Use of Codeine-Containing Analgesics in Children Under 12 Years of Age Subsequent to CYP2D6 Genetic Testing; Establishment of a Public Docket; Request for Comments

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The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket to solicit public comment on specific questions pertaining to the use of codeine for analgesia in children under 12 years of age, and the use of cytochrome P450 2D6 (CYP2D6) testing in children under 12 years of age prior to treatment with codeine-containing analgesics. These questions are posed in section II.