Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use; Amendment of Monograph for OTC Bronchodilator Drug Products; Correction
other · Food and Drug Administration · Rule · Published 1997-03-04 · Effective 1997-03-04 · 62 FR 9684
Document
Document number
97-5210
Federal Register citation
62 FR 9684
CFR reference
21 CFR 341
Type
Rule
Action
Final rule; correction.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1997-03-04
Effective date
1997-03-04
HHS docket
Docket No. 94N-0247
Abstract
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.