U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

All TitlesTitle 21Chapter IPart 112Subpart 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?
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