Manufacturers who participate in Medicaid are required under the 340B statute to enter into an agreement with the Secretary under which the manufacturer must agree to charge a price that will not exceed the amount determined under statute (ceiling price) when selling covered outpatient drugs to 340B covered entities. This agreement, known as the Pharmaceutical Pricing Agreement (PPA), must be signed by a manufacturer as a condition for participating in Medicaid. Signing the PPA does not prohibit a manufacturer from charging a price for a covered outpatient drug that is lower than the 340B ceiling price. A manufacturer may not condition the offer of 340B discounts upon a covered entity's assurance of compliance with section 340B Program requirements.
Covered Entity Termination Effective 1/1/2014 (PDF - 139 KB)
Covered Entity Termination Effective 10/1/013 (PDF - 177 KB)
Covered Entity Terminations Effective 7/1/2013 (PDF - 105 KB)
Covered Entity Terminations Effective 4/1/2013 (PDF - 206 KB)
Pharmaceutical Pricing Agreement (PDF - 67 KB)
Manufacturer Change Form (PDF - 30 KB) to update information with the 340B program
340B Database Guide for Manufacturers (PDF - 927 KB)
Sign-up to receive HRSA e-mail updates for manufacturers.