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Federally Qualified Health Center (FQHC)

This checklist outlines compliance and operational considerations for new  340B-registered health centers and is a resource for existing health centers to review their program setups periodically. 

GETTING STARTED – Part I (Goal: complete within 3 weeks of registration start date) 

    • Confirm that your entity’s information is correct on the HRSA Office of Pharmacy Affairs Information System (OPAIS). 

    • Establish your entity-specific policy and procedure manual. See Community Health Center Sample 340B Policy and Procedure Manual.  

    • Contact your wholesaler to ensure that your 340B account is correctly set up to receive best pricing [Public Health  Service (PHS)/340B pricing and 340B Prime Vendor Program (PVP) contracts] after becoming active on OPAIS. 

    • Check with your internal legal department to ensure that all necessary contracts are reviewed and executed prior to starting any operations. 

    • Watch 340B University OnDemand for Health CentersTM. Register at Covered Entities; select FQHC; New User. 

    • Identify which drug inventory model works best for your entity – physical versus virtual versus physician/clinic administered medications. Module: 340B Drug Delivery Models 

    • Identify all areas where you use 340B drugs. See 340B Universe Mapping Template. 

GETTING STARTED – Part II (Goal: complete during the next 3–6 weeks) 

    • Identify and inform the individuals in your entity who need to be directly involved in your 340B program (e.g.,  compliance, purchasing, billing). See 340B FTE and Coordinator Job Description Template. 

    • Forward your purchasing individual’s contact information to 340B PVP Membership Services so we can keep that person up to date with the 340B PVP Contract Updates newsletter. 

    • Access your PVP pricing catalog through the secure PVP website portal. If you need assistance, please call  Apexus Answers. Watch navigation videos. and  

    • Review and consider enrollment in the 340B PVP vaccine program (must be signed into the PVP secure portal). 

NEXT STEPS (6 weeks–9 months) 

    • Create a material breach policy for your entity. See Establishing Material Breach Threshold Tool. 

    • Communicate your use of 340B savings to internal leadership using the Calculating 340B Net Financial Impact and Use of Savings Template. 

    • Review the 340B Prime Vendor education tools for additional resources. – Attend 340B University; see important dates. 

    • Develop internal and external audit plans. 


    • Recertify: HRSA requires you to recertify your entity annually. (View the HRSA recertification webinar and contact  a 340B specialist at Apexus Answers for additional assistance) 

    • Review annually: 340B compliance committee reviews policies and procedures for applicability and appropriateness

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