§1315.06. Assessment of Annual Needs; Types of quotas.
21 C.F.R. § 1315.06
The four types of quotas are:
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.
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.
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.
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, and revision history
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]