§1320a–7i Reporting of Information Relating to Drug Samples

Summary

Each year by April 1 (starting in 2012), drug makers and their officially recorded distributors must send the federal government, in the form the government requires, information about drug samples they handled during the prior year. They must report what samples were requested and what samples were actually given out, and how many. The reports must be grouped by the requesting practitioner’s name, address, job title, and signature (or the name of whoever signed for the practitioner), plus any other categories the government asks for. This rule covers samples sent by mail or carrier and samples given by other means. Definitions in one line each: Applicable drug — a drug treated as a sample under federal drug law and for which payment can be made by Medicare, Medicaid (state plans), or CHIP (or a waiver). Authorized distributor of record — the distributor officially listed under the drug law. Manufacturer — the drug maker as defined under the drug law.