Revisions to the Requirements Applicable to Blood, Blood Components, and Source Plasma
other · Food and Drug Administration · Rule · Published 2001-08-06 · Effective 2001-09-05 · 66 FR 40886
Document
Document number
01-19461
Federal Register citation
66 FR 40886
CFR reference
21 CFR 606
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2001-08-06
Effective date
2001-09-05
HHS docket
Docket No. 98N-0673
Abstract
The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood, blood components, and Source Plasma to be more consistent with current practices in the blood industry and to remove unnecessary or outdated requirements. FDA is issuing this final rule as part of the agency's "Blood Initiative" in which FDA is reviewing and revising, when appropriate, its regulations, policies, guidance, and procedures related to blood, blood components, and Source Plasma.