# Orphan Drug Regulations
> **Food and Drug Administration** · Final rule. · Published 2013-06-12 · Effective 2013-08-12 · 78 FR 35117
## Document
- **Document number:** 2013-13930
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 78 FR 35117
- **CFR reference:** 21 CFR 316
- **Publication date:** 2013-06-12
- **Effective date:** 2013-08-12
- **HHS docket:** Docket No. FDA-2011-N-0583
## Abstract

The Food and Drug Administration (FDA) is issuing final regulations amending the 1992 Orphan Drug Regulations issued to implement the Orphan Drug Act. These amendments are intended to clarify regulatory provisions and make minor improvements to address issues that have arisen since those regulations were issued.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2013/06/12/2013-13930/orphan-drug-regulations)
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