Proposed Order | Order Number OTC000037 | View Federal Register Notice ⬈
Order Title: 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
Summary
FDA is issuing this proposed administrative order (proposed order) to establish requirements for the packaging of certain over-the-counter (OTC) monograph drugs. This proposed order, if finalized, will require OTC monograph drugs that are 1) in an orally disintegrating tablet (ODT) or film dosage form and 2) subject to an OTC monograph identified in the order (see § B001.1), to be packaged in single-unit or unit-dose containers to be considered generally recognized as safe and effective. You may submit comments on this proposed order (OTC000037) electronically in docket number FDA-2025-N-1359 in the Federal eRulemaking Portal at https://www.regulations.gov/. See the proposed order for instructions. Comments will be accepted at any time beginning on June 5, 2025 until 11:59 pm Eastern Time at the end of August 4, 2025.
Current Orders
| Published Date | Document Title | Supporting Documents |
|---|---|---|
| 06/05/2025 | 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 | N/A |