On July 24, 2012, the Health Resources and Services Administration, Office of Pharmacy Affairs (OPA) issued a Notice replacing the current registration deadlines for new 340B Drug Pricing Program (340B) covered entities and additions of outpatient facilities, and establishing new registration deadlines for contract pharmacy arrangements. Effective October 1, 2012, the deadline for registration of new covered entities and additions of outpatient facilities will be moved back from approximately 30 days before the start of each quarter to approximately 75 days before the start of each quarter. Rather than permitting registrations for new covered entities and additions of outpatient facilities at any time up to the first day of the last month in a quarter (to be effective the first day of the next quarter), OPA will now only accept registrations during a specified 15-day period for each quarter. Contract pharmacies, which are not currently subject to specified registration deadlines and may register on a rolling basis, will also be subject to the new registration periods beginning October 1, 2012. The new registration periods are as follows:
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In the Notice, OPA also states that all new enrollments and additions of outpatient facilities must be accompanied by a complete package of enrollment and supporting materials submitted via the online enrollment process on a single day during the registration period. Contract pharmacy registrations will not be considered complete until OPA has received an original, signed copy of the registration form. Registrations submitted with incomplete packages will not be considered.
These new registration deadlines reflect a significant change from the current policy. Entities that are contemplating 340B enrollment or addition of outpatient facilities or contract pharmacies after October 1, 2012 should be aware of the revised registration deadlines and limited period for submitting registration materials.