View Rule
View EO 12866 Meetings | Printer-Friendly Version Download RIN Data in XML |
HHS/FDA | RIN: 0910-AC18 | Publication ID: Spring 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: Final Rule Stage |
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:
|
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 |