REGULATIONS
Rulings
AD/CVD
Notices
HTSUS
U.S. Code
Regs
More
Ports
About
Updates
Apps
Larger font
Smaller font
SEARCH
Sort by Rank
Titles Ascending
Titles Descending
10 per page
25 Result/page
50 Result/page
Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 112
Subpart P - Subpart P—Variances
§ 112.171 - Who may request a variance from the requirements of this part?
§ 112.172 - How may a State, tribe, or foreign country request a variance from one or more requirements of this part?
§ 112.173 - What must be included in the Statement of Grounds in a petition requesting a variance?
§ 112.174 - What information submitted in a petition requesting a variance or submitted in comments on such a petition are publicly available?
§ 112.175 - Who responds to a petition requesting a variance?
§ 112.176 - What process applies to a petition requesting a variance?
§ 112.177 - Can an approved variance apply to any person other than those identified in the petition requesting that variance?
§ 112.178 - Under what circumstances may FDA deny a petition requesting a variance?
§ 112.179 - When does a variance approved by FDA become effective?
§ 112.180 - Under what circumstances may FDA modify or revoke an approved variance?
§ 112.181 - What procedures apply if FDA determines that an approved variance should be modified or revoked?
§ 112.182 - What are the permissible types of variances that may be granted?
authority:
21 U.S.C. 321
,
331
,
342
,
350h
,
371
;
42 U.S.C. 243
,
264
,
271
source:
80 FR 74547, Nov. 27, 2015, unless otherwise noted.
.list_box li,p,.cm-search-info,.cm-search-detail,.abt span,.expand-collapse_top
Get the CustomsMobile app!