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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 | Section 3 as follows:
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6 | (225 ILCS 85/3)
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7 | (Section scheduled to be repealed on January 1, 2020)
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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 | registered nurses, physician assistants, veterinarians, | ||||||
17 | podiatric physicians, or
optometrists, within the limits of | ||||||
18 | their
licenses, are
compounded, filled, or dispensed; or (3) | ||||||
19 | which has upon it or
displayed within
it, or affixed to or used | ||||||
20 | in connection with it, a sign bearing the word or
words | ||||||
21 | "Pharmacist", "Druggist", "Pharmacy", "Pharmaceutical
Care", | ||||||
22 | "Apothecary", "Drugstore",
"Medicine Store", "Prescriptions", | ||||||
23 | "Drugs", "Dispensary", "Medicines", or any word
or words of |
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1 | similar or like import, either in the English language
or any | ||||||
2 | other language; or (4) where the characteristic prescription
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3 | sign (Rx) or similar design is exhibited; or (5) any store, or
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4 | shop,
or other place with respect to which any of the above | ||||||
5 | words, objects,
signs or designs are used in any advertisement.
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6 | (b) "Drugs" means and includes (1) 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 (1), (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: | ||||||
2 | (1) the interpretation and the provision of assistance | ||||||
3 | in the monitoring, evaluation, and implementation of | ||||||
4 | prescription drug orders; | ||||||
5 | (2) the dispensing of prescription drug orders; | ||||||
6 | (3) participation in drug and device selection; | ||||||
7 | (4) drug administration limited to the administration | ||||||
8 | of oral, topical, injectable, and inhalation as follows: | ||||||
9 | (A) in the context of patient education on the | ||||||
10 | proper use or delivery of medications; | ||||||
11 | (B) vaccination of patients 14 years of age and | ||||||
12 | older pursuant to a valid prescription or standing | ||||||
13 | order, by a physician licensed to practice medicine in | ||||||
14 | all its branches, upon completion of appropriate | ||||||
15 | training, including how to address contraindications | ||||||
16 | and adverse reactions set forth by rule, with | ||||||
17 | notification to the patient's physician and | ||||||
18 | appropriate record retention, or pursuant to hospital | ||||||
19 | pharmacy and therapeutics committee policies and | ||||||
20 | procedures; and | ||||||
21 | (C) administration of injections of | ||||||
22 | alpha-hydroxyprogesterone caproate, pursuant to a | ||||||
23 | valid prescription, by a physician licensed to | ||||||
24 | practice medicine in all its branches, upon completion | ||||||
25 | of appropriate training, including how to address | ||||||
26 | contraindications and adverse reactions set forth by |
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1 | rule, with notification to the patient's physician and | ||||||
2 | appropriate record retention, or pursuant to hospital | ||||||
3 | pharmacy and therapeutics committee policies and | ||||||
4 | procedures; | ||||||
5 | (5) vaccination of patients ages 10 through 13 limited | ||||||
6 | to the Influenza (inactivated influenza vaccine and live | ||||||
7 | attenuated influenza intranasal vaccine) and Tdap (defined | ||||||
8 | as tetanus, diphtheria, acellular pertussis) vaccines, | ||||||
9 | pursuant to a valid prescription or standing order, by a | ||||||
10 | physician licensed to practice medicine in all its | ||||||
11 | branches, upon completion of appropriate training, | ||||||
12 | including how to address contraindications and adverse | ||||||
13 | reactions set forth by rule, with notification to the | ||||||
14 | patient's physician and appropriate record retention, or | ||||||
15 | pursuant to hospital pharmacy and therapeutics committee | ||||||
16 | policies and procedures; | ||||||
17 | (6) drug regimen review; | ||||||
18 | (7) drug or drug-related research; | ||||||
19 | (8) the provision of patient counseling; | ||||||
20 | (9) the practice of telepharmacy; | ||||||
21 | (10) the provision of those acts or services necessary | ||||||
22 | to provide pharmacist care; | ||||||
23 | (11) medication therapy management; and | ||||||
24 | (12) the responsibility for compounding and labeling | ||||||
25 | of drugs and devices (except labeling by a manufacturer, | ||||||
26 | repackager, or distributor of non-prescription drugs and |
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1 | commercially packaged legend drugs and devices), proper | ||||||
2 | and safe storage of drugs and devices, and maintenance of | ||||||
3 | required records. | ||||||
4 | A pharmacist who performs any of the acts defined as the | ||||||
5 | practice of pharmacy in this State must be actively licensed as | ||||||
6 | a pharmacist under this Act.
