03-16111. Antidiarrheal Drug Products for Over-the-Counter Human Use; Final Monograph; Correction

AGENCY:

Food and Drug Administration.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of April 17, 2003 (68 FR 18869). That document issued a final monograph that established conditions under which over-the-counter (OTC) antidiarrheal drug products (to control the symptoms of diarrhea) are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products. The document published with an inadvertent error. This document corrects that error.

DATES:

The rule is effective April 19, 2004.

FOR FURTHER INFORMATION CONTACT:

Mary S. Robinson or Gerald M. Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2222.

SUPPLEMENTARY INFORMATION:

In FR Doc. 03-9380, appearing on page 18869 in the Federal Register of Thursday, April 17, 2003, the following correction is made:

§ 310.545

[Corrected]

On page 18881, in the first column, in § 310.545 Drug products containing certain active ingredients offered over-the-counter (OTC) for certain uses, in paragraph (d)(1), in line 8, “(a)(18)(i)(A) of this section” is corrected to read “(a)(18) of this section (except as covered by paragraph (d)(22) of this section).”

Dated: June 19, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.