PARRIS N. GLENDENING, Governor

Ch. 614

[12-508.] 12-504.

(a)     In this section, "brand name" means the proprietary name a manufacturer
places on a drug, OR DEVICE, OR DIAGNOSTIC product or its container.

(b)     A pharmacist may substitute a generically equivalent drug, OR DEVICE, OR
DIAGNOSTIC product, of the same dosage form and strength, for any brand name drug,
OR DEVICE, OR DIAGNOSTIC 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 United States Food and Drug
Administration's current list of approved drug; OR DEVICE, OR DIAGNOSTIC products
with therapeutic equivalence evaluations; and

(3)     The consumer is charged less for the substituted drug, OR DEVICE, OR
DIAGNOSTIC than the price of the brand name drug; OR DEVICE, OR DIAGNOSTIC.

(c)     If a drug, OR DEVICE, OR DIAGNOSTIC product is substituted under this
section, the pharmacist shall:

(1)     Notify the patient in writing that the drug, OR DEVICE, OR DIAGNOSTIC
product dispensed is a generic equivalent of the prescribed drug, OR DEVICE, OR
DIAGNOSTIC product; and

(2)     Record on the prescription and keep a record of the name and
manufacturer of the substituted drug, OR DEVICE, OR DIAGNOSTIC product.

(d)     The Department may list any additional drug, OR DEVICE, OR DIAGNOSTIC
products that are determined by the Department to meet requirements that are adequate
to assure product quality and therapeutic equivalence, after an opportunity for public
comment as provided in Title 10, Subtitle 1 of the State Government Article.

(e)     The Department may disqualify a drug, OR DEVICE, OR DIAGNOSTIC product
on the United States Food and Drug Administration's current list from being used in
Maryland as a generic substitute if the Department determines that the drug, OR
DEVICE, OR DIAGNOSTIC is therapeutically nonequivalent or has a negative physical or
biological effect on the consumer of that drug, OR DEVICE, OR DIAGNOSTIC product:

(1)     After providing an opportunity for public comment as provided in Title
10, Subtitle 1 of the State Government Article; or

(2)     Prior to providing an opportunity for public comment, if the Department
believes that a particular generic drug, OR DEVICE, OR DIAGNOSTIC product constitutes
an imminent danger to the public health, safety or welfare, and the Department:

(i) Provides an opportunity for public comment as provided in Title
10, Subtitle 1 of the State Government Article within 30 days of disqualifying the DRUG,
OR DEVICE, OR DIAGNOSTIC product; and

(ii) After providing an opportunity for public comment, determines
whether the DRUG, OR DEVICE, OR DIAGNOSTIC product should remain disqualified.

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