U.S. Code of Federal Regulations
Regulations most recently checked for updates: Feb 08, 2023
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 subject to the applicable provisions in this paragraph.
(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: Provided, That, in the case of a biological product exported in labeled final containers, the Administrator may authorize by permit the importation of a limited number for research and evaluation by the producing licensee; and
(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”: Provided, That such products shall not be diverted to domestic use.
(d) Completed inactivated liquid products, antiserums, and antitoxins, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.
(e) Concentrated inactivated liquid product, completed except for dilution to the proper strength for use, may be exported in large multiple-dose containers identified with an approved label that contains the words “For Export Only” prominently displayed.