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HHS/FDA RIN: 0910-AC18 Publication ID: Fall 2003 
Title: Aluminum in Large- and Small-Volume Parenterals Used in Total Parenteral Nutrition 
Abstract: The final rule will revise 21 CFR 323(c) to permit small-volume parenterals and pharmacy bulk packages that contain 25 mcg/L or less of aluminum to state "contains no more than 25 mcg/L" rather than the exact amount of aluminum. 
Agency: Department of Health and Human Services(HHS)  Priority: Other Significant 
RIN Status: Previously published in the Unified Agenda Agenda Stage of Rulemaking: Completed Actions 
Major: No  Unfunded Mandates: No 
CFR Citation: 21 CFR 201.323(c) 
Legal Authority: 21 USC 321(n); 21 USC 352; 21 USC 355; 21 USC 371(a); 21 CFR 201.51; 21 CFR 201.100; 21 CFR 314.125 
Legal Deadline:  None
Timetable:
Action Date FR Cite
NPRM  08/12/2002  67 FR 52429 
Final Action  06/03/2003  68 FR 32979 
Regulatory Flexibility Analysis Required: Undetermined  Government Levels Affected: None 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
Agency Contact:
Christine F. Rogers
Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
Suite 3059 (HFD-7), Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Bldg. 51, Room 6316,
Silver Spring, MD 20993-0002
Phone:301 796-3601
Fax:301 847-8440
Email: christine.rogers@fda.hhs.gov

 
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