Drug Approvals: Circumstances Under Which an Active Ingredient May Be Simultaneously Marketed in Both a Prescription Drug Product and an Over-the-Counter Drug Product

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The Food and Drug Administration (FDA) is issuing this advance notice of proposed rulemaking to request comment on whether to initiate a rulemaking to codify its interpretation of section 503(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301, et seq.), regarding when an active ingredient may be simultaneously marketed in both a prescription drug product and an over-the-counter (OTC) drug product.