21 CFR § 314.170 Applications for FDA Approval to Market a New Drug

§ 314.170 Adulteration and misbranding of an approved drug.

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

⚠ 4 pending changes to Part 314

All drugs, including those the Food and Drug Administration approves under section 505 of the act and this part, are subject to the adulteration and misbranding provisions in sections 501, 502, and 503 of the act. FDA is authorized to regulate approved new drugs by regulations issued through informal rulemaking under sections 501, 502, and 503 of the act.

[50 FR 7493, Feb. 22, 1985. Redesignated at 57 FR 17983, Apr. 28, 1992, and amended at 64 FR 402, Jan. 5, 1999]

← § 314.162 Removal of a drug product from the list.§ 314.200 Notice of opportunity for hearing; notice of participation and request for hearing; grant or denial of hearing. →