---
kind: "section"
citation: "16 C.F.R. § 1702.16"
title: "16"
number: "1702.16"
heading: "Petitions requesting an exemption for a drug or a new drug."
url: "https://uscodex.org/cfr/16/1702.16"
---

# §1702.16. Petitions requesting an exemption for a drug or a new drug.

- (a) Where the petition requests an exemption for a drug, as defined in [section 201(g)(1)](/cfr/16/201.md?p=g-1) of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 321(g)(1)](/usc/21/321.md?p=g-1), the petitioner shall include those reports required to be filed under the Food and Drug Administration's Adverse Reaction Reporting Program.
- (b) [Reserved]

## Notes

### Amendments

[45 FR 13064, Feb. 28, 1980, as amended at 66 FR 40115, Aug. 2, 2001]

### Authority

Authority: 15 U.S.C. 1471(4), 1472, 1474, 1269(a), 2079(a); 21 U.S.C. 371(a).

### Source

Source: 45 FR 13064, Feb. 28, 1980, unless otherwise noted.

### Amendments

[45 FR 13064, Feb. 28, 1980, as amended at 66 FR 40115, Aug. 2, 2001]