💊FDA Proposes New Packaging Rules for Over-the-Counter Drugs
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
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.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The proposed order imposes packaging requirements for OTC drugs, which mandates businesses to adapt their packaging strategies to comply. This could increase operational costs and affect supply chain logistics. Compliance with these requirements is essential to avoid product misbranding and potential market access issues.