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Office of Pharmacy Affairs Information System (OPAIS) Pharmaceutical Industry

Robinson+Cole Health Law Diagnosis

HRSA Confirms End of COVID Waiver of Advance Registration Requirement for Provider-Based Clinics

On September 27, 2023, the Health Resources and Services Administration (HRSA) issued a Notice in the Federal Register applicable to all 340B Program hospitals that formally ends a COVID-era waiver of the long-standing HRSA...more

Quarles & Brady LLP

HRSA Notice Provides Clarity on 340B Child Site Registration Requirements

Quarles & Brady LLP on

After months of relative uncertainty, the Health Resources and Services Administration (HRSA) published a Notice confirming the end to a COVID-19 pandemic-era flexibility that allowed unregistered child sites to utilize 340B...more

McDermott Will & Emery

HRSA Announces New Registration and Recertification Requirements for 340B Program

McDermott Will & Emery on

The Office of Pharmacy Affairs (OPA) of the Health Resources and Services Administration (HRSA) recently issued a new Program Update that includes new covered entity registration and recertification requirements, as well as...more

Baker Donelson

HRSA to Enforce 340B Program Oversight of Drug Manufacturers Next Year and Share 340B Ceiling Prices with Covered Entities

Baker Donelson on

Two recent announcements by the Health Resources and Services Administration (HRSA) highlight the agency's plans for increased oversight in the next year of drug manufacturers under the 340B drug pricing program and...more

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