94TH GENERAL ASSEMBLY
State of Illinois
2005 and 2006
HB0647

 

Introduced 1/28/2005, by Rep. Jack D. Franks

 

SYNOPSIS AS INTRODUCED:
 
225 ILCS 85/3   from Ch. 111, par. 4123
225 ILCS 85/16a   from Ch. 111, par. 4136a
225 ILCS 85/16b new
225 ILCS 85/35.1   from Ch. 111, par. 4155.1

    Amends the Pharmacy Practice Act of 1987. Provides for the registration of foreign mail-order pharmacies as nonresident pharmacies if specified disclosures and certifications are provided and the pharmacies are located in a foreign country, state or province whose pharmacy laws and regulations have been determined by the Department of Financial and Professional Regulation to be substantially similar to those of the State of Illinois and whose regulatory scheme for approval and quality contro of prescription drugs has been found by the Department to be substantially equivalent tol that of the State of Illinois and the federal government. Effective immediately.


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FISCAL NOTE ACT MAY APPLY

 

 

A BILL FOR

 

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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 by
5 changing Sections 3, 16a, and 35.1 and adding Section 16b as
6 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8     (Section scheduled to be repealed on January 1, 2008)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 for
15 sale at retail, or displayed for sale at retail; or (2) where
16 prescriptions of physicians, dentists, veterinarians,
17 podiatrists, or therapeutically certified optometrists, within
18 the limits of their licenses, are compounded, filled, or
19 dispensed; or (3) which has upon it or displayed within it, or
20 affixed to or used in connection with it, a sign bearing the
21 word or words "Pharmacist", "Druggist", "Pharmacy",
22 "Pharmaceutical Care", "Apothecary", "Drugstore", "Medicine
23 Store", "Prescriptions", "Drugs", "Medicines", or any word or
24 words of similar or like import, either in the English language
25 or any other language; or (4) where the characteristic
26 prescription sign (Rx) or similar design is exhibited; or (5)
27 any store, or shop, or other place with respect to which any of
28 the above words, objects, signs or designs are used in any
29 advertisement.
30     (b) "Drugs" means and includes (l) articles recognized in
31 the official United States Pharmacopoeia/National Formulary
32 (USP/NF), or any supplement thereto and being intended for and

 

 

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1 having for their main use the diagnosis, cure, mitigation,
2 treatment or prevention of disease in man or other animals, as
3 approved by the United States Food and Drug Administration, but
4 does not include devices or their components, parts, or
5 accessories; and (2) all other articles intended for and having
6 for their main use the diagnosis, cure, mitigation, treatment
7 or prevention of disease in man or other animals, as approved
8 by the United States Food and Drug Administration, but does not
9 include devices or their components, parts, or accessories; and
10 (3) articles (other than food) having for their main use and
11 intended to affect the structure or any function of the body of
12 man or other animals; and (4) articles having for their main
13 use and intended for use as a component or any articles
14 specified in clause (l), (2) or (3); but does not include
15 devices or their components, parts or accessories.
16     (c) "Medicines" means and includes all drugs intended for
17 human or veterinary use approved by the United States Food and
18 Drug Administration.
19     (d) "Practice of pharmacy" means the provision of
20 pharmaceutical care to patients as determined by the
21 pharmacist's professional judgment in the following areas,
22 which may include but are not limited to (1) patient
23 counseling, (2) interpretation and assisting in the monitoring
24 of appropriate drug use and prospective drug utilization
25 review, (3) providing information on the therapeutic values,
26 reactions, drug interactions, side effects, uses, selection of
27 medications and medical devices, and outcome of drug therapy,
28 (4) participation in drug selection, drug monitoring, drug
29 utilization review, evaluation, administration,
30 interpretation, application of pharmacokinetic and laboratory
31 data to design safe and effective drug regimens, (5) drug
32 research (clinical and scientific), and (6) compounding and
33 dispensing of drugs and medical devices.
34     (e) "Prescription" means and includes any written, oral,
35 facsimile, or electronically transmitted order for drugs or
36 medical devices, issued by a physician licensed to practice

 

 

