---
kind: "section"
citation: "21 C.F.R. § 1315.02"
title: "21"
number: "1315.02"
heading: "Definitions."
url: "https://uscodex.org/cfr/21/1315.02"
---

# §1315.02. Definitions.

- (a) Except as specified in paragraphs [(b)](#b) and [(c)](#c) of this section, any term contained in this part shall have the definition set forth in section 102 of the Act ([21 U.S.C. 802](/usc/21/802.md)) or [part 1300](/cfr/21/part1300.md) of this chapter.
- (b) The term net disposal means, for a stated period, the sum of [paragraphs (b)(1) through (b)(3)](#b-1..b-3) of this section minus the sum of paragraphs [(b)(4)](#b-4) and [(b)(5)](#b-5) of this section:
  - (1) The quantity of ephedrine, pseudoephedrine, or phenylpropanolamine distributed by the registrant to another person.
  - (2) The quantity of that chemical used by the registrant in the production of (or converted by the registrant into) another chemical or product.
  - (3) **The quantity of that chemical otherwise disposed of by the registrant.**
  - (4) **The quantity of that chemical returned to the registrant by any purchaser.**
  - (5) The quantity of that chemical distributed by the registrant to a registered manufacturer of that chemical for purposes other than use in the production of, or conversion into, another chemical or in the manufacture of dosage forms of that chemical.
- (c) Ephedrine, pseudoephedrine, and phenylpropanolamine include their salts, optical isomers, and salts of optical isomers.

## Notes

### Authority

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

### Source

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