340B Registration Dates and Changes

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340B Registration Dates and Changes

Starting on October 1st we have new 340B registration rules from the OPA

New rules regarding registration for covered entities 340B entities, OP facilities, and contract pharmacies have been changed. This change begins with the October 1st submission. In the past, covered entities were able to submit 30 before the quarterly due date.

Federal Register /Vol. 77, No. 142 /Tuesday, July 24, 2012 /Notices 43343 correspondence issued by HRSA on the subject.

(A) Registration Period for New Covered Entities and for the Addition of Outpatient Facilities

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;
  • 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. For more information on what constitutes a complete package, visit the Office of Pharmacy Affairs (OPA) Web site at www.hrsa.gov/opa.

(B) Registration Period for Contract Pharmacies

The registration period for 340B Program registration of contract pharmacies 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;
  • 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. The contract pharmacy registration process is not complete unless the registration form has been completed in its entirety and the original, signed copy is received by OPA. Signed contract pharmacy registration forms are due to OPA within 15 days from the time online registration was completed. Incomplete packages will not be considered. For more information on what constitutes a complete package, visit the OPA Web site at www.hrsa.gov.opa.


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