21 C.F.R. § 1315.30

Procurement and import quotas.

Last amended: 2016Year: 2026Length: 126 wordsSubsections: 3Official source

Cite as 21 C.F.R. § 1315.30 (2026)

(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.
21 C.F.R. § 1315.30: Procurement and import quotas. | Justis AI