Bulk Ephedrine-Containing Medicaments (Not in Measured Doses)

Ephedrine is a List I chemical under the Controlled Substances Act because it is a direct precursor to methamphetamine. Beyond standard FDA drug admissibility requirements, importers must be registered with the DEA, obtain import permits for each shipment, and comply with DEA advance notification and recordkeeping rules. These obligations apply regardless of whether the ephedrine is the sole active ingredient or part of a combination formulation.

The HTS packaging condition (bulk vs. measured-dose) determines the correct tariff heading but does not alter DEA obligations — both bulk and dosage-form ephedrine imports require DEA registration and permitting. However, the distinction matters for FDA classification of the product as a bulk drug substance versus a finished drug product, which affects the applicable cGMP standard and the type of FDA review at entry.