§ 25-26-13-2 — Definitions

Indiana § 25-26-13-2

• Jurisdiction: Indiana
• Title 25: PROFESSIONS AND OCCUPATIONS
• Art. 26: PHARMACISTS, PHARMACIES, DRUG STORES
• Ch. 13: Regulation of Pharmacists and Pharmacies ─ Creation

Text

As used in this chapter:
"Administering" means the direct application of a drug to the body
of a person by injection, inhalation, ingestion, or any other means.
"Board" means the Indiana board of pharmacy.
"Controlled drugs" are those drugs on schedules I through V of the
federal Controlled Substances Act or on schedules I through V of IC 35-48-2.
"Coronavirus disease" means the disease caused by the severe acute
respiratory syndrome coronavirus 2 virus (SARS-CoV-2).
"Counseling" means effective communication between a pharmacist
and a patient concerning the contents, drug to drug interactions, route,
dosage, form, directions for use, precautions, and effective use of a
drug or device to improve the therapeutic outcome of the patient
through the effective use of the drug or device.
"Dispensing" means issuing one (1) or more doses of a drug in a
suitable container with appropriate labeling for subsequent
administration to or use by a patient.
"Drug" means:
(1) articles or substances recognized in the official United States
Pharmacopoeia, official National Formulary, official
Homeopathic Pharmacopoeia of the United States, or any
supplement to any of them;
(2) articles or substances intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of disease in man or animals;
(3) articles other than food intended to affect the structure or any
function of the body of man or animals; or
(4) articles intended for use as a component of any article
specified in subdivisions (1) through (3) and devices.
"Drug order" means a written order in a hospital or other health care
institution for an ultimate user for any drug or device, issued and
signed by a practitioner, or an order transmitted by other means of
communication from a practitioner, which is immediately reduced to
writing by the pharmacist, registered nurse, or other licensed health
care practitioner authorized by the hospital or institution. The order
shall contain the name and bed number of the patient; the name and
strength or size of the drug or device; unless specified by individual
institution policy or guideline, the amount to be dispensed either in
quantity or days; adequate directions for the proper use of the drug or
device when it is administered to the patient; and the name of the
prescriber.
"Drug regimen review" means the retrospective, concurrent, and
prospective review by a pharmacist of a patient's drug related history
that includes the following areas:
(1) Evaluation of prescriptions or drug orders and patient records
for drug allergies, rational therapy contradictions, appropriate
dose and route of administration, appropriate directions for use,
or duplicative therapies.
(2) Evaluation of prescriptions or drug orders and patient records
for drug-drug, drug-food, drug-disease, and drug-clinical
laboratory interactions.
(3) Evaluation of prescriptions or drug orders and patient records
for adverse drug reactions.
(4) Evaluation of prescriptions or drug orders and patient records
for proper utilization and optimal therapeutic outcomes.
"Drug utilization review" means a program designed to measure and
assess on a retrospective and prospective basis the proper use of drugs.
"Device" means an instrument, apparatus, implement, machine,
contrivance, implant, in vitro reagent, or other similar or related article
including any component part or accessory, which is:
(1) recognized in the official United States Pharmacopoeia,
official National Formulary, or any supplement to them;
(2) intended for use in the diagnosis of disease or other conditions
or the cure, mitigation, treatment, or prevention of disease in man
or other animals; or
(3) intended to affect the structure or any function of the body of
man or other animals and which does not achieve any of its
principal intended purposes through chemical action within or on
the body of man or other animals and which is not dependent
upon being metabolized for the achievement of any of its
principal intended purposes.
"Electronic data intermediary" means an entity that provides the
infrastructure that connects a computer system or another electronic
device used by a prescribing practitioner with a computer system or
another electronic device used by a pharmacy to facilitate the secure
transmission of:
(1) an electronic prescription order;
(2) a refill authorization request;
(3) a communication; and
(4) other patient care information;
between a practitioner and a pharmacy.
"Electronic signature" means an electronic sound, symbol, or
process:
(1) attached to or logically associated with a record; and
(2) executed or adopted by a person;
with the intent to sign the record.
"Electronically transmitted" or "electronic transmission" means the
transmission of a prescription in electronic form. The term does not
include the transmission of a prescription by facsimile.
"Investigational or new drug" means any drug which is limited by
state or federal law to use under professional supervision of a
practitioner authorized by law to prescribe or administer such drug.
"Legend drug" has the meaning set forth in IC 16-18-2-199.
"License" and "permit" are interchangeable and mean a written
certificate from the Indiana board of pharmacy for the practice of
pharmacy or the operation of a pharmacy.
"Medication therapy management" means a distinct service or group
of services that optimize therapeutic outcomes for individuals that are
independent of, but may occur in conjunction with, the provision of a
medication or medical device. The term includes the following
services:
(1) Performing or obtaining assessments of an individual's health
status.
(2) Formulating a medication treatment plan.
(3) Selecting, initiating, modifying, or administering medication
