Labeling Requirements for Systemic Antibacterial Drug Products Intended for Human Use; Correction
other · Food and Drug Administration · Rule · Published 2003-03-17 · 68 FR 12584
Document
Document number
03-6232
Federal Register citation
68 FR 12584
CFR reference
21 CFR 201
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
2003-03-17
HHS docket
Docket No. 00N-1463
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of February 6, 2003 (68 FR 6062). The document amended FDA's regulations to require that the labeling for all systemic antibacterial drug products intended for human use include certain statements about using antibiotics in a way that will reduce the development of drug-resistant bacterial strains. The document was published with an inadvertent error. This document corrects that error.