# 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for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/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/2359800d-6604-4abc-9239-c326823db9f3

> FDA guidance document: 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for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry. Issue date: June 04, 2025. Get complete insights and analysis.

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## Details

- Title: 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for Minor Changes C001: Minor Changes to Solid Oral Dosage Forms for Certain Over-the-Counter Monograph Drugs: Draft Guidance for Industry
- Communication Type: Guidance Document
- Product Type: drugs
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-06-04
- Comment Close Date: 2025-10-03
- Last Changed: 2025-06-05
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2025-D-1358">FDA-2025-D-1358</a>

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