For export only.

CFR · 2024-01-01 · US · Title 9

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. (a) Biological products which have been packaged and labeled for export or which have been exported, shall be (1) After leaving the licensed establishment, a biological product shall not be bottled, repackaged, relabeled, or otherwise altered in any way while in the United States; and (2) An exported biological product shall not be returned to the United States: (3) An exported biological product which is bottled, rebottled, or altered in any way in a foreign country shall not bear a label which indicates by establishment license number that it has been prepared in the United States. (b) Desiccated and frozen liquid products, packaged and labeled as for domestic use, may be exported without the diluent required for rehydration or dilution, as the case may be, if the labeling includes adequate instructions for preparing the product for use and the words “For Export Only”. (c) Final containers of products, labeled or unlabeled, may be exported in sealed shipping boxes, adequately identified as to contents with an approved label, and plainly marked “For Export Only”: (d) Completed inactivated liquid products, antiserums, and antitoxins, may be exported in large multiple-dose containers identified wit

official document · source cfr-2024 · id 9:§ 112.8