March 4, 2010 – The long-awaited 340B multiple contract pharmacy guidelines have been issued by the Health Resources and Services Administration (HRSA) and will be published in the March 5 Federal Register. They will take effect on April 5.
The guidelines will permit 340B covered entities to contract with more than one outpatient pharmacy or to have both an in-house outpatient pharmacy and a contract pharmacy to provide outpatient pharmacy services. The Monitor is currently reviewing the guidelines and comparing them to the proposed version published on January 12, 2007. We will provide further details and analysis within the next few days.
At first glance, it appears that covered entities will be required to perform annual audits of their contract pharmacy arrangements and to recertify annually that the arrangements comply with 340B requirements and are accurately listed on the HRSA database. In addition, rather than allowing covered entities to contract with third parties which in turn have 340B-compliant agreements with contract pharmacies, it appears that the pharmacies must still have direct contracts with 340B providers. With respect to chain pharmacies, however, a covered entity may enter into one contract as long as each participating pharmacy location within the chain is listed in the contract and complies with the requirements.
The Pharmacy Services Support Center (PSSC) has announced that it and HRSA will be hosting an interactive webinar on the guidelines and that additional information on the webinar will be posted on the PSSC Web site and the Office of Pharmacy Affairs Web site.