Novartis sued HRSA yesterday to stop it from enforcing its interpretation of the 340B statute's contract pharmacy requirements, and from imposing civil monetary penalties against Novartis for alleged violations. | Shutterstock

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BREAKING: Novartis Sues HRSA in Defense of its 340B Contract Pharmacy Policy

Novartis Pharmaceuticals has sued the U.S. Health Resources and Services Administration (HRSA) over the agency’s May 17 letter telling the company its restrictions on 340B pricing to covered entities that use contract pharmacies are illegal.

Novartis told 340B Report late this afternoon it sued HRSA yesterday May 31 in U.S. District Court for the District of Columbia “to prevent the agency from enforcing its interpretation of the 340B statute, which Novartis believes is erroneous, and imposing civil monetary penalties (CMPs). We are confident that the Novartis 340B contract pharmacy policy is in full compliance with the 340B statute and all binding regulations.”

Novartis Pharmaceuticals has sued the U.S. Health Resources and Services Administration (HRSA) over the agency’s May 17 letter telling the company its restrictions on 340B pricing to covered entities that use contract pharmacies are illegal.

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