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1 medicine in all its branches, dentist, veterinarian, or
2 podiatrist, or therapeutically certified optometrist, within
3 the limits of their licenses, by a physician assistant in
4 accordance with subsection (f) of Section 4, or by an advanced
5 practice nurse in accordance with subsection (g) of Section 4,
6 containing the following: (l) name of the patient; (2) date
7 when prescription was issued; (3) name and strength of drug or
8 description of the medical device prescribed; and (4) quantity,
9 (5) directions for use, (6) prescriber's name, address and
10 signature, and (7) DEA number where required, for controlled
11 substances. DEA numbers shall not be required on inpatient drug
12 orders.
13     (f) "Person" means and includes a natural person,
14 copartnership, association, corporation, government entity, or
15 any other legal entity.
16     (g) "Department" means the Department of Professional
17 Regulation.
18     (h) "Board of Pharmacy" or "Board" means the State Board of
19 Pharmacy of the Department of Professional Regulation.
20     (i) "Director" means the Director of Professional
21 Regulation.
22     (j) "Drug product selection" means the interchange for a
23 prescribed pharmaceutical product in accordance with Section
24 25 of this Act and Section 3.14 of the Illinois Food, Drug and
25 Cosmetic Act.
26     (k) "Inpatient drug order" means an order issued by an
27 authorized prescriber for a resident or patient of a facility
28 licensed under the Nursing Home Care Act or the Hospital
29 Licensing Act, or "An Act in relation to the founding and
30 operation of the University of Illinois Hospital and the
31 conduct of University of Illinois health care programs",
32 approved July 3, 1931, as amended, or a facility which is
33 operated by the Department of Human Services (as successor to
34 the Department of Mental Health and Developmental
35 Disabilities) or the Department of Corrections.
36     (k-5) "Pharmacist" means an individual health care

 

 

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1 professional and provider currently licensed by this State to
2 engage in the practice of pharmacy.
3     (l) "Pharmacist in charge" means the licensed pharmacist
4 whose name appears on a pharmacy license and who is responsible
5 for all aspects of the operation related to the practice of
6 pharmacy.
7     (m) "Dispense" means the delivery of drugs and medical
8 devices, in accordance with applicable State and federal laws
9 and regulations, to the patient or the patient's representative
10 authorized to receive these products, including the
11 compounding, packaging, and labeling necessary for delivery,
12 and any recommending or advising concerning the contents and
13 therapeutic values and uses thereof. "Dispense" does not mean
14 the physical delivery to a patient or a patient's
15 representative in a home or institution by a designee of a
16 pharmacist or by common carrier. "Dispense" also does not mean
17 the physical delivery of a drug or medical device to a patient
18 or patient's representative by a pharmacist's designee within a
19 pharmacy or drugstore while the pharmacist is on duty and the
20 pharmacy is open.
21     (n) "Domestic mail-order pharmacy" means a pharmacy that is
22 located in a state of the United States, other than Illinois,
23 that delivers, dispenses or distributes, through the United
24 States Postal Service or other common carrier, to Illinois
25 residents, any substance which requires a prescription.
26     (n-5) "Foreign mail-order pharmacy" means a pharmacy that
27 is located in a country other than the United States that
28 delivers, dispenses, or distributes, through the United States
29 Postal Service or other common carrier, to Illinois residents
30 any substance that requires a prescription.
31     (o) "Compounding" means the preparation, mixing,
32 assembling, packaging, or labeling of a drug or medical device:
33 (1) as the result of a practitioner's prescription drug order
34 or initiative that is dispensed pursuant to a prescription in
35 the course of professional practice; or (2) for the purpose of,
36 or incident to, research, teaching, or chemical analysis; or

 

 

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1 (3) in anticipation of prescription drug orders based on
2 routine, regularly observed prescribing patterns.
3     (p) "Confidential information" means information,
4 maintained by the pharmacist in the patient's records, released
5 only (i) to the patient or, as the patient directs, to other
6 practitioners and other pharmacists or (ii) to any other person
7 authorized by law to receive the information.
8     (q) "Prospective drug review" or "drug utilization
9 evaluation" means a screening for potential drug therapy
10 problems due to therapeutic duplication, drug-disease
11 contraindications, drug-drug interactions (including serious
12 interactions with nonprescription or over-the-counter drugs),
13 drug-food interactions, incorrect drug dosage or duration of
14 drug treatment, drug-allergy interactions, and clinical abuse
15 or misuse.
16     (r) "Patient counseling" means the communication between a
17 pharmacist or a student pharmacist under the direct supervision
18 of a pharmacist and a patient or the patient's representative
19 about the patient's medication or device for the purpose of
20 optimizing proper use of prescription medications or devices.
21 The offer to counsel by the pharmacist or the pharmacist's
22 designee, and subsequent patient counseling by the pharmacist
23 or student pharmacist, shall be made in a face-to-face
24 communication with the patient or patient's representative
25 unless, in the professional judgment of the pharmacist, a
26 face-to-face communication is deemed inappropriate or
27 unnecessary. In that instance, the offer to counsel or patient
28 counseling may be made in a written communication, by
29 telephone, or in a manner determined by the pharmacist to be
30 appropriate.
31     (s) "Patient profiles" or "patient drug therapy record"
32 means the obtaining, recording, and maintenance of patient
33 prescription information, including prescriptions for
34 controlled substances, and personal information.
35     (t) "Pharmaceutical care" includes, but is not limited to,
36 the act of monitoring drug use and other patient care services

