315.010 Definitions for chapter.

1,727 words·~8 min read·/ky/chapter-315/315-010

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

As used in this chapter, unless the context requires otherwise:

(1)"Administer" means the direct application of a drug to a patient or research subject

by injection, inhalation, or ingestion, whether topically or by any other means;

(2)"Administrative activities of a pharmacy" means the following functions performed

by a pharmacy adhering to all local, state, and federal patient privacy laws:

(a)Investigating and researching a patient's insurance benefits and updating the

patient profile regarding insurance coverage;

(b)Billing and collections activities, including:

1. Contacting patients for copayments and coinsurance payments; and

2. Communicating with insurance companies;

(c)Performing patient financial assistance activities and updating patient records

accordingly;

(d)Opening faxes and accessing electronic prescriptions for the purposes of

setting up patient demographic and insurance profiles, excluding height,

weight, and allergy information, so long as the activity does not involve the

entering of a prescription order into the dispensing or medication management

system;

(e)Initiating insurance prior authorizations for submission to the licensed

pharmacy, including communications with the prescribing physician to

collect, record, and transmit information to insurance companies, so long as

the activity does not include the authorization or receipt of new or refill

prescription orders;

(f)Answering and transferring telephone calls, whether or not such calls require

accessing a patient record, so long as the call does not involve the

interpretation, evaluation, or implementation of a drug order; and

(g)Communicating with patients via telephone or electronically regarding refill

reminders, so long as the communication does not involve the interpretation,

evaluation, or implementation of a drug order and a pharmacist is readily

available for patient consultation;

(3)"Association" means the Kentucky Pharmacists Association;

(4)"Board" means the Kentucky Board of Pharmacy;

(5)"Collaborative care agreement" means a written agreement between a pharmacist or

pharmacists and a practitioner or practitioners that outlines a plan of cooperative

management of patients' drug-related health care needs where:

(a)Patients' drug-related health care needs fall within the practitioner's or

practitioners' statutory scope of practice;

(b)Patients are referred by the practitioner or practitioners to the pharmacist or

pharmacists; and

(c)The agreement:

1. Identifies the practitioner or practitioners and the pharmacist or

pharmacists who are parties to the agreement;

2. Specifies the drug-related regimen to be provided, and how drug therapy

is to be monitored; and

3. Stipulates the conditions for initiating, continuing, or discontinuing drug

therapy and conditions which warrant modifications to dose, dosage

regimen, dosage form, or route of administration;

(6)"Compound" or "compounding" means the preparation or labeling of a drug

pursuant to or in anticipation of a valid prescription drug order, including but not

limited to packaging, intravenous admixture, or manual combination of drug

ingredients. "Compounding," as used in this chapter, shall not preclude simple

reconstitution, mixing, or modification of drug products prior to administration by

nonpharmacists;

(7)"Confidential information" means information which is accessed or maintained by a

pharmacist in a patient's record, or communicated to a patient as part of patient

counseling, whether it is preserved on paper, microfilm, magnetic media, electronic

media, or any other form;

(8)"Continuing education unit" means ten

(10)contact hours of board approved

continuing pharmacy education. A "contact hour" means fifty

(50)continuous

minutes without a break period;

(9)"Dispense" or "dispensing" means to deliver one

(1)or more doses of a prescription

drug in a suitable container, appropriately labeled for subsequent administration to

or use by a patient or other individual entitled to receive the prescription drug;

(10)"Drug" means any of the following:

(a)Articles recognized as drugs or drug products in any official compendium or

supplement thereto;

(b)Articles, other than food, intended to affect the structure or function of the

body of man or other animals;

(c)Articles, including radioactive substances, intended for use in the diagnosis,

cure, mitigation, treatment or prevention of disease in man or other animals;

(d)Articles intended for use as a component of any articles specified in

paragraphs

(a)to

(c)of this subsection;

(11)"Drug regimen review" means retrospective, concurrent, and prospective review by

a pharmacist of a patient's drug-related history, including but not limited to the

following areas:

(a)Evaluation of prescription drug orders and patient records for:

1. Known allergies;

2. Rational therapy contraindications;

3. Appropriate dose and route of administration;

4. Appropriate directions for use; or

5. Duplicative therapies;

(b)Evaluation of prescription drug orders and patient records for drug-drug,

drug-food, drug-disease, and drug-clinical laboratory interactions;

(c)Evaluation of prescription drug orders and patient records for adverse drug

reactions; or

(d)Evaluation of prescription drug orders and patient records for proper

utilization and optimal therapeutic outcomes;

(12)"Immediate supervision" means under the physical and visual supervision of a

pharmacist;

(13)"Manufacturer" or "virtual manufacturer" of a product means:

(a)A person that holds an application approved under 21 U.S.C. sec. 355 or a

license issued under 42 U.S.C. sec. 262 for such product, or if such product is

not the subject of an approved application or license, the person who

manufactured the product;

