FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

HHS Delays 340B Overcharging Penalties Until October

May 26, 2017

HHS has once again pushed back the effective date of its final rule instituting fines for drugmakers that overcharge for products under the 340B drug discount program.

The rule is now set to take effect Oct. 1.

The final rule, published in early January by the Health Resources and Services Administration, includes civil penalties of up to $5,000 for each time a 340B provider paid a manufacturer more than the established ceiling price for a single drug, regardless of the number of units. The penalty also applies to orders placed through wholesalers and distributors.

The 340B program enrolls safety-net medical providers and requires companies to offer outpatient drugs with discounts up to 50 percent.

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