You are correct.I been reading the FDA guide lines. http://www.ecfr.gov/cgi-bin/text-idx?SID=b1a72296f5d75600330da92a762a0ac5&node=se21.5.312_121&rgn=div8 http://www.ecfr.gov/cgi-bin/text-idx?c=ecfr&SID=51cf70689d51f0ea4147c0a8ac649321&rgn=div5&view=text&node=21:5.0.1.1.6&idno=21