Imported hormonal and spermicidal contraceptive preparations must be covered by an FDA-approved NDA or ANDA, and the foreign manufacturing facility must be registered with FDA and subject to inspection. Shipments are subject to FDA examination at the port of entry; products that are unapproved, misbranded, or adulterated are subject to refusal of admission. Importers should maintain documentation linking each shipment to the applicable approval and facility registration. Admissibility classification is complex — consult a licensed customs broker and confirm FDA compliance status before importation.

Heading 300660 covers finished contraceptive preparations — formulated products ready for end use — rather than the bulk hormone active pharmaceutical ingredients (APIs), which are classified elsewhere (typically under heading 2937). The distinction turns on whether the product is a formulated dosage form or a bulk chemical intermediate, and misclassification between these headings is a common audit finding for pharmaceutical importers.