FDA may place a shipment on import alert or detain it at the port of entry if required documentation — including certificates of analysis and evidence of cGMP compliance — is absent or inadequate. Importers should ensure each lot is accompanied by full quality documentation from an FDA-registered foreign establishment to avoid automatic detention.

Both lines cover penicillin derivatives not specifically named elsewhere in the heading, but they represent distinct tariff breakouts within the US schedule. Importers should review the specific chemical identity of their compound against the tariff schedule's language and, if uncertain, seek a CBP binding ruling to confirm which line applies — misclassification between these two lines can affect duty liability and statistical reporting.