HHS - 21 CFR PART 344
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
active, Most Current
| Organization: | HHS |
| Publication Date: | 1 April 2014 |
| Status: | active |
| Page Count: | 3 |
scope:
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions in this part in addition to each of the general conditions established in § 330.1.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21 unless otherwise noted.
Document History
April 1, 2023
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
April 1, 2021
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
April 1, 2020
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
April 1, 2019
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THECOUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
April 1, 2018
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
April 1, 2017
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
April 1, 2016
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
April 1, 2015
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...
21 CFR PART 344
April 1, 2014
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter topical otic drug product in a form suitable for topical administration is generally recognized as safe and effective and is not misbranded if it meets each of the conditions...