2708

LAWS OF MARYLAND

Ch. 335

Annotated Code of Maryland

(1981 Volume and 1981 Supplement)

SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF
MARYLAND, That section(s) of the Annotated Code of Maryland
read(s) as follows:

Article - Health Occupations

12-508.

(d) 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] AUTOMATICALLY SHALL list all drug
products that the Commissioner of Food and Drugs has:

(i) Approved as safe and effective; and

(ii) Determined to be therapeutically
equivalent;

(2)   [Shall] AUTOMATICALLY SHALL list all drug
products that:

(i) Were not subject to premarketing
approval for safety and effectiveness under the Federal
Food, Drug, and Cosmetic Act;

(ii) Are manufactured by firms meeting the
requirements of that act;

(iii) Are subject to pharmacopoeial
standards that are adequate to assure product quality; and

(iv) Have been determined by the
Commissioner of Food and Drugs to meet any other
requirements necessary to assure therapeutic equivalence;
and

(3)  May list any additional drug products that
are determined by the Department to meet requirements, that
are adequate to assure product quality and therapeutic
equivalence.

SECTION 2. AND BE IT FURTHER ENACTED, That this Act
shall take effect July 1, 1982.

Approved May 20, 1982.