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7 | (e) "Prescription" means and includes any written, oral, | ||||||
8 | facsimile, or
electronically transmitted order for drugs
or | ||||||
9 | medical devices, issued by a physician licensed to practice | ||||||
10 | medicine in
all its branches, dentist, veterinarian, podiatric | ||||||
11 | physician, or
optometrist, within the
limits of his or her | ||||||
12 | license their licenses , by a physician assistant in accordance | ||||||
13 | with
subsection (f) of Section 4, or by an advanced practice | ||||||
14 | registered nurse in
accordance with subsection (g) of Section | ||||||
15 | 4, containing the
following: (1) name
of the patient; (2) date | ||||||
16 | when prescription was issued; (3) name
and strength of drug or | ||||||
17 | description of the medical device prescribed;
and (4) quantity; | ||||||
18 | (5) directions for use; (6) prescriber's name,
address,
and | ||||||
19 | signature; and (7) DEA registration number where required, for | ||||||
20 | controlled
substances.
The prescription may, but is not | ||||||
21 | required to, list the illness, disease, or condition for which | ||||||
22 | the drug or device is being prescribed. DEA registration | ||||||
23 | numbers shall not be required on inpatient drug orders. A | ||||||
24 | prescription for medication other than controlled substances | ||||||
25 | shall be valid for up to 15 months from the date issued for the | ||||||
26 | purpose of refills, unless the prescription states otherwise.
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1 | (f) "Person" means and includes a natural person, | ||||||
2 | partnership,
association, corporation, government entity, or | ||||||
3 | any other legal
entity.
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4 | (g) "Department" means the Department of Financial and
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5 | Professional Regulation.
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6 | (h) "Board of Pharmacy" or "Board" means the State Board
of | ||||||
7 | Pharmacy of the Department of Financial and Professional | ||||||
8 | Regulation.
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9 | (i) "Secretary"
means the Secretary
of Financial and | ||||||
10 | Professional Regulation.
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11 | (j) "Drug product selection" means the interchange for a
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12 | prescribed pharmaceutical product in accordance with Section | ||||||
13 | 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | ||||||
14 | Cosmetic Act.
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15 | (k) "Inpatient drug order" means an order issued by an | ||||||
16 | authorized
prescriber for a resident or patient of a facility | ||||||
17 | licensed under the
Nursing Home Care Act, the ID/DD Community | ||||||
18 | Care Act, the MC/DD Act, the Specialized Mental Health | ||||||
19 | Rehabilitation Act of 2013, the Hospital Licensing Act, or the | ||||||
20 | University of Illinois Hospital Act "An Act in relation to
the | ||||||
21 | founding and operation of the University of Illinois Hospital | ||||||
22 | and the
conduct of University of Illinois health care | ||||||
23 | programs", approved July 3, 1931,
as amended , or a facility | ||||||
24 | which is operated by the Department of Human
Services (as | ||||||
25 | successor to the Department of Mental Health
and Developmental | ||||||
26 | Disabilities) or the Department of Corrections.
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1 | (k-5) "Pharmacist" means an individual health care | ||||||
2 | professional and
provider currently licensed by this State to | ||||||
3 | engage in the practice of
pharmacy.
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4 | (l) "Pharmacist in charge" means the licensed pharmacist | ||||||
5 | whose name appears
on a pharmacy license and who is responsible | ||||||
6 | for all aspects of the
operation related to the practice of | ||||||
7 | pharmacy.
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8 | (m) "Dispense" or "dispensing" means the interpretation, | ||||||
9 | evaluation, and implementation of a prescription drug order, | ||||||
10 | including the preparation and delivery of a drug or device to a | ||||||
11 | patient or patient's agent in a suitable container | ||||||
12 | appropriately labeled for subsequent administration to or use | ||||||
13 | by a patient in accordance with applicable State and federal | ||||||
14 | laws and regulations.
