Full Text of HB4260 95th General Assembly
HB4260 95TH GENERAL ASSEMBLY
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95TH GENERAL ASSEMBLY
State of Illinois
2007 and 2008 HB4260
Introduced , by Rep. Jack D. Franks SYNOPSIS AS INTRODUCED: |
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225 ILCS 85/3 |
from Ch. 111, par. 4123 |
225 ILCS 85/16a |
from Ch. 111, par. 4136a |
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Amends the Pharmacy Practice Act. Provides that a pharmacy that is located in a province of Canada may obtain a nonresident
special pharmacy registration from the Department of Financial and Professional Regulation upon meeting certain criteria set forth under the Act.
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A BILL FOR
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HB4260 |
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LRB095 14847 RAS 40787 b |
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| AN ACT concerning regulation.
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| Be it enacted by the People of the State of Illinois,
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| represented in the General Assembly:
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| Section 5. The Pharmacy Practice Act is amended by changing | 5 |
| Sections 3 and 16a as follows:
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| (225 ILCS 85/3) (from Ch. 111, par. 4123)
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| (Section scheduled to be repealed on January 1, 2018)
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| Sec. 3. Definitions. For the purpose of this Act, except | 9 |
| where otherwise
limited therein:
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| (a) "Pharmacy" or "drugstore" means and includes every | 11 |
| store, shop,
pharmacy department, or other place where | 12 |
| pharmacist
care is
provided
by a pharmacist (1) where drugs, | 13 |
| medicines, or poisons are
dispensed, sold or
offered for sale | 14 |
| at retail, or displayed for sale at retail; or
(2)
where
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| prescriptions of physicians, dentists, advanced practice | 16 |
| nurses, physician assistants, veterinarians, podiatrists, or
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| optometrists, within the limits of their
licenses, are
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| compounded, filled, or dispensed; or (3) which has upon it or
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| displayed within
it, or affixed to or used in connection with | 20 |
| it, a sign bearing the word or
words "Pharmacist", "Druggist", | 21 |
| "Pharmacy", "Pharmaceutical
Care", "Apothecary", "Drugstore",
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| "Medicine Store", "Prescriptions", "Drugs", "Dispensary", | 23 |
| "Medicines", or any word
or words of similar or like import, |
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LRB095 14847 RAS 40787 b |
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| either in the English language
or any other language; or (4) | 2 |
| where the characteristic prescription
sign (Rx) or similar | 3 |
| design is exhibited; or (5) any store, or
shop,
or other place | 4 |
| with respect to which any of the above words, objects,
signs or | 5 |
| designs are used in any advertisement.
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| (b) "Drugs" means and includes (l) articles recognized
in | 7 |
| the official United States Pharmacopoeia/National Formulary | 8 |
| (USP/NF),
or any supplement thereto and being intended for and | 9 |
| having for their
main use the diagnosis, cure, mitigation, | 10 |
| treatment or prevention of
disease in man or other animals, as | 11 |
| approved by the United States Food and
Drug Administration, but | 12 |
| does not include devices or their components, parts,
or | 13 |
| accessories; and (2) all other articles intended
for and having | 14 |
| for their main use the diagnosis, cure, mitigation,
treatment | 15 |
| or prevention of disease in man or other animals, as approved
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| by the United States Food and Drug Administration, but does not | 17 |
| include
devices or their components, parts, or accessories; and | 18 |
| (3) articles
(other than food) having for their main use and | 19 |
| intended
to affect the structure or any function of the body of | 20 |
| man or other
animals; and (4) articles having for their main | 21 |
| use and intended
for use as a component or any articles | 22 |
| specified in clause (l), (2)
or (3); but does not include | 23 |
| devices or their components, parts or
accessories.
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| (c) "Medicines" means and includes all drugs intended for
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| human or veterinary use approved by the United States Food and | 26 |
| Drug
Administration.
