# RIN 0910-AA74
> **Food and Drug Administration** · Final rule. · Published 2000-01-26 · Effective 2001-01-26 · 65 FR 4103
## Document
- **Document number:** 00-1788
- **Category:** other
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 65 FR 4103
- **CFR reference:** 21 CFR 201
- **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.

## Source
- [Federal Register document](https://www.federalregister.gov/documents/2000/01/26/00-1788/rin-0910-aa74)
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