340B covered entities may elect to dispense 340B drugs to patients through contract pharmacy services, an arrangement in which the 340B covered entity signs a written contract with a pharmacy to provide pharmacy services. The use of an individual contract pharmacy or multiple contract pharmacies is voluntary, and a covered entity should first determine its needs for pharmacy services and the appropriate distribution mechanism for those services when deciding whether or not to utilize a contract pharmacy. The written contract should identify all pharmacy locations and all covered entity locations that will use 340B Drugs. HRSA recommends that the written agreement include all essential elements of the contract pharmacy guidelines (75 Fed. Reg. 10272 (March 5, 2010)).
Guidelines for Contract Pharmacy Services
Notice Regarding 340B Drug Pricing Program — Contract Pharmacy Services (PDF - 268 KB) are the guidelines that govern the operation and compliance of contract pharmacies for 340B covered entities.
Contract pharmacies must register for the 340B Program and be listed as active on the 340B OPAIS prior to dispensing 340B drugs on a covered entity's behalf. Covered entities are responsible for ensuring compliance of their contract pharmacy arrangement(s) with all 340B Program requirements. Contract pharmacies must carve-out Medicaid (i.e., not use 340B drugs for Medicaid patients), unless the covered entity has an arrangement in place 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 - 53 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 in the checklist will facilitate a smooth registration. Carve-in requests will be reviewed by HRSA and once approved, and listed on the 340B OPAIS as carve-in, the entity may begin carving-in the contract pharmacies at the beginning of the next quarter. Contact the 340B Prime Vendor Program (PVP) for more information about carving-in contract pharmacies. Failure to list contract pharmacies correctly in the 340B OPAIS may be cause for removal of the contract pharmacies from the 340B Program. HRSA reserves the right to request documentation for clarification or check compliance at any time.
In order to fulfill the ongoing obligation of compliance, all covered entities are required to provide oversight of the contract pharmacy, maintain auditable records and are expected to conduct, at a minimum, annual audits of their contract pharmacies, completed by an independent auditing firm. Any compliance activity or audit performed by a covered entity that indicates a violation of 340B Program requirements should be disclosed to HRSA at firstname.lastname@example.org and include the entity’s plan to address the violation.
How to Register a Contract Pharmacy
Covered entities that elect to utilize contract pharmacy arrangements are required to register each contract pharmacy. Covered entities must register contract pharmacy arrangements online during an open registration period after a written contract is in place.
Contract pharmacies must be listed with correct names and addresses to avoid delays in implementation. Contract pharmacies may not participate in the 340B Program until approved by the Office of Pharmacy Affairs and the contract pharmacy is listed as active on the 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 have 340B OPAIS user accounts to enter 340B OPAIS records, perform recertification, update records or register additional entities or 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 “email@example.com” to the email program’s spam filter.
- Review the 340B OPAIS Online Help - Contract Pharmacies
- Register the contract pharmacy online. Please note that the registration function is only available during an open registration period. New registrations are accepted October 1-15, January 1-15, April 1-15 and July 1-15. If approved by OPA, the contract pharmacy may begin participating on the first day of the upcoming quarter.
- Coordinate registration of your contract pharmacy. If the PC creates the registration, the AO will receive email task notifications indicating there are contract pharmacy registrations to authorize and submit to HRSA. The AO must perform this task within 15 calendar days from the time the online registration request was submitted, or the arrangement will be cancelled and the entity will have to wait until the next open registration period to register the contract pharmacy. If the AO creates and submits the contract pharmacy registration, the AO and PC will be notified after the AO authorizes and submits the contract pharmacy registration to HRSA.
- 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.
- Know the pharmacy’s Drug Enforcement Agency (DEA) number and pharmacy address before beginning the registration process.
- Be proactive if your contract pharmacy is changing ownership. Contact the PVP for technical assistance to ensure a smooth transition.
- Verify that the contract pharmacy name and address listed in the contract pharmacy agreement match what is registered in 340B OPAIS.
- Verify that your 340B OPAIS records reflect the most up to date information about the contract pharmacy. It is the covered entity’s responsibility to ensure that covered entity 340B OPAIS information is current at all times.
- Please notify HRSA immediately if there are changes to your contract pharmacy arrangement.
- Utilize the “help” section in 340B OPAIS to access the user guides. You can also contact the PVP for technical assistance before and during the registration period. The PVP can answer questions prior to registration to help prepare for registration, and during registration if you need assistance.