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§ 960.2. Definitions

Purdon's Pennsylvania Statutes and Consolidated StatutesTitle 35 P.S. Health and SafetyEffective: September 19, 2016

Purdon's Pennsylvania Statutes and Consolidated Statutes
Title 35 P.S. Health and Safety (Refs & Annos)
Chapter 6B. Drugs, Poisons and Dangerous Substances
Generic Equivalent Drug Law (Refs & Annos)
Effective: September 19, 2016
35 P.S. § 960.2
§ 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. § 201 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),1 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 for interchangeability pursuant to the Public Health Service Act (58 Stat. 682, 42 U.S.C. § 201 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),2 known as the “Pharmacy Act.”
“Prescriber” means any duly licensed physician, dentist, veterinarian or other practitioner licensed to write prescriptions intended for the treatment of3 prevention of disease in man or animals.
“Secretary” means the Secretary of Health.

Credits

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; 2016, July 20, P.L. 830, No. 95, § 1, effective in 60 days [Sept. 19, 2016].

Footnotes

35 P.S. § 780-101 et seq.
63 P.S. § 390-1 et seq.
So in original.
35 P.S. § 960.2, PA ST 35 P.S. § 960.2
Current through Act 10 of the 2024 Regular Session. Some statute sections may be more current, see credits for details.
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