KRS § 217.822 — KY Code / Title XVIII / Chapter 217 / Section 217.822
217.822 Substitution of equivalent drug or interchangeable biological product -- Substitute must be lower in price than prescribed drug or biological product -- Selection by pharmacist not practice of medicine -- Liability of pharmacist -- Pharmacist to communicate to prescribing practitioner the specific biological product dispensed
Status: in_force

217.822 Substitution of equivalent drug or interchangeable biological product --

Substitute must be lower in price than prescribed drug or biological product --

Selection by pharmacist not practice of medicine -- Liability of pharmacist --

Pharmacist to communicate to prescribing practitioner the specific biological

product dispensed.

(1) When a pharmacist receives a prescription for a brand name drug which is not listed

by generic name in the nonequivalent drug product formulary prepared by the

board, the pharmacist shall select a lower-priced therapeutically equivalent drug

which the pharmacist has in stock, unless otherwise instructed by the patient at the

point of purchase or by the patient's practitioner. If a lower-priced selection is made,

the label on the container of the drug shall show the name of the drug dispensed.

(2) When a pharmacist receives a prescription for a brand name biological product

which is not listed by name in the nonequivalent drug product formulary prepared

by the board, the pharmacist shall dispense a lower-priced interchangeable

biological product, if there is one in stock, unless otherwise instructed by the patient

at the point of purchase or by the patient's prescribing practitioner. If an

interchangeable product is selected, the label on the container shall show the name

of the biological product dispensed.

(3) When an equivalent drug product or interchangeable biological product is dispensed

in lieu of a brand name drug prescribed, the price of the equivalent drug or

interchangeable biological product dispensed shall be lower in price to the

purchaser than the drug product prescribed.

(4) If, in the opinion of a practitioner, it is to the best interest of the practitioner's

patient that an equivalent drug or interchangeable biological product should not be

dispensed, the practitioner may indicate in the manner of his or her choice on the

prescription "Do Not Substitute," except that the indication shall not be preprinted

on a prescription.

(5) The selection of any drug or interchangeable biological product by a pharmacist

under the provisions of this section shall not constitute the practice of medicine.

(6) A pharmacist who selects an equivalent drug product or interchangeable biological

product pursuant to KRS 217.815 to 217.826 assumes no greater liability for

selecting the dispensed drug product than would be incurred in dispensing a

prescription for a drug product or biological product prescribed by its generic,

nonbrand, or proper name.

(7) When a pharmacist receives a generically written prescription for a multiple source

drug product, he or she shall dispense an equivalent drug product in accordance

with the provisions of KRS 217.815 to 217.826.

(8) When a pharmacist receives a prescription for a biological product written by

nonbrand or proper name, he or she shall dispense an interchangeable biological

product in accordance with the provisions of KRS 217.814 to 217.826, provided

that the interchangeable product has been deemed by the United States Food and

Drug Administration to be interchangeable with that specific reference product as

identified by the nonbrand or proper name.

(9) A pharmacist shall not substitute a biological product for a prescribed biological

product unless the substituted product is an interchangeable biological product for

the prescribed biological product.

(10) (a) Within five (5) business days following the dispensing of a biological product,

the dispensing pharmacist or the pharmacist's designee shall communicate to

the prescribing practitioner the specific product provided to the patient,

including the name of the product and the manufacturer.

(b) Communication shall be conveyed by making an entry that is electronically

accessible to the prescribing practitioner through:

1. An interoperable electronic medical records system;

2. An electronic prescribing technology;

3. A pharmacy benefit management system; or

4. A pharmacy record.

(c) Communication entries into an electronic records system as described in this

subsection are presumed to provide notice to the prescribing practitioner.

Otherwise, the pharmacist shall communicate the biological product dispensed

to the prescribing practitioner using facsimile, telephone, electronic

transmission, or other prevailing means. Communication to the prescribing

practitioner, or the prescribing practitioner's office personnel, using facsimile,

telephone, electronic transmission, or other prevailing means shall be

presumed to provide notice to the prescribing practitioner.

(d) Communication shall not be required where:

1. There is no United States Food and Drug Administration-approved

interchangeable biological product for the product prescribed;

2. A refill prescription is not changed from the product dispensed on the

prior filling of the prescription; or

3. The prescribing practitioner indicates "Do Not Substitute" on the

prescription.

(e) Communication received by the prescribing practitioner from the dispensing

pharmacist or the pharmacist's designee shall be treated in accordance with the

standards of acceptable and prevailing practice of the prescribing practitioner

within the Commonwealth of Kentucky and the following as they relate to

patient records:

1. The principles of ethics of the American Medical Association;

2. The code of ethics of the American Osteopathic Association;

3. The principles of ethics and code of professional conduct of the

American Dental Association;

4. The code of ethics of the American Chiropractic Association;

5. The principles of veterinary medical ethics of the American Veterinary

Medical Association;

6. The code of ethics of the American Optometric Association; or

7. The code of ethics for nurses of the American Nurses Association.