Full Text of SB1715 101st General Assembly
SB1715enr 101ST GENERAL ASSEMBLY |
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| 1 | | AN ACT concerning regulation.
| 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 is amended by changing | 5 | | Section 3 as follows:
| 6 | | (225 ILCS 85/3)
| 7 | | (Section scheduled to be repealed on January 1, 2020)
| 8 | | Sec. 3. Definitions. For the purpose of this Act, except | 9 | | where otherwise
limited therein:
| 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
| 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
| 3 | | sign (Rx) or similar design is exhibited; or (5) any store, or
| 4 | | shop,
or other place with respect to which any of the above | 5 | | words, objects,
signs or designs are used in any advertisement.
| 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
| 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.
| 24 | | (c) "Medicines" means and includes all drugs intended for
| 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 | | (B-5) following the initial administration of | 22 | | long-acting or extended release form opioid | 23 | | antagonists by a physician licensed to practice | 24 | | medicine in all its branches, administration of | 25 | | injections of long-acting or extended-release form | 26 | | opioid antagonists for the treatment of substance use |
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| 1 | | disorder, pursuant to a valid prescription by a | 2 | | physician licensed to practice medicine in all its | 3 | | branches, upon completion of appropriate training, | 4 | | including how to address contraindications and adverse | 5 | | reactions, including, but not limited to, respiratory | 6 | | depression and the performance of cardiopulmonary | 7 | | resuscitation, set forth by rule, with notification to | 8 | | the patient's physician and appropriate record | 9 | | retention, or pursuant to hospital pharmacy and | 10 | | therapeutics committee policies and procedures; | 11 | | (C) administration of injections of | 12 | | alpha-hydroxyprogesterone caproate, pursuant to a | 13 | | valid prescription, by a physician licensed to | 14 | | practice medicine in all its branches, upon completion | 15 | | of appropriate training, including how to address | 16 | | contraindications and adverse reactions set forth by | 17 | | rule, with 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 | | (D) administration of injections of long-term | 22 | | antipsychotic medications pursuant to a valid | 23 | | prescription by a physician licensed to practice | 24 | | medicine in all its branches, upon completion of | 25 | | appropriate training conducted by an Accreditation | 26 | | Council of Pharmaceutical Education accredited |
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| 1 | | provider, including how to address contraindications | 2 | | and adverse reactions set forth by rule, with | 3 | | notification to the patient's physician and | 4 | | appropriate record retention, or pursuant to hospital | 5 | | pharmacy and therapeutics committee policies and | 6 | | procedures. | 7 | | (5) vaccination of patients ages 10 through 13 limited | 8 | | to the Influenza (inactivated influenza vaccine and live | 9 | | attenuated influenza intranasal vaccine) and Tdap (defined | 10 | | as tetanus, diphtheria, acellular pertussis) vaccines, | 11 | | pursuant to a valid prescription or standing order, by a | 12 | | physician licensed to practice medicine in all its | 13 | | branches, upon completion of appropriate training, | 14 | | including how to address contraindications and adverse | 15 | | reactions set forth by rule, with notification to the | 16 | | patient's physician and appropriate record retention, or | 17 | | pursuant to hospital pharmacy and therapeutics committee | 18 | | policies and procedures; | 19 | | (6) drug regimen review; | 20 | | (7) drug or drug-related research; | 21 | | (8) the provision of patient counseling; | 22 | | (9) the practice of telepharmacy; | 23 | | (10) the provision of those acts or services necessary | 24 | | to provide pharmacist care; | 25 | | (11) medication therapy management; and | 26 | | (12) the responsibility for compounding and labeling |
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| 1 | | of drugs and devices (except labeling by a manufacturer, | 2 | | repackager, or distributor of non-prescription drugs and | 3 | | commercially packaged legend drugs and devices), proper | 4 | | and safe storage of drugs and devices, and maintenance of | 5 | | required records. | 6 | | A pharmacist who performs any of the acts defined as the | 7 | | practice of pharmacy in this State must be actively licensed as | 8 | | a pharmacist under this Act.