"Dispense" or "dispensing" does not mean | ||||||
15 | the physical delivery to a patient or a
patient's | ||||||
16 | representative in a home or institution by a designee of a | ||||||
17 | pharmacist
or by common carrier. "Dispense" or "dispensing" | ||||||
18 | also does not mean the physical delivery
of a drug or medical | ||||||
19 | device to a patient or patient's representative by a
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20 | pharmacist's designee within a pharmacy or drugstore while the | ||||||
21 | pharmacist is
on duty and the pharmacy is open.
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22 | (n) "Nonresident pharmacy"
means a pharmacy that is located | ||||||
23 | in a state, commonwealth, or territory
of the United States, | ||||||
24 | other than Illinois, that delivers, dispenses, or
distributes, | ||||||
25 | through the United States Postal Service, commercially | ||||||
26 | acceptable parcel delivery service, or other common
carrier, to |
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1 | Illinois residents, any substance which requires a | ||||||
2 | prescription.
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3 | (o) "Compounding" means the preparation and mixing of | ||||||
4 | components, excluding flavorings, (1) as the result of a | ||||||
5 | prescriber's prescription drug order or initiative based on the | ||||||
6 | prescriber-patient-pharmacist relationship in the course of | ||||||
7 | professional practice or (2) for the purpose of, or incident | ||||||
8 | to, research, teaching, or chemical analysis and not for sale | ||||||
9 | or dispensing. "Compounding" includes the preparation of drugs | ||||||
10 | or devices in anticipation of receiving prescription drug | ||||||
11 | orders based on routine, regularly observed dispensing | ||||||
12 | patterns. Commercially available products may be compounded | ||||||
13 | for dispensing to individual patients only if all of the | ||||||
14 | following conditions are met: (i) the commercial product is not | ||||||
15 | reasonably available from normal distribution channels in a | ||||||
16 | timely manner to meet the patient's needs and (ii) the | ||||||
17 | prescribing practitioner has requested that the drug be | ||||||
18 | compounded.
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19 | (p) (Blank).
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20 | (q) (Blank).
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21 | (r) "Patient counseling" means the communication between a | ||||||
22 | pharmacist or a student pharmacist under the supervision of a | ||||||
23 | pharmacist and a patient or the patient's representative about | ||||||
24 | the patient's medication or device for the purpose of | ||||||
25 | optimizing proper use of prescription medications or devices. | ||||||
26 | "Patient counseling" may include without limitation (1) |
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1 | obtaining a medication history; (2) acquiring a patient's | ||||||
2 | allergies and health conditions; (3) facilitation of the | ||||||
3 | patient's understanding of the intended use of the medication; | ||||||
4 | (4) proper directions for use; (5) significant potential | ||||||
5 | adverse events; (6) potential food-drug interactions; and (7) | ||||||
6 | the need to be compliant with the medication therapy. A | ||||||
7 | pharmacy technician may only participate in the following | ||||||
8 | aspects of patient counseling under the supervision of a | ||||||
9 | pharmacist: (1) obtaining medication history; (2) providing | ||||||
10 | the offer for counseling by a pharmacist or student pharmacist; | ||||||
11 | and (3) acquiring a patient's allergies and health conditions.
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12 | (s) "Patient profiles" or "patient drug therapy record" | ||||||
13 | means the
obtaining, recording, and maintenance of patient | ||||||
14 | prescription
information, including prescriptions for | ||||||
15 | controlled substances, and
personal information.
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16 | (t) (Blank).
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17 | (u) "Medical device" or "device" means an instrument, | ||||||
18 | apparatus, implement, machine,
contrivance, implant, in vitro | ||||||
19 | reagent, or other similar or related article,
including any | ||||||
20 | component part or accessory, required under federal law to
bear | ||||||
21 | the label "Caution: Federal law requires dispensing by or on | ||||||
22 | the order
of a physician". A seller of goods and services who, | ||||||
23 | only for the purpose of
retail sales, compounds, sells, rents, | ||||||
24 | or leases medical devices shall not,
by reasons thereof, be | ||||||
25 | required to be a licensed pharmacy.
