The 340B Program enables covered entities to stretch scarce federal resources as far as possible, reaching more eligible patients and providing more comprehensive services. Manufacturers participating in Medicaid agree to provide outpatient drugs to covered entities at significantly reduced prices.

A person receiving 340B drugs must be a patient of the covered entity. However, unique circumstances may be considered to decide if an individual fits the definition of patient (PDF - 31 KB), and if they qualify to receive 340B drugs. A shortened health record may be enough for purposes of the 340B Drug Pricing Program.

Our website provides resources to help 340B Program stakeholders with navigating the 340B Program, including registration and implementation, requirements compliance, program integrity, and more: Educational webinars; FAQs; Monthly program updates; Audit results; Manufacturer notices; Listen to our 340B Welcome Webinar for an introduction to ...

The 340B registration and pricing databases are known as the 340B Office of Pharmacy Affairs Information System (340B OPAIS). Authorized users of 340B OPAIS must have a user account with appropriate roles and permissions granted by HRSA.

Keep 340B Office of Pharmacy Affairs Information System (OPAIS) records accurate and up to date. Register all outpatient facilities and contract pharmacies. Re-certify eligibility every year. Prevent diversion to ineligible patients (PDF - 31 KB). Covered entities must not resell or transfer 340B drugs to ineligible patients. Prevent duplicate ...

Under section 340B(a) of the Public Health Service Act (PHSA), the 340B ceiling price is calculated by subtracting the unit rebate amount (URA) from the average manufacturer price (AMP) for the smallest unit of measure of each covered outpatient drug (as identified by the product's 11-digit National Drug Code (NDC).

HRSA’s 340B Program audits review covered entity compliance with several statutory provisions, including eligibility status, duplicate discounts, and diversion in accordance with sections 340B(a)(4), (5)(A) and (B) of the PHSA.

340B Drug Pricing Program Database. Home; Search. Search Covered Entities; Search Contract Pharmacies; Search Manufacturers; Reports; Help; Login; Welcome to 340B OPAIS. What would you like to do? Office of Pharmacy Affairs Main Menu. Search Reports I am a Participant. Have questions? Contact the 340B Prime Vendor

A 340B covered entity may sign a written contract with one or more pharmacies to provide pharmacy services and 340B drugs to authorized patients. A covered entity should decide if it needs pharmacy services and the appropriate distribution mechanism for those services, when choosing to use contract pharmacy services.

The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices. allows nonprofit healthcare organizations to receive outpatient drugs at significantly reduced prices.