HARRY HUGHES, Governor

485

12-508. SUBSTITUTION OF GENERIC EQUIVALENT FOR BRAND NAME
DRUG PRODUCTS.

(A)  DEFINITIONS.

(1)  IN THIS SECTION, THE FOLLOWING WORDS HAVE
THE MEANINGS INDICATED.

(2)  "BRAND NAME" MEANS THE PROPRIETARY NAME A
MANUFACTURER PLACES ON A DRUG PRODUCT OR ITS CONTAINER.

(3)  "COMMISSIONER OF FOOD AND DRUGS" MEANS THE
COMMISSIONER OF FOOD AND DRUGS OF THE UNITED STATES FOOD AND
DRUG ADMINISTRATION.

(B)  IN GENERAL.

A PHARMACIST MAY SUBSTITUTE A GENERICALLY EQUIVALENT
DRUG PRODUCT, OF THE SAME DOSAGE FORM AND STRENGTH, FOR ANY
BRAND NAME DRUG PRODUCT PRESCRIBED, IF:

(1)  THE AUTHORIZED PRESCRIBER DOES NOT STATE
EXPRESSLY THAT THE PRESCRIPTION IS TO BE DISPENSED ONLY AS
DIRECTED;

(2)  THE SUBSTITUTION IS RECOGNIZED IN THE
FORMULARY OF AUTHORIZED SUBSTITUTIONS PUBLISHED BY THE
DEPARTMENT UNDER SUBSECTION (D) OF THIS SECTION; AND

(3)  THE CONSUMER IS CHARGED LESS FOR THE
SUBSTITUTED DRUG THAN THE PRICE OF THE BRAND NAME DRUG.

(C)  REQUIREMENTS ON SUBSTITUTION.

IF A DRUG PRODUCT IS SUBSTITUTED UNDER THIS SECTION,
THE PHARMACIST SHALL:

(1)  NOTIFY THE PATIENT IN WRITING THAT THE DRUG
PRODUCT DISPENSED IS A GENERIC EQUIVALENT OF THE PRESCRIBED
DRUG PRODUCT; AND

(2)  RECORD ON THE PRESCRIPTION AND KEEP A RECORD
OF THE NAME AND MANUFACTURER OF THE SUBSTITUTED DRUG
PRODUCT.

(D)  FORMULARY OF AUTHORIZED SUBSTITUTIONS.

THE DEPARTMENT SHALL PUBLISH AND, AT LEAST EVERY 6
MONTHS, UPDATE A FORMULARY THAT LISTS THOSE SUBSTITUTIONS
THAT MAY BE MADE UNDER THIS SECTION. THE FORMULARY:

(1) SHALL LIST ALL DRUG PRODUCTS THAT THE
COMMISSIONER OF FOOD AND DRUGS HAS:

(I) APPROVED AS SAFE AND EFFECTIVE; AND