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How 340B Is Governed

 

The 340B Drug Discount program is governed in at least three different ways:

1. The Legislation passed by the United States Congress that dictates the legal requirements of the program.

2. The United States Code of Federal Regulations, which contains the official statements of HRSA, the regulatory agency overseeing the program.

3. The statements of the Prime Vendor Program administrator, which has unofficial yet influential guidance on how the legislation and regulation is to be construed.