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.

 

"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)].

 

"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.

 

"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.  "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.  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.

 

"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.

 

"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.

 

(Source:  Amended at 39 Ill. Reg. 6267, effective April 23, 2015)