Section 1330.10 Definitions

Section 1330.10  Definitions

"Act"

means the Pharmacy Practice Act [225 ILCS 85].

"Automated

Dispensing and Storage Systems" include, but are not limited to,

mechanical systems that perform operations or activities, other than counting,

compounding or administration, relative to the storage, packaging or dispensing

of medications, and that collect, control and maintain all transaction

information.

"Beyond

Use Date" means a drug's expiration date.

"Board"

means the State Board of Pharmacy.

"Community

Pharmacy" means any pharmacy that engages in general community pharmacy

practice and that is open to, or offers pharmacy service to, the general

public.

"Deliver"

means the actual, constructive or attempted transfer of possession of a

prescription medication.

"Department"

means the Department of Financial and Professional Regulation.

"Direct

Supervision" means in the immediate physical presence of the person

supervised.

"Director"

means the Director of the Division of Professional Regulation with the

authority delegated by the Secretary.

"Dispense"

means to interpret, verify computer entry of, select the prescribed product

for, prepare and/or deliver a prescription medication to an ultimate consumer

or to a person authorized to receive the prescription medication by or pursuant

to the lawful order of a practitioner, including the compounding, packaging

and/or labeling necessary for delivery and any recommending, advising and

counseling concerning the contents, therapeutic values, uses and any

precautions, warnings and/or advice concerning consumption.  Dispense does not

mean the physical delivery to a patient or a patient's representative in a home

or institution by a designee of a pharmacist or by common carrier or the

physical delivery of a drug or medical device to a patient or patient's

representative by a pharmacist's designee within a pharmacy or drugstore while

the pharmacist is on duty and the pharmacy is open

ncerning consumption.  Dispense does not

mean the physical delivery to a patient or a patient's representative in a home

or institution by a designee of a pharmacist or by common carrier or the

physical delivery of a drug or medical device to a patient or patient's

representative by a pharmacist's designee within a pharmacy or drugstore while

the pharmacist is on duty and the pharmacy is open.

"Dispensing Error" means

any preventable event that may cause or lead to inappropriate medication use or

patient harm. Such events may be related to professional practice, health care

products, procedures and systems, including: prescribing; order communication;

product labeling, packaging and nomenclature; compounding; dispensing;

distribution; administration; education; monitoring; and use.

"Distribute"

means to deliver, other than by dispensing, a prescription medication.

"Division"

means the Department of Financial and Professional Regulation-Division of

Professional Regulation.

"Drug Compliance

Coordinator" means the chief pharmacy coordinator, appointed by the

Secretary, who shall serve as the executive administrator and the chief

enforcement officer of the Act, pursuant to Section 11(d) of the Pharmacy

Practice Act.

"Drug Regimen Review"

means

and includes the evaluation of prescription drug orders and patient

records for:

known allergies;

drug or potential therapy

contraindications;

reasonable dose, duration of

use, and route of administration, taking into consideration factors such as

age, gender, and contraindications;

reasonable directions for use;

potential or actual adverse

drug reactions;

drug-drug interactions;

drug-food interactions;

drug-disease contraindications;

therapeutic duplication;

patient laboratory values when

authorized and available;

proper utilization (including

over or under utilization) and optimum therapeutic outcomes; and

abuse and misuse

[225 ILCS

85/3(y)]

nder, and contraindications;

reasonable directions for use;

potential or actual adverse

drug reactions;

drug-drug interactions;

drug-food interactions;

drug-disease contraindications;

therapeutic duplication;

patient laboratory values when

authorized and available;

proper utilization (including

over or under utilization) and optimum therapeutic outcomes; and

abuse and misuse

[225 ILCS

85/3(y)].

"Electronic Format"

includes, but is not limited to, information obtained via the Internet or

stored on personal digital assistant, smart phone, tablet, etc.