therapy.
(4) Monitoring and evaluating an individual's response to therapy,
including safety and effectiveness.
(5) Performing a comprehensive medication review to identify,
resolve, and prevent medication related problems, including
adverse drug events.
(6) Documenting the care delivered and communicating essential
information to the patient's other health care providers.
(7) Providing education and training designed to enhance patient
understanding and appropriate use of the individual's medications.
(8) Providing information and support services and resources
designed to enhance patient adherence with the individual's
therapeutic regimens, including medication synchronization.
(9) Coordinating and integrating medication therapy management
services within the broader health care services being provided to
an individual.
(10) Providing other patient care services allowable by law.
"Nonprescription drug" means a drug that may be sold without a
prescription and that is labeled for use by a patient in accordance with
state and federal laws.
"Person" means any individual, partnership, copartnership, firm,
company, corporation, association, joint stock company, trust, estate,
or municipality, or a legal representative or agent, unless this chapter
expressly provides otherwise.
"Practitioner" has the meaning set forth in IC 16-42-19-5.
"Pharmacist" means a person licensed under this chapter.
"Pharmacist intern" means a person who is:
(1) permitted by the board to engage in the practice of pharmacy
while under the personal supervision of a pharmacist and who is
satisfactorily progressing toward meeting the requirements for
licensure as a pharmacist;
(2) a graduate of an approved college of pharmacy or a graduate
who has established educational equivalency by obtaining a
Foreign Pharmacy Graduate Examination Committee Certificate
and who is permitted by the board to obtain practical experience
as a requirement for licensure as a pharmacist;
(3) a qualified applicant awaiting examination for licensure; or
(4) an individual participating in a residency or fellowship
program.
"Pharmacy" means any facility, department, or other place where
prescriptions are filled or compounded and are sold, dispensed, offered,
or displayed for sale and which has as its principal purpose the
dispensing of drug and health supplies intended for the general health,
welfare, and safety of the public, without placing any other activity on
a more important level than the practice of pharmacy.
"The practice of pharmacy" or "the practice of the profession of
pharmacy" means a patient oriented health care profession in which
pharmacists interact with and counsel patients and with other health
care professionals concerning drugs and devices used to enhance
patients' wellness, prevent illness, and optimize the outcome of a drug
or device, by accepting responsibility for performing or supervising a
pharmacist intern or an unlicensed person under section 18.5 of this
chapter to do the following acts, services, and operations:
(1) The offering of or performing of those acts, service operations,
or transactions incidental to the interpretation, evaluation, and
implementation of prescriptions or drug orders.
(2) The compounding, labeling, administering, dispensing, or
selling of drugs and devices, including radioactive substances,
whether dispensed under a practitioner's prescription or drug
order or sold or given directly to the ultimate consumer.
(3) The proper and safe storage and distribution of drugs and
devices.
(4) The maintenance of proper records of the receipt, storage,
sale, and dispensing of drugs and devices.
(5) Counseling, advising, and educating patients, patients'
caregivers, and health care providers and professionals, as
necessary, as to the contents, therapeutic values, uses, significant
problems, risks, and appropriate manner of use of drugs and
devices.
(6) Assessing, recording, and reporting events related to the use
of drugs or devices.
(7) Provision of the professional acts, professional decisions, and
professional services necessary to maintain all areas of a patient's
pharmacy related care as specifically authorized to a pharmacist
under this article.
(8) Provision of medication therapy management.
"Prescription" means a written order or an order transmitted by other
means of communication from a practitioner to or for an ultimate user
for any drug or device containing:
(1) the name and address of the patient;
(2) the date of issue;
(3) the name and strength or size (if applicable) of the drug or
device;
(4) the amount to be dispensed (unless indicated by directions and
duration of therapy);
(5) adequate directions for the proper use of the drug or device by
the patient;
(6) the name of the practitioner; and
(7) if the prescription:
(A) is in written form, the signature of the practitioner; or
(B) is in electronic form, the electronic signature of the
practitioner.
"Record" means all papers, letters, memoranda, notes, prescriptions,
drug orders, invoices, statements, patient medication charts or files,
computerized records, or other written indicia, documents, or objects
which are used in any way in connection with the purchase, sale, or
handling of any drug or device.
"Sale" means every sale and includes:
(1) manufacturing, processing, transporting, handling, packaging,
or any other production, preparation, or repackaging;
(2) exposure, offer, or any other proffer;
(3) holding, storing, or any other possession;
(4) dispensing, giving, delivering, or any other supplying; and
(5) applying, administering, or any other using.
As added by Acts 1977, P.L.276, SEC.1. Amended by
P.L.149-1987, SEC.72; P.L.2-1993, SEC.144; P.L.187-1999, SEC.1;
P.L.270-2001, SEC.2; P.L.288-2001, SEC.1; P.L.1-2002, SEC.97;
P.L.204-2005, SEC.14; P.L.98-2006, SEC.2; P.L.94-2007, SEC.1;
P.L.5-2015, SEC.57; P.L.89-2015, SEC.1; P.L.207-2021, SEC.30;
P.L.143-2022, SEC.55.