---
kind: "section"
citation: "21 C.F.R. § 1315.05"
title: "21"
number: "1315.05"
heading: "Applicability."
url: "https://uscodex.org/cfr/21/1315.05"
---

# §1315.05. Applicability.


This part applies to all of the following:

- (a) Persons registered to manufacture (including repackaging or relabeling) or to import ephedrine, pseudoephedrine, or phenylpropanolamine as bulk chemicals.
- (b) Persons registered to manufacture (including repackaging or relabeling) or to import prescription and over-the-counter drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine that may be lawfully marketed and distributed in the United States under the Federal Food, Drug, and Cosmetic Act.

## Notes

### Authority

Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.

### Source

Source: 72 FR 37448, July 10, 2007, unless otherwise noted.