| 9 | | (e) "Prescription" means and includes any written, oral, | 10 | | facsimile, or
electronically transmitted order for drugs
or | 11 | | medical devices, issued by a physician licensed to practice | 12 | | medicine in
all its branches, dentist, veterinarian, podiatric | 13 | | physician, or
optometrist, within the
limits of his or her | 14 | | license, by a physician assistant in accordance with
subsection | 15 | | (f) of Section 4, or by an advanced practice registered nurse | 16 | | in
accordance with subsection (g) of Section 4, containing the
| 17 | | following: (1) name
of the patient; (2) date when prescription | 18 | | was issued; (3) name
and strength of drug or description of the | 19 | | medical device prescribed;
and (4) quantity; (5) directions for | 20 | | use; (6) prescriber's name,
address,
and signature; and (7) DEA | 21 | | registration number where required, for controlled
substances.
| 22 | | The prescription may, but is not required to, list the illness, | 23 | | disease, or condition for which the drug or device is being | 24 | | prescribed. DEA registration numbers shall not be required on | 25 | | inpatient drug orders. A prescription for medication other than | 26 | | controlled substances shall be valid for up to 15 months from |
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| 1 | | the date issued for the purpose of refills, unless the | 2 | | prescription states otherwise.
| 3 | | (f) "Person" means and includes a natural person, | 4 | | partnership,
association, corporation, government entity, or | 5 | | any other legal
entity.
| 6 | | (g) "Department" means the Department of Financial and
| 7 | | Professional Regulation.
| 8 | | (h) "Board of Pharmacy" or "Board" means the State Board
of | 9 | | Pharmacy of the Department of Financial and Professional | 10 | | Regulation.
| 11 | | (i) "Secretary"
means the Secretary
of Financial and | 12 | | Professional Regulation.
| 13 | | (j) "Drug product selection" means the interchange for a
| 14 | | prescribed pharmaceutical product in accordance with Section | 15 | | 25 of
this Act and Section 3.14 of the Illinois Food, Drug and | 16 | | Cosmetic Act.
| 17 | | (k) "Inpatient drug order" means an order issued by an | 18 | | authorized
prescriber for a resident or patient of a facility | 19 | | licensed under the
Nursing Home Care Act, the ID/DD Community | 20 | | Care Act, the MC/DD Act, the Specialized Mental Health | 21 | | Rehabilitation Act of 2013, the Hospital Licensing Act, or the | 22 | | University of Illinois Hospital Act, or a facility which is | 23 | | operated by the Department of Human
Services (as successor to | 24 | | the Department of Mental Health
and Developmental | 25 | | Disabilities) or the Department of Corrections.
| 26 | | (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" or "dispensing" means the interpretation, | 8 | | evaluation, and implementation of a prescription drug order, | 9 | | including the preparation and delivery of a drug or device to a | 10 | | patient or patient's agent in a suitable container | 11 | | appropriately labeled for subsequent administration to or use | 12 | | by a patient in accordance with applicable State and federal | 13 | | laws and regulations.
"Dispense" or "dispensing" 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" or "dispensing" | 17 | | also does not mean the physical delivery
of a drug or medical | 18 | | device to a patient or patient's representative by a
| 19 | | pharmacist's designee within a pharmacy or drugstore while the | 20 | | pharmacist is
on duty and the pharmacy is open.
| 21 | | (n) "Nonresident pharmacy"
means a pharmacy that is located | 22 | | in a state, commonwealth, or territory
of the United States, | 23 | | other than Illinois, that delivers, dispenses, or
distributes, | 24 | | through the United States Postal Service, commercially | 25 | | acceptable parcel delivery service, or other common
carrier, to | 26 | | Illinois residents, any substance which requires a |
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| 1 | | prescription.
| 2 | | (o) "Compounding" means the preparation and mixing of | 3 | | components, excluding flavorings, (1) as the result of a | 4 | | prescriber's prescription drug order or initiative based on the | 5 | | prescriber-patient-pharmacist relationship in the course of | 6 | | professional practice or (2) for the purpose of, or incident | 7 | | to, research, teaching, or chemical analysis and not for sale | 8 | | or dispensing. "Compounding" includes the preparation of drugs | 9 | | or devices in anticipation of receiving prescription drug | 10 | | orders based on routine, regularly observed dispensing | 11 | | patterns. Commercially available products may be compounded | 12 | | for dispensing to individual patients only if all of the | 13 | | following conditions are met: (i) the commercial product is not | 14 | | reasonably available from normal distribution channels in a | 15 | | timely manner to meet the patient's needs and (ii) the | 16 | | prescribing practitioner has requested that the drug be | 17 | | compounded.
