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From the Food and Drug Administration
March 4, 1998

Generic Substitution

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JAMA. 1998;279(9):645. doi:10.1001/jama.279.9.645-JFD80000-3-1

The FDA has asked health professional organizations for assistance in informing their members of its position on generic substitution. The FDA has been receiving inquiries from state legislatures, state pharmacy boards, and drug utilization review committees as they consider issues related to the substitution of medications characterized as narrow therapeutic index drug products. A particular issue is whether the safety and efficacy profile of these products could change if a switch were made from a brand-name product to an FDA-designated, therapeutically equivalent, generic drug product.

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