093_HB3906
LRB093 13996 AMC 19408 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 Sections 3, 16a, and 35.1 and adding Section 16b
6 as follows:
7 (225 ILCS 85/3) (from Ch. 111, par. 4123)
8 (Section scheduled to be repealed on January 1, 2008)
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
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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
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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
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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 health care
8 professional and provider currently licensed by this State to
9 engage in the practice of pharmacy.
10 (l) "Pharmacist in charge" means the licensed pharmacist
11 whose name appears on a pharmacy license and who is
12 responsible for all aspects of the operation related to the
13 practice of pharmacy.
14 (m) "Dispense" means the delivery of drugs and medical
15 devices, in accordance with applicable State and federal laws
16 and regulations, to the patient or the patient's
17 representative authorized to receive these products,
18 including the compounding, packaging, and labeling necessary
19 for delivery, and any recommending or advising concerning the
20 contents and therapeutic values and uses thereof. "Dispense"
21 does not mean the physical delivery to a patient or a
22 patient's representative in a home or institution by a
23 designee of a pharmacist or by common carrier. "Dispense"
24 also does not mean the physical delivery of a drug or medical
25 device to a patient or patient's representative by a
26 pharmacist's designee within a pharmacy or drugstore while
27 the pharmacist is on duty and the pharmacy is open.
28 (n) "Domestic mail-order pharmacy" means a pharmacy that
29 is located in a state of the United States, other than
30 Illinois, that delivers, dispenses or distributes, through
31 the United States Postal Service or other common carrier, to
32 Illinois residents, any substance which requires a
33 prescription.
34 (n-5) "Foreign mail-order pharmacy" means a pharmacy
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1 that is located in a country other than the United States
2 that delivers, dispenses, or distributes, through the United
3 States Postal Service or other common carrier, to Illinois
4 residents any substance that requires a prescription.
5 (o) "Compounding" means the preparation, mixing,
6 assembling, packaging, or labeling of a drug or medical
7 device: (1) as the result of a practitioner's prescription
8 drug order or initiative that is dispensed pursuant to a
9 prescription in the course of professional practice; or (2)
10 for the purpose of, or incident to, research, teaching, or
11 chemical analysis; or (3) in anticipation of prescription
12 drug orders based on routine, regularly observed prescribing
13 patterns.
14 (p) "Confidential information" means information,
15 maintained by the pharmacist in the patient's records,
16 released only (i) to the patient or, as the patient directs,
17 to other practitioners and other pharmacists or (ii) to any
18 other person 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
28 a pharmacist or a student pharmacist under the direct
29 supervision of a pharmacist and a patient or the patient's
30 representative about the patient's medication or device for
31 the purpose of optimizing proper use of prescription
32 medications or devices. The offer to counsel by the
33 pharmacist or the pharmacist's designee, and subsequent
34 patient counseling by the pharmacist or student pharmacist,
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1 shall be made in a face-to-face communication with the
2 patient or patient's representative unless, in the
3 professional judgment of the pharmacist, a face-to-face
4 communication is deemed inappropriate or unnecessary. In
5 that instance, the offer to counsel or patient counseling may
6 be made in a written communication, by telephone, or in a
7 manner determined by the pharmacist to be 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
13 to, the act of monitoring drug use and other patient care
14 services intended to achieve outcomes that improve the
15 patient's quality of life but shall not include the sale of
16 over-the-counter drugs by a seller of goods and services who
17 does not dispense prescription drugs.
18 (u) "Medical device" means an instrument, apparatus,
19 implement, machine, contrivance, implant, in vitro reagent,
20 or other similar or related article, including any component
21 part or accessory, required under federal law to bear the
22 label "Caution: Federal law requires dispensing by or on the
23 order of a physician". A seller of goods and services who,
24 only for the purpose of retail sales, compounds, sells,
25 rents, or leases medical devices shall not, by reasons
26 thereof, be required to 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 (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
33 (Section scheduled to be repealed on January 1, 2008)
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1 Sec. 16a. (a) The Department shall establish rules and
2 regulations, consistent with the provisions of this Act,
3 governing domestic mail-order pharmacies, including
4 pharmacies providing services via the Internet, which sell,
5 or offer for sale, drugs, medicines, or other pharmaceutical
6 services in this State.
7 (b) The Board shall require and provide for an annual
8 nonresident special pharmacy registration for all pharmacies
9 located outside of this State that dispense medications for
10 Illinois residents and mail, ship, or deliver prescription
11 medications into this State. Nonresident special pharmacy
12 registration shall be granted by the Board upon the
13 disclosure and certification by a pharmacy:
14 (1) that it is licensed in the state in which the
15 dispensing facility is located and from which the drugs
16 are dispensed;
17 (2) of the location, names, and titles of all
18 principal corporate officers and all pharmacists who are
19 dispensing drugs to residents of this State;
20 (3) that it complies with all lawful directions and
21 requests for information from the board of pharmacy of
22 each state in which it is licensed or registered, except
23 that it shall respond directly to all communications from
24 the Board concerning emergency circumstances arising from
25 the dispensing of drugs to residents of this State;
26 (4) that it maintains its records of drugs
27 dispensed to residents of this State so that the records
28 are readily retrievable from the records of other drugs
29 dispensed;
30 (5) that it cooperates with the Board in providing
31 information to the board of pharmacy of the state in
32 which it is licensed concerning matters related to the
33 dispensing of drugs to residents of this State; and
34 (6) that during its regular hours of operation, but
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1 not less than 6 days per week, for a minimum of 40 hours
2 per week, a toll-free telephone service is provided to
3 facilitate communication between patients in this State
4 and a pharmacist at the pharmacy who has access to the
5 patients' records. The toll-free number must be disclosed
6 on the label affixed to each container of drugs dispensed
7 to residents of this State.
