Corticosteroid Hormone Medicaments in Dosage Form

The US schedule assigns dexamethasone and methylprednisolone their own 10-digit lines because of their commercial volume and regulatory monitoring interest. A product containing dexamethasone as its active corticosteroid should be classified under 3004320010 rather than the residual line. Products containing other corticosteroids (e.g., prednisone, hydrocortisone, betamethasone) that are not specifically named fall under 3004320060. Importers should confirm the active ingredient identity on the certificate of analysis.

Yes. Injectable corticosteroid products, particularly those manufactured at facilities with prior FDA warning letters or import alerts, are subject to enhanced examination. FDA has historically placed sterile injectable manufacturers on import alert for cGMP deficiencies. Importers should review the FDA import alert database for their specific foreign manufacturer before committing to a supply arrangement.