View Rule
| Printer-Friendly Version Download RIN Data in XML |
| HHS/FDA | RIN: 0910-AA01 | Publication ID: Spring 2003 |
| Title: Over-the-Counter (OTC) Drug Review | |
| 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. SMALL ENTITIES AFFECTED: The effects, if any, vary depending on the individual rulemaking. However, the Agency anticipates that the rules would not have a significant economic impact on a substantial number of small entities as defined by the Regulatory Flexibility Act. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
| RIN Status: Previously published in the Unified Agenda | Agenda Stage of Rulemaking: Prerule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 201; 21 CFR 310; 21 CFR 330 to 350 | |
| Legal Authority: 21 USC 321p; 21 USC 351 to 353; 21 USC 355; 21 USC 360a; 21 USC 371a; 21 USC 331; 21 USC 360; 21 USC 360b; 21 USC 361; 21 USC 371 | |
|
Legal Deadline:
None |
||||||||||||||||||||||||||||||||||||||||||||||||
Timetable:
|
||||||||||||||||||||||||||||||||||||||||||||||||
Child RIN List:
|
| Regulatory Flexibility Analysis Required: Yes | Government Levels Affected: None |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
|
Agency Contact: Gerald M. Rachanow Regulatory Counsel, Division of Over-the-Counter Drug Products Department of Health and Human Services Food and Drug Administration HFD-560, Center for Drug Evaluation and Research (HFD-560), 5600 Fishers Lane, Rockville, MD 20857 Phone:301 827-2241 Fax:301 827-2315 Email: gerald.rachanow@fda.hhs.gov |
|
