§112.5. Review and approval of labeling. — Inbound Citations
9 C.F.R. § 112.5
Statutory Authority
Cited by 3 regulations in release Current.
Citations to 9 U.S.C. § 112.5 as a whole
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(iv) Labels in finished form or sketches prepared as prescribed in § 112.5 of this subchapter, together with information regarding all claims to be made on labels and in advertising matter to be used in connection with or related to the biological product.
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(a) Labels to be used on a licensed biological product prepared by a subsidiary operating in a licensed establishment shall be submitted in accordance with § 112.5. Only labels approved for use on such product shall be used by the subsidiary.
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The applicable regulations for packaging and labeling a biological product produced in the United States shall apply to such biological product if exported from the United States except as otherwise provided in this section. Only labels approved as provided in § 112.5 shall be used.