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| (d) "Practice of pharmacy" means (1) the interpretation and | 2 |
| the provision of assistance in the monitoring, evaluation, and | 3 |
| implementation of prescription drug orders; (2) the dispensing | 4 |
| of prescription drug orders; (3) participation in drug and | 5 |
| device selection; (4) drug administration limited to the | 6 |
| administration of oral, topical, injectable, and inhalation as | 7 |
| follows: in the context of patient education on the proper use | 8 |
| or delivery of medications; vaccination of patients 14 years of | 9 |
| age and older pursuant to a valid prescription or standing | 10 |
| order, by a physician licensed to practice medicine in all its | 11 |
| branches, upon completion of appropriate training, including | 12 |
| how to address contraindications and adverse reactions set | 13 |
| forth by rule, with notification to the patient's physician and | 14 |
| appropriate record retention, or pursuant to hospital pharmacy | 15 |
| and therapeutics committee policies and procedures; (5) drug | 16 |
| regimen review; (6) drug or drug-related research; (7) the | 17 |
| provision of patient counseling; (8) the practice of | 18 |
| telepharmacy; (9) the provision of those acts or services | 19 |
| necessary to provide pharmacist care; (10) medication therapy | 20 |
| management; and (11) the responsibility for compounding and | 21 |
| labeling of drugs and devices (except labeling by a | 22 |
| manufacturer, repackager, or distributor of non-prescription | 23 |
| drugs and commercially packaged legend drugs and devices), | 24 |
| proper and safe storage of drugs and devices, and maintenance | 25 |
| of required records. A pharmacist who performs any of the acts | 26 |
| defined as the practice of pharmacy in this State must be |
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LRB095 14847 RAS 40787 b |
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| actively licensed as a pharmacist under this Act.
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| (e) "Prescription" means and includes any written, oral, | 3 |
| facsimile, or
electronically transmitted order for drugs
or | 4 |
| medical devices, issued by a physician licensed to practice | 5 |
| medicine in
all its branches, dentist, veterinarian, or | 6 |
| podiatrist, or
optometrist, within the
limits of their | 7 |
| licenses, by a physician assistant in accordance with
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| subsection (f) of Section 4, or by an advanced practice nurse | 9 |
| in
accordance with subsection (g) of Section 4, containing the
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| following: (l) name
of the patient; (2) date when prescription | 11 |
| was issued; (3) name
and strength of drug or description of the | 12 |
| medical device prescribed;
and (4) quantity, (5) directions for | 13 |
| use, (6) prescriber's name,
address
and signature, and (7) DEA | 14 |
| number where required, for controlled
substances.
DEA numbers | 15 |
| shall not be required on inpatient drug orders.
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| (f) "Person" means and includes a natural person, | 17 |
| copartnership,
association, corporation, government entity, or | 18 |
| any other legal
entity.
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| (g) "Department" means the Department of Financial and
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| Professional Regulation.
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| (h) "Board of Pharmacy" or "Board" means the State Board
of | 22 |
| Pharmacy of the Department of Financial and Professional | 23 |
| Regulation.
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| (i) "Secretary"
means the Secretary
of Financial and | 25 |
| Professional Regulation.
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| (j) "Drug product selection" means the interchange for a
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| prescribed pharmaceutical product in accordance with Section | 2 |
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this Act and Section 3.14 of the Illinois Food, Drug and | 3 |
| Cosmetic Act.
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| (k) "Inpatient drug order" means an order issued by an | 5 |
| authorized
prescriber for a resident or patient of a facility | 6 |
| licensed under the
Nursing Home Care Act or the Hospital | 7 |
| Licensing Act, or "An Act in relation to
the founding and | 8 |
| operation of the University of Illinois Hospital and the
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| 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.
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| (k-5) "Pharmacist" means an individual health care | 15 |
| professional and
provider currently licensed by this State to | 16 |
| engage in the practice of
pharmacy.
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| (l) "Pharmacist in charge" means the licensed pharmacist | 18 |
| whose name appears
on a pharmacy license and who is responsible | 19 |
| for all aspects of the
operation related to the practice of | 20 |
| pharmacy.
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| (m) "Dispense" or "dispensing" means the interpretation, | 22 |
| evaluation, and implementation of a prescription drug order, | 23 |
| including the preparation and delivery of a drug or device to a | 24 |
| patient or patient's agent in a suitable container | 25 |
| appropriately labeled for subsequent administration to or use | 26 |
| by a patient in accordance with applicable State and federal |
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LRB095 14847 RAS 40787 b |
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| laws and regulations.