"Electronic

Transmission of Prescriptions" and "electronically transmitted

prescriptions" means the communication of original prescriptions, refill

authorizations, or medication orders, including controlled substances to the

extent permitted by federal law, from an authorized licensed prescriber, or his

or her authorized agent, to the pharmacy of the patient's choice by electronic

means, including, but not limited to, telephone, facsimile machine, computer,

computer modem or any other electronic device or authorized means.

"Institutional

Pharmacy" means any pharmacy that is located in or outside a facility

licensed under the Nursing Home Care Act [210 ILCS 45], the Hospital Licensing

Act [225 ILCS 85], or the University of Illinois Hospital Act [110 ILCS 330] or

a facility that is operated by the Department of Human Services or the

Department of Corrections, and that provides pharmacy services to residents or

patients of the facility, as well as employees, prescribers and students of the

facility.

"Home

Pharmacy" means the location of a pharmacy's primary operations.

"Medication

Order" means a prescription issued by a physician or other authorized

prescriber for a resident or patient of a facility served by an institutional

pharmacy

Corrections, and that provides pharmacy services to residents or

patients of the facility, as well as employees, prescribers and students of the

facility.

"Home

Pharmacy" means the location of a pharmacy's primary operations.

"Medication

Order" means a prescription issued by a physician or other authorized

prescriber for a resident or patient of a facility served by an institutional

pharmacy.

"Nonresident

Pharmacy" means a pharmacy that is located outside this State that ships,

delivers, dispenses or distributes into Illinois by any means any drugs,

medicines, pharmaceutical services or devices requiring a prescription.

"Nuclear

Pharmacist" means a pharmacist who provides radiopharmaceutical services

and has satisfied the requirements of Section 1330.540(i).

"Nuclear

Pharmacy" means any pharmacy that provides and/or offers for sale

radiopharmaceuticals.

"On

File" as used in Section 19 of the Act and this Part means the maintenance

at the transferor pharmacy of the transferred prescription, whether previously

filled or unfilled. For previously filled prescriptions at a transferor

pharmacy located in Illinois, the prescriptions shall be maintained pursuant to

the recordkeeping requirements of Section 18 of the Act.  For previously

unfilled prescriptions at a transferor pharmacy located in Illinois, the

prescriptions shall be maintained in a readily retrievable format in a suitable

book, file or recordkeeping system for a period of not less than 5 years.  For

previously filled and unfilled prescriptions at a transferor pharmacy located

in a state other than Illinois, the prescriptions shall be maintained pursuant

to the recordkeeping requirements of that state.

"Patient

Counseling" means the communication between a pharmacist or a student

pharmacist under the supervision of a pharmacist and a patient or the patient's

representative about the patient's medication or device for the purpose of

optimizing proper use of prescription medications or devices

ois, the prescriptions shall be maintained pursuant

to the recordkeeping requirements of that state.

"Patient

Counseling" means the communication between a pharmacist or a student

pharmacist under the supervision of a pharmacist and a patient or the patient's

representative about the patient's medication or device for the purpose of

optimizing proper use of prescription medications or devices.

"Patient

counseling" may include without limitation:

obtaining a medication history;

acquiring a patient's allergies and health conditions;

facilitation

of the patient's understanding of the intended use of the medication;

proper directions for use;

significant potential adverse events;

potential food-drug interactions; and

the need to be compliant with the medication therapy.

A pharmacy technician may only participate in the following aspects of

patient counseling under the supervision of a pharmacist:

obtaining

medication history;

providing

the offer for counseling by a pharmacist or student pharmacist; and

acquiring

a patient's allergies and health conditions

. [225 ILCS 85/3(r)]

"Patient

Profiles" or "Patient Drug Therapy Record" means the obtaining,

recording and maintenance of patient prescription and personal information.

"Pharmacist"

means a currently licensed pharmacist.

"Pharmacy

Services" means the provision of any services listed within the definition

of the "practice of pharmacy" found in Section 3(d) of the Act.

