HARRY HUGHES, Governor                               1669

(e) The Department of Health and Mental Hygiene shall:

(1) [establish] ESTABLISH AND MAINTAIN a list of

drugs for which drug—product selection is restricted or

prohibited. This formulary—shall—contain those drugs for

which there is evidence of actual or potential

bio-inequivalency of therapeutic significance. The formulary
may be added to or deleted from as necessary but shall be

updated at least once every six months.

(2) ESTABLISH AND MAINTAIN A DRUG FORMULARY OF
EQUIVALENT DRUG PRODUCTS. THE FORMULARY:

(I)   SHALL LIST ALL DRUG PRODUCTS THAT THE
COMMISSIONER OF FOOD AND DRUG, UNITED STATES FOOD AND DRUG
ADMINISTRATION, HAS APPROVED AS SAFE AND EFFECTIVE, AND HAS
DETERMINED TO BE THERAPEUTICALLY EQUIVALENT;

(II)   SHALL LIST ALL DRUG PRODUCTS THAT
WERE NOT SUBJECT TO PREMARKETING APPROVAL FOR SAFETY AND
EFFECTIVENESS UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC
ACT, ARE MANUFACTURED BY FIRMS MEETING THE REQUIREMENTS OF
THAT ACT, ARE SUBJECT TO PHARMACOPOEIAL STANDARDS ADEQUATE
TO ASSURE PRODUCT QUALITY, AND HAVE BEEN DETERMINED BY THE
COMMISSIONER OF FOOD AND DRUGS TO MEET ANY OTHER
REQUIREMENTS NECESSARY TO ASSURE THERAPEUTIC EQUIVALENCE;
AND

(III)   MAY LIST ADDITIONAL DRUG PRODUCTS
THAT ARE DETERMINED BY THE DEPARTMENT TO MEET REQUIREMENTS
ADEQUATE TO ASSURE PRODUCT QUALITY AND THERAPEUTIC
EQUIVALENCE; AND

(3) (2) PROVIDE FOR REVISION OF THE FORMULARIES
AS NECESSARY BUT NOT LESS THAN EVERY 6 MONTHS; AND

(4) (3) PROVIDE FOR DISTRIBUTION OF THE
FORMULARIES AND REVISIONS TO ALL PHARMACIES AND PRESCRIBERS
LICENSED IN THIS STATE AND TO OTHER APPROPRIATE INDIVIDUALS.

(F) THE DEPARTMENT OF HEALTH AND MENTAL HYGIENE SHALL:

(1)   ASSESS THE NEED FOR PUBLIC EDUCATION
REGARDING THE PROVISIONS OF THIS SECTION;

(2)   PROVIDE FOR THAT EDUCATION IF APPROPRIATE;

AND

(3)   MONITOR THE EFFECTS OF THE SECTION
PERIODICALLY.

SECTION 2. AND BE IT FURTHER ENACTED, That this Act
shall take effect July 1, 1979.

Approved May 29, 1979.