Revision of Requirements Applicable to Albumin (Human), Plasma Protein Fraction (Human), and Immune Globulin (Human)
other · Food and Drug Administration · Rule · Published 2000-08-28 · Effective 2000-09-27 · 65 FR 52016
Document
Document number
00-21897
Federal Register citation
65 FR 52016
CFR reference
21 CFR 640
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-08-28
Effective date
2000-09-27
HHS docket
Docket No. 98N-0608
Abstract
The Food and Drug Administration (FDA) is amending the biologics regulations by removing, revising, or updating specific regulations applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements. FDA is taking this action 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 products, including blood derivatives.