35 Pa. Stat. § 960.2

Current through Pa Acts 2024-53, 2024-56 through 2024-111
Section 960.2 - Definitions

As used in this act:

"Biological product" shall have the same meaning as "biological product" in the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 207 et seq.).

"Department" means the Department of Health.

"Drug" shall have the same meaning as drug in the act of April 14, 1972 (P.L. 233, No. 64), known as as "The Controlled Substance, Drug, Device and Cosmetic Act."

"Generically equivalent drug" means a drug product that the Commissioner of Food and Drugs of the United States Food and Drug Administration has approved as safe and effective and has determined to be therapeutically equivalent, as listed in "The Approved Drug Products with Therapeutic Equivalence Evaluations" (Food and Drug Administration "Orange Book"), provided, however, that drug products found by the United States Food and Drug Administration to have a narrow therapeutic range shall not be considered generically equivalent for the purposes of this act.

"Interchangeable biological product" means a biological product licensed by the United States Food and Drug Administration and determined to meet the safety standards forinterchangeability pursuant to the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 207 et seq.) or a biological product approved under section 505 of the Federal Food, Drug, and Cosmetic Act (52 Stat. 1040, 21 U.S.C. § 355 ) and determined by the United States Food and Drug Administration to be therapeutically equivalent to a prescribed biological product.

"Pharmacist" shall have the same meaning as pharmacist in the act of September 27, 1961 (P.L. 1700, No. 699), known as the "Pharmacy Act."

"Prescriber" means any duly licensed physician, dentist, veterinarian or other practitioner licensed to write prescriptions intended for the treatment of prevention of disease in man or animals.

"Secretary" means the Secretary of Health.

35 P.S. § 960.2

Amended by P.L. TBD 2016 No. 95, § 1, eff. 9/18/2016.
1976, Nov. 24, P.L. 1163, No. 259, § 2, imd. effective. Amended 1990 , July 11, P.L. 509, No. 121, § 1, effective in 60 days.