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26 | (v) "Unique identifier" means an electronic signature, |
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1 | handwritten
signature or initials, thumb print, or other | ||||||
2 | acceptable biometric
or electronic identification process as | ||||||
3 | approved by the Department.
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4 | (w) "Current usual and customary retail price" means the | ||||||
5 | price that a pharmacy charges to a non-third-party payor.
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6 | (x) "Automated pharmacy system" means a mechanical system | ||||||
7 | located within the confines of the pharmacy or remote location | ||||||
8 | that performs operations or activities, other than compounding | ||||||
9 | or administration, relative to storage, packaging, dispensing, | ||||||
10 | or distribution of medication, and which collects, controls, | ||||||
11 | and maintains all transaction information. | ||||||
12 | (y) "Drug regimen review" means and includes the evaluation | ||||||
13 | of prescription drug orders and patient records for (1)
known | ||||||
14 | allergies; (2) drug or potential therapy contraindications;
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15 | (3) reasonable dose, duration of use, and route of | ||||||
16 | administration, taking into consideration factors such as age, | ||||||
17 | gender, and contraindications; (4) reasonable directions for | ||||||
18 | use; (5) potential or actual adverse drug reactions; (6) | ||||||
19 | drug-drug interactions; (7) drug-food interactions; (8) | ||||||
20 | drug-disease contraindications; (9) therapeutic duplication; | ||||||
21 | (10) patient laboratory values when authorized and available; | ||||||
22 | (11) proper utilization (including over or under utilization) | ||||||
23 | and optimum therapeutic outcomes; and (12) abuse and misuse.
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24 | (z) "Electronically transmitted prescription" means a | ||||||
25 | prescription that is created, recorded, or stored by electronic | ||||||
26 | means; issued and validated with an electronic signature; and |
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1 | transmitted by electronic means directly from the prescriber to | ||||||
2 | a pharmacy. An electronic prescription is not an image of a | ||||||
3 | physical prescription that is transferred by electronic means | ||||||
4 | from computer to computer, facsimile to facsimile, or facsimile | ||||||
5 | to computer.
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6 | (aa) "Medication therapy management services" means a | ||||||
7 | distinct service or group of services offered by licensed | ||||||
8 | pharmacists, physicians licensed to practice medicine in all | ||||||
9 | its branches, advanced practice registered nurses authorized | ||||||
10 | in a written agreement with a physician licensed to practice | ||||||
11 | medicine in all its branches, or physician assistants | ||||||
12 | authorized in guidelines by a supervising physician that | ||||||
13 | optimize therapeutic outcomes for individual patients through | ||||||
14 | improved medication use. In a retail or other non-hospital | ||||||
15 | pharmacy, medication therapy management services shall consist | ||||||
16 | of the evaluation of prescription drug orders and patient | ||||||
17 | medication records to resolve conflicts with the following: | ||||||
18 | (1) known allergies; | ||||||
19 | (2) drug or potential therapy contraindications; | ||||||
20 | (3) reasonable dose, duration of use, and route of | ||||||
21 | administration, taking into consideration factors such as | ||||||
22 | age, gender, and contraindications; | ||||||
23 | (4) reasonable directions for use; | ||||||
24 | (5) potential or actual adverse drug reactions; | ||||||
25 | (6) drug-drug interactions; | ||||||
26 | (7) drug-food interactions; |
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1 | (8) drug-disease contraindications; | ||||||
2 | (9) identification of therapeutic duplication; | ||||||
3 | (10) patient laboratory values when authorized and | ||||||
4 | available; | ||||||
5 | (11) proper utilization (including over or under | ||||||
6 | utilization) and optimum therapeutic outcomes; and | ||||||
7 | (12) drug abuse and misuse. | ||||||
8 | "Medication therapy management services" includes the | ||||||
9 | following: | ||||||
10 | (1) documenting the services delivered and | ||||||
11 | communicating the information provided to patients' | ||||||
12 | prescribers within an appropriate time frame, not to exceed | ||||||
13 | 48 hours; | ||||||
14 | (2) providing patient counseling designed to enhance a | ||||||
15 | patient's understanding and the appropriate use of his or | ||||||
16 | her medications; and | ||||||
17 | (3) providing information, support services, and | ||||||
18 | resources designed to enhance a patient's adherence with | ||||||
19 | his or her prescribed therapeutic regimens. | ||||||
20 | "Medication therapy management services" may also include | ||||||
21 | patient care functions authorized by a physician licensed to | ||||||
22 | practice medicine in all its branches for his or her identified | ||||||
23 | patient or groups of patients under specified conditions or | ||||||
24 | limitations in a standing order from the physician. | ||||||
25 | "Medication therapy management services" in a licensed | ||||||
26 | hospital may also include the following: |
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1 | (1) reviewing assessments of the patient's health | ||||||
2 | status; and | ||||||
3 | (2) following protocols of a hospital pharmacy and | ||||||
4 | therapeutics committee with respect to the fulfillment of | ||||||
5 | medication orders.
