21 CFR § 1315.21 - Individual manufacturing quotas.
---
identifier: "/us/cfr/t21/s1315.21"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1315.21 - Individual manufacturing quotas."
title_number: 21
title_name: "Food and Drugs"
section_number: "1315.21"
section_name: "Individual manufacturing quotas."
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"
---
# 1315.21 Individual manufacturing quotas.
The Administrator shall, on or before December 1 of each year, fix for and issue to each person registered to manufacture in bulk ephedrine, pseudoephedrine, or phenylpropanolamine who applies for a manufacturing quota an individual manufacturing quota authorizing that person to manufacture during the next calendar year a quantity of that chemical. Any manufacturing quota fixed and issued by the Administrator is subject to his authority to reduce or limit it at a later date pursuant to § 1315.26 and to his authority to revoke or suspend it at any time pursuant to §§ 1301.36, 1309.43, 1309.44, or 1309.45 of this chapter.
[72 FR 37448, July 10, 2007, as amended at 88 FR 60143, Aug. 31, 2023]