Rules and Regulations. Final rule; correction
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/register/2003/04/14/03-9067·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 8010-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 341 [Docket No. 76N-052G] RIN 0910-AA01 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. [FR Doc. 03-9067 Filed 4-11-03; 8:45 am]
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