21 CFR 1315.01 – Scope
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This part specifies procedures governing the establishment of an assessment of annual needs, procurement and manufacturing quotas pursuant to section 306 of the Act (21 U.S.C. § 826), and import quotas pursuant to section 1002 of the Act (21 U.S.C. § 952) for ephedrine, pseudoephedrine, and phenylpropanolamine.