21 CFR 1315.05
§ 1315.05 Applicability.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 1315.05, § 1315.05 Applicability, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/92196
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Full text
This part applies to all of the following:
(a) Persons registered to manufacture (including repackaging or relabeling) or to import ephedrine, pseudoephedrine, or phenylpropanolamine as bulk chemicals.
(b) Persons registered to manufacture (including repackaging or relabeling) or to import prescription and over-the-counter drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine that may be lawfully marketed and distributed in the United States under the Federal Food, Drug, and Cosmetic Act.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.