 

 

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1 intended to achieve outcomes that improve the patient's quality
2 of life but shall not include the sale of over-the-counter
3 drugs by a seller of goods and services who does not dispense
4 prescription drugs.
5     (u) "Medical device" means an instrument, apparatus,
6 implement, machine, contrivance, implant, in vitro reagent, or
7 other similar or related article, including any component part
8 or accessory, required under federal law to bear the label
9 "Caution: Federal law requires dispensing by or on the order of
10 a physician". A seller of goods and services who, only for the
11 purpose of retail sales, compounds, sells, rents, or leases
12 medical devices shall not, by reasons thereof, be required to
13 be a licensed pharmacy.
14     (v) "Unique identifier" means an electronic signature,
15 handwritten signature or initials, thumb print, or other
16 acceptable individual biometric or electronic identification
17 process as approved by the Department.
18 (Source: P.A. 92-880, eff. 1-1-04; 93-571, eff. 8-20-03.)
 
19     (225 ILCS 85/16a)  (from Ch. 111, par. 4136a)
20     (Section scheduled to be repealed on January 1, 2008)
21     Sec. 16a. (a) The Department shall establish rules and
22 regulations, consistent with the provisions of this Act,
23 governing domestic mail-order pharmacies, including pharmacies
24 providing services via the Internet, which sell, or offer for
25 sale, drugs, medicines, or other pharmaceutical services in
26 this State.
27     (b) The Board shall require and provide for an annual
28 nonresident special pharmacy registration for all pharmacies
29 located outside of this State that dispense medications for
30 Illinois residents and mail, ship, or deliver prescription
31 medications into this State. Nonresident special pharmacy
32 registration shall be granted by the Board upon the disclosure
33 and certification by a pharmacy:
34         (1) that it is licensed in the state in which the
35     dispensing facility is located and from which the drugs are

 

 

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1     dispensed;
2         (2) of the location, names, and titles of all principal
3     corporate officers and all pharmacists who are dispensing
4     drugs to residents of this State;
5         (3) that it complies with all lawful directions and
6     requests for information from the board of pharmacy of each
7     state in which it is licensed or registered, except that it
8     shall respond directly to all communications from the Board
9     concerning emergency circumstances arising from the
10     dispensing of drugs to residents of this State;
11         (4) that it maintains its records of drugs dispensed to
12     residents of this State so that the records are readily
13     retrievable from the records of other drugs dispensed;
14         (5) that it cooperates with the Board in providing
15     information to the board of pharmacy of the state in which
16     it is licensed concerning matters related to the dispensing
17     of drugs to residents of this State; and
18         (6) that during its regular hours of operation, but not
19     less than 6 days per week, for a minimum of 40 hours per
20     week, a toll-free telephone service is provided to
21     facilitate communication between patients in this State
22     and a pharmacist at the pharmacy who has access to the
23     patients' records. The toll-free number must be disclosed
24     on the label affixed to each container of drugs dispensed
25     to residents of this State.
26     (c) The provisions of this Section do not apply to
27 pharmacies for which registration is provided under Section
28 16b.
29 (Source: P.A. 91-438, eff. 1-1-00.)
 