"Radiopharmaceutical"

means any substance defined as a drug in Section 3(b) of the Act that exhibits

spontaneous disintegration of unstable nuclei with the emission of nuclear

particles or photons and includes any nonradioactive reagent kit or nuclide

generator that is intended to be used in the preparation of any such substance

but does not include drugs such as carbon-containing compounds of

potassium-containing salts that contain trace quantities of naturally occurring

radionuclides

bits

spontaneous disintegration of unstable nuclei with the emission of nuclear

particles or photons and includes any nonradioactive reagent kit or nuclide

generator that is intended to be used in the preparation of any such substance

but does not include drugs such as carbon-containing compounds of

potassium-containing salts that contain trace quantities of naturally occurring

radionuclides.  Radiopharmaceuticals include radioactive biological products as

defined in the Federal Food, Drug and Cosmetic Act (21 USC 301 et seq.) and

regulations promulgated under that Act.

"Radiopharmaceutical

Quality Assurance" means, but is not limited to, the performance of

appropriate chemical, biological and physical tests on potential

radiopharmaceuticals, and the interpretation of the resulting data to determine

their suitability for use in humans and animals, including internal test

assessment, authentication of product history and the keeping of proper records

in these regards.

"Radiopharmaceutical

Service" means the compounding, dispensing, labeling and delivery of

radiopharmaceuticals; the participation in radiopharmaceutical selection and

radiopharmaceutical utilization reviews; the proper and safe storage and distribution

of radiopharmaceuticals as determined by the Illinois Emergency Management

Agency; the maintenance of radiopharmaceutical quality assurance; the

responsibility for advising, where necessary or required, of diagnostic and

therapeutic values, hazards and use of radioactive pharmaceuticals; and the

offering or performance of those acts, services, operations or transactions

necessary in the conduct, operation, management and control of a nuclear

pharmacy.

"Registrant"

means a licensed pharmacist, registered assistant pharmacist, certified

pharmacy technician, student pharmacist, or registered pharmacy technician

therapeutic values, hazards and use of radioactive pharmaceuticals; and the

offering or performance of those acts, services, operations or transactions

necessary in the conduct, operation, management and control of a nuclear

pharmacy.

"Registrant"

means a licensed pharmacist, registered assistant pharmacist, certified

pharmacy technician, student pharmacist, or registered pharmacy technician.

"Remote Consultation

Site" means a location, other than that of the home pharmacy, where

prescriptions filled at the home pharmacy are stored and dispensed by a

pharmacy technician, certified pharmacy technician and/or student pharmacist

under the direct, remote supervision of a pharmacist located at, or contracted

with, the home pharmacy.

"Remote

Dispensing Site" means a location other than that of the home pharmacy

where a supply of prescription drugs is maintained and prescriptions are filled

and dispensed by a certified pharmacy technician and/or student pharmacist

under the direct, remote supervision of a pharmacist located at, or contracted

with, the home pharmacy.

"Remote

Medication Order Processing" means receiving, interpreting or clarifying

medication orders; data entry and transferring of medication order information;

performing drug utilization review; interpreting clinical data; performing

therapeutic interventions; and providing drug information concerning medication

orders or drugs from a remote pharmacy.

"Remote Pharmacy" means any pharmacy that provides pharmacy

services at a location other than the home pharmacy.

"Secretary" means the Secretary of the Department of Financial

and Professional Regulation.

"Student

Pharmacist" means a person registered as a pharmacy technician who is

enrolled in a pharmacy program and is designated as a "student

pharmacist" pursuant to Section 9 of the Act.

"Ultimate

Consumer" means the person for whom a drug is intended

rvices at a location other than the home pharmacy.

"Secretary" means the Secretary of the Department of Financial

and Professional Regulation.

"Student

Pharmacist" means a person registered as a pharmacy technician who is

enrolled in a pharmacy program and is designated as a "student

pharmacist" pursuant to Section 9 of the Act.

"Ultimate

Consumer" means the person for whom a drug is intended.

"Unique

Identifier" means an electronic signature, handwritten signature or

initials, thumb print or other acceptable individual biometric or electronic

identification process approved by the Division.