21 C.F.R. Section 101.54 law "CFR - Code of Federal Regulations Title 21" "CFR - Code of Federal Regulations Title 21" "CFR - Code of Federal Regulations Title 21" "CFR - Code of Federal Regulations Title 21" "CFR - Code of Federal Regulations Title 21" "CFR - Code of Federal Regulations Title 21" "CFR - Code of Federal Regulations Title 21" laws "CFR - Code of Federal Regulations Title 21" regulated definitions by the FDA