Title 40

SECTION 82.116

82.116 Compliance by manufacturers or importers incorporating products manufactured with controlled substances.

§ 82.116 Compliance by manufacturers or importers incorporating products manufactured with controlled substances.

(a) Compliance by manufacturers or importers incorporating products manufactured with controlled substances, or importing products manufactured with controlled substances. Each manufacturer or importer of a product incorporating another product to which § 82.102 (a)(3) or (b)(2) applies, that is purchased from another manufacturer or supplier, is not required to pass through and incorporate the labeling information that accompanies such incorporated product in a warning statement accompanying the manufacturer's or importer's finished product. Importers of products to which § 82.102 (a)(3) or (b)(2) applies are required to apply a label, or to ensure that a label has been properly applied at the site of U.S. Customs clearance.

(b) Reliance on reasonable belief. The importer of a product purchased or obtained from a foreign manufacturer or supplier, which product may have been manufactured with a controlled substance, may rely on the information that it receives with the purchased product, and is not required to independently investigate whether the requirements of this subpart are applicable to the purchased or obtained product, as long as the importer reasonably believes that there was no use of controlled substances by the final manufacturer of the product being imported.

(c) Contractual obligations. An importer's contractual relationship with its supplier under which the supplier is required to accurately label, consistent with the requirements of this subpart, any products manufactured with a controlled substance that are supplied to the importer, or to certify to the importer whether a product was or was not manufactured with a controlled substance is evidence of reasonable belief.

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