21 CFR § 1315.06 - Assessment of Annual Needs; Types of quotas.

---
identifier: "/us/cfr/t21/s1315.06"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 1315.06 - Assessment of Annual Needs; Types of quotas."
title_number: 21
title_name: "Food and Drugs"
section_number: "1315.06"
section_name: "Assessment of Annual Needs; Types of 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"
---


# 1315.06 Assessment of Annual Needs; Types of quotas.

The four types of quotas are:

(a) Assessment of annual needs, which establishes the total quantity of ephedrine, pseudoephedrine, and phenylpropanolamine necessary to be manufactured and imported by all manufacturers and importers in a calendar year.

(b) Individual manufacturing quotas, which establish the maximum quantity of ephedrine, pseudoephedrine, and phenylpropanolamine that a registered manufacturer may manufacture during a calendar year. This type of quota is only issued to DEA-registered bulk manufacturers.

(c) Procurement quotas, which establish the maximum quantity of ephedrine, pseudoephedrine, and phenylpropanolamine that a registered manufacturer may procure during a calendar year for the purpose of manufacturing into dosage-forms or other substances.

(d) Import quotas, which establish the maximum quantity of ephedrine, pseudoephedrine, and phenylpropanolamine that a registered importer may import during the calendar year for distribution to their DEA-registered customers.

[88 FR 60142, Aug. 31, 2023]