💊FDA Draft Guidance on OTC Monograph Minor Changes Available
Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs; Draft Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry titled "Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs." The purpose of this guidance is to provide recommendations for how requestors can comply with the requirements described in the Proposed Administrative Order (OTC000038) titled Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs (hereinafter referred to as C001).
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The draft guidance for OTC monograph drugs outlines compliance requirements for changes to solid oral dosage forms, which directly affects companies manufacturing OTC products. Non-compliance may lead to regulatory penalties or product market withdrawal, making adherence critical.