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HHS - 21 CFR PART 349

OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE

active, Most Current
Organization: HHS
Publication Date: 1 April 2016
Status: active
Page Count: 6
scope:

(a) An over-the-counter ophthalmic 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 and each of the general conditions established in ยง 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
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
April 1, 2021
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
April 1, 2020
OPHTHALMIC DRUG PRODUCTS FOR OVER-THECOUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
April 1, 2019
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
April 1, 2018
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
April 1, 2017
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
a) An over-the-counter ophthalmic 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...
21 CFR PART 349
April 1, 2016
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
April 1, 2015
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
April 1, 2014
OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter ophthalmic 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...
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