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.

See the complete list of eligible entities.

We require registration and approval for covered entities to participate in the 340B Program.

We limit the registration period for 340B Program registration of new covered entities and the addition of outpatient facilities 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.

If 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 the dates we list above except when the Secretary declares a Public Health Emergency.

In addition to the complete online registration, you must submit any required supporting documentation on the same day you complete online registration. We will not consider incomplete packages.

Grantee Registration

Hospital Registration

Date Last Reviewed:  August 2019