Revision of requirements applicable to albumin (human), plasma protein fraction (human), and immune globulin (human); confirmation in part and technical amendment. Food and Drug Administration, HHS. Direct final rule; confirmation in part and technical amendment.
The Food and Drug Administration (FDA) is confirming in part the direct final rule that appeared in the Federal Register of May 14, 1999 (64 FR 26282). The direct final rule amends 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applicable to blood derivative products to be more consistent with current practices and to remove unnecessary or outdated requirements.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 confirming the provisions for which no significant adverse comments were received. The agency received significant adverse comments on certain provisions and is hereby amending Title 21 Code of Federal Regulations to reinstate the former provisions. In addition, FDA is correcting the precision of the value for protein concentration that was inadvertently omitted from the codified section of the direct final rule.
D001798:Blood Proteins; D001800:Blood Specimen Collection / Q000592:standards; D006801:Humans; D007136:Immunoglobulins; D007883:Legislation, Medical; D012016:Reference Values; D012709:Serum Albumin; D014481:United States; D014486:United States Food and Drug Administration
D001798:Blood Proteins; D007136:Immunoglobulins; D012709:Serum Albumin