01-26315. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Partial Final Rule for Combination Drug Products Containing a Bronchodilator; 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 September 27, 2001 (66 FR 49276). The document issued a final rule establishing that cough-cold combination drug products containing any oral bronchodilator active ingredient in combination with any analgesic(s) or analgesic-antipyretic(s), anticholinergic, antihistamine, oral antitussive, or stimulant active ingredient are not generally recognized as safe and effective and are misbranded for over-the-counter (OTC) use. The document published with two inadvertent errors. This document corrects those errors.

DATES:

This rule is effective October 19, 2001.

FOR FURTHER INFORMATION CONTACT:

Joyce Strong, Office of Policy, Planning, and Legislation (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010.

SUPPLEMENTARY INFORMATION:

In FR Doc. 01-24127, appearing on page 49276 in the Federal Register of Thursday, September 27, 2001, the following corrections are made:

1. On page 49276, in the second column, in the third line, “Food and Drug Administration.” is corrected to read “Food and Drug Administration”.

2. On page 49276, in the second column, in the fourth line, “21 CFR part 341” is corrected to read “21 CFR part 310”.

Dated: October 9, 2001.

Margaret M. Dotzel,

Associate Commissioner for Policy