| 18 | | (p) (Blank).
| 19 | | (q) (Blank).
| 20 | | (r) "Patient counseling" means the communication between a | 21 | | pharmacist or a student pharmacist under the supervision of a | 22 | | pharmacist and a patient or the patient's representative about | 23 | | the patient's medication or device for the purpose of | 24 | | optimizing proper use of prescription medications or devices. | 25 | | "Patient counseling" may include without limitation (1) | 26 | | obtaining a medication history; (2) acquiring a patient's |
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| 1 | | allergies and health conditions; (3) facilitation of the | 2 | | patient's understanding of the intended use of the medication; | 3 | | (4) proper directions for use; (5) significant potential | 4 | | adverse events; (6) potential food-drug interactions; and (7) | 5 | | the need to be compliant with the medication therapy. A | 6 | | pharmacy technician may only participate in the following | 7 | | aspects of patient counseling under the supervision of a | 8 | | pharmacist: (1) obtaining medication history; (2) providing | 9 | | the offer for counseling by a pharmacist or student pharmacist; | 10 | | and (3) acquiring a patient's allergies and health conditions.
| 11 | | (s) "Patient profiles" or "patient drug therapy record" | 12 | | means the
obtaining, recording, and maintenance of patient | 13 | | prescription
information, including prescriptions for | 14 | | controlled substances, and
personal information.
| 15 | | (t) (Blank).
| 16 | | (u) "Medical device" or "device" means an instrument, | 17 | | apparatus, implement, machine,
contrivance, implant, in vitro | 18 | | reagent, or other similar or related article,
including any | 19 | | component part or accessory, required under federal law to
bear | 20 | | the label "Caution: Federal law requires dispensing by or on | 21 | | the order
of a physician". A seller of goods and services who, | 22 | | only for the purpose of
retail sales, compounds, sells, rents, | 23 | | or leases medical devices shall not,
by reasons thereof, be | 24 | | required to be a licensed pharmacy.
| 25 | | (v) "Unique identifier" means an electronic signature, | 26 | | handwritten
signature or initials, thumb print, or other |
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| 1 | | acceptable biometric
or electronic identification process as | 2 | | approved by the Department.
| 3 | | (w) "Current usual and customary retail price" means the | 4 | | price that a pharmacy charges to a non-third-party payor.
| 5 | | (x) "Automated pharmacy system" means a mechanical system | 6 | | located within the confines of the pharmacy or remote location | 7 | | that performs operations or activities, other than compounding | 8 | | or administration, relative to storage, packaging, dispensing, | 9 | | or distribution of medication, and which collects, controls, | 10 | | and maintains all transaction information. | 11 | | (y) "Drug regimen review" means and includes the evaluation | 12 | | of prescription drug orders and patient records for (1)
known | 13 | | allergies; (2) drug or potential therapy contraindications;
| 14 | | (3) reasonable dose, duration of use, and route of | 15 | | administration, taking into consideration factors such as age, | 16 | | gender, and contraindications; (4) reasonable directions for | 17 | | use; (5) potential or actual adverse drug reactions; (6) | 18 | | drug-drug interactions; (7) drug-food interactions; (8) | 19 | | drug-disease contraindications; (9) therapeutic duplication; | 20 | | (10) patient laboratory values when authorized and available; | 21 | | (11) proper utilization (including over or under utilization) | 22 | | and optimum therapeutic outcomes; and (12) abuse and misuse.
| 23 | | (z) "Electronically transmitted prescription" means a | 24 | | prescription that is created, recorded, or stored by electronic | 25 | | means; issued and validated with an electronic signature; and | 26 | | transmitted by electronic means directly from the prescriber to |
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| 1 | | a pharmacy. An electronic prescription is not an image of a | 2 | | physical prescription that is transferred by electronic means | 3 | | from computer to computer, facsimile to facsimile, or facsimile | 4 | | to computer.
