03-9067. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Final Monograph for Combination Drug Products; Correction

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; correction.

SUMMARY:

The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of December 23, 2002 (67 FR 78158). The document issued a final monograph that established conditions under which over-the-counter (OTC) cold, cough, allergy, bronchodilator, and antiasthmatic (cough-cold) combination drug products are generally recognized as safe and effective and not misbranded as part of its ongoing review of OTC drug products.

DATES:

The regulation is effective December 23, 2004.

FOR FURTHER INFORMATION CONTACT:

Cazemiro R. Martin 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. 02-32158 appearing on page 78158 in the Federal Register of Monday, December 23, 2002, the following corrections are made:

§ 341.40

[Corrected]

1. On page 78168, in the second column, in Part 341 Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use, under the authority citation, in amendment 2, “Section 341.40 is added to subpart C to read as follows:” is corrected to read “Section 341.40 is added to subpart B to read as follows:”

§ 341.70

[Corrected]

2. On page 78170, in the second column, in § 341.70 Labeling of OTC drug products containing ingredients that are used for treating concurrent symptoms (in either a single-ingredient or combination drug product), in paragraph (b), “Repeat every hour as needed or as directed by a doctor.” is corrected to read “Repeat every 2 hours as needed or as directed by a doctor.”

Dated: April 8, 2003.

Jeffrey Shuren,

Assistant Commissioner for Policy.