# Anorectal Drug Products for Over-the-Counter Human Use
> **Food and Drug Administration** · Final rule. · Published 2003-08-26 · Effective 2003-09-25 · 68 FR 51167
## Document
- **Document number:** 03-21749
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 68 FR 51167
- **CFR reference:** 21 CFR 310
- **Publication date:** 2003-08-26
- **Effective date:** 2003-09-25
- **HHS docket:** Docket No. 1980N-0050
## Abstract

The Food and Drug Administration (FDA) is issuing a final rule establishing that any over-the-counter (OTC) drug product containing a combination of hydrocortisone and pramoxine hydrochloride (HCl) for anorectal use is not generally recognized as safe and effective and is misbranded. This combination product is not currently marketed OTC. This final rule discusses data on the combination of hydrocortisone and pramoxine HCl that were still under review when an earlier final rule on OTC anorectal drug products was issued. This rule is part of FDA's ongoing review of OTC drug products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2003/08/26/03-21749/anorectal-drug-products-for-over-the-counter-human-use)
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