Cephalosporins, which share the beta-lactam ring structure but differ from penicillins, are generally classified under the residual subheading 294190 rather than under 294110 (penicillins), because 294110 is limited to compounds with a penicillanic acid structure. Confirm the specific compound's structure against the subheading text, and consider requesting a CBP binding ruling for novel cephalosporin derivatives.

FDA requires that the foreign manufacturing facility be registered in FDA's drug establishment registration system and that the antibiotic API be covered by an applicable Drug Master File or new drug application. Shipments may be subject to FDA examination at the port of entry, and products from facilities on import alert will be detained. Working with a licensed customs broker and an FDA regulatory consultant is advisable for first-time importers.