[Federal Register Volume 68, Number 123 (Thursday, June 26, 2003)]
[Rules and Regulations]
[Page 37963]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-16111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. 78N-036D]
RIN 0910-AA01


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

AGENCY: Food and Drug Administration.

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 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:


Sec.  310.545  [Corrected]

    On page 18881, in the first column, in Sec.  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.
[FR Doc. 03-16111 Filed 6-25-03; 8:45 am]
BILLING CODE 4160-01-S