340B Manufacturer Update

Office of Pharmacy Affairs Update

The Health Resources and Services Administration (HRSA), Healthcare Systems Bureau (HSB), Office of Pharmacy Affairs (OPA) is providing an update to manufacturers participating in the 340B Drug Pricing Program (340B Program).

Accuracy of Information

Each manufacturer has a record in the 340B Office of Pharmacy Affairs Information System (OPAIS) that identifies the manufacturer’s participation in the 340B Program, along with important contact information. HRSA requests that each manufacturer immediately review their record and ensure its accuracy. Please review, verify, and submit any changes to the manufacturer’s record that are not accurate via an online change request. Instructions on how a manufacturer can manage their 340B records are located at https://www.hrsa.gov/opa/340b-opais/index.html. This information is used by HRSA and covered entities to contact manufacturers regarding important issues related to the 340B Program. For example, HRSA uses information in 340B OPAIS to initiate communication with manufacturers for updates to 340B OPAIS and other meaningful announcements that may affect manufacturer participation. In addition, accurate records allow covered entities and external stakeholders to maintain good faith discussions for questions or matters of concern.

Reporting Responsibilities

Until such time that the pricing component of 340B OPAIS is available, manufacturers are not required to submit quarterly pricing data to HRSA as stated in the Pharmaceutical Pricing Agreement, but may voluntarily do so by sending an email to 340bpricing@hrsa.gov. HRSA continues to make progress in its efforts to make the pricing system available to manufacturers and covered entities and we will provide details on the timelines and instructions for full implementation as we move forward. HRSA will complete its work on the system once final pricing policy is in place. Please stay tuned to our website for any updates related to the system. The pricing system will strengthen HRSA’s commitment to transparency and our ability to ensure manufacturer compliance with 340B requirements. Manufacturers may submit pricing, or pricing related questions, to 340bpricing@hrsa.gov. For technical assistance, or if you need further information, the 340B Prime Vendor Program is available at ApexusAnswers@340bpvp.com or by phone at 888-340-2787.

Date Last Reviewed:  August 2018