The “safe harbor” regulations describe various payment and business practices that, although they potentially implicate the Federal anti-kickback statute, are not treated as offenses under the statute.
The safe harbor regulations, in their entirety, can be found here.
Links to Federal Register notices containing preambles to the safe harbor regulations appear below.
Fact Sheet – Fact Sheet-Final Rule (hhs.gov)
Final Rule: Removal of Safe Harbor Protection for Rebates Involving Prescription Pharmaceuticals and Creation of New Safe Harbor Protection for Certain Point-of-Sale Reductions in Price on Prescription Pharmaceuticals and Certain Pharmacy Benefit Manager Service Fees
only in America … sigh