other · Food and Drug Administration · Rule · Published 2000-01-26 · Effective 2001-01-26 · 65 FR 4103
Document
Document number
00-1788
Federal Register citation
65 FR 4103
CFR reference
21 CFR 201
Type
Rule
Action
Final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2000-01-26
Effective date
2001-01-26
HHS docket
Docket No. 90N-0056
Abstract
The Food and Drug Administration (FDA) is amending its regulations to add certain labeling requirements for aluminum content in large volume parenterals (LVP's), small volume parenterals (SVP's), and pharmacy bulk packages (PBP's) used in total parenteral nutrition (TPN). FDA is also specifying an upper limit of aluminum permitted in LVP's and requiring applicants to submit to FDA validated assay methods for determining aluminum content in parenteral drug products. The agency is adding these requirements because of evidence linking the use of parenteral drug products containing aluminum to morbidity and mortality among patients on TPN therapy, especially among premature neonates and patients with impaired kidney function.