---
kind: "section"
citation: "21 C.F.R. § 556.1"
title: "21"
number: "556.1"
heading: "Scope."
url: "https://uscodex.org/cfr/21/556.1"
---

# §556.1. Scope.

- (a) The Federal Food, Drug, and Cosmetic Act requires an applicant seeking approval or conditional approval of a new animal drug to submit a proposed tolerance as part of its new animal drug application when such a tolerance is needed to assure that the proposed use of the new animal drug will be safe (see sections [512(b)(1)(H)](/cfr/21/512.md?p=b-1-H) and [571(a)(2)(A)](/cfr/21/571.md?p=a-2-A) of the Federal Food, Drug, and Cosmetic Act). FDA assigns tolerances for animal drugs used in food-producing animals as part of the application approval process. Tolerances for approved and conditionally approved new animal drugs are codified in [subpart B](/cfr/21/subpartB.md) of this part.
- (b) Compounds that have been found to be carcinogenic are regulated under [subpart E of part 500](/cfr/21/part500-subpartE.md) of this chapter.

## Notes

### Authority

Authority: 21 U.S.C. 342, 360b, 371.

### Source

Source: 84 FR 32993, July 11, 2019, unless otherwise noted.