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Code · CFR · Title 21 — Food and Drugs · Part 1315 — Importation and Production Quotas for Ephedrine, Pseudoephedrine, and Phenylpropanolamine · § 1315.30

§ 1315.30. Procurement and import quotas.

126 words·~1 min read·/us/cfr/t21/s§ 1315.30·

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(a)To determine the estimated needs for, and to insure an adequate and uninterrupted supply of, ephedrine, pseudoephedrine, and phenylpropanolamine the Administrator shall issue procurement and import quotas.
(b)A procurement quota authorizes a registered manufacturer to procure and use quantities of each chemical for the following purposes:
(1)Manufacturing the bulk chemical into dosage forms.
(2)Manufacturing the bulk chemical into other substances.
(3)Repackaging or relabeling the chemical or dosage forms.
(c)An import quota authorizes a registered importer to import quantities of the chemical for the following purposes:
(1)Distribution of the chemical to a registered manufacturer that has a procurement quota for the chemical.
(2)Other distribution of the chemical consistent with the legitimate medical and scientific needs of the United States.
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§ 1315.30
Procurement and import quotas.
Fed. Reg.×1
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