part_subject: "APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG"
subpart_code: "D"
subpart_subject: "FDA Action on Applications and Abbreviated Applications"
section_number: "314.170"
section_subject: "Adulteration and misbranding of an approved drug."
cfr_reference: "21 CFR 314.170"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 300 to 499"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
---
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.