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

Food and Drug Administration, HHS.

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.

Submit electronic comments on the proposed administrative order by August 4, 2025.

The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of August 4, 2025. Please note that late, untimely filed comments will not be considered. Instructions for submitting comments are contained in the proposed order OTC000037, which can be viewed in the OTC Monographs@FDA portal at https://dps.fda.gov/​omuf. Comments must be submitted electronically.