Section 340B(a)(4) of the Public Health Service Act (PHS) Act (42 U.S.C. 256b) lists the various types of organizations eligible to participate in and purchase discounted drugs under the 340B Program. For a complete list of eligible entities, visit the OPA Web site Eligibility Tab. Registration and approval are required for covered entities to participate in the 340B Program.

The registration period for 340B Program registration of new covered entities and the addition of outpatient facilities shall be limited to the following: January 1-January 15 for an effective start date of April 1; April 1-April 15 for an effective start date of July 1; July 1-July 15 for an effective start date of October 1; and October 1-October 15 for an effective start date of January 1.

In situations where the 15th falls on a Saturday, Sunday, or Federal holiday, the deadline will be the next business day. Covered entities will not be able to submit registrations outside of these date parameters listed above except when the Secretary has declared a Public Health Emergency. In addition to the complete on-line registration, any required supporting documentation must be submitted on the same day as on-line registration is completed. Incomplete packages will not be considered.

Grantee Registration

Hospital Registration

Date Last Reviewed:  April 2019