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.
21 CFR Part 314 · Applications for FDA Approval to Market a New Drug
§ 314.170 Adulteration and misbranding of an approved drug
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
Amendment history
Federal Register documents that created or amended this section.
- 50 FR 7493 22 Feb 1985
- 57 FR 17983 28 Apr 1992
- 64 FR 402 5 Jan 1999