
7 Hospital Licensing Act, or "An Act in relation to the founding
8 and operation of the University of Illinois Hospital and the
9 conduct of University of Illinois health care programs",
10 approved July 3, 1931, as amended, or a facility which is
11 operated by the Department of Human Services (as successor to
12 the Department of Mental Health and Developmental
13 Disabilities) or the Department of Corrections, and which
14 provide pharmacy services to residents or patients of the
15 facility, as well as employees, prescribers and students of the
16 facility.
17     Division IV. Licenses for pharmacies which provide or offer
18 for sale radioactive materials.
19     Division V. Licenses for pharmacies which hold licenses in
20 Division II or Division III which also provide pharmacy
21 services to the general public, or pharmacies which are located
22 in or whose primary pharmacy service is to ambulatory care
23 facilities or schools of veterinary medicine or other such
24 institution or facility.
25     Division VI. Licenses for pharmacies that provide pharmacy
26 services to patients of institutions serviced by pharmacies
27 with a Division II or Division III license, without using their
28 own supply of drugs. Division VI pharmacies may provide
29 pharmacy services only in cooperation with an institution's
30 pharmacy or pharmacy provider. Nothing in this paragraph shall
31 constitute a change to the practice of pharmacy as defined in
32 Section 3 of this Act. Nothing in this amendatory Act of the
33 94th General Assembly shall in any way alter the definition or
34 operation of any other division of pharmacy as provided in this

 

 

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1 Act.
2     The Director may waive the requirement for a pharmacist to
3 be on duty at all times for State facilities not treating human
4 ailments.
5     It shall be unlawful for any person, who is not a licensed
6 pharmacy or health care facility, to purport to be such or to
7 use in name, title, or sign designating, or in connection with
8 that place of business, any of the words: "pharmacy",
9 "pharmacist", "pharmacy department", "apothecary", "druggist",
10 "drug", "drugs", "medicines", "medicine store", "drug
11 sundries", "prescriptions filled", or any list of words
12 indicating that drugs are compounded or sold to the lay public,
13 or prescriptions are dispensed therein. Each day during which,
14 or a part which, such representation is made or appears or such
15 a sign is allowed to remain upon or in such a place of business
16 shall constitute a separate offense under this Act.
17     The holder of any license or certificate of registration
18 shall conspicuously display it in the pharmacy in which he is
19 engaged in the practice of pharmacy. The registered pharmacist
20 in charge shall conspicuously display his name in such
21 pharmacy. The pharmacy license shall also be conspicuously
22 displayed.
23 (Source: P.A. 92-880, eff. 1-1-04.)
 
24     (225 ILCS 85/18)  (from Ch. 111, par. 4138)
25     (Section scheduled to be repealed on January 1, 2008)
26     Sec. 18. Record retention.
27     (a) Except as provided in subsection (b), there There shall
28 be kept in every drugstore or pharmacy a suitable book, file,
29 or electronic record keeping system in which shall be preserved
30 for a period of not less than 5 years the original of every
31 written prescription and the original transcript or copy of
32 every verbal prescription filled, compounded, or dispensed, in
33 such pharmacy; and such book or file of prescriptions shall at

 

 

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1 all reasonable times be open to inspection to the pharmacy
2 coordinator and the duly authorized agents or employees of the
3 Department.
4     Every prescription filled or refilled shall contain the
5 unique identifier of the person authorized to practice pharmacy
6 under the provision of this Act who fills or refills the
7 prescription.
8     Records kept pursuant to this Section may be maintained in
9 an alternative data retention system, such as a direct digital
10 imaging system, provided that:
11         (1) the records maintained in the alternative data
12     retention system contain all of the information required in
13     a manual record;
14         (2) the data processing system is capable of producing
15     a hard copy of the electronic record on the request of the
16     Board, its representative, or other authorized local,
17     State, or federal law enforcement or regulatory agency; and
18         (3) the digital images are recorded and stored only by
19     means of a technology that does not allow subsequent
20     revision or replacement of the images.
21     As used in this Section, "digital imaging system" means a
22 system, including people, machines, methods of organization,
23 and procedures, that provides input, storage, processing,
24 communications, output, and control functions for digitized
25 representations of original prescription records.
26     Inpatient drug orders may be maintained within an
27 institution in a manner approved by the Department.
28     (b) The record retention requirements for a Division VI
29 pharmacy shall be set by rule.
30 (Source: P.A. 92-880, eff. 1-1-04.)
 
31     Section 99. Effective date. This Act takes effect upon
32 becoming law.".