Manufacturers

Manufacturers have access to the new integrated 340B Office of Pharmacy Affairs Information System.  HRSA OPA is proud to announce the launch of 340B OPAIS fully electronic Pharmaceutical Pricing Agreement (PPA) and PPA Addendum registration process, as well as other enhanced features. New information will be broadcasted about 340B OPAIS through electronic communications and via this news box for future announcements regarding 340B OPAIS.

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), and the subsequent PPA Addendum, 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.

Manufacturer Resources

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340B OPAIS Online Help for Public Users

Pharmaceutical Pricing Agreement (PDF - 634 KB)

Pharmaceutical Pricing Agreement Addendum (PDF - 498 KB)

Date Last Reviewed:  July 2018