> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Comments Sought on OTC Drugs Under GRASE
- URL: https://www.fdaweb.com/comments-sought-on-otc-drugs-under-grase/
- Published: 2017-08-23T12:00:00.000Z
- Updated: 2026-09-14T22:42:54.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139452

*Federal Register* notice: FDA is seeking comment on an information collection entitled “Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded — 21 CFR 330.14.” FDA regulations at 21 CFR 330.14 establish additional criteria and procedures for classifying over-the-counter (OTC) drugs as generally recognized as safe and effective and not misbranded. The regulations state that OTC drug products introduced into the U.S. market after the OTC drug review began and OTC drug products without any marketing experience in the United States can be evaluated under the monograph process if the conditions (e.g., active ingredients) meet certain “time and extent” criteria outlined in the regulations. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-08-23/pdf/2017-17842.pdf?ref=fdaweb.com).