In order to comply with the ongoing obligation to comply, all covered entities are required to supervise the contract pharmacy, maintain verifiable records and conduct annual audits of their contract pharmacies by an independent accounting firm. Any compliance activity or audit performed by a registered entity that indicates a violation of the requirements of the 340B program must be disclosed to THE HRSA and include the company`s plan to remedy the violation. Affected companies that decide to use pharmacy contracts must register each contract pharmacy. The companies concerned must register online pharmacy contracts during a registration period opened after a written contract. Contract pharmacies should be listed with the correct names and addresses to avoid delays in implementation. Contract pharmacies cannot participate in the 340B program until they have been approved by the Bureau of Pharmaceutical Affairs and the contract pharmacy is not listed on the 340B OPAIS. Companies covered by 340B may choose to provide 340B drugs to patients through contract pharmacy services, an agreement in which the company covered by 340B signs a written contract with a pharmacy to provide pharmacy services. The use of a single contract pharmacy or several contract pharmacies is voluntary and a covered entity should first determine its pharmacy service needs and the appropriate distribution mechanism for those services when deciding whether or not to use a contract pharmacy. The written contract should identify all pharmacy locations and all covered business locations that use 340B drugs. HRSA recommends that the written agreement include all the essential elements of the Guidelines for Contract Pharmacies (75 Fed. Reg. 10272 (5 March 2010)).
Contract pharmacies must enroll in the 340B program and be enrolled in OPAIS 340B before dispensing 340B drugs on behalf of a covered company. The companies concerned are responsible for compliance with their pharmacy contract(s) with all the requirements of the 340B program. Contract pharmacies must outsource Medicaid (i.e., not use 340B drugs for Medicaid patients) unless the covered entity has an agreement with the state Medicaid agency to avoid double discounts. The covered company must notify hrsa of these agreements. The Covered Entity Acquisition Application Checklist contains information on how to determine the right to hatch. Requests for pharmacies under a cutting contract should be sent to OPAexclusion@hrsa.gov. Answering all the points on the checklist makes it easy to sign up smoothly. Outbreak applications will be reviewed by HRSA and, once approved and registered as an authentication option on the OPAIS 340B, the Company may begin training in contract pharmacies early in the next quarter.
Contact the 340B Prime Vendor Program (PVP) for more information on sculpture contract pharmacies. Failure to correctly register contract pharmacies in OPAIS 340B may be a reason for the withdrawal of contract pharmacies from the 340B program. HRSA reserves the right to request documents for clarification or to verify compliance at any time. Notice regarding the Drug Pricing Program 340B — Contract Pharmacy Services (PDF – 72.6 KB) are the guidelines that govern the operation and compliance of contract pharmacies for businesses covered by 340B.