Illinois Administrative Code › Title 68 - PROFESSIONS AND OCCUPATIONS › Part 1330 - PHARMACY PRACTICE ACT › Subpart A - GENERAL PROVISIONS › Section 1330.10 - Definitions

Current through Register Vol. 48, No. 28, July 12, 2024
"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.