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6 | (bb) "Pharmacist care" means the provision by a pharmacist | ||||||
7 | of medication therapy management services, with or without the | ||||||
8 | dispensing of drugs or devices, intended to achieve outcomes | ||||||
9 | that improve patient health, quality of life, and comfort and | ||||||
10 | enhance patient safety.
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11 | (cc) "Protected health information" means individually | ||||||
12 | identifiable health information that, except as otherwise | ||||||
13 | provided, is:
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14 | (1) transmitted by electronic media; | ||||||
15 | (2) maintained in any medium set forth in the | ||||||
16 | definition of "electronic media" in the federal Health | ||||||
17 | Insurance Portability and Accountability Act; or | ||||||
18 | (3) transmitted or maintained in any other form or | ||||||
19 | medium. | ||||||
20 | "Protected health information" does not include | ||||||
21 | individually identifiable health information found in: | ||||||
22 | (1) education records covered by the federal Family | ||||||
23 | Educational Right and Privacy Act; or | ||||||
24 | (2) employment records held by a licensee in its role | ||||||
25 | as an employer. | ||||||
26 | (dd) "Standing order" means a specific order for a patient |
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1 | or group of patients issued by a physician licensed to practice | ||||||
2 | medicine in all its branches in Illinois. | ||||||
3 | (ee) "Address of record" means the designated address | ||||||
4 | recorded by the Department in the applicant's application file | ||||||
5 | or licensee's license file maintained by the Department's | ||||||
6 | licensure maintenance unit. | ||||||
7 | (ff) "Home pharmacy" means the location of a pharmacy's | ||||||
8 | primary operations.
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9 | (gg) "Email address of record" means the designated email | ||||||
10 | address recorded by the Department in the applicant's | ||||||
11 | application file or the licensee's license file, as maintained | ||||||
12 | by the Department's licensure maintenance unit. | ||||||
13 | (Source: P.A. 99-180, eff. 7-29-15; 100-208, eff. 1-1-18; | ||||||
14 | 100-497, eff. 9-8-17; 100-513, eff. 1-1-18; revised 9-29-17.) | ||||||
15 | Section 10. The Illinois Food, Drug and Cosmetic Act is | ||||||
16 | amended by changing Section 2.36 as follows:
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17 | (410 ILCS 620/2.36) (from Ch. 56 1/2, par. 502.36)
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18 | Sec. 2.36.
"Prescription" means and includes any order for | ||||||
19 | drugs or
medical devices, written, facsimile, or verbal by a | ||||||
20 | physician licensed
to
practice medicine in all its branches, | ||||||
21 | dentist, veterinarian,
or podiatric physician containing the | ||||||
22 | following: (1) name of the
patient; (2) date when prescription | ||||||
23 | was given; (3) name and strength of
drug or description of the | ||||||
24 | medical device prescribed; (4) quantity, (5)
directions
for |
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1 | use, (6) prescriber's name, address and signature, and (7) DEA
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2 | number where
required, for controlled substances. A | ||||||
3 | prescription for medication other than controlled substances | ||||||
4 | shall be valid for up to 15 months from the date issued for the | ||||||
5 | purpose of refills, unless the prescription states otherwise.
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6 | (Source: P.A. 98-214, eff. 8-9-13.)
|