8 (c) The provisions of this Section do not apply to
9 pharmacies for which registration is provided under Section
10 16b.
11 (Source: P.A. 91-438, eff. 1-1-00.)
12 (225 ILCS 85/16b new)
13 Sec. 16b. Foreign mail-order pharmacy.
14 (a) Notwithstanding any other Section of this Act, the
15 Department shall provide for the registration of foreign
16 mail-order pharmacies as nonresident pharmacies, upon the
17 disclosure and certification by a foreign mail-order pharmacy
18 of the following:
19 (1) That it is licensed in the country, state, or
20 province in which the dispensing facility is located and
21 from which the drugs are dispensed.
22 (2) The location, names, and titles of all
23 principal corporate officers and all pharmacists who are
24 dispensing drugs to residents of this State.
25 (3) That it complies with all lawful directions and
26 requests for information from the board of pharmacy of
27 each country, state, or province in which it is licensed
28 or registered, except that it shall respond directly to
29 all communications from the Board concerning emergency
30 circumstances arising from the dispensing of drugs to
31 residents of this State.
32 (4) That it maintains its records of drugs
33 dispensed to residents of this State so that the records
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1 are readily retrievable from the records of other drugs
2 dispensed.
3 (5) That it cooperates with the Board of Pharmacy
4 in providing information to the board of pharmacy of the
5 country, state, or province in which it is licensed
6 concerning matters related to the dispensing of drugs to
7 residents of this State.
8 (6) That during its regular hours of operation, but
9 not less than 6 days per week, for a minimum of 40 hours
10 per week, a toll-free telephone service is provided to
11 facilitate communication between patients in this State
12 and a pharmacist at the pharmacy who has access to the
13 patients' records. The toll-free number must be disclosed
14 on the label affixed to each container or drugs dispenses
15 to residents of this State.
16 (7) That it consents to the jurisdiction of the
17 Department over pharmacy practices affecting the State of
18 Illinois.
19 (b) Only a pharmacy located within a foreign country,
20 state, or province whose pharmacy laws and regulations have
21 been determined by the Department to be substantially similar
22 to those of the State of Illinois and whose regulatory scheme
23 for approval and quality control of prescription drugs has
24 been found by the Department to be substantially equivalent
25 to that of the State of Illinois and the federal government
26 may be registered as a nonresident pharmacy.
27 (c) The Department's criteria for determining
28 substantial equivalence shall be set by rule.
29 (d) The Department shall maintain a list of all foreign
30 countries, states, and provinces that have been evaluated on
31 its website with a designation of "approved" or "denied". Any
32 pharmacy located within a foreign country, state, or province
33 that has not been evaluated by the Department may request
34 that the Department conduct an evaluation.
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1 (225 ILCS 85/35.1) (from Ch. 111, par. 4155.1)
2 (Section scheduled to be repealed on January 1, 2008)
3 Sec. 35.1. (a) If any person violates the provision of
4 this Act, the Director may, in the name of the People of the
5 State of Illinois, through the Attorney General of the State
6 of Illinois, or the State's Attorney of any county in which
7 the action is brought, petition, for an order enjoining such
8 violation or for an order enforcing compliance with this Act.
9 Upon the filing of a verified petition in such court, the
10 court may issue a temporary restraining order, without notice
11 or bond, and may preliminarily and permanently enjoin such
12 violation, and if it is established that such person has
13 violated or is violating the injunction, the Court may punish
14 the offender for contempt of court. Proceedings under this
15 Section shall be in addition to, and not in lieu of, all
16 other remedies and penalties provided by this Act.
17 (b) If any person shall practice as a pharmacist or hold
18 himself out as a pharmacist or operate a pharmacy or
19 drugstore, including a domestic mail-order pharmacy under
20 Section 16a or a foreign mail-order pharmacy under Section
21 16b, without being licensed under the provisions of this Act,
22 then any licensed pharmacist, any interested party or any
23 person injured thereby may, in addition to the Director,
24 petition for relief as provided in subsection (a) of this
25 Section.
26 Whoever knowingly practices or offers to practice in this
27 State without being appropriately licensed or registered
28 under this Act shall be guilty of a Class A misdemeanor and
29 for each subsequent conviction, shall be guilty of a Class 4
30 felony.
31 (c) Whenever in the opinion of the Department any person
32 not licensed in good standing under this Act violates any
33 provision of this Act, the Department may issue a rule to
34 show cause why an order to cease and desist should not be
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1 entered against him. The rule shall clearly set forth the
2 grounds relied upon by the Department and shall provide a
3 period of 7 days from the date of the rule to file an answer
4 to the satisfaction of the Department. Failure to answer to
5 the satisfaction of the Department shall cause an order to
6 cease and desist to be issued forthwith.
7 (Source: P.A. 92-678, eff. 7-16-02.)
8 Section 99. Effective date. This Act takes effect upon
9 becoming law.