§1315.30. Procurement and import quotas.
21 C.F.R. § 1315.30
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.
A procurement quota authorizes a registered manufacturer to procure and use quantities of each chemical for the following purposes:
Manufacturing the bulk chemical into dosage forms.
Manufacturing the bulk chemical into other substances.
Repackaging or relabeling the chemical or dosage forms.
An import quota authorizes a registered importer to import quantities of the chemical for the following purposes:
Distribution of the chemical to a registered manufacturer that has a procurement quota for the chemical.
Other distribution of the chemical consistent with the legitimate medical and scientific needs of the United States.
Notes, amendments, and revision history
Authority
Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.
Source
Source: 72 FR 37448, July 10, 2007, unless otherwise noted.