21 CFR § 314.104 Applications for FDA Approval to Market a New Drug

§ 314.104 Drugs with potential for abuse.

Current through Sep 8, 2026 · Read all of Part 314

⚠ 4 pending changes to Part 314

The Food and Drug Administration will inform the Drug Enforcement Administration under section 201(f) of the Controlled Substances Act (21 U.S.C. 801) when an application or abbreviated application is submitted for a drug that appears to have an abuse potential.

[57 FR 17989, Apr. 28, 1992]

← § 314.103 Dispute resolution.§ 314.105 Approval of an NDA and an ANDA. →