| 5 | | (aa) "Medication therapy management services" means a | 6 | | distinct service or group of services offered by licensed | 7 | | pharmacists, physicians licensed to practice medicine in all | 8 | | its branches, advanced practice registered nurses authorized | 9 | | in a written agreement with a physician licensed to practice | 10 | | medicine in all its branches, or physician assistants | 11 | | authorized in guidelines by a supervising physician that | 12 | | optimize therapeutic outcomes for individual patients through | 13 | | improved medication use. In a retail or other non-hospital | 14 | | pharmacy, medication therapy management services shall consist | 15 | | of the evaluation of prescription drug orders and patient | 16 | | medication records to resolve conflicts with the following: | 17 | | (1) known allergies; | 18 | | (2) drug or potential therapy contraindications; | 19 | | (3) reasonable dose, duration of use, and route of | 20 | | administration, taking into consideration factors such as | 21 | | age, gender, and contraindications; | 22 | | (4) reasonable directions for use; | 23 | | (5) potential or actual adverse drug reactions; | 24 | | (6) drug-drug interactions; | 25 | | (7) drug-food interactions; | 26 | | (8) drug-disease contraindications; |
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| 1 | | (9) identification of therapeutic duplication; | 2 | | (10) patient laboratory values when authorized and | 3 | | available; | 4 | | (11) proper utilization (including over or under | 5 | | utilization) and optimum therapeutic outcomes; and | 6 | | (12) drug abuse and misuse. | 7 | | "Medication therapy management services" includes the | 8 | | following: | 9 | | (1) documenting the services delivered and | 10 | | communicating the information provided to patients' | 11 | | prescribers within an appropriate time frame, not to exceed | 12 | | 48 hours; | 13 | | (2) providing patient counseling designed to enhance a | 14 | | patient's understanding and the appropriate use of his or | 15 | | her medications; and | 16 | | (3) providing information, support services, and | 17 | | resources designed to enhance a patient's adherence with | 18 | | his or her prescribed therapeutic regimens. | 19 | | "Medication therapy management services" may also include | 20 | | patient care functions authorized by a physician licensed to | 21 | | practice medicine in all its branches for his or her identified | 22 | | patient or groups of patients under specified conditions or | 23 | | limitations in a standing order from the physician. | 24 | | "Medication therapy management services" in a licensed | 25 | | hospital may also include the following: | 26 | | (1) reviewing assessments of the patient's health |
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| 1 | | status; and | 2 | | (2) following protocols of a hospital pharmacy and | 3 | | therapeutics committee with respect to the fulfillment of | 4 | | medication orders.
| 5 | | (bb) "Pharmacist care" means the provision by a pharmacist | 6 | | of medication therapy management services, with or without the | 7 | | dispensing of drugs or devices, intended to achieve outcomes | 8 | | that improve patient health, quality of life, and comfort and | 9 | | enhance patient safety.
| 10 | | (cc) "Protected health information" means individually | 11 | | identifiable health information that, except as otherwise | 12 | | provided, is:
| 13 | | (1) transmitted by electronic media; | 14 | | (2) maintained in any medium set forth in the | 15 | | definition of "electronic media" in the federal Health | 16 | | Insurance Portability and Accountability Act; or | 17 | | (3) transmitted or maintained in any other form or | 18 | | medium. | 19 | | "Protected health information" does not include | 20 | | individually identifiable health information found in: | 21 | | (1) education records covered by the federal Family | 22 | | Educational Right and Privacy Act; or | 23 | | (2) employment records held by a licensee in its role | 24 | | as an employer. | 25 | | (dd) "Standing order" means a specific order for a patient | 26 | | or group of patients issued by a physician licensed to practice |
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| 1 | | medicine in all its branches in Illinois. | 2 | | (ee) "Address of record" means the designated address | 3 | | recorded by the Department in the applicant's application file | 4 | | or licensee's license file maintained by the Department's | 5 | | licensure maintenance unit. | 6 | | (ff) "Home pharmacy" means the location of a pharmacy's | 7 | | primary operations.
| 8 | | (gg) "Email address of record" means the designated email | 9 | | address recorded by the Department in the applicant's | 10 | | application file or the licensee's license file, as maintained | 11 | | by the Department's licensure maintenance unit. | 12 | | (Source: P.A. 99-180, eff. 7-29-15; 100-208, eff. 1-1-18; | 13 | | 100-497, eff. 9-8-17; 100-513, eff. 1-1-18; 100-804, eff. | 14 | | 1-1-19; 100-863, eff. 8-14-18 .)
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