30     (225 ILCS 85/16b new)
31     Sec. 16b. Foreign mail-order pharmacy.
32     (a) Notwithstanding any other Section of this Act, the
33 Department shall provide for the registration of foreign
34 mail-order pharmacies as nonresident pharmacies, upon the
35 disclosure and certification by a foreign mail-order pharmacy

 

 

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1 of the following:
2         (1) That it is licensed in the country, state, or
3     province in which the dispensing facility is located and
4     from which the drugs are dispensed.
5         (2) The location, names, and titles of all principal
6     corporate officers and all pharmacists who are dispensing
7     drugs to residents of this State.
8         (3) That it complies with all lawful directions and
9     requests for information from the board of pharmacy of each
10     country, state, or province in which it is licensed or
11     registered, except that it shall respond directly to all
12     communications from the Board concerning emergency
13     circumstances arising from the dispensing of drugs to
14     residents of this State.
15         (4) That it maintains its records of drugs dispensed to
16     residents of this State so that the records are readily
17     retrievable from the records of other drugs dispensed.
18         (5) That it cooperates with the Board of Pharmacy in
19     providing information to the board of pharmacy of the
20     country, state, or province in which it is licensed
21     concerning matters related to the dispensing of drugs to
22     residents of this State.
23         (6) That during its regular hours of operation, but not
24     less than 6 days per week, for a minimum of 40 hours per
25     week, a toll-free telephone service is provided to
26     facilitate communication between patients in this State
27     and a pharmacist at the pharmacy who has access to the
28     patients' records. The toll-free number must be disclosed
29     on the label affixed to each container of drugs dispensed
30     to residents of this State.
31         (7) That it consents to the jurisdiction of the
32     Department over pharmacy practices affecting the State of
33     Illinois.
34     (b) Only a pharmacy located within a foreign country,
35 state, or province whose pharmacy laws and regulations have
36 been determined by the Department to be substantially similar

 

 

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1 to those of the State of Illinois and whose regulatory scheme
2 for approval and quality control of prescription drugs has been
3 found by the Department to be substantially equivalent to that
4 of the State of Illinois and the federal government may be
5 registered as a nonresident pharmacy.
6     (c) The Department's criteria for determining substantial
7 equivalence shall be set by rule.
8     (d) The Department shall maintain a list of all foreign
9 countries, states, and provinces that have been evaluated on
10 its website with a designation of "approved" or "denied". Any
11 pharmacy located within a foreign country, state, or province
12 that has not been evaluated by the Department may request that
13 the Department conduct an evaluation.
 
14     (225 ILCS 85/35.1)  (from Ch. 111, par. 4155.1)
15     (Section scheduled to be repealed on January 1, 2008)
16     Sec. 35.1. (a) If any person violates the provision of this
17 Act, the Director may, in the name of the People of the State
18 of Illinois, through the Attorney General of the State of
19 Illinois, or the State's Attorney of any county in which the
20 action is brought, petition, for an order enjoining such
21 violation or for an order enforcing compliance with this Act.
22 Upon the filing of a verified petition in such court, the court
23 may issue a temporary restraining order, without notice or
24 bond, and may preliminarily and permanently enjoin such
25 violation, and if it is established that such person has
26 violated or is violating the injunction, the Court may punish
27 the offender for contempt of court. Proceedings under this
28 Section shall be in addition to, and not in lieu of, all other
29 remedies and penalties provided by this Act.
30     (b) If any person shall practice as a pharmacist or hold
31 himself out as a pharmacist or operate a pharmacy or drugstore,
32 including a domestic mail-order pharmacy under Section 16a or a
33 foreign mail-order pharmacy under Section 16b, without being
34 licensed under the provisions of this Act, then any licensed
35 pharmacist, any interested party or any person injured thereby

 

 

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1 may, in addition to the Director, petition for relief as
2 provided in subsection (a) of this Section.
3     Whoever knowingly practices or offers to practice in this
4 State without being appropriately licensed or registered under
5 this Act shall be guilty of a Class A misdemeanor and for each
6 subsequent conviction, shall be guilty of a Class 4 felony.
7     (c) Whenever in the opinion of the Department any person
8 not licensed in good standing under this Act violates any
9 provision of this Act, the Department may issue a rule to show
10 cause why an order to cease and desist should not be entered
11 against him. The rule shall clearly set forth the grounds
12 relied upon by the Department and shall provide a period of 7
13 days from the date of the rule to file an answer to the
14 satisfaction of the Department. Failure to answer to the
15 satisfaction of the Department shall cause an order to cease
16 and desist to be issued forthwith.
17 (Source: P.A. 92-678, eff. 7-16-02.)
 
18     Section 99. Effective date. This Act takes effect upon
19 becoming law.