21 CFR 207.55 - What additional drug listing information may FDA require?

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart D [§ 207.41 - § 207.57]

§ 207.55 - What additional drug listing information may FDA require?

For a particular listed drug, upon our request, the registrant must briefly state the basis for its belief that the drug is not subject to section 505 or 512 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.

authority: 21 U.S.C. 321,331,351,352,355,360,360b,371,374,381,393; 42 U.S.C. 262,264,271

source: 81 FR 60212, Aug. 31, 2016, unless otherwise noted.

cite as: 21 CFR 207.55