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 22, 2025
Title 21 - Food and Drugs last revised: May 19, 2025
All Titles
Title 21
Chapter I
Part 316 - PART 316—ORPHAN DRUGS
Subpart A [§ 316.1 - § 316.4] - Subpart A—General Provisions
Subpart B [§ 316.10 - § 316.14] - Subpart B—Written Recommendations for Investigations of Orphan Drugs
Subpart C [§ 316.20 - § 316.30] - Subpart C—Designation of an Orphan Drug
Subpart D [§ 316.31 - § 316.36] - Subpart D—Orphan-drug Exclusive Approval
Subpart E [§ 316.40 - § 316.40] - Subpart E—Open Protocols for Investigations
Subpart F [§ 316.50 - § 316.52] - Subpart F—Availability of Information
authority:
21 U.S.C. 360aa
,
360bb
,
360cc
,
360dd
,
371
source:
57 FR 62085, Dec. 29, 1992, unless otherwise noted.
.list_box li,p,.cm-search-info,.cm-search-detail,.abt span,.expand-collapse_top
Get the CustomsMobile app!