Human drugs: Cold, cough, allergy, bronchodilator, and antiasthmatic products (OTC)— Combination products; final monograph; correction,

[Federal Register: April 14, 2003 (Volume 68, Number 71)]

[Rules and Regulations]

[Page 17881]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr14ap03-4]

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:

Sec. 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:''

   Sec. 341.70 [Corrected]

2. On page 78170, in the second column, in Sec. 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]

   BILLING CODE 4160-01-S