1. 21 U.S.C. §§ 823, 827-29 (West 2012)
2. 21 C.F.R. § 1305 et seq. (2013)
3. 21 U.S.C. §§ 823, 827-29 (West 2012); 21 C.F.R. § 1306.04
4. (a) (2013); 21 C.F.R. § 1305 et seq. (2013); 42 C.F.R. § 8.12 (2013).
5. 42 C.F.R §482.12 (2011); 42 C.F.R §482.21 (2011); 42 C.F.R §482.22 (2011).