Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements; Correction
other · US Department of Health and Human Services · Rule · Published 1997-03-31 · Effective 1997-07-15 · 62 FR 15110
Document
Document number
97-7970
Federal Register citation
62 FR 15110
CFR reference
21 CFR 310
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
US Department of Health and Human Services
Publication date
1997-03-31
Effective date
1997-07-15
HHS docket
Docket Nos. 91P-0186 and 93P-0306
Abstract
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of January 15, 1997 (62 FR 2218). The final rule amended the regulations to require label warning statements on products taken in solid oral dosage form to supplement the dietary intake of iron or to provide iron for therapeutic purposes and to require unit dose packaging for iron-containing products that contain 30 milligrams or more of iron per dosage unit. The final rule was published with some typographical errors. This document corrects those errors.