PRINTER'S NO. 3499
No. 2499 Session of 1986
INTRODUCED BY ITKIN, E. Z. TAYLOR, D. W. SNYDER, FREEMAN,
MRKONIC, MORRIS, WAMBACH, RYBAK, TRUMAN, VROON, YANDRISEVITS,
HOWLETT, BATTISTO, PISTELLA, HALUSKA, KUKOVICH, PUNT, TRELLO,
PETRONE, OLIVER, AFFLERBACH, FARGO, MERRY, VAN HORNE,
DISTLER, JOSEPHS, MICHLOVIC, JOHNSON, VEON, PERZEL, BROUJOS,
SEVENTY, FOX, CESSAR, RICHARDSON AND BARBER, MAY 28, 1986
REFERRED TO COMMITTEE ON HEALTH AND WELFARE, MAY 28, 1986
AN ACT
1 Amending the act of November 24, 1976 (P.L.1163, No.259),
2 entitled "An act relating to the prescribing and dispensing
3 of generic equivalent drugs," requiring the department to
4 publish updated formulary lists.
5 The General Assembly of the Commonwealth of Pennsylvania
6 hereby enacts as follows:
7 Section 1. Section 5(a) of the act of November 24, 1976
8 (P.L.1163, No.259), referred to as the Generic Equivalent Drug
9 Law, is amended to read:
10 Section 5. (a) The Department of Health shall have the
11 power and its duty shall be to:
12 (1) Administer and enforce the provisions of this act.
13 (2) Adopt necessary regulations consistent with this act.
14 (3) Publicize the provisions of this act.
15 (4) [Distribute in cooperation with the Pennsylvania Board
16 of Pharmacy periodically an updated formulary of generically
17 equivalent drug products to all pharmacies in the Commonwealth.]
1 The department shall publish and, at least every six months,
2 update a formulary that lists those substitutions that may be
3 made under this section. The formulary:
4 (i) automatically shall list all drug products that the
5 Commissioner of Food and Drugs of the United States Food and
6 Drug Administration has:
7 (A) approved as safe and effective; and
8 (B) determined to be therapeutically equivalent;
9 (ii) automatically shall list all drug products that:
10 (A) were not subject to premarketing approval for safety and
11 effectiveness under the Federal Food, Drug, and Cosmetic Act
12 Stat. 1040, 21 U.S.C. § 301 et seq.);
13 (B) are manufactured by firms meeting the requirements of
14 that act;
15 (C) are subject to pharmacopoeial standards that are
16 adequate to assure product quality; and
17 (D) have been determined by the Commissioner of Food and
18 Drugs to meet any other requirements necessary to assure
19 therapeutic equivalence; and
20 (iii) may list any additional drug products that are
21 determined by the department to meet requirements that are
22 adequate to assure product quality and therapeutic equivalence.
23 * * *
24 Section 2. This act shall take effect in 60 days.
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