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Hospitals › Outsourcing

BakerHostetler

FDA Clarifies Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act

BakerHostetler on

On June 27, 2023 the FDA published Prohibition on Wholesaling Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Draft Guidance for Industry. In this draft guidance, FDA provides examples of activities prohibited...more

Mintz - Health Care Viewpoints

OIG Report Finds a Small Percentage of Hospitals Do Not Obtain Compounded Drugs from FDA-Registered Outsourcing Facilities

Mintz - Health Care Viewpoints on

On June 6, 2019, the U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a report that found that, among a sample U.S. hospitals that obtained non-patient-specific (NPS) compounded drugs...more

Mintz - Health Care Viewpoints

New Compounding Policies from FDA May Affect Hospital and Health System Pharmacy Operations

Mintz - Health Care Viewpoints on

Last month, FDA released three draft guidance documents that are expected to have significant implications for traditional pharmacy-based compounding and the distribution of those drug products....more

King & Spalding

FDA Issues Three Draft Guidance Documents For Drug Compounders

King & Spalding on

On April 15, 2016, the U.S. Food and Drug Administration (“FDA”) issued three new draft guidance documents related to human drug compounding under the Food, Drug, and Cosmetic Act (“FD&C Act”), as amended by Title I of the...more

Foley & Lardner LLP

At The Intersection of New Bundled Payment Programs and New Discharge Rules: Private Equity Opportunities

Foley & Lardner LLP on

Recently, CMS has promulgated new bundled payment rules for Comprehensive Joint Replacement(CJR) that require the mandatory participation of approximately 800 hospitals across the US. This bundle includes not only the...more

Foley & Lardner LLP

Outsourcing Ambulatory and Outpatient Services: What Hospitals Need to Know

Foley & Lardner LLP on

We are in the midst of a trend involving the “outsourcing” of certain outpatient and ambulatory services by hospitals and health systems. These outsourcing transactions often involve partnerships with for-profit, specialty ...more

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