21 CFR § 1315.05 - Applicability.

---
identifier: "/us/cfr/t21/s1315.05"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1315.05 - Applicability."
title_number: 21
title_name: "Food and Drugs"
section_number: "1315.05"
section_name: "Applicability."
chapter_name: "DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE"
part_number: "1315"
part_name: "IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 802, 821, 826, 871(b), 952."
regulatory_source: "72 FR 37448, July 10, 2007, unless otherwise noted."
cfr_part: "1315"
---


# 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.