Sec. 562.001. DEFINITIONS. In this subchapter: (1) "Biological product" has the meaning assigned by Section 351, Public Health Service Act (42 U.S.C. Section 262). (1-a) "Generically equivalent" means a drug that is pharmaceutically equivalent and therapeutically equivalent to the drug prescribed. (1-b) "Interchangeable," in reference to a biological product, has the meaning assigned by Section 351, Public Health Service Act (42 U.S.C. Section 262), or means a biological product that is designated as therapeutically equivalent to another product by the United States Food and Drug Administration in the most recent edition or supplement of the United States Food and Drug Administration's Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book. (2) "Pharmaceutically equivalent" means drug products that have identical amounts of the same active chemical ingredients in the same dosage form and that meet the identical compendial or other applicable standards of strength, quality, and purity according to the United States Pharmacopoeia or another nationally recognized compendium. (3) "Therapeutically equivalent" means pharmaceutically equivalent drug products that, if administered in the same amounts, will provide the same therapeutic effect, identical in duration and intensity.
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