§ 112.9 - Biological products imported for research and evaluation.

§ 112.9 Biological products imported for research and evaluation.

A biological product imported for research and evaluation under a permit issued in accordance with § 104.4, with the exception of products imported under § 104.4(d), shall be labeled as provided in this section.

(a) The label shall identify the product and the name and address of the manufacturer and shall provide instructions for proper use of the product, including all warnings and cautions needed by the permittee to safely use the product.

(b) Labels on each product to be further distributed in accordance with § 103.3 shall bear the statement “Notice! For Experimental Use Only - Not for Sale!”

(c) The labeling shall contain any other information deemed necessary by the Administrator and specified on the permit.

[50 FR 46417, Nov. 8, 1985, as amended at 56 FR 66784, Dec. 26, 1991]