Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the-Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms
The Food and Drug Administration (FDA) is announcing the availability on its website of the proposed administrative order (proposed order) (OTC000037) entitled "Over-the-Counter Monograph Condition B001: Single-Unit or Unit-Dose Containers for Over-the- Counter Monograph Drugs in Orally Disintegrating Tablet and Film Dosage Forms." This proposed order, if finalized, will require over-the- counter (OTC) monograph drugs in an orally disintegrating tablet (ODT) or film dosage form that are subject to specified OTC monographs to be packaged in single-unit or unit-dose containers.
Abstract as published in the Federal Register.
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