Statutes, codes, and regulations
New York Codes, Rules and Regulations
Title 10 - DEPARTMENT OF HEALTHChapter II - Administrative Rules and RegulationsSubchapter E - Food And Drug Products; ResearchPart 60 - Food And Drug Products
Subpart 60-2 - Drug Substitution
Section 60-2.2 - Omissions from the list of safe, effective and therapeutically equivalent prescription drugs

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 60-2.2

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Current through Register Vol. 46, No. 42, October 16, 2024
Section 60-2.2 - Omissions from the list of safe, effective and therapeutically equivalent prescription drugs

The omission of a drug product from the list of drug products in no way automatically implies that such product is known to be therapeutically nonequivalent to other similar products nor that it is ineffective. Such omission shall indicate that an appropriate bioequivalence standard for all pharmaceutical equivalents of such drug has not yet been established, or that appropriate evidence that the standard has been met by such product has not been submitted to the Food and Drug Administration.

N.Y. Comp. Codes R. & Regs. Tit. 10 §§ 60-2.2