# Over-the-Counter Monograph Order Requests: Format and Content - FDA Guidance Document

Source: https://www.globalkeysolutions.net/guidances/guidance-document/over-the-counter-monograph-order-requests-format-and-content/eb4d3058-6081-407e-aa26-b551185c8260

> FDA guidance document: Over-the-Counter Monograph Order Requests: Format and Content. Issue date: April 13, 2023. Get complete insights and analysis.

---

## Details

- Title: Over-the-Counter Monograph Order Requests: Format and Content
- 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: 2023-04-13
- Comment Close Date: 2023-06-12
- Last Changed: 2023-04-13
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2023-D-1188">FDA-2023-D-1188</a>

## Related Documents

- [Establishing Impurity Specifications for Antibiotics](https://www.globalkeysolutions.net/guidances/guidance-document/establishing-impurity-specifications-for-antibiotics/5bb8badb-7c32-4b76-bfc9-bbb8ab55fb84)
- [Formal Meetings Between the Food and Drug Administration and Sponsors or Requestors of Over-the-Counter Monograph Drugs](https://www.globalkeysolutions.net/guidances/guidance-document/formal-meetings-between-the-food-and-drug-administration-and-sponsors-or-requestors-of-over-the-counter-monograph-drugs/b75646c9-df1f-4b38-a2d8-dea9f3410853)
- [Content and Format of Composition Statement and Corresponding Statement of Ingredients in Labeling in NDAs and ANDAs](https://www.globalkeysolutions.net/guidances/guidance-document/content-and-format-of-composition-statement-and-corresponding-statement-of-ingredients-in-labeling-in-ndas-and-andas/a430f093-c9f8-4001-aef8-771d98ffdbf0)