Pub. L. 100-670, tit. I, sec. 106
DRUGS PRIMARILY MANUFACTURED USING BIOTECHNOLOGY.
SEC. 106. DRUGS PRIMARILY MANUFACTURED USING BIOTECHNOLOGY. Notwithstanding section 512(b)(2) of the Federal Food, Drug, and Cosmetic Act, the Secretary of Health and Human Services may not approve an abbreviated application submitted under such section for a new animal drug which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site specific genetic manipulation techniques.