# Requirements for Blood and Blood Components Intended for Transfusion or for Further Manufacturing Use
> **Food and Drug Administration** · Final rule. · Published 2015-05-22 · Effective 2016-05-23 · 80 FR 29842
## Document
- **Document number:** 2015-12228
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 80 FR 29842
- **CFR reference:** 21 CFR 606
- **Publication date:** 2015-05-22
- **Effective date:** 2016-05-23
- **HHS docket:** Docket No. FDA-2006-N-0040 (formerly Docket No. 2006N-0221)
## Abstract

The Food and Drug Administration (FDA) is amending the regulations applicable to blood and blood components, including Source Plasma, to make the donor eligibility and testing requirements more consistent with current practices in the blood industry, to more closely align the regulations with current FDA recommendations, and to provide flexibility to accommodate advancing technology. In order to better assure the safety of the nation's blood supply and to help protect donor health, FDA is revising the requirements for blood establishments to test donors for infectious disease, and to determine that donors are eligible to donate and that donations are suitable for transfusion or further manufacture. FDA is also requiring establishments to evaluate donors for factors that may adversely affect the safety, purity, and potency of blood and blood components or the health of a donor during the donation process. Accordingly, these regulations establish requirements for donor education, donor history, and donor testing. These regulations also implement a flexible framework to help both FDA and industry to more effectively respond to new or emerging infectious agents that may affect blood product safety.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2015/05/22/2015-12228/requirements-for-blood-and-blood-components-intended-for-transfusion-or-for-further-manufacturing)
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