[Federal Register Volume 60, Number 161 (Monday, August 21, 1995)]
[Proposed Rules]
[Page 43421]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20607]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 341

[Docket No. 95N-0205]
RIN 0905-AA06


Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug 
Products for Over-the-Counter Human Use; Proposed Amendment of 
Monograph for OTC Bronchodilator Drug Products; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of proposed rulemaking; correction.

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SUMMARY: The Food and Drug Administration (FDA) is correcting a 
proposal that appeared in the Federal Register of July 27, 1995 (60 FR 
38643). That document proposed to amend the final monograph for over-
the-counter (OTC) bronchodilator drug products to remove the 
ingredients ephedrine, ephedrine hydrochloride, ephedrine sulfate, and 
racephedrine hydrochloride and to classify these ingredients as not 
generally recognized as safe and effective for OTC use. The document 
was published with two errors. This document corrects those errors.

FOR FURTHER INFORMATION CONTACT: LaJuana D. Caldwell, Office of Policy 
(HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-443-2994.

SUPPLEMENTARY INFORMATION: In FR Doc. 95-18448, appearing on page 38643 
in the Federal Register of July 27, 1995, the following corrections are 
made:


Sec. 310.545  [Corrected]

    1. On page 38646, in the third column, in Sec. 310.545 Drug 
products containing certain active ingredients offered over-the-counter 
(OTC) for certain uses, in paragraph (a)(6)(iv)(D), the words ``August 
28, 1995'' are corrected to read ``(date 30 days after date of 
publication of the final rule)''; and in paragraph (d)(27), the words 
``August 28, 1995'' are corrected to read ``(Date 30 days after date of 
publication of the final rule)''.

    Dated: August 14, 1995.
 William K. Hubbard,
 Acting Deputy Commissioner for Policy.
[FR Doc. 95-20607 Filed 8-18-95; 8:45 am]
BILLING CODE 4160-01-F