---
kind: "section"
citation: "21 C.F.R. § 1315.06"
title: "21"
number: "1315.06"
heading: "Assessment of Annual Needs; Types of quotas."
url: "https://uscodex.org/cfr/21/1315.06"
---

# §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.

## Notes

### Amendments

[88 FR 60142, Aug. 31, 2023]

### Authority

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

### Source

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

### Amendments

[88 FR 60142, Aug. 31, 2023]