Standard: HHS - 21 CFR PART 344
TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
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(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.
|Organization:||Food and Drug Administration (Medical Products Quality Assurance)|
|Document Number:||21 cfr part 344|
|Change Type:||COMPLETE REVISION|
|Most Recent Revision:||YES|
|Document #||Change Type||Update Date||Revision||Status|
|21 CFR PART 344||Change Type: COMPLETE REVISION||Update Date: 2017-04-01||Status: ACTV|
|21 CFR PART 344||Change Type: COMPLETE REVISION||Update Date: 2014-04-01||Status: ACTV|
|21 CFR PART 344||Change Type: COMPLETE REVISION||Update Date: 2015-04-01||Status: ACTV|