(b)A co-licensed partner of the person described in paragraph

(a)of this

subsection that obtains the product directly from a person described in this

paragraph or paragraph

(a)of this subsection;

(c)An affiliate of a person described in paragraph

(a)or

(b)of this subsection

who receives the product directly from a person described in this paragraph or

in paragraph

(a)or

(b)of this subsection; or

(d)Any person, except a pharmacist compounding in the normal course of

professional practice;

(14)"Medical order" means a lawful order of a specifically identified practitioner for a

specifically identified patient for the patient's health care needs. "Medical order"

may or may not include a prescription drug order;

(15)"Nonprescription drugs" means nonnarcotic medicines or drugs which may be sold

without a prescription and are prepackaged and labeled for use by the consumer in

accordance with the requirements of the statutes and regulations of this state and the

federal government;

(16)"Outsourcing facility" means a facility at one

(1)geographic location or address

that:

(a)Is engaged in the compounding of human sterile drugs without a patient-

specific prescription;

(b)Has registered as an outsourcing facility with the secretary of the United

States Department of Health and Human Services, Food and Drug

Administration; and

(c)Complies with all applicable state and federal requirements;

(17)"Pharmacist" means a natural person licensed by this state to engage in the practice

of the profession of pharmacy;

(18)"Pharmacist intern" means a natural person who is:

(a)Currently certified by the board to engage in the practice of pharmacy under

the direction of a licensed pharmacist and who satisfactorily progresses

toward meeting the requirements for licensure as a pharmacist;

(b)A graduate of an approved college or school of pharmacy or a graduate who

has established educational equivalency by obtaining a Foreign Pharmacy

Graduate Examination Committee (FPGEC) certificate, who is currently

licensed by the board for the purpose of obtaining practical experience as a

requirement for licensure as a pharmacist;

(c)A qualified applicant awaiting examination for licensure as a pharmacist or

the results of an examination for licensure as a pharmacist; or

(d)An individual participating in a residency or fellowship program approved by

the board for internship credit;

(19)"Pharmacy" means every place where:

(a)Drugs are dispensed under the direction of a pharmacist;

(b)Prescription drug orders are compounded under the direction of a pharmacist;

(c)A registered pharmacist maintains patient records and other information for

the purpose of engaging in the practice of pharmacy, whether or not

prescription drug orders are being dispensed;

(20)"Pharmacy-related primary care" means the pharmacists' activities in patient

education, health promotion, and assistance in the selection and use of over-the-

counter drugs and appliances for the treatment of common diseases and injuries, as

well as those other activities falling within their statutory scope of practice;

(21)"Pharmacy technician" means a natural person who works under the immediate

supervision, or general supervision if otherwise provided for by statute or

administrative regulation, of a pharmacist for the purpose of assisting a pharmacist

with the practice of pharmacy;

(22)"Practice of pharmacy" means interpretation, evaluation, and implementation of

medical orders and prescription drug orders; responsibility for dispensing

prescription drug orders, including radioactive substances; participation in drug and

drug-related device selection; administration of medications or biologics in the

course of dispensing or maintaining a prescription drug order; the administration of

adult immunizations pursuant to prescriber-approved protocols; the administration

of immunizations to individuals five

(5)to seventeen

(17)years of age pursuant to

prescriber-approved protocols with the consent of a parent or guardian; the

administration of immunizations to a child as defined in KRS 214.032, pursuant to

protocols as authorized by KRS 315.500; drug evaluation, utilization, or regimen

review; maintenance of patient pharmacy records; and provision of patient

counseling and those professional acts, professional decisions, or professional

services necessary to maintain and manage all areas of a patient's pharmacy-related

care, including pharmacy-related primary care as defined in this section;

(23)"Practitioner" has the same meaning given in KRS 217.015(35);

(24)"Prescription drug" means a drug which:

(a)Under federal law is required to be labeled with either of the following

statements:

1. "Caution: Federal law prohibits dispensing without prescription";

2. "Caution: Federal law restricts this drug to use by, or on the order of, a

licensed veterinarian";

3. "Rx Only"; or

4. "Rx"; or

(b)Is required by any applicable federal or state law or administrative regulation

to be dispensed only pursuant to a prescription drug order or is restricted to

use by practitioners;

(25)"Prescription drug order" means an original or new order from a practitioner for

drugs, drug-related devices or treatment for a human or animal, including orders

issued through collaborative care agreements or protocols authorized by the board.

Lawful prescriptions result from a valid practitioner-patient relationship, are

intended to address a legitimate medical need, and fall within the prescribing

practitioner's scope of professional practice;

(26)"Society" means the Kentucky Society of Health-Systems Pharmacists;

(27)"Supervision" means the presence of a pharmacist on the premises to which a

pharmacy permit is issued, who is responsible, in whole or in part, for the

professional activities occurring in the pharmacy; and

(28)"Wholesaler" means any person who legally buys drugs for resale or distribution to

persons other than patients or consumers.