[Federal Register Volume 62, Number 42 (Tuesday, March 4, 1997)]
[Rules and Regulations]
[Page 9684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-5210]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 341

[Docket No. 94N-0247]
RIN 0910-AA01


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; correction.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is correcting a final 
monograph for over-the-counter (OTC) bronchodilator drug products that 
appeared in the Federal Register of May 20, 1996 (61 FR 25142). The 
document amended the final monograph for OTC bronchodilator drug 
products by removing pressurized metered-dose aerosol container dosage 
forms for the ingredients epinephrine, epinephrine bitartrate, and 
racepinephrine hydrochloride. The document was published with an 
inadvertent error in one of the amendatory instructions. This document 
corrects that error.

EFFECTIVE DATE: March 4, 1997.

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. 96-12499, appearing on page 25142 
in the Federal Register of Monday, May 20, 1996, the following 
correction is made: On page 25146, in the 3d column, amendatory 
instruction 4 is corrected to read as follows:
    4. Section 341.76 is amended by removing the heading for paragraph 
(d)(2), and paragraphs (d)(2)(i) and (e), by redesignating paragraph 
(d)(2)(ii) as paragraph (d)(2), and by revising the heading of newly 
redesignated paragraph (d)(2) to read as follows:

    Dated: February 24, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-5210 Filed 3-3-97; 8:45 am]
BILLING CODE 4160-01-F