HHS - 21 CFR PART 346
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
active, Most Current
| Organization: | HHS |
| Publication Date: | 1 April 2020 |
| Status: | active |
| Page Count: | 6 |
scope:
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if it meets each condition in this part and each general condition established in § 330.1 of this chapter.
(b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 212 unless otherwise noted.
Document History
April 1, 2023
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
April 1, 2021
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
21 CFR PART 346
April 1, 2020
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
April 1, 2019
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
April 1, 2018
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
April 1, 2017
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
April 1, 2016
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
April 1, 2015
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...
April 1, 2014
ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
(a) An over-the-counter anorectal drug product in a form suitable for external (topical) or intrarectal (rectal) administration is generally recognized as safe and effective and is not misbranded if...