FDA allowing small compounding pharmacies to supply hospitals

The FDA is temporarily allowing small compounding pharmacies to supply hospitals that aren't able to buy drugs from their usual manufacturers, STAT reported. 

Small compounding pharmacies are typically only authorized to compound drugs in small quantities for specific prescriptions. 

But hospitals have struggled to obtain drugs needed to put patients on ventilators, such as sedatives, anesthetics, painkillers and muscle relaxants. Orders for such drugs are being filled and shipped to hospitals just 53 percent of the time.

To ease shortages, the FDA now will allow small compounding pharmacies to make and sell the drugs to hospitals that can't buy them from their typical manufacturers. 

The FDA also began allowing outsourcing facilities to sell drugs to hospitals last week. 

Scott Brunner, head of the Alliance for Pharmacy Compounding, praised the FDA's decision, according to STAT

But Lee Rosebush, who represents the Outsourcing Facility Association, told STAT the move could hurt larger compounders and may put the public at risk because smaller compounders aren't held to the same quality standards as large outsourcing facilities. 

"This decision is as shocking as it is dangerous. At a time when American citizens are expecting the FDA to help protect them during this crisis, they just put them at higher risk," Mr. Rosebush told STAT.

Read the full article here.


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