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1 | AN ACT concerning regulation.
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2 | Be it enacted by the People of the State of Illinois,
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3 | represented in the General Assembly:
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4 | Section 5. The Pharmacy Practice Act is amended by changing | ||||||||||||||||||||||||||
5 | Sections 3 and 16a as follows:
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6 | (225 ILCS 85/3) (from Ch. 111, par. 4123)
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7 | (Section scheduled to be repealed on January 1, 2018)
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8 | Sec. 3. Definitions. For the purpose of this Act, except | ||||||||||||||||||||||||||
9 | where otherwise
limited therein:
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10 | (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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15 | prescriptions of physicians, dentists, advanced practice | ||||||||||||||||||||||||||
16 | nurses, physician assistants, veterinarians, podiatrists, or
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17 | optometrists, within the limits of their
licenses, are
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18 | compounded, filled, or dispensed; or (3) which has upon it or
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19 | 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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22 | "Medicine Store", "Prescriptions", "Drugs", "Dispensary", | ||||||||||||||||||||||||||
23 | "Medicines", or any word
or words of similar or like import, |
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1 | 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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6 | (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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16 | 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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24 | (c) "Medicines" means and includes all drugs intended for
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25 | human or veterinary use approved by the United States Food and | ||||||
26 | Drug
Administration.
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1 | (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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1 | actively licensed as a pharmacist under this Act.
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2 | (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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8 | 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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10 | 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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16 | (f) "Person" means and includes a natural person, | ||||||
17 | copartnership,
association, corporation, government entity, or | ||||||
18 | any other legal
entity.
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19 | (g) "Department" means the Department of Financial and
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20 | Professional Regulation.
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21 | (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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24 | (i) "Secretary"
means the Secretary
of Financial and | ||||||
25 | Professional Regulation.
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26 | (j) "Drug product selection" means the interchange for a
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1 | prescribed pharmaceutical product in accordance with Section | ||||||
2 | 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | ||||||
3 | Cosmetic Act.
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4 | (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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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.
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14 | (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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17 | (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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21 | (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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1 | 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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7 | pharmacist's designee within a pharmacy or drugstore while the | ||||||
8 | pharmacist is
on duty and the pharmacy is open.
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9 | (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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16 | (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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1 | 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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6 | (p) (Blank).
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7 | (q) (Blank).
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8 | (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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25 | (s) "Patient profiles" or "patient drug therapy record" | ||||||
26 | means the
obtaining, recording, and maintenance of patient |
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1 | prescription
information, including prescriptions for | ||||||
2 | controlled substances, and
personal information.
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3 | (t) (Blank).
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4 | (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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13 | (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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17 | (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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19 | (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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1 | allergies; (2) drug or potential therapy contraindications;
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2 | (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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11 | (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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16 | (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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1 | 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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1 | (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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4 | "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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16 | (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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21 | (cc) "Protected health information" means individually | ||||||
22 | identifiable health information that, except as otherwise | ||||||
23 | provided, is:
| ||||||
24 | (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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1 | 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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19 | (Source: P.A. 94-459, eff. 1-1-06; 95-689, eff. 10-29-07.)
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20 | (225 ILCS 85/16a) (from Ch. 111, par. 4136a)
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21 | (Section scheduled to be repealed on January 1, 2018)
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22 | 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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1 | sale, drugs, medicines, or other pharmaceutical
services in | ||||||
2 | this State.
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3 | (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:
| ||||||
10 | (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;
| ||||||
13 | (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;
| ||||||
16 | (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
| ||||||
21 | from the dispensing of drugs to residents of this State;
| ||||||
22 | (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;
| ||||||
25 | (5) that it cooperates with the Board in providing | ||||||
26 | information to the
board of pharmacy of the state or |
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1 | province in which it is licensed concerning matters
related | ||||||
2 | to the dispensing of drugs to residents of this State; and
| ||||||
3 | (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.
| ||||||
11 | (Source: P.A. 95-689, eff. 10-29-07.)
|