Tag Archives: HRSA

HRSA Establishes January 1, 2019 Effective Date for 340B Ceiling Price and Civil Monetary Penalty Rule

On November 30, 2018, the Department for Health and Human Services (“HHS”) Health Resources and Services Administration (“HRSA”) will publish its final rule to change the effective date for its 340B Drug Pricing Program ceiling price and manufacturer civil monetary penalty final rule to January 1, 2019.

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HRSA Finally Publishes Final Contract Pharmacy Guidelines For 340B Program

On March 5, 2010, the Health Resources and Services Administration (“HRSA”) published the final Contract Pharmacy Guidelines, nearly three years after the close of the comment period to its proposed guidelines.[1] The final guidelines now formally recognize the ability of a 340B covered entity to enter into a broader range of arrangements with contract pharmacies.

To what extent can covered entities enter agreements with contract pharmacies?

Prior to the issuance of these final guidelines, a covered entity was allowed to use only a single point of service for pharmacy such that it could not supplement an in-house pharmacy with a contract arrangement. Also, prior to the issuance of these final guidelines, a covered entity could only enter into an agreement with one contract pharmacy. A limited variety of other arrangements could be approved as Alternative Methods Demonstration Projects. These final guidelines now expand the types of permissible contract pharmacy arrangements. 

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