Code of Federal Regulations (Last Updated: November 8, 2024) |
Title 42 - Public Health |
Chapter I - Public Health Service, Department of Health and Human Services |
SubChapter A - General Provisions |
Part 10 - 340B Drug Pricing Program |
Subpart A - General Provisions |
§ 10.2 - Summary of 340B Drug Pricing Program.
Latest version.
-
§ 10.2 Summary of 340B Drug Pricing Program.
Section 340B of the PHSA instructs the Secretary of Health and Human Services to enter into agreements with manufacturers of covered outpatient drugs under which the amount required to be paid to these manufacturers by certain statutorily-defined covered entities does not exceed the average manufacturer price for the drug under title XIX of the Social Security Act (SSA) reduced by a rebate percentage which is calculated as indicated in 340B(a)(1) and 340B(a)(2)(A). Manufacturers participating in the 340B Drug Pricing Program (340B Program) are required to provide these discounts on all covered outpatient drugs sold to participating 340B covered entities. 340B ceiling price.