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Code · CFR · Title 21 — Food and Drugs · Part 1315 — Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine · § 1315.06

§ 1315.06. Assessment of Annual Needs; Types of quotas.

139 words·~1 min read·/us/cfr/t21/s§ 1315.06·

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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]
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§ 1315.06
Assessment of Annual Needs; Types of quotas.
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