"Dispense" or "dispensing" does not mean | 2 |
| the physical delivery to a patient or a
patient's | 3 |
| representative in a home or institution by a designee of a | 4 |
| pharmacist
or by common carrier. "Dispense" or "dispensing" | 5 |
| also does not mean the physical delivery
of a drug or medical | 6 |
| device to a patient or patient's representative by a
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| pharmacist's designee within a pharmacy or drugstore while the | 8 |
| pharmacist is
on duty and the pharmacy is open.
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| (n) "Nonresident pharmacy"
means a pharmacy that is located | 10 |
| in a state, commonwealth, or territory
of the United States, | 11 |
| other than Illinois, or in a province of Canada, that delivers, | 12 |
| dispenses, or
distributes, through the United States Postal | 13 |
| Service, commercially acceptable parcel delivery service, or | 14 |
| other common
carrier, to Illinois residents, any substance | 15 |
| which requires a prescription.
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| (o) "Compounding" means the preparation and mixing of | 17 |
| components, excluding flavorings, (1) as the result of a | 18 |
| prescriber's prescription drug order or initiative based on the | 19 |
| prescriber-patient-pharmacist relationship in the course of | 20 |
| professional practice or (2) for the purpose of, or incident | 21 |
| to, research, teaching, or chemical analysis and not for sale | 22 |
| or dispensing. "Compounding" includes the preparation of drugs | 23 |
| or devices in anticipation of receiving prescription drug | 24 |
| orders based on routine, regularly observed dispensing | 25 |
| patterns. Commercially available products may be compounded | 26 |
| for dispensing to individual patients only if all of the |
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LRB095 14847 RAS 40787 b |
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| following conditions are met: (i) the commercial product is not | 2 |
| reasonably available from normal distribution channels in a | 3 |
| timely manner to meet the patient's needs and (ii) the | 4 |
| prescribing practitioner has requested that the drug be | 5 |
| compounded.
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| (p) (Blank).
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| (q) (Blank).
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| (r) "Patient counseling" means the communication between a | 9 |
| pharmacist or a pharmacy intern under the supervision of a | 10 |
| pharmacist and a patient or the patient's representative about | 11 |
| the patient's medication or device for the purpose of | 12 |
| optimizing proper use of prescription medications or devices. | 13 |
| "Patient counseling" may include without limitation (1) | 14 |
| obtaining a medication history; (2) acquiring a patient's | 15 |
| allergies and health conditions; (3) facilitation of the | 16 |
| patient's understanding of the intended use of the medication; | 17 |
| (4) proper directions for use; (5) significant potential | 18 |
| adverse events; (6) potential food-drug interactions; and (7) | 19 |
| the need to be compliant with the medication therapy. A | 20 |
| pharmacy technician may only participate in the following | 21 |
| aspects of patient counseling under the supervision of a | 22 |
| pharmacist: (1) obtaining medication history; (2) providing | 23 |
| the offer for counseling by a pharmacist or intern; and (3) | 24 |
| acquiring a patient's allergies and health conditions.
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| (s) "Patient profiles" or "patient drug therapy record" | 26 |
| means the
obtaining, recording, and maintenance of patient |
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| prescription
information, including prescriptions for | 2 |
| controlled substances, and
personal information.
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| (t) (Blank).
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| (u) "Medical device" means an instrument, apparatus, | 5 |
| implement, machine,
contrivance, implant, in vitro reagent, or | 6 |
| other similar or related article,
including any component part | 7 |
| or accessory, required under federal law to
bear the label | 8 |
| "Caution: Federal law requires dispensing by or on the order
of | 9 |
| a physician". A seller of goods and services who, only for the | 10 |
| purpose of
retail sales, compounds, sells, rents, or leases | 11 |
| medical devices shall not,
by reasons thereof, be required to | 12 |
| be a licensed pharmacy.
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| (v) "Unique identifier" means an electronic signature, | 14 |
| handwritten
signature or initials, thumb print, or other | 15 |
| acceptable biometric
or electronic identification process as | 16 |
| approved by the Department.
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| (w) "Current usual and customary retail price" means the | 18 |
| price that a pharmacy charges to a non-third-party payor
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| (x) "Automated pharmacy system" means a mechanical system | 20 |
| located within the confines of the pharmacy or remote location | 21 |
| that performs operations or activities, other than compounding | 22 |
| or administration, relative to storage, packaging, dispensing, | 23 |
| or distribution of medication, and which collects, controls, | 24 |
| and maintains all transaction information. | 25 |
| (y) "Drug regimen review" means and includes the evaluation | 26 |
| of prescription drug orders and patient records for (1)
known |
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LRB095 14847 RAS 40787 b |
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| allergies; (2) drug or potential therapy contraindications;
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| (3) reasonable dose, duration of use, and route of | 3 |
| administration, taking into consideration factors such as age, | 4 |
| gender, and contraindications; (4) reasonable directions for | 5 |
| use; (5) potential or actual adverse drug reactions; (6) | 6 |
| drug-drug interactions; (7) drug-food interactions; (8) | 7 |
| drug-disease contraindications; (9) therapeutic duplication; | 8 |
| (10) patient laboratory values when authorized and available; | 9 |
| (11) proper utilization (including over or under utilization) | 10 |
| and optimum therapeutic outcomes; and (12) abuse and misuse.
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| (z) "Electronic transmission prescription" means any | 12 |
| prescription order for which a facsimile or electronic image of | 13 |
| the order is electronically transmitted from a licensed | 14 |
| prescriber to a pharmacy. "Electronic transmission | 15 |
| prescription" includes both data and image prescriptions.
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| (aa) "Medication therapy management services" means a | 17 |
| distinct service or group of services offered by licensed | 18 |
| pharmacists, physicians licensed to practice medicine in all | 19 |
| its branches, advanced practice nurses authorized in a written | 20 |
| agreement with a physician licensed to practice medicine in all | 21 |
| its branches, or physician assistants authorized in guidelines | 22 |
| by a supervising physician that optimize therapeutic outcomes | 23 |
| for individual patients through improved medication use. In a | 24 |
| retail or other non-hospital pharmacy, medication therapy | 25 |
| management services shall consist of the evaluation of | 26 |
| prescription drug orders and patient medication records to |
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| resolve conflicts with the following: | 2 |
| (1) known allergies; | 3 |
| (2) drug or potential therapy contraindications; | 4 |
| (3) reasonable dose, duration of use, and route of | 5 |
| administration, taking into consideration factors such as | 6 |
| age, gender, and contraindications; | 7 |
| (4) reasonable directions for use; | 8 |
| (5) potential or actual adverse drug reactions; | 9 |
| (6) drug-drug interactions; | 10 |
| (7) drug-food interactions; | 11 |
| (8) drug-disease contraindications; | 12 |
| (9) identification of therapeutic duplication; | 13 |
| (10) patient laboratory values when authorized and | 14 |
| available; | 15 |
| (11) proper utilization (including over or under | 16 |
| utilization) and optimum therapeutic outcomes; and | 17 |
| (12) drug abuse and misuse. | 18 |
| "Medication therapy management services" includes the | 19 |
| following: | 20 |
| (1) documenting the services delivered and | 21 |
| communicating the information provided to patients' | 22 |
| prescribers within an appropriate time frame, not to exceed | 23 |
| 48 hours; | 24 |
| (2) providing patient counseling designed to enhance a | 25 |
| patient's understanding and the appropriate use of his or | 26 |
| her medications; and |
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| (3) providing information, support services, and | 2 |
| resources designed to enhance a patient's adherence with | 3 |
| his or her prescribed therapeutic regimens.
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| "Medication therapy management services" may also include | 5 |
| patient care functions authorized by a physician licensed to | 6 |
| practice medicine in all its branches for his or her identified | 7 |
| patient or groups of patients under specified conditions or | 8 |
| limitations in a standing order from the physician. | 9 |
| "Medication therapy management services" in a licensed | 10 |
| hospital may also include the following: | 11 |
| (1) reviewing assessments of the patient's health | 12 |
| status; and | 13 |
| (2) following protocols of a hospital pharmacy and | 14 |
| therapeutics committee with respect to the fulfillment of | 15 |
| medication orders.
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| (bb) "Pharmacist care" means the provision by a pharmacist | 17 |
| of medication therapy management services, with or without the | 18 |
| dispensing of drugs or devices, intended to achieve outcomes | 19 |
| that improve patient health, quality of life, and comfort and | 20 |
| enhance patient safety.
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| (cc) "Protected health information" means individually | 22 |
| identifiable health information that, except as otherwise | 23 |
| provided, is:
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| (1) transmitted by electronic media; | 25 |
| (2) maintained in any medium set forth in the | 26 |
| definition of "electronic media" in the federal Health |
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LRB095 14847 RAS 40787 b |
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| Insurance Portability and Accountability Act; or | 2 |
| (3) transmitted or maintained in any other form or | 3 |
| medium. | 4 |
| "Protected health information" does not include individually | 5 |
| identifiable health information found in: | 6 |
| (1) education records covered by the federal | 7 |
| Family Educational Right and Privacy Act; or | 8 |
| (2) employment records held by a licensee in its | 9 |
| role as an employer. | 10 |
| (dd) "Standing order" means a specific order for a patient | 11 |
| or group of patients issued by a physician licensed to practice | 12 |
| medicine in all its branches in Illinois. | 13 |
| (ee) "Address of record" means the address recorded by the | 14 |
| Department in the applicant's or licensee's application file or | 15 |
| license file, as maintained by the Department's licensure | 16 |
| maintenance unit. | 17 |
| (ff) "Home pharmacy" means the location of a pharmacy's | 18 |
| primary operations.
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| (Source: P.A. 94-459, eff. 1-1-06; 95-689, eff. 10-29-07.)
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| (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
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| (Section scheduled to be repealed on January 1, 2018)
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| Sec. 16a. (a) The Department shall establish rules and | 23 |
| regulations,
consistent with the provisions of this Act, | 24 |
| governing nonresident
pharmacies,
including pharmacies | 25 |
| providing services via the Internet,
which sell, or offer for |
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| sale, drugs, medicines, or other pharmaceutical
services in | 2 |
| this State.
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| (b) The Board shall require and provide for an annual | 4 |
| nonresident
special pharmacy registration for all pharmacies | 5 |
| located outside of this
State that dispense medications for | 6 |
| Illinois residents and mail, ship, or
deliver prescription | 7 |
| medications into this State. Nonresident special
pharmacy | 8 |
| registration shall be granted by the Board upon the disclosure | 9 |
| and
certification by a pharmacy:
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| (1) that it is licensed in the state or province in | 11 |
| which the dispensing facility
is located and from which the | 12 |
| drugs are dispensed;
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| (2) of the location, names, and titles of all principal | 14 |
| corporate
officers and all pharmacists who are dispensing | 15 |
| drugs to residents of this
State;
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| (3) that it complies with all lawful directions and | 17 |
| requests for
information from the board of pharmacy of each | 18 |
| state or province in which it is
licensed or registered, | 19 |
| except that it shall respond directly to all
communications | 20 |
| from the Board concerning emergency circumstances arising
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| from the dispensing of drugs to residents of this State;
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| (4) that it maintains its records of drugs dispensed to | 23 |
| residents of
this State so that the records are readily | 24 |
| retrievable from the records of
other drugs dispensed;
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| (5) that it cooperates with the Board in providing | 26 |
| information to the
board of pharmacy of the state or |
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| province in which it is licensed concerning matters
related | 2 |
| to the dispensing of drugs to residents of this State; and
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| (6) that during its regular hours of operation, but not | 4 |
| less than 6
days per week, for a minimum of 40 hours per | 5 |
| week, a toll-free telephone
service is provided to | 6 |
| facilitate communication between patients in this
State | 7 |
| and a pharmacist at the pharmacy who has access to the | 8 |
| patients'
records. The toll-free number must be disclosed | 9 |
| on the label affixed to
each container of drugs dispensed | 10 |
| to residents of this State.
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| (Source: P.A. 95-689, eff. 10-29-07.)
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