Tariff classification of lanolin anhydrous I.P. turned on pharmacopoeial status, medicinal use, and bulk drug exemption criteria.

Lanolin anhydrous I.P. was considered for tariff classification under Heading 15.07 and for exemption as a pharmacopoeial bulk drug under the relevant notifications. The record indicated that the product was distinct from degras, was described in the Pharmacopoeia as a pharmaceutical aid, conformed to I.P. standards, and was used in medicinal preparations, which supported examination of exemption criteria tied to pharmacopoeial standards and medicinal use. Because the proper tariff entry had not been satisfactorily determined by a speaking order, the matter was remanded for reconsideration of classification and the consequential exemption claim on the chemical and pharmacopoeial evidence.

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Issues: Whether lanolin anhydrous I.P. was classifiable under Heading 15.07 or could be treated as a pharmacopoeial pharmaceutical product eligible for exemption as a bulk drug under the relevant notifications.

Analysis: The product was found to be distinct from degras and not merely a residue of fatty substances. The Pharmacopoeia described it as a pharmaceutical aid, and the record showed that it conformed to I.P. standards and was used in medicinal preparations. The exemption notifications defined bulk drugs with reference to pharmacopoeial standards and use in diagnosis, treatment, mitigation, prevention of disease, or as an ingredient in formulations. On the material before it, the proper tariff entry had not been satisfactorily determined by a speaking order, and the Assistant Collector was required to reconsider the matter on the basis of the chemical and pharmacopoeial evidence.

Conclusion: The impugned order was set aside and the matter was remanded for fresh consideration of the proper classification and consequential exemption claim.

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