97-7970. Iron-Containing Supplements and Drugs: Label Warning Statements and Unit-Dose Packaging Requirements; Correction

[Federal Register Volume 62, Number 61 (Monday, March 31, 1997)]
[Rules and Regulations]
[Pages 15110-15111]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-7970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 310

[Docket Nos. 91P-0186 and 93P-0306]


Iron-Containing Supplements and Drugs: Label Warning Statements 
and Unit-Dose Packaging Requirements; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

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SUMMARY: 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.

DATES:  Effective July 15, 1997.

FOR FURTHER INFORMATION CONTACT: Linda S. Kahl, Center for Food Safety 
and Applied Nutrition (HFS-206), Food and Drug Administration, 200 C 
St. SW., Washington, DC 20204, 202-418-3101.

SUPPLEMENTARY INFORMATION:

[[Page 15111]]

    In FR Doc. 97-947, beginning on page 2218 in the Federal Register 
of January 15, 1997, the following corrections are made in Sec. 310.518 
Drug products containing iron or iron salts:


Sec. 310.518   [Corrected]

    1. On page 2250, in the second column, in paragraph (b)(2), 
beginning in the fourth line, the phrase ``the provisions of 
Sec. 111.50(a) of this chapter'' is corrected to read ``the provisions 
of paragraph (a) of this section''.
    2. On page 2250, in the third column, in paragraph (c)(5), in the 
second line, the phrase ``paragraph (b)(1) of this section'' is 
corrected to read ``paragraph (c)(1) of this section''.

    Dated: March 25, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-7970 Filed 3-28-97; 8:45 am]
BILLING CODE 4160-01-F