Ortho-acetylsalicylic acid — universally recognized as aspirin — along with its salts and esters, is classified as an organic chemical intermediate at 2918220000, covering both pharmaceutical-grade active ingredient and industrial-grade material. When imported as a drug substance or pharmaceutical ingredient, FDA oversight applies, including registration of foreign drug establishments and compliance with current Good Manufacturing Practice (cGMP) standards. Importers sourcing aspirin API should be prepared for FDA examination and may need to reference Drug Master Files, while bulk chemical importers should verify whether the material meets the purity specifications required for their intended application.

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