definiens: means any domestic law governing the quality, identify, strength, purity, safety, efficacy, research development, rec ordkeeping, testing, manufacturing, processing, pac kaging, labeling, commercialization, promotion, sale, stora ge, transportation, importation, exportation, marke ting or distribution of pharmaceutical drugs, including the ( 1 ) FDCA ; ( 2 ) United States Federal Medicare and M edicaid statutes and related state or local statutes ; ( 3 ) h ealthcare fraud laws ( including the federal Anti - Ki ckback Statute ( 42 U.S.C. § 1320a-7b(b ) ), Stark Law ( 42 U.S.C. § 139 5nn ) and False Claims Act ( 31 U.S.C. § 3729 ) ; ( 4 ) He alth Insurance Portability and Accountability Act of 199 6 ( 42 U.S.C. § 1320d et . seq . ), as amended by the He alth Information Technology for Economic and Clinical He alth Act ; ( 5 ) the Patient Protection and Affordable Care Act, as amended ) ; ( 6 ) the PhRMA Code on Interaction s with Healthcare Professionals ( 7 ) all guidelines and program guidance issued by the Office of Inspector General for the U.S. Department of Health and Human Services ; ( 8) the Physician Payments Sunshine Act ; ( 9 ) civil monetary penalties laws ( 42 U.S.C. § 1320a -7a ) ; ( 10 ) Public Health Service Act ( 42 U.S.C. § 256b ) ; a nd ( 11 ) all rules, guidelines and regulations under such laws, all as now or hereafter may be in effect