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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.

During Initial Registration:
It is the Covered entity’s responsibility to pay close attention to all alerts during the registration process and upload necessary supporting documentation on the same day that the registration is submitted. Registrations may be rejected if supporting documentation is not submitted.

NOTE: A covered entity cannot register a contract pharmacy as a covered entity.

During OPA Review of Registration:
PLEASE NOTE: It is the entity’s responsibility to review the OPA reviewer comments each time a registration is sent back in OPAIS to determine if there are any items that require action for that particular registration.

If the entity is unable to act on the registration for any reason, please make a note in the review box and return it to OPA and explain the issue. Registrations returned without action will be rejected. OPA will not approve any registration if it is returned without a response from the entity.

Date Last Reviewed: