part_subject: "IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE"
subpart_code: "D"
subpart_subject: "Procurement and Import Quotas"
section_number: "1315.30"
section_subject: "Procurement and import quotas."
cfr_reference: "21 CFR 1315.30"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Part 1300 to End"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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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.