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HHS/FDA

RIN: 0910-AF38

Publication ID: Spring 2019

Title: Over-the-Counter (OTC) Drug Review--Laxative Drug Products
Abstract: The OTC drug review establishes conditions under which OTC drugs are considered generally recognized as safe and effective, and not misbranded. After a final monograph (i.e., final rule) is issued, only OTC drugs meeting the conditions of the monograph, or having an approved new drug application, may be legally marketed. The final rule listed will address the professional labeling for sodium phosphate drug products.
Agency: Department of Health and Human Services(HHS)	Priority: Substantive, Nonsignificant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
Major: No	Unfunded Mandates: No
EO 13771 Designation: Regulatory
CFR Citation: 21 CFR 201 21 CFR 310 21 CFR 330 to 358
Legal Authority: 21 U.S.C. 321 21 U.S.C. 331 21 U.S.C. 351 to 353 21 U.S.C. 355 21 U.S.C. 371

Legal Deadline: None

Timetable:

Action	Date	FR Cite
Final Action (Granular Psyllium)	03/29/2007	72 FR 14669
Final Action Effective (Granular Psyllium)	10/01/2007
NPRM (Professional Labeling--Sodium Phosphate)	02/11/2011	76 FR 7743
NPRM Comment Period End	03/14/2011
Final Rule	To Be Determined

Regulatory Flexibility Analysis Required: Yes	Government Levels Affected: Local, State
Small Entities Affected: Businesses	Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: Yes
Related RINs: Split from 0910-AA01
Agency Contact: Janice Adams-King Regulatory Health Project Manager Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research, WO 22, Room 5416, 10903 New Hampshire Avenue, Silver Spring, MD 20993 Phone:301 796-3713 Fax:301 796-9899 Email: janice.adams-king@fda.hhs.gov