Title 40

SECTION 82.112

82.112 Removal of label bearing warning statement.

§ 82.112 Removal of label bearing warning statement.

(a) Prohibition on removal. Except as described in paragraph (b) or (c) of this section, any warning statement that accompanies a product or container introduced into interstate commerce, as required by this subpart, must remain with the product or container and any product incorporating such product or container, up to and including the point of sale to the ultimate consumer.

(b) Incorporation of warning statement by subsequent manufacturers. A manufacturer of a product that incorporates a product that is accompanied by a label bearing the warning statement may remove such label from the incorporated product if the information on such label is incorporated into a warning statement accompanying the manufacturer's product, or if, pursuant to paragraph (c) of this section, the manufacturer of the product is not required to pass through the information contained on or incorporated in the product's label.

(c) Manufacturers that incorporate products manufactured with controlled substances. A manufacturer that incorporates into its own product a component product that was purchased from another manufacturer, was manufactured with a process that uses a controlled substance(s), but does not contain such substance(s), may remove such label from the incorporated product and need not apply a warning statement to its own product, if the manufacturer does not use a controlled substance in its own manufacturing process. A manufacturer that uses controlled substances in its own manufacturing process, and is otherwise subject to the regulations of this subpart, must label pursuant to § 82.106, but need not include information regrading the incorporated product on the required label.

(d) Manufacturers, distributors, wholesalers, retailers that sell spare parts manufactured with controlled substances solely for repair. Manufacturers, distributors, wholesalers, and retailers that purchase spare parts manufactured with a class I or class II substance from another manufacturer or supplier, and sell such spare parts for the sole purpose of repair, are not required to pass through an applicable warning label if such products are removed from the original packaging provided by the manufacturer from whom the products are purchased. Manufacturers of the spare parts manufactured with controlled substances must still label their products; furthermore, manufacturers, importers, and distributors of such products must pass through the labeling information as long as products remain assembled and packaged in the manner assembled and packaged by the original manufacturer. This exemption shall not apply if a spare part is later used for manufacture and/or for purposes other than repair.

[60 FR 4020, Jan. 19, 1995, as amended at 79 FR 64289, Oct. 28, 2014]

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