definiens: means the FDA Act, the Controlled Substances Act ( 21 U.S.C. § 801 et seq . ), Medicare ( Title XVIII ofthe Social Security Act ) and Medicaid ( Title XIX of the Social Security Act ), the federal Anti - kickback Statute ( 42 U.S.C. § 1320a-7b(b ) ), the Stark Anti - Self - Referral Law ( 42 U.S.C. § § 1395nn ), the Anti - Inducement Law ( 42 U.S.C. § 1320a-7a(a)(5)),the civil False Claims Act ( 31 U.S.C. § § 3729 et seq . ), the administrative False Claims Law ( 42 U.S.C. § 1320a-7b(a ) ), theHealth Insurance Portability and Accountability Act of 1996 ( 42 U.S.C. § 1320d et seq . ), the exclusion laws ( 42 U.S.C. 1320a-7 ), all regulations or guidance promulgated pursuant to such Laws, and any other Law which regulates the design, development, testing, studying, manufacturing, processing, storing, importing or exporting, licensing, labeling or packaging, distributing or marketing of pharmaceutical products, or related to kickbacks, patient or program charges, recordkeeping, claims process, documentation requirements, medical necessity, referrals, the hiring of employees or acquisition of services orsupplies from those who have been excluded from government health care programs, quality, safety, privacy, security, pharmacy practice and compounding, licensure, accreditation or any other aspect of providing health care or pharmacyservices