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U.S. Supreme Court Sides with 340B Hospitals in Significant $1.6 Billion Part B Drug Payment Ruling

On June 15, 2022, after many years of ongoing litigation, the U.S. Supreme Court unanimously overturned a substantial Medicare Part B payment reduction to many 340B Program participating hospitals related to certain...more

FDA Publishes New Guidance on Compounding Animal Drugs from Bulk Drug Substances

The wait is finally over. On April 14, 2022, the Food and Drug Administration (FDA) published its guidance for industry #256 (GFI 256), describing FDA’s position on the legality of compounding animal drugs from bulk...more

Kentucky Board of Pharmacy Continues to Research and Review Proposed Non-Resident Pharmacy Permit Regulations

At the March 30, 2022 Kentucky Board of Pharmacy meeting, the Regulation Committee reported on its March 15 meeting where it discussed the new proposed non-resident pharmacy permit regulation. The Committee requested...more

Federal Spending Bill Offers Re-Enrollment Path for Some Hospitals

In a move welcomed by the growing number of hospitals forced out of the 340B Program due to falling disproportionate share hospital (DSH) adjustment percentages, Congress has passed a measure offering a chance to rejoin....more

Kentucky Board of Pharmacy Regulation Committee Proposes New Requirement of Licensure for All Out-of-State Pharmacists

On March 15, 2022, the Regulation Committee for the Kentucky Board of Pharmacy reviewed potential amendments and proposed regulations governing non-resident pharmacy licensure in the state. Among the proposed changes is a...more

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