The 340B Showdown: HRSA Proceeds Towards Enforcement Despite Litigation
FDA Law Blog
SEPTEMBER 29, 2021
Use of contract pharmacies ballooned after a guidance issued by HRSA in 2010 allowed covered entities to use multiple contract pharmacies to dispense drugs to covered entity patients. HRSA based its opinion on the statute and agency precedents over the last 25 years. see for example, this letter to Astra Zeneca).
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