PILOT AND SMALL SCALE MANUFACTURE.

SEC. 124. PILOT AND SMALL SCALE MANUFACTURE. (a) Human Drugs.—Section 505(c) (21 U.S.C. 355(c)) is amended by adding at the end the following: 111 STAT. 2325 “(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.”. (b) Animal Drugs.—Section 512(c) (21 U.S.C. 360b(c)) is amended by adding at the end the following: “(4) A drug manufactured in a pilot or other small facility may be used to demonstrate the safety and effectiveness of the drug and to obtain approval for the drug prior to manufacture of the drug in a larger facility, unless the Secretary makes a determination that a full scale production facility is necessary to ensure the safety or effectiveness of the drug.”.