95-20564. Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Proposed Amendment of Monograph for OTC Bronchodilator Drug Products; Correction

[Federal Register Volume 60, Number 160 (Friday, August 18, 1995)]
[Proposed Rules]
[Page 43091]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-20564]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 310 and 341

[Docket No. 94N-0247]
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 March 9, 1995 (60 FR 
13014). That document proposed to amend the final monograph for over-
the-counter (OTC) bronchodilator drug products to remove pressurized 
metered-dose aerosol container dosage forms for the ingredients 
epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. 
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. 95-5825, appearing on page 13014 
in the Federal Register of March 8, 1995, the following corrections are 
made:


Sec. 310.545  [Corrected]

    1. On page 13020, 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)(C), the words ``April 
10, 1995'' are corrected to read ``(date 30 days after date of 
publication of the final rule)''; and in paragraph (d)(26), the words 
``April 10, 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. 95-20564 Filed 8-17-95; 8:45 am]
BILLING CODE 4160-01-F