StacksVerified U.S. regulatory reference

21 CFR §1315.05

Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
This part applies to all of the following:
  1. (a)Persons registered to manufacture (including repackaging or relabeling) or to import ephedrine, pseudoephedrine, or phenylpropanolamine as bulk chemicals.
  2. (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.