---
kind: "section"
citation: "21 C.F.R. § 207.55"
title: "21"
number: "207.55"
heading: "What additional drug listing information may FDA require?"
url: "https://uscodex.org/cfr/21/207.55"
---

# §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](/cfr/21/505.md) or [512](/cfr/21/512.md) of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act.


## Notes

### Authority

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

### Source

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