# Current Good Manufacturing Practice Requirements for Combination Products
> **Food and Drug Administration** · Final rule. · Published 2013-01-22 · Effective 2013-07-22 · 78 FR 4307
## Document
- **Document number:** 2013-01068
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 78 FR 4307
- **CFR reference:** 21 CFR 4
- **Publication date:** 2013-01-22
- **Effective date:** 2013-07-22
- **HHS docket:** Docket No. FDA-2009-N-0435
## Abstract

The Food and Drug Administration (FDA or Agency) is issuing this regulation on the current good manufacturing practice (CGMP) requirements applicable to combination products. This rule is intended to promote the public health by clarifying which CGMP requirements apply when drugs, devices, and biological products are combined to create combination products. In addition, the rule sets forth a transparent and streamlined regulatory framework for firms to use when demonstrating compliance with CGMP requirements for "single-entity" and "co-packaged" combination products.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2013/01/22/2013-01068/current-good-manufacturing-practice-requirements-for-combination-products)
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