Amino-Acids and Esters with One Oxygen Function (NESOI)

When aromatic amino acids are imported for pharmaceutical use, FDA may require the foreign manufacturer to be registered as a drug establishment and the facility to be listed in FDA's drug registration database. Drug master files (DMFs) may also be relevant if the material is an API or API intermediate. Importers should work with an FDA regulatory consultant in addition to a customs broker.

Aromatic amino acids and esters of Chinese origin are more likely to fall within Section 301 tariff lists than their non-aromatic counterparts, which are often captured in separate basket lines (e.g., 2922494950 or 2922498050). Confirming the compound's aromatic or non-aromatic character — based on its molecular structure — is therefore a critical first step in assessing total landed cost for Chinese-origin shipments.