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Third Circuit Denies 340B Program Contract Pharmacy Arrangements


Wednesday, July 7, 2021
Recent court decisions and the subsequent rescission of a key advisory opinion have left the status of contract pharmacy programs in continued flux. On 30 December 2020, the Department of Health and Human Services (HHS) released Advisory Opinion 20-06 (the Advisory Opinion) stating that drug manufacturers are required to deliver drugs to contract pharmacies and charge no more than the 340B ceiling price. On 16 June 2021, the U.S. District Court for the District of Delaware issued a Memorandum Opinion (Decision) in 
AstraZeneca Pharmaceuticals LP v. Becerra, a case that challenged the validity of the Advisory Opinion, narrowly holding that Congress has not clearly and unambiguously spoken regarding the unlimited use of contract pharmacies by covered entities under the 340B Program. ....

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