# Current Good Tissue Practice for Human Cell, Tissue, and Cellular and Tissue-Based Product Establishments; Inspection and Enforcement
> **Food and Drug Administration** · Final rule. · Published 2004-11-24 · Effective 2005-05-25 · 69 FR 68612
## Document
- **Document number:** 04-25798
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 69 FR 68612
- **CFR reference:** 21 CFR 16
- **Publication date:** 2004-11-24
- **Effective date:** 2005-05-25
- **HHS docket:** Docket No. 1997N-484P
## Abstract

The Food and Drug Administration (FDA) is requiring human cell, tissue, and cellular and tissue-based product (HCT/P) establishments to follow current good tissue practice (CGTP), which governs the methods used in, and the facilities and controls used for, the manufacture of HCT/Ps; recordkeeping; and the establishment of a quality program. The agency is also issuing new regulations pertaining to labeling, reporting, inspections, and enforcement that will apply to manufacturers of those HCT/Ps regulated solely under the authority of the Public Health Service Act (PHS Act), and not as drugs, devices, and/or biological products. The agency's actions are intended to improve protection of the public health while keeping regulatory burden to a minimum, which in turn would encourage significant innovation.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2004/11/24/04-25798/current-good-tissue-practice-for-human-cell-tissue-and-cellular-and-tissue-based-product)
---
*AI Analytics · CC0 1.0*