Contract Pharmacy Services

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. A covered entity should identify all pharmacy locations and all covered entity locations that will use 340B drugs in a written contract. The Notice Regarding 340B Drug Pricing Program — Contract Pharmacy Services (PDF - 166 KB) provides guidelines for the operation and compliance of contract pharmacies for 340B covered entities.

Guidelines for contract pharmacy services

Entity responsibilities

A contract pharmacy must be registered for the 340B Program and show as active in the 340B Office of Pharmacy Affairs Information System (OPAIS) before dispensing 340B drugs on a covered entity's behalf. A covered entity must ensure compliance of its contract pharmacy arrangement(s) with all 340B Program requirements.

Contract pharmacies must carve-out Medicaid (i.e., 340B drugs should not be dispensed to Medicaid patients), unless the covered entity has an arrangement with the state Medicaid agency to prevent duplicate discounts. The covered entity must report such arrangements to HRSA. The Checklist for Covered Entity Carve-In Request (DOCX - 90 KB) provides information to determine carve-in eligibility. Carve-in contract pharmacy requests should be sent to OPAexclusion@hrsa.gov. Responding to all of the items on the checklist will facilitate a smooth registration. We will review requests to carve-in. If a request is approved and listed in 340B OPAIS, the entity may begin to carve-in the contract pharmacy at the beginning of the next quarter.

Failure to list a contract pharmacy correctly in 340B OPAIS may result in its removal from the covered entity's 340B Program. HRSA reserves the right to request records, or check compliance at any time. Contact the 340B Prime Vendor Program (PVP) for more information about carving-in contract pharmacies.

Audit requirements

In order to fulfill the ongoing obligation of compliance, covered entities must:

• Provide oversight of their contract pharmacies
• Audit their contract pharmacies using an independent audit firm at least once a year
• Maintain records that we can audit
• Report non-compliance with 340B Program requirements to us at 340bselfdisclosure@hrsa.gov with plans to address the violation(s)

How to register a contract pharmacy

A covered entity that chooses to use a contract pharmacy must sign a written contract with the contract pharmacy. Then it must register the contract pharmacy in OPAIS during an open registration period.

A contract pharmacy must be listed with its correct name and address in 340B OPAIS. It may not participate in the 340B Program until we approve it and list it as active in 340B OPAIS.

Registration process for a contract pharmacy

• Set up the covered entity's Authorizing Official (AO) and Primary Contact (PC) account in 340B OPAIS. The AO and PC must enter or update 340B OPAIS records, perform recertification, or register additional entities and contract pharmacies. For more information on how to create a 340B OPAIS user account, visit 340B OPAIS and choose "help" in the upper right-hand corner of the page. To ensure that the AO and PC receive 340B OPAIS email notifications, add "noreply@hrsa.gov" to the email program's spam filter.
• Review the 340B OPAIS Online Help - Contract Pharmacies.
• Register the contract pharmacy online. The registration function is only available during these open registration periods: October 1 – 15, January 1 – 15, April 1 – 15, and July 1 – 15. If we approve, the contract pharmacy may begin giving out 340B drugs on the first day of the next quarter.
• Coordinate the registration of your contract pharmacy. First, the PC should create the contract pharmacy registration. Second, the AO receives an email notice to authorize and submit it to HRSA. The AO must finish this task within 15 calendar days from the online registration request. If the AO doesn't finish this task within 15 calendar days, the request will be cancelled and the covered entity will have to wait until the next open registration period to register the contract pharmacy. If the AO creates, authorizes, and submits the contract pharmacy registration, the AO and PC will receive notices.

Helpful tips:

• Be prepared to complete the registration in one session. Incomplete registrations cannot be saved for later submission. Only AOs and PCs can register contract pharmacies.
• Have the pharmacy's Drug Enforcement Agency (DEA) number and pharmacy address available.
• Be proactive if your contract pharmacy is changing ownership. Contact the PVP for technical assistance to ensure a smooth transition.
• Verify the contract pharmacy name and address listed in the contract pharmacy agreement match the information in the 340B OPAIS.
• Verify that your 340B OPAIS records about the contract pharmacy are up-to-date. A covered entity must ensure its information in 340B OPAIS is accurate.
• Notify us right away of any changes to your contract pharmacy arrangement.
• Use the "help" section in 340B OPAIS to access the user guides. You can contact the PVP for